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Information Index: Trachea Transplants and Paolo Macchiarini, M.D.

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what's new [Response to nofication of allegation of scientific misconduct in 2012 poster presentation: see Notification of Appeal for Investigation of Scientific Misconduct RE: Poster Publication: First in Man Synthetic Nanofiber Trachea] Paolo Macchiarini Response to KI Case 2-3289_2016 2016-10-17 http://www.circare.org/info/pm/pm-reply-case2-3289_2016.pdf

Jed Johnson (Nanofiber Solutions, LLC Response to KI Case 2-3289_2016 2016-10-17 http://www.circare.org/info/pm/jj-reply-case2-3289_2016.pdf

Cover Letter, Petition for an Investigation of Research Misconduct RE: Tracheal Transplantation, Clinical Trial Protocol, Version A, February 5, 2012 by Dr. Macchiarini and Request to the Karolinska Institutet to Report to Competent Authorities of the Russian Federation 2016-12-15 http://www.circare.org/info/pm/coverletter-20161215.pdf

Petition for an Investigation of Research Misconduct RE: Tracheal Transplantation, Clinical Trial Protocol, Version A, February 5, 2012 by Dr. Macchiarini and Request to the Karolinska Institutet to Report to Competent Authorities of the Russian Federation 2016-12-15 http://www.circare.org/info/pm/petition-20161215.pdf

Tracheal Transplantation Clinical Trial Protocol Version A, Paolo Macchiarini, M.D., Ph.D. 2012-02-05 English version (2016-12-15) http://www.circare.org/info/pm/macchiarini-trachealtransplant-protocol-20120205.pdf

Russian language version, Tracheal Transplantation Clinical Trial Protocol, Version A 2012-02-05 http://www.circare.org/info/pm/plan_rus.pdf ; originally posted at http://regmedgrant.ksma.ru/files/2_Plan_rus.pdf

[Lancet 2008 bomb] The murky passage of the Clinic surgeon that caused the Nobel Institute scandal Carmen Jané el periódico 2016-09-12 http://bit.ly/2cS06WD

Central Ethical Review Board Expert Group for Misconduct in Research Statement Ref. no. 01-2016, 2016-09-06 Macchiarini et al., Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats. Nat Comm (2014;5:3562) http://www.circare.org/info/pm/O1-2016-statement-expert-group-for-misconduct-in-research-160906-eng.pdf

Does this suggest the Nat Comm paper was rejected by Nature Medicine? challenge met not. Reference 10. Sjoqvist S, Jungebluth P, Lim ML, et al. Tissue engineered esophagus- challenge met. (Nature Medicine, in revision), p. 13/14 Karolinska Institute Decision No. 2-3397/2013 Extension of Paolo Macchiarini's employment 2014-01-14 http://www.circare.org/info/pm/ki-macchiarini-prolongation.pdf

Notification of Appeal for Investigation of Scientific Misconduct RE: Poster Publication: First in Man Synthetic Nanofiber Trachea. Jed Johnson, Philipp Jungebluth, Paolo Macchiarini Nanofiber Solutions LLC, Columbus, Ohio, Karolinska Institutet, Stockholm, Sweden, Aug 2012. 2016-08-30 http://www.circare.org/info/pm/appeal-misconduct-20160830.pdf

National Science Foundation FOIA Response SBIR Phase 1: Development of a Tissue Engineered Trachea. Jed Johnson, Nanofiber Solutions Award 1315524 Final Project Report 2016-08-26 http://www.circare.org/info/pm/1315524-finalprojectreport.pdf

National Science Foundation FOIA Response SBIR Phase 1: Development of a Tissue Engineered Trachea. Jed Johnson, Nanofiber Solutions Award 1315524 Project Outcomes Report 2016-08-26 http://www.circare.org/info/pm/1315524-projectoutcomesreport.pdf

National Science Foundation FOIA Response SBIR Phase 1: Development of a Tissue Engineered Trachea. Jed Johnson, Nanofiber Solutions Award 1315524 Final Project Report Poster titled Development of a Tissue Engineered Trachea 2016-08-26 http://www.circare.org/info/pm/1315524-poster-tissueengineeredtrachea.pdf

SBIR Success Story Nanofiber Solutions 2013-12-19 [shows the trailer for SuperCells, i.e. the miracle in Krasnodar that wasn't] https://www.youtube.com/watch?v=hmFFhMo-YZo

Primers/Explainers

Macchiarini and Karolinska: the biomedical ethics meltdown. Leonid Schneider For Better Science Blog 2016-02-21: https://forbetterscience.wordpress.com/2016/02/21/macchiarini-and-karolinska-the-biomedical-ethics-meltdown/

Reading about embattled trachea surgeon Paolo Macchiarini? Here's what you need to know. Retraction Watch 2016-02-12: http://retractionwatch.com/2016/02/12/reading-about-embattled-trachea-surgeon-paolo-macchiarini-heres-what-you-need-to-know/

Stem cell hype in clinical tissue engineering of hollow organs Alexey Bersenev 2016-04-10 http://stemcellassays.com/2016/04/stem-cell-hype-in-clinical-tissue-engineering-of-hollow-organs/

Video

Pt. 1 Fatal Experiments: The Downfall of a Supersurgeon BBC4 Storyville (Star surgeon) http://www.bbc.co.uk/programmes/b080k2z4

The Experiments Pt. 1 Star surgeon English Language Transcript http://www.circare.org/info/pm/experiments-subtitles-pt1.pdf

Pt. 2 Fatal Experiments: The Downfall of a Supersurgeon BBC4 Storyville (Every surgeon has his graveyard) http://www.bbc.co.uk/programmes/b0813msd

The Experiments Pt. 2 Every surgeon has his graveyard English Language Transcript http://www.circare.org/info/pm/experiments-subtitles-pt2.pdf

Pt. 3 Fatal Experiments: The Downfall of a Supersurgeon BBC4 Storyville (The maze of truth) http://www.bbc.co.uk/programmes/b0813n4j

The Experiments Pt. 3 The maze of truth English Language Transcript http://www.circare.org/info/pm/experiments-subtitles-pt3.pdf

Swedish Television (SVT) Experimenten, Produced by Bosse Lindquist [ed.: don't be put off by the fact that it's in Swedish; the interviews with Dr. Macchiarini are in English as are others]

Introduction in English : http://www.svt.se/dokument-inifran/experimenten-in-english

The Experiments Additional Material [in English] : http://www.svt.se/dokument-inifran/did-paolo-macchiarini-describe-his-experiments-truthfully-in-his-scientific-articles

The Experiments Pt. 1 : http://www.svtplay.se/video/5848124/dokument-inifran-experimenten/dokument-inifran-experimenten-stjarnkirurgen

The Experiments Pt. 2 : http://www.svtplay.se/video/5990228/dokument-inifran-experimenten/dokument-inifran-experimenten-avsnitt-2

The Experiments Pt. 3 : http://www.svtplay.se/video/6123392/dokument-inifran-experimenten/dokument-inifran-experimenten-sanningens-labyrint

Macchiarini – stjärnkirurg till varje pris Swedish Television (SVT) May 2015 http://www.svt.se/ug/macchiarini-stjarnkirurg-till-varje-pris

Alexander Seifalian Future of Organ Development TEDMEDLive Talk Imperial College 2013-05-18 https://www.youtube.com/watch?v=DR4D24bDPaQ

Phillip Jungebluth From Bench to Beside (sic) … and Back to Bench University of St. Andrews TEDx Talk 2014 http://www.tedxuniversityofstandrews.com/talks/aihlqJOMtME/From-Bench-to-Beside----and-Back-to-Bench/

COMPLEMENT d'enquête : quand l'homme défie la nature 2014-10-30 [segment on Paolo Macchiarini begins at 7:32 NB Krasnodar trachea transplant patient Dmitri Onagda hospitalized post-transplant] https://www.youtube.com/watch?v=Q7Jw5JkciJk

Promo, k22 Film and Entertainment, Super Cells, Wolfram Giese, Director and Producer http://eurovisionshowcase.com/sites/default/files/public/attachments/programme/zdf-arte_supercells-treatment.pdf

Super Cells (documentary 52 minutes) https://www.youtube.com/watch?v=gMdP8b498Yo

Christopher Lyles' Story 2011-10-16 https://www.youtube.com/watch?v=UOacezn_FMQ

[Chris Lyles] Man Travels To Sweden For Life-Saving Trachea Operation WBAL TV 11 Baltimore 2012-02-03 https://www.youtube.com/watch?v=s61iE863jyw

Icelandic news program featuring Andemariam Beyene, first patient to receive a synthetic trachea from Dr. Macchiarini at Karolinska Institute Hospital [ed.: interviews with Mr. Beyene are in English] : https://www.youtube.com/watch?v=IOkk7wLIzE4

Medical Innovations: The world's first trachea transplant on a child Royal Society of Medicine 2010-07-10 [Martin Elliot, Paolo Macchiarini] https://videos.rsm.ac.uk/video/medical-innovations-the-world-s-first-trachea-transplant-on-a-child

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News

Macchiarini and his Russian megagrant Leonid Schneider For Better Science Blog 2017-01-10 https://forbetterscience.com/2017/01/10/macchiarini-and-his-russian-megagrant/

Macchiarini reported back: Accused of having misled the authorities Hewa Abdelzadeh Sveriges Radio 2017-01-05 http://tinyurl.com/heq577r

Nya anklagelser: Macchiarini lurade till sig ryska tillstånd Yvonne Åstrand Swedish Television 2017-01-05 http://www.svt.se/nyheter/lokalt/stockholm/nya-anklagelser-macchiarini-lurade-till-sig-ryska-tillstand

Scandal surgeon notified again Hewa Abdelzadeh Sveriges Radio 2017-01-05 [English courtesy of Google Translate] http://tinyurl.com/zdfswq3

Blue thread 2 Alla Astakhova Blog 2017-01-05 [English courtesy of Google Translate] http://tinyurl.com/hnvolg3

Bavarian court sentences me to prison if I dare repeat unwelcome facts of Walles trachea transplants Leonid Schneider For Better Science Blog 2017-01-03 https://forbetterscience.wordpress.com/2017/01/03/bavarian-court-sentences-me-to-prison-if-i-dare-repeat-unwelcome-facts-of-walles-trachea-transplants/

German Macchiarini—linked researchers Thorsten and Heike Walles bully blogger with libel threats to surpress information about their apparently irregular experimental transplant surgery Christian Munthe Philosophical Comment Blog 2017-01-04 http://philosophicalcomment.blogspot.se/2017/01/german-macchiarini-linked-researchers.html

New notification: Cover Letter, Petition for an Investigation of Research Misconduct RE: Tracheal Transplantation, Clinical Trial Protocol, Version A, February 5, 2012 by Dr. Macchiarini and Request to the Karolinska Institutet to Report to Competent Authorities of the Russian Federation 2016-12-15 http://www.circare.org/info/pm/coverletter-20161215.pdf

Petition for an Investigation of Research Misconduct RE: Tracheal Transplantation, Clinical Trial Protocol, Version A, February 5, 2012 by Dr. Macchiarini and Request to the Karolinska Institutet to Report to Competent Authorities of the Russian Federation 2016-12-15 http://www.circare.org/info/pm/petition-20161215.pdf

Tracheal Transplantation Clinical Trial Protocol Version A, Paolo Macchiarini, M.D., Ph.D. 2012-02-05 English version (2016-12-15) http://www.circare.org/info/pm/macchiarini-trachealtransplant-protocol-20120205.pdf

Russian language version, Tracheal Transplantation Clinical Trial Protocol, Version A 2012-02-05 http://www.circare.org/info/pm/plan_rus.pdf ; originally posted at http://regmedgrant.ksma.ru/files/2_Plan_rus.pdf

Yuletide Greetings from Jungebluth's lawyer Leonid Schneider For Better Science Blog 2016-12-27 https://forbetterscience.wordpress.com/2016/12/27/yuletide-greetings-from-jungebluths-lawyer/

Paolo Macchiarini speculations and facts Kazan Federal University 2016-12-25 [English translation courtesy of Microsoft Bing] http://bit.ly/2idMom3

Chernobyl Swedish Medicine found a job in Kazan Meduza 2016-12-22 [English courtesy of Google Translate] http://bit.ly/2inCrQf

Kazan University hired the doctor accused of murder Russian Telegraph 2016-12-22 [English courtesy of Google Translate] http://bit.ly/2ib2Ror

Birchall's trachea transplant trial at UCL suspended by health authorities Leonid Schneider For Better Science Blog 2016-12-21 https://forbetterscience.wordpress.com/2016/12/21/birchalls-trachea-transplant-trial-at-ucl-suspended-by-health-authorities/

Macchiarini, Jungebluth guilty of research fraud, KI demands retraction of Nature Communications paper Leonid Schneider For Better Science Blog 2016-12-20 https://forbetterscience.wordpress.com/2016/12/20/macchiarini-jungebluth-guilty-of-fraud-ki-demands-retraction-of-nature-communications-paper/

Karolinska in denial Johan Thyberg, Ph.D. For Better Science Blog 2016-12-19 https://forbetterscience.wordpress.com/2016/12/19/karolinska-in-denial-by-johan-thyberg/

Foreign professor suspected of manslaughter finds refuge at Kazan University Marina Yudkevich Kazan Evening News 2016-12-15 [English courtesy of Google Translate] http://tinyurl.com/znv7h8v

UK university launches inquiry into links to work of controversial surgeon Hannah Devlin The Guardian 2016-12-12 https://www.theguardian.com/science/2016/dec/12/leading-uk-university-launches-inquiry-into-links-with-work-of-controversial-surgeon-paolo-macchiarini

UCL launches special inquiry into regenerative medicine research UCL Press Release 2016-09-16 https://www.ucl.ac.uk/news/news-articles/0916/160916-special-inquiry-regenerative-medicine

Untangling forgotten tracheal transplants of Heike and Thorsten Walles, who set a lawyer upon me Leonid Schneider For Better Science Blog 2016-12-01 https://forbetterscience.wordpress.com/2016/12/10/untangling-forgotten-tracheal-transplants-of-heike-and-thorsten-walles-who-set-a-lawyer-upon-me/

Patients sacrificed management rewarded Anna Bäsén and Tomas Carlsson Expressen 2016-12-10 [English courtesy of Google Translate] http://tinyurl.com/zxzf3hx

Always take care of family no matter what Hanne Kjøller Expressen 2016-12-10 [English courtesy of Google Translate] http://tinyurl.com/hszgz8u

He was fired after scandal Expressen Anna Bäsén [English courtesy of Google Translate] http://tinyurl.com/jl2matw

KI criticized over cheating charges against whistleblower in Macchiarini-matter Läkartidningen Joakim Andersson 2016-12-08 [English courtesy of Google Translate] http://tinyurl.com/jstdmyn

Hannover thesis investigation and secret Heidelberg research of Philipp Jungebluth Leonid Schneider For Better Science Blog 2016-12-01 https://forbetterscience.wordpress.com/2016/12/01/hannover-thesis-investigation-and-secret-heidelberg-research-of-philipp-jungebluth/

Collapse of Biotrachea, or how Macchiarini's greed saved human lives Leonid Schneider For Better Science Blog 2016-11-16 https://forbetterscience.wordpress.com/2016/11/16/collapse-of-biotrachea-or-how-macchiarinis-greed-saved-human-lives/

2016 AAAS Kavli Science Journalism Awards In Depth Reporting Gold Award Bosse Lindquist, Johannes Hallbom, Johan Brõnstad, Anna Nordbeck, Jakob Larsson, Johannes Wahlström, and Emil Engerdahl. Swedish Public Television (SVT) The Experiments: The Star Surgeon 2016-11-16 http://sjawards.aaas.org/2016winners#tvgold

New Swedish legislation protects whistleblowers Gunhild Wallin Nordic Labor Journal 2016-11-16 http://www.nordiclabourjournal.org/i-fokus/in-focus-2016/collective-decision-making/article.2016-11-14.2173050896

Paolo Macchiarini: A Surgeon's Downfall — Could it Happen Here? Ed Fletcher HuffPo UK 2016-11-15 http://www.huffingtonpost.co.uk/ed-fletcher/paolo-macchiarini-a-surge_b_12979076.html

He risked everything to uncover the scandal Helena Ingman NWT.se [English courtesy of Google Translate] 2016-11-12 http://bit.ly/2gkn4KC

Surgeon under investigation after deaths Lisa Robinson WBAL TV Baltimore 2016-10-27 http://www.wbaltv.com/article/surgeon-under-investigation-after-deaths/7665564

Claudia's trachea Leonid Schneider For Better Science Blog 2016-11-02 https://forbetterscience.wordpress.com/2016/11/02/claudias-trachea/

La tráquea de Claudia Leonid Schneider Hipertextual 2016-10-27 [be patient, English language version coming soon] https://hipertextual.com/especiales/macchiarini-trasplante-traquea-claudia-castillo

Fatal experiments: a maverick surgeon strikes back Nell Frizell The Guardian 2016-10-25 https://www.theguardian.com/tv-and-radio/2016/oct/25/fatal-experiments-maverick-surgeon-paolo-macchiarini-strikes-back

Macchiarini strikes back Dagens Medicin 2016-10-20 http://bit.ly/2eVTFp8

Macchiarini strikes back Clas Svahn Dagens Nyheter 2016-10-20 http://bit.ly/2enu49y

Macchiarini paper in Nature journal earns expression of concern for data questions Retraction Watch Alison McCook 2016-10-14 http://retractionwatch.com/2016/10/14/macchiarini-paper-in-nature-earns-expression-of-concern-for-data-concerns/

Criticism is growing: some feel ashamed to work at Karolinska Fredrik Mellgren Svenska Dagbladet 2016-10-14 [English courtesy of Google Translate] http://bit.ly/2eciB8j

Whistleblower Macchiarini scandal may grow Läkartidningen Joakim Andersson 2016-10-12 http://bit.ly/2dyMXkV

Swedish Medical Society (Lakaresallskapet) Seminar 2016-10-11 https://www.youtube.com/watch?v=B7pYotdvrfY

ARW reveals: Ombudsman missed Macchiarini affair Academic Rights Watch 2016-10-09 http://bit.ly/2ekXmll

The newly found innocence of Paolo Macchiarini Leonid Schneider For Better Science Blog 2016-09-23 https://forbetterscience.wordpress.com/2016/09/23/the-newly-found-innocence-of-paolo-macchiarini/

Macchiarini, truth and science missing Alessio Gagioli Corriere Fiorentino 2016-09-23 [English courtesy of Google Translate] http://bit.ly/2dmMjaQ

No scam, Macchiarini acquitted Toscana Media News 2016-09-22 (Macchiarini living in Russia) http://bit.ly/2d3kAfn

Macchiarini's study passed examination in Barcelona Carl-Magnus Hake Dagens Medicin 2016-09-21 [English courtesy of Google Translate] http://bit.ly/2djTmDR

FRAUD SURGERY Commission concludes that Macchiarini's trachea transplant was successful La Vanguardia 2016-09-13 [English courtesy of Google Translate] http://bit.ly/2dgoeX2

Former hospital director on Macchiarini recruitment and KI Elizabeth Ohlin Läkartidningen 2016-09-21 [English courtesy of Google Translate] http://bit.ly/2cWNfo8

Clara Hellner Gumpert: The Karolinska Institute after the Macchiarini scandal BMJ Blog 2016-09-19 http://blogs.bmj.com/bmj/2016/09/19/clara-hellner-gumpert-the-karolinska-institute-after-the-macchiarini-scandal/

Business managers are forced to resign after Macchiarini scandal Charlotta Kjellberg and Isabelle Beckman Dagens Medicin 2016-09-16 http://bit.ly/2cCm7sF

Heart-Lung Foundation requires millions of KI Johan Zachrisson Winberg SVT 2016-09-15 http://www.svt.se/nyheter/inrikes/hjart-lungfonden-kraver-miljonbelopp-av-ki

Heart and Lung Foundation calls back the contributions to the scandal surgeon Paolo Macchiarini at the Karolinska Institute 2016-09-15 http://bit.ly/2cdumhA

Macchiarini's operations used in advertising Carl-Magnus Hake Dagens Medicin 2016-09-14 http://bit.ly/2cJctXi

The murky passage of the Clinic surgeon that caused the Nobel Institute scandal Carmen Jané el periódico 2016-09-12 http://bit.ly/2cS06WD

Meet the filmmakers who cracked open the case against star surgeon Macchiarini Alison McCook, Retraction Watch 2016-09-12 http://retractionwatch.com/2016/09/12/meet-the-filmmakers-who-cracked-open-the-case-against-star-surgeon-macchiarini/

[Lancet 2008 bomb] The murky passage of the Clinic surgeon that caused the scandal Nobel Institute Carmen Jané el perió 2016-09-12 http://bit.ly/2cS06WD

Macchiarini acolyte Philipp Jungebluth lost surgeon job in Heidelberg Leonid Scheider For Better Science Blog 2016-09-12 https://forbetterscience.wordpress.com/2016/09/12/macchiarini-acolyte-philipp-jungebluth-lost-surgeon-job-in-heidelberg/

Another one of Macchiarini's operations accused of cheating Carl-Magnus Hake Dagens Medicin 2016-09-12 http://bit.ly/2cEgUkr

Macchiarini and the bonfire of greed Leonid Scheider For Better Science Blog 2016-09-10 https://forbetterscience.wordpress.com/2016/09/10/macchiarini-and-the-bonfire-of-greed/

Paolo Macchiarini: A surgeon's downfall William Kremer BBC Magazine 2012-09-10 http://www.bbc.com/news/magazine-37311038

Panel finds misconduct in rat paper by star surgeon Paolo Macchiarini Gretchen Vogel Science 2016-09-09 http://www.sciencemag.org/news/2016/09/panel-finds-misconduct-rat-paper-star-surgeon-paolo-macchiarini

Central Ethical Review Board Expert Group for Misconduct in Research Statement Ref. no. 01-2016, 2016-09-06 Macchiarini et al., Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats. Nat Comm (2014;5:3562) http://www.circare.org/info/pm/O1-2016-statement-expert-group-for-misconduct-in-research-160906-eng.pdf

Related? Reference 10. Sjoqvist S, Jungebluth P, Lim ML, et al. Tissue engineered esophagus- challenge met. (Nature Medicine, in revision), p. 13/14 Karolinska Institute Decision No. 2-3397/2013 Extension of Paolo Macchiarini's employment 2014-01-14 http://www.circare.org/info/pm/ki-macchiarini-prolongation.pdf

Ethical reviewer: Macchiarini's research misleading The Local 2016-09-09 http://www.thelocal.se/20160909/swedish-ethical-reviewer-macchiarinis-research-misleading

KI: Macchiarini's co-authors suspended from animal research Carl-Magnus Hake Dagens Medicin 2016-09-09 [English translation courtesy of Google Translate] http://tinyurl.com/hb6p5oj

Doctor: we have been met with disbelief the whole way Expressen Michael Töpffer 2016-09-06 [English translation courtesy of Microsoft Translate] http://bit.ly/2cwUMZp

After the reports Macchiarini responds Anna Basen Expressen 2016-09-08 [English translation courtesy of Microsoft Translate] http://bit.ly/2cLYlNi

Biggest scandal in Swedish medicine touches Nobel Prize with two committee members asked to resign Travis M. Andrews Washington Post 2016-09-07 https://www.washingtonpost.com/news/morning-mix/wp/2016/09/07/biggest-scandal-in-swedish-medicine-touches-nobel-prize-as-two-committee-members-asked-to-resign/

Another scathing report causes more eminent heads to roll in the Macchiarini scandal Gretchen Vogel Science 2016-09-06 http://www.sciencemag.org/news/2016/09/another-scathing-report-causes-more-eminent-heads-roll-macchiarini-scandal

Macchiarini investigations outcome: the Karolinska Institutet Leonid Schneider For Better Science Blog 2016-09-05 [about half of KI report is available in machine translated in English] https://forbetterscience.wordpress.com/2016/09/05/macchiarini-investigations-outcome-the-karolinska-institutet/

Karolinska Institute and the Macchiarini Case English Language Summary 2016-09-05 http://www.circare.org/info/pm/ki-externalreportsumm.pdf Accessed on 2016-10-06 at http://ki.se/sites/default/files/karolinska_institutet_and_the_macchiarini_case_summary_in_english_and_swedish.pdf

Karolinska Institutet och Macchiarini-ärendet En extern granskning 2016-09-05 http://www.circare.org/info/pm/ki-externrep-swe.pdf Accessed on 2016-10-06 at http://ki.se/sites/default/files/karolinska_institutet_och_macchiariniarendet_en_extern_granskingrev.pdf

Karolinska Institute and the Macchiarini Case An external report 2016-09 English via Google Translate [no corrections, for recreational use, rely on the official Swedish version] http://bit.ly/2dkbRVR

Macchiarini Investigations: Karolinska University Hospital Leonid Schneider For Better Science Blog 2016-09-02 https://forbetterscience.wordpress.com/2016/09/02/macchiarini-investigations-outcome-karolinska-university-hospital/

In slippery eel's company Dagens Nyheter 2016-08-31 http://bit.ly/2durpGw

The Macchiarini Case investigation of the synthetic trachea transplantations at Karolinska University hospital 2016-08-31 [English language summary] http://www.circare.org/info/pm/macchiarini-case-summ-eng.pdf

The Macchiarini Case investigation of the synthetic trachea transplantations at Karolinska University hospital 2016-08-31 Google Translation into English - do not rely on this document http://www.circare.org/info/pm/fallet-macch-google-20160903.pdf

Fallet Macchiarini Utredning av verksamheten med transplantationer av syntetiska luftstrupar vid Karolinska Universitetssjukhuset 2016-08-31 [Swedish] http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/Fallet%20Macchiarini%20rapport.pdf

Panel: Swedish hospital should never have hired star surgeon Gretchen Vogel Science 2016-09-01 http://www.sciencemag.org/news/2016/09/panel-swedish-hospital-should-never-have-hired-star-surgeon

How UCL throat surgeon Martin Birchall misleads patients and tricks public funders For Better Science Blog Leonid Schneider 2016-08-25 https://forbetterscience.wordpress.com/2016/08/25/how-ucl-throat-surgeon-martin-birchall-misleads-patients-and-tricks-public-funders/

NICE! Visselblåsande läkare fick pris Daniel Rydén 2016-08-24 [KI physicians receive award from Swedish Surgical Society for courage and strength in reporting misconduct by Paolo Macchiarini] http://www.sydsvenskan.se/2016-08-24/visselblasande-lakare-fick-pris

Presentation av extern granskning av Macchiarini-ärendet Karolinska Institute Press Release 2016-08-24 [KI announcement of presentation of report of Macchiarini investigation on 5 Sept., 2016] http://news.cision.com/se/karolinska-institutet/r/presentation-av-extern-granskning-av-macchiarini-arendet,c2064780

After KI scandal: More reports research fraud Jani Pirttisalo Svenska Dagbladet 2016-08-10 [English courtesy of Google Translate] http://tinyurl.com/jed4hdr

Patient photographed without permission during Macchiarini's surgery Jani Pirttisalo Svenska Dagbladet 2016-07-07 [in English via Google translate] http://tinyurl.com/h9xcrqo

Brexiting out of EU research and patient rights Leonid Schneider For Better Science Blog 2016-06-30 https://forbetterscience.wordpress.com/2016/06/30/brexiting-out-of-eu-research-and-patient-rights/

Stem cell doc faces manslaughter charge over transplants Karl Ritter AP/CBS News 2016-06-22 http://www.cbsnews.com/news/sweden-stem-cell-paolo-macchiarini-involuntary-manslaughter-windpipe-transplant/

As Macchiarini Faces Charges, Biostage Forges Ahead With New Tech Ben Fidler Xconomy 2016-06-23 http://www.xconomy.com/boston/2016/06/23/as-macchiarini-faces-charges-biostage-forges-ahead-with-new-tech/

Macchiarini cheated patients The prosecutor asks two years and six months Valentina Marrota Corriere Fiorentino 2016-06-16 [English via Google translate] http://tinyurl.com/zlnfpbz

Attorney: Macchiarini has not acted alone Jani Pirttisalo Svenska Dagbladet 2016-06-22 [English via Google translate] http://tinyurl.com/zf3vp9u

Regenerating in Hannover, Part 1: how Macchiarini got ideas Leonid Schneider For Better Science Blog 2016-06-16 https://forbetterscience.wordpress.com/2016/06/16/regenerating-in-hannover-part-1-how-macchiarini-got-ideas/

The bloody doctor's companions Hanne Kjöller Dagens Nyheter 2016-05-31 [English via Google translate] http://tinyurl.com/z4qdp58

Notification of Suspected Research Misconduct by 4 Macchiarini whistleblowers Leonid Schneider For Better Science Blog 2016-05-23 https://forbetterscience.wordpress.com/2016/05/23/notification-of-suspected-research-misconduct-by-4-macchiarini-whistleblowers/

(Zhadyra Iglikova) The Forgotten patient Johannes Wahlstrom Filter 2016-05-20: [In English courtesy of Google translate] http://tinyurl.com/gp4hbj7
Wahlstrom obtained a letter written by Julia Tuulik to one of the producers of the Arte documentary SuperCells:
Everything is very, very bad with me. I have spent over six months in the hospital in Krasnodar. I have undergone over 30 surgeries under general anesthesia. Three weeks after the first operation was opened a purulent fistula my neck, and my neck rot since. I weigh 47 kg. I can barely walk. I have trouble breathing, and now I have no voice. And it smells so strongly of me that people backs away. The other patient stink same. Artificial trachea is just crap.
Unfortunately, Julia.

Macchiarini's victim fighting for her life Johannes Wahlstrom and Mattias Göransson 2016-05-19 [In English courtesy of Microsoft translator] http://www.microsofttranslator.com/bv.aspx?from=&to=en&a=http%3A%2F%2Fwww.aftonbladet.se%2Fkultur%2Farticle22849259.ab

We will be rescued by bodies from a test tube? Promo for Forecasts TV show Rus News Journal Undated: http://rusnewsjournal.com/2/59818/

The main result of the year – The first regenerative medicine surgery in Russia Maria Konovalenko Science for Life Extension Foundation 2010-12-30: https://mariakonovalenko.wordpress.com/2010/12/30/the-main-result-of-the-year-the-first-regenerative-medicine-surgery-in-russia/

International Videoconference Report 2012-02-16 [Krasnodar trachea transplant trial]: http://www.circare.org/info/pm/report_videoconf_eng.pdf
Possibilities of bioengineered tracheal transplantation for patients with diseases of upper airways were discussed during this online conference. … Specialists from National Research Centre of Surgery named after B.V. Petrovsky, Russian Academy of Medical Sciences, Moscow, presented case of the patient who had cadaveric tracheal transplant.

Bazarov D, Parshin V et al. CTS 2013 Congress Oral Communications 10 21.2 – Transplantation of a regenerative and cadaver trachea – novel technology in management of subtotal tracheal stenosis: long term results and lessons learned: https://www.tts.org/component/tts/?view=presentation&id=13624

Management of total cicatricial stenoses of a trachea by replacement of trachea produced by technologies of the regenerative medicine Parshin VD, Macchiarini P. et al. European Respiratory Journal 38 (Suppl 55) 2011-09-01: http://erj.ersjournals.com/content/38/Suppl_55/p3077

Macchiarini's patients, the real situation Leonid Schneider For Better Science Blog 2016-05-07 https://forbetterscience.wordpress.com/2016/05/07/macchiarinis-patients-the-real-situation/

(Paolo Macchiarini) The first big interview after the silence Läkartidningen Michael Lövtrup 2016-05-04 [in English courtesy of Google translate] http://tinyurl.com/hor6akl

Macchiarini: Karolinska knew all Prescilia Haddad SVT 2016-05-04 [text in English courtesy of Google translate; video interview in English] http://tinyurl.com/grfh396

The stem cell faith healers, or magic inside your bone marrow Leonid Schneider For Better Science Blog 2016-04-26 https://forbetterscience.wordpress.com/2016/04/26/the-stem-cell-faith-healers-or-magic-inside-your-bone-marrow/

California Stem Cell Research and a Super Doc: Inside a $4.4 Million Windpipe Grant at UC Davis David Jensen California Stem Cell Report 2016-04-22 http://californiastemcellreport.blogspot.mx/2016/04/california-stem-cell-research-and-super.html

Karolinska Institutet investigating new case involving researcher Paolo Macchiarini Karolinska Institute Press Release 2016-04-23 http://ki.se/en/news/karolinska-institutet-investigating-new-case-involving-researcher-paolo-macchiarini

Jungebluth P1, Holzgraefe B et al. Autologous Peripheral Blood Mononuclear Cells as Treatment in Refractory Acute Respiratory Distress Syndrome. Respiration. 2015;90(6):481-92. doi: 10.1159/000441799. Epub 2015 Nov 28. http://dx.doi.org/10.1159/000441799

Who ordered the attack on Russian Medicine? Yevgeny Yakovenko 2016-04-13 [in English courtesy of Google Translate] http://tinyurl.com/homlrso

Macchiarini and the tracheal regeneration scandal, by Pierre Delaere Leonid Schneider For Better Science 2016-04-02 https://forbetterscience.wordpress.com/2016/04/02/macchiarini-and-the-tracheal-regeneration-scandal-by-pierre-delaere/

Lancet issues expression of concern for 2011 Macchiarini paper Alison McCook Retraction Watch 2016-04-01 http://retractionwatch.com/2016/04/01/lancet-issues-expression-of-concern-for-2011-macchiarini-paper/

The Russian government has funded medical experiments on humans Yulia Kalinina MKRU 2016-03-31 [in English courtesy of Google Translate] http://tinyurl.com/zf7nmtb

Harvard Apparatus Regenerative Technology (HART) Changes Name to Biostage, Inc. (NASDAQ: BSTG) Harvard Apparatus Regenerative Technology, Inc. Press Release 2016-03-31 http://www.prnewswire.com/news-releases/harvard-apparatus-regenerative-technology-changes-name-to-biostage-inc-nasdaq-bstg-300243888.html

Macchiarini, Birchall, Seifalian and EU-funded human experimenting. Leonid Schneider For Better Science Blog 2016-03-27 https://forbetterscience.wordpress.com/2016/03/27/macchiarini-birchall-seifalian-and-eu-funded-human-experimenting/

Superstar doctor fired from Swedish institute over research lies Philip Oltermann The Guardian 2016-03-24 https://www.theguardian.com/science/2016/mar/23/superstar-doctor-fired-from-swedish-institute-over-research-lies-allegations-windpipe-surgery

Prestigious Karolinska Institute dismisses controversial trachea surgeon Alison Abbott Nature News 2016-03-23 http://www.nature.com/news/prestigious-karolinska-institute-dismisses-controversial-trachea-surgeon-1.19629

Italian surgeon fired from Swedish research institute Agence France-Presse Global Post 2016-03-23 http://www.globalpost.com/article/6750214/2016/03/23/italian-surgeon-fired-swedish-research-institute

Karolinska Institute fires fallen star surgeon Paolo Macchiarini Martin Enserink Science 2016-03-23 http://www.sciencemag.org/news/2016/03/karolinska-institute-fires-fallen-star-surgeon-paolo-macchiarini

Macchiarini dismissed from Karolinska Alison McCook Retraction Watch 2016-03-23 http://retractionwatch.com/2016/03/23/macchiarini-dismissed-from-karolinska/

Macchiarini's German (ex-)friends: Jungebluth and Bader Leonid Schneider For Better Science Blog 2016-03-15: https://forbetterscience.wordpress.com/2016/03/15/macchiarinis-german-ex-friends-jungebluth-and-bader/

Macchiarini, a verdict from Rome His transplants have been a failure Alessio Gaggioli, Giulio Gori (Translation by Brando de Leonardis) Corriere Fiorentino 2016-02-08: http://corrierefiorentino.corriere.it/firenze/notizie/cronaca/16_febbraio_08/macchiarini-verdict-from-rome-f4922444-ce73-11e5-84b6-e3afc18b58d6.shtml

In Toscana giudizi opposti, ma erano autocertificati Alessio Gaggioli and Giulio Gori Corriere Fiorentino 2016-02-07: (English translation courtesy of Google Translate): http://tinyurl.com/hj92t9o

Corriere Fiorentino search for Macchiarini: http://tinyurl.com/hj57y9r

Copy URL and use Google Translate

Help Rachael Breathe Facebook Update 2016-03-26: https://www.facebook.com/groups/198660840207194/permalink/1028665673873369

Avråddes från att opereras av Macchiarini svt Nyheter 2016-02-21 [translated from Swedish to English courtesy of Google Translate; story about U.S. citizen Rachael Phillips and how she was dissuaded from allowing Dr Macchiarini to perform a synthetic trachea transplant by a warning from a UK surgeon ] http://tinyurl.com/jz3zn8k

Fletcher Allen Has a Candidate for Groundbreaking Windpipe Transplant Seven Days Ken Picard 2011-08-03 http://www.sevendaysvt.com/vermont/fletcher-allen-has-a-candidate-for-groundbreaking-windpipe-transplant/Content?oid=2144010

$30M malpractice settlement against doctor who worked at Chicago hospitals Ameet Sachdev Chicago Tribune 2016-02-22: [Dr Mark Holterman worked with Paolo Macchiarini to perform synthetic trachea transplant on Hannah Warren at Illinois Children's Hospital] http://www.chicagotribune.com/business/ct-rush-medical-malpractice-settlement-0223-biz-20160222-story.html

Karolinska Institute has 'lost confidence in Paolo Macchiarini, says it won't renew his contract Gretchen Vogel Science News 2016-02-04: http://www.sciencemag.org/news/2016/02/karolinska-institute-has-lost-confidence-paolo-macchiarini-says-it-wont-renew-his

The Celebrity Surgeon Who Used Love, Money, and the Pope to Scam an NBC News Producer Adam Ciralsky Vanity Fair 2016-01-31: http://www.vanityfair.com/news/2016/01/celebrity-surgeon-nbc-news-producer-scam

New Probes for Mystery Surgeon Exposed by Vanity Fair Adam Ciralsky Vanity Fair 2016-02-05: http://www.vanityfair.com/news/2016/02/paolo-macchiarini-celebrity-surgeon-exposed-by-vanity-fair

Artificial-windpipe pioneer under scrutiny again David Cyranowski Nature News 2016-02-01 http://www.nature.com/news/artificial-windpipe-pioneer-under-scrutiny-again-1.19272

Investigations launched into artificial tracheas David Cyranowski Nature News 2014-11-28: http://www.nature.com/news/investigations-launched-into-artificial-tracheas-1.16431

Leading Surgeon Is Accused of Misconduct in Experimental Transplant Operations Henry Fountain New York Times 2014-11-24 http://www.nytimes.com/2014/11/25/world/leading-surgeon-is-accused-of-misconduct-in-experimental-transplant-operations.html

Trachea transplants test the limits Gretchen Vogel Science 2013;340(6130):266-268 (subscription required) http://science.sciencemag.org/content/340/6130/266

Russian Megagrant Report for the First Half-year 2014 [ed. what happened to the baby mentioned at the end of this report?] http://www.circare.org/info/pm/report_1st_half_2014.pdf

Synthetic Windpipe Transplant Boost For Tissue Engineering Ira Flatow NPR Science Friday 2012-01-20 [interview with Paolo Macchiarini, M.D.] http://www.npr.org/2012/01/20/145525008/synthetic-windpipe-transplant-boost-for-tissue-engineering

[UK patient S.D.] BBC2 Great Ormond Street Experimental Surgery Subtitles 2012-06-19: http://www.circare.org/info/pm/bbc2-subtitles-expersurg.pdf

Great Ormond Street: how far should surgeons push the boundaries? NPR RadioTimes 2012-06-19: http://www.radiotimes.com/news/2012-06-19/great-ormond-street-how-far-should-surgeons-push-the-boundaries

Great Ormond Street Hospital Trachea Service Procedures and treatments http://www.gosh.nhs.uk/health-professionals/clinical-specialties/tracheal-information-health-professionals/procedures-and-treatments

Family's tribute after shock heart attack claims teen Lindsey Sampson Gazette Live 2012-03-13: http://www.gazettelive.co.uk/news/local-news/familys-tribute-after-shock-heart-3675304

[Hannah Warren] Toddler who made history with trachea transplant dies at OSF St. Francis Pam Adams Peoria Journal Star 2013-07-08 http://www.pjstar.com/x606639034/Toddler-who-made-history-with-trachea-transplant-dies-at-OSF-St-Francis

Our View: Remembering Hannah Warren, who lit the way forward Peoria Journal Star 2013-07-08 http://www.pjstar.com/x1905493640/Our-View-Remembering-Hannah-Warren-who-lit-the-way-forward

Young Girl Given Bioengineered Windpipe Dies Henry Fountain New York Times 2013-07-07 http://www.nytimes.com/2013/07/08/science/young-girl-given-bioengineered-windpipe-dies.html

In Memory of Hannah Warren Kate Vassilyeva (2010-2013) 2015-01-21 http://xyzanswers.blogspot.com/2015/01/in-memory-of-hannah-warren-2010-2013.html

NBC special looks at experimental windpipe transplant performed at Children's Hospital Pam Adams Peoria Journal Star 2014-06-25 http://www.pjstar.com/article/20140625/NEWS/140629479

Help Hannah Breathe Hannah Warren GoFundMe https://www.giveforward.com/fundraiser/qbr

Toddler youngest in world to get lab-made windpipe in Peoria operation Pam Adams Peoria Journal Star 2013-05-01 http://www.pjstar.com/x1213307415/Toddler-youngest-in-world-to-get-lab-made-windpipe-in-Peoria-operation

Our View: A life-saving moment for Hannah, and a landmark for Peoria Peoria Journal Star 2013-05-01 http://www.pjstar.com/x1961184270/Our-View-A-life-saving-moment-for-Hannah-and-a-landmark-for-Peoria

Harvard Apparatus Regenerative Technology's InBreath Scaffold and Bioreactor Used in First U.S. Transplant of a Regenerated Trachea Harvard Bioscience Press Release 2013-04-30 http://investor.harvardbioscience.com/releasedetail.cfm?releaseid=760507

Trachea Transplant at Children's Hospital of Illinois Gives Korean Toddler New Windpipe Children's Hospital of Illinois Press Release 2013-04-30 http://www.childrenshospitalofillinois.org/trachea-surgery/press.html

Hannah's Story Children's Hospital of Illinois http://www.childrenshospitalofillinois.org/trachea-surgery/

[first mention of Hannah Warren, 9 mo] Making a trachea from scratch Thomas H. Maugh II Los Angeles Times 2011-07-11 http://articles.latimes.com/2011/jul/09/health/la-he-trachea-qandA-20110709

[Christopher Lyles] Synthetic Windpipe Is Used to Replace Cancerous One Henry Fountain New York Times 2012-01-12 http://www.nytimes.com/2012/01/13/health/research/surgeons-transplant-synthetic-trachea-in-baltimore-man.html

[Andemarian Beyene] A First: Organs Tailor-Made With Body's Own Cells Henry Fountain New York Times 2012-09-15 http://www.nytimes.com/2012/09/16/health/research/scientists-make-progress-in-tailor-made-organs.html

[UK and Careggi patient K.S.] British cancer girl saved by windpipe made from her own stem cells Jenny Hope Daily Mail 2010-08-04 http://www.dailymail.co.uk/health/article-1299877/British-cancer-girl-saved-windpipe-stem-cells.html

Tracey Hayter Fund Raising Page for CLIC Sargent https://www.justgiving.com/tracey-hayter/

The Experiments Pt. 1 36 minutes, interview with Martin Birchall: http://www.svt.se/dokument-inifran/se-program/dokument-inifran-experimenten-stjarnkirurgen

Funeral for Keziah Shorten packs out Tonbridge church Tonbridge Courier 2012-02-04 http://www.courier.co.uk/Funeral-Keziah-Shorten-packs-Tonbridge-church/story-15130657-detail/story.html

Trapianti Media Planet No. 1 Nov 2010 http://doc.mediaplanet.com/all_projects/6030.pdf

Alliance Medical IORT mobile service used in the first trachea transplant in the world with innovative technique Alliance Medical Press Release 2010-07-12 (Italian to English courtesy of Google Translate) http://tinyurl.com/jrjfcls

European Commission Community Research and Development Information Service (CORDIS) Biotrachea Project reference: 280584 Periodic Report Summary 1 http://cordis.europa.eu/result/rcn/141304_en.html
Due to an adverse effect of Intra-operative Radiotherapy (IORT) in a single patient this will not be continued clinically until it has been fully evaluated in pre-clinical models. A murine model has been established for this purpose.

[Italian patient Luigi] Kuban surgeons were the first in the world to cure a rare disease of the trachea Lina Beam 2014-07-06 [translation courtesy of Google Translate] http://tinyurl.com/z63v4m9

I was rescued by Macchiarini in Russia La Republica 2014-07-14 [in English via Google translate] http://tinyurl.com/hed5f9a

One surgeon, so many doubts Editorial Corriere Fiorentio 2014-11-27 [notes Careggi paid to send a patient to Krasnodar to be operated on my Paolo Macchiarini; translation courtesy of Google Translate] http://tinyurl.com/hd39g3w

[Barcelona patient Claudia Castillo] World's first stem cell transplant patient: 'My murdered brother and the professor's pigs gave me the strength to live' Jo MacFarlane and Tom Worden Daily Mail 2008-11-23 http://www.dailymail.co.uk/news/article-1088567/World-8217-s-stem-cell-transplant-patient-My-murdered-brother-sick-aunt-professors-pigs-gave-strength-live.html

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Publications

Editorial Expression of Concern: Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats Nature Communications 7, 13310 (2016) doi:10.1038/ncomms13310 2016-10-14 http://www.nature.com/articles/ncomms13310

Central Ethical Review Board Expert Group for Misconduct in Research Statement Ref. no. 01-2016, 2016-09-06 Macchiarini et al., Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats. Nat Comm (2014;5:3562) http://www.circare.org/info/pm/O1-2016-statement-expert-group-for-misconduct-in-research-160906-eng.pdf

Delaere PR, Van Raemdonck D. Tracheal replacement J Thorac Dis. 2016 Mar; 8(Suppl 2): S186–S196. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4775267/

Lowenthal J, Sugarman J. Ethics and Policy Issues for Stem Cell Research and Pulmonary Medicine Chest. 2015;147(3):824-834http://journal.publications.chestnet.org/article.aspx?articleid=2173430

Jaus MO, Gonfiotti A, Barale P, Macchiarini, P. Airway Remodeling: Preliminary Experience with Bio-Absorbable Airway Stents in Adults AATS Annual Meeting 2014 http://www.circare.org/info/pm/aats2014-slides.pdf

Delaere PR, Van Raemdonck D. The trachea: The first tissue-engineered organ? The Journal of Thoracic and Cardiovascular Surgery 2014;147:1128-32 http://dx.doi.org/10.1016/j.jtcvs.2013.12.024

Macchiarini P. Reply to the Editor The Journal of Thoracic and Cardiovascular Surgery 148; 1: 365 - 366 http://dx.doi.org/10.1016/j.jtcvs.2014.03.024

Delaere PR, Van Raemdonck D. Reply The Journal of Thoracic and Cardiovascular Surgery 148; 1: 366 http://dx.doi.org/10.1016/j.jtcvs.2014.03.044

Berg M, Ejnell H et al. Replacement of a tracheal stenosis with a tissue-engineered human trachea using autologous stem cells: a case report Tissue Eng Part A. 2014 Jan;20(1-2):389-97 https://www.researchgate.net/publication/256447916_Replacement_of_a_Tracheal_Stenosis_with_a_Tissue-Engineered_Human_Trachea_Using_Autologous_Stem_Cells_A_Case_Report

Bazarov D, Parshin V et al. CTS 2013 Congress Oral Communications 10 21.2 – Transplantation of a regenerative and cadaver trachea – novel technology in management of subtotal tracheal stenosis: long term results and lessons learned: https://www.tts.org/component/tts/?view=presentation&id=13624

Parshin VD, Macchiarini P. et al. Management of total cicatricial stenoses of a trachea by replacement of trachea produced by technologies of the regenerative medicine European Respiratory Journal 38 (Suppl 55) 2011-09-01: http://erj.ersjournals.com/content/38/Suppl_55/p3077

Polyakov I, Macchiarini P et al. P 213 Artificial Tracheo–Laryngeal Complex Transplantation in Patients with Tracheal Diseases. Early Results (A 6–Month Follow–up Period). Krasnodar (Russian Federation) Experience Interact CardioVasc Thorac Surg (2013) 17 (suppl 1): S55-S56 http://icvts.oxfordjournals.org/content/17/suppl_1/S55.4.abstract

Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study. Lancet 2011;378:1997-2004 https://www.researchgate.net/publication/51836588_Tracheobronchial_transplantation_with_a_stem-cell-seeded_bioartificial_nanocomposite_A_proof-of-concept_study

Correspondence Claesson-Welch L. Hansson GK. Tracheobronchial transplantation: The Royal Swedish Academy of Sciences' concerns Lancet 387:942, 5 March 2016 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2900520-1/fulltext

Correspondence Macchiarini P. Tracheobronchial transplantation Lancet 387: 339, 23 January 2016 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2900111-2/fulltext

Correspondence Hörnlund A. Clarification regarding ethical review of Paolo Macchiarini's research Lancet 387: 1816, April 30, 2016 http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(16)30320-8.pdf

Expression of concern –Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study The Lancet, 387 (2016) 1359. doi:10.1016/S0140-6736(16)30091-5 http://www.circare.org/info/pm/eoc-lancet-20160402.pdf

Partington L, Mordan NJ, Mason C, Knowles JC, Kim HW, Lowdell MW, Birchall MA, Wall IB. Lowdell MW, Birchall M, Thrasher AJ. Use of compassionate-case ATMP in preclinical data for clinical trial applications. Lancet. 2012 Jun 23;379(9834):2341. http://doi.org/f2ff94

Elliott MJ, De Coppi P, Speggiorin S, et al. Stem-cell-based, tissue engineered tracheal replacement in a child: a 2-year follow-up study. Lancet 2012;380:994-1000. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4487824/

Hamilton NJ et al. Tissue-Engineered Tracheal Replacement in a Child: A 4-Year Follow-Up Study Am J Transplant. 2015 Oct; 15(10): 2750–2757. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737133/

Jungebluth, Philipp A Potential Approach For Tracheal Reconstruction – Biotissue Engineering Of A Tracheal Tubular Graft Dissertation zur Erlangung des Doktorgrades der Medizin in der Medizinischen Hochschule Hannover 2010-06-10 (large file, slow to load) https://www.deutsche-digitale-bibliothek.de/binary/XE6O6BZRTAAYDTI72GQIU4OIUJICDYHJ/full/1.pdf

Macchiarini P. Trachea-guided generation: déjà vu all over again? J Thorac Cardiovasc Surg. 2004 Jul;128(1):14-6. http://www.jtcvsonline.org/article/S0022-5223(04)00086-8/pdf

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Russian Mega Grant Trachea Transplant Trial

Update 2016-05-20: the Mega Grant website has been moved to http://regmedgrant.ksma.ru/index.php?id=4&lang=eng after the regmedgrant.com domain registration expired.

Agreement No. 11. G34.31.0065 between the Ministry of education and science of the Russian Federation, a Russian institution of higher learning, and a leading scientist providing a scientific research project on the provision of a monetary grant of the Government of the Russian Federation designed to support research projects implemented by leading scientists at Russian institutions of higher learning (Russian) http://www.circare.org/info/pm/mgagrmt-rus.pdf

Agreement No. 11. G34.31.0065 between the Ministry of education and science of the Russian Federation, a Russian institution of higher learning, and a leading scientist providing a scientific research project on the provision of a monetary grant of the Government of the Russian Federation designed to support research projects implemented by leading scientists at Russian institutions of higher learning (English) http://www.circare.org/info/pm/mgagrmt-eng.pdf

Ministry of Education and Science of the Russian Federation Science and technologies Department. Prolongation of research project. Signed by Deputy head of the department A.O Ladniy, Jan 24, 2014 http://www.circare.org/info/pm/mgext-20140124-eng.pdf

The patients were discharged after first bioartificial stem-cell based laryngo-tracheal transplantation. Krasnodar Regional Hospital Mega Grant Press Release 2012-06-18 http://www.circare.org/info/pm/megagrant-pr-20120618.pdf

Mega Grant Tracheal Transplantation (research plan) Version A. Paolo Macchiarini, Leading Scientist 2012-02-05 [in Russian] http://www.circare.org/info/pm/plan_rus.pdf Accessed on 2016-09-25 at http://regmedgrant.ksma.ru/files/2_Plan_rus.pdf

Resolution of the Ethical Commission Protocol No. 8, Clinical trial protocol Trachea transplantation: the use of synthetic bioengineered scaffold, manufactured on the basis of polymeric fiber and seeded with autologous mononuclear cells. Paolo Macchiarini, Leading scientist. Kuban State Medical University Ethical Commission 2011-12-21 http://www.circare.org/info/pm/protocol8.pdf Accessed on 2016-09-25 at http://regmedgrant.ksma.ru/files/protocol8.pdf

Resolution of the Ethical Commission Protocol No. 9, Revised clinical trial protocol Tracheal transplantation (research plan) Version A. Paolo Macchiarini, Leading scientist. Kuban State Medical University Ethical Commission 2012-02-15 http://www.circare.org/info/pm/protocol9.pdf Accessed on 2016-09-25 at http://regmedgrant.ksma.ru/files/protocol9.pdf

Resolution of the Ethical Commission Protocol No. 11. Revised clinical trial protocol Tracheal transplantation (research plan) Version A (2012-02-05), alteration of the composition of tracheal matrix (PET and PU 50/50) for better compliance to physical characteristics and measures of human trachea and compatibility with protheses, created for the patient. Paolo Macchiarini, Leading scientist. Kuban State Medical University Ethical Commission 2012-05-29 http://www.circare.org/info/pm/protocol11.pdf Accessed on 2016-09-25 at http://regmedgrant.ksma.ru/files/protocol11.pdf

Local Ethics Committee under State Budget Institution of Public Health Department Regional Clinical Hospital No. 1 after Prof. S.V. Ochapovsky Protocol No. 45 (abstract) Clinical trial replacement of trachea, using a synthetic bioengineered scaffold seeded with autologous mononuclear cells, Paolo Macchiarini, Leading scientist. 2012-01-24 http://www.circare.org/info/pm/protocol45.pdf Accessed on 2016-09-25 at http://regmedgrant.ksma.ru/files/protocol45.pdf

Local Ethics Committee under State Budget Institution of Public Health Department Regional Clinical Hospital No. 1 after Prof. S.V. Ochapovsky Protocol No. 49 (abstract). Revisions to clinical trial replacement of trachea, using a synthetic bioengineered scaffold seeded with autologous mononuclear cells, Paolo Macchiarini, Leading scientist. 2012-05-31 http://www.circare.org/info/pm/protocol49.pdf Accessed on 2016-09-25 at http://regmedgrant.ksma.ru/files/protocol49.pdf

CV of Paolo Macchiarini, Leading Scientist 2011-09-14 http://www.circare.org/info/pm/CV_eng.pdf Accessed on 2016-09-25 at: http://regmedgrant.ksma.ru/files/CV_eng.pdf

Russian Megagrant Report for the First Half-year 2014 [ed. what happened to the baby mentioned at the end of this report?] http://www.circare.org/info/pm/report_1st_half_2014.pdf

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Documents Karolinska Institute Misconduct

Karolinska Institute physicians' request for investigation of allegations of scientific misconduct by Paolo Macchiarini, M.D. 2014-08-18: http://retractionwatch.com/wp-content/uploads/2014/12/Letter-to-Prof-Hamsten.pdf

Analysis of 6 papers of Paolo Macchiarini: http://retractionwatch.com/wp-content/uploads/2014/12/Analysis-of-Clinical-Outcome-of-Synthetic-Tracheal-Transplantation.pdf

Appendices 1-10: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-1-10.pdf

Appendices 11-20: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-11-20-review-article.pdf

Appendices 21-30: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-21-30.pdf

Appendices 31-40: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-31-40.pdf

Appendices 41-50: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-41-54.pdf

Karolinska Institute physicians' amendment to request for investigation of allegations of scientific misconduct by Paolo Macchiarini, M.D. 2014-09-24: http://www.circare.org/info/pm/web-amendment-to-formal-appeal-24sep2014-2.pdf

Tables 1 – 3 : http://www.circare.org/info/pm/web-amendment-tables-1-3-24sep2014.pdf

Amendment Appendices 1-10: http://www.circare.org/info/pm/web-appendix-amendment-1-10.pdf

Amendment Appendices 11-19: http://www.circare.org/info/pm/web-appendix-amendment-11-19.pdf

Purported consent form signed by Mr. Andemariam Beyene (patient 1): http://www.circare.org/info/pm/beyene-consent.pdf

Swedish Medical Products Agency Police Report re: synthetic trachea transplants performed by Paolo Macchiarini, M.D. at Karolinska University Hospital 2015-04-09 [in Swedish; select all, copy and paste into Google translate] http://www.circare.org/info/pm/mpa-pm-20150409.pdf

English translation of KI external investigator Bengt Gerdin re: Final Report, allegations of misconduct by Paolo Macchiarini 2015-05-13: http://www.circare.org/info/pm/gerdin-finalrpt-20150513.pdf

Paolo Macchiarini reply to KI physicians' allegations of misconduct 2015-04-06: http://www.svt.se/svts/article2971402.svt/binary/PM%20yttrande%20i%20april..pdf

Paolo Macchiarini reply to allegations of scientific misconduct 2015-06-26: http://www.circare.org/info/pm/si-Paolo Macchiarini response.pdf

Drs. Cengiz Gebiteken and Adnan Sayr to Niels Lynöe, KI Ethics Council, regarding allegations of scientific misconduct against Paolo Macchiarini 2015-01-27 http://www.circare.org/info/pm/gebitekin-sayr-20150127.pdf

Karolinska University Hospital Macchiarini Case Investigation, p. 50 (about Yesim Cetir)
Facts 3. Description of the process for Patient 3
The third patient is a 22 year old woman from Turkey. At a sweat surgery in July 2011 in Turkey damaged her windpipe. They tried unsuccessfully to repair the damage by sewing, resistant, and put a flap of chest muscle. After being assessed for a synthetic trachea transplantation in March 2012, she checked in at the Karolinska University Hospital July 23, 2012. Her condition was assessed as being stable, but she suffered from recurrent cough. She was not assessed at any journaled multidisciplinary conference. It should be noted that two Turkish professors in Thoracic Surgery has certified that they participated in a multidisciplinary meeting before operations [3]. We do not have been able to identify the exact circumstances of this meeting.

ref. 3 = Certification from Professor Cengiz Gebiteken, Bursa, and Professor Adnan Sayar, Istanbul, to Professor Niels Lynöe, president of KI Ethics, above. See below for Karolinska University Hospital Macchiarini Case Investigation

The Macchiarini Case investigation of the synthetic trachea transplantations at Karolinska University hospital 2016-08-31 [English language summary] http://www.circare.org/info/pm/macchiarini-case-summ-eng.pdf

The Macchiarini Case investigation of the synthetic trachea transplantations at Karolinska University hospital 2016-08-31 Google Translation into English - do not rely on this document http://www.circare.org/info/pm/fallet-macch-google-20160903.pdf

Fallet Macchiarini Utredning av verksamheten med transplantationer av syntetiska luftstrupar vid Karolinska Universitetssjukhuset 2016-08-31 [Swedish] http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/Fallet%20Macchiarini%20rapport.pdf

Ola Hermanson Comments and clarifications regarding the allegations against Jungebluth et al. Lancet. 2011 2015-06-29 http://www.circare.org/info/pm/hermanson-20150629.pdf

Karolinska Institute physicians' response to Macchiarini's reply 2015-05-07 http://www.circare.org/info/pm/Response-from-four.pdf

Karolinska Institute Decision, Suspected Scientific Misconduct in the Case of Professor Paolo Macchiarini Ref. 2-2184/2014 2015-08-28: http://ki.se/sites/default/files/decision_2_2-2184-2014.pdf

Karolinska Institute Decision, Suspected Scientific Misconduct in the Case of Professor Paolo Macchiarini Ref. 2-2184/2014 2015-08-28: [falsification in rat esophagus paper] http://ki.se/sites/default/files/desicion_1_2-2184-2014.pdf

Letter from Professor Bengt Gerdin to KI Vice Chancellor Anders Hamsten re: bizarre handling of allegations of scientific misconduct against Paolo Macchiarini 2015-12-21 http://www.circare.org/info/pm/gerdin-hamsten-20151221.pdf

Gerdin, B. Mina perspektiv på det slutliga beslutet 2015-12-21 http://www.circare.org/info/pm/gerdin-perspektiv20151221.pdf

Karolinska Institute Investigation of CV of Paolo Macchiarini 2016-02-16http://ki.se/sites/default/files/investigation_of_cv.pdf

Paolo Macchiarini CV 2011-09-14 http://www.circare.org/info/pm/CV_eng.pdf [Obtained 2016-03-24 from the Russian Mega Grant website at: http://www.regmedgrant.com/files/CV_eng.pdf]

Paolo Macchiarini, M.D., Ph.D., Karolinska Institute job application 2014-08-06 http://www.circare.org/info/pm/pm-kijobapplic-2014-Dnr 2-1097-2014.pdf

Li Felländer-Tsai Letter to Enrico Rossi re: Paolo Macchiarini bad press 2010-09-12 http://www.circare.org/info/pm/tsai-rossi.pdf

Paolo Macchiarini, M.D. Visiting Physician Permit Application File Illinois Department of Financial and Professional Regulation 2012-2013 [Hannah Warren's trachea transplant at Children's Hospital of Illinois] http://www.circare.org/info/pm/pm-idfpr-applic.pdf

Lucca Medica 2012-11-05 pp. 9-10 http://www.circare.org/info/pm/http://www.circare.org/info/pm/luccamedica-20121105.pdf

KI Vice Chancellor's Letter to the Professors, Karolinska Institute re: Paolo Macchiarini, M.D. and unethical research 2016-01-26 [in the wake of Experimenten] http://www.circare.org/info/pm/vice-chancellors_letter_to_the_professors_160126.pdf

In the second episode of Dokument inifrån, it was mentioned that Karolinska in Stockholm had helped with the final selection [of patients to receive surgery in Russia]. This is information that the documentary makers obtained from the Russian project's website. There are memoranda from an international video conference that took place in February 2012, attended by a number of employees of KI and Karolinska University Hospital. The Swedish participants have a completely different view. According to them, the purpose was to try to see if it was possible to meet over continents with the aid of video technology (in this case Russia, Sweden, Italy and the USA). At this video conference, experiences from previous and current patient cases were shared, which is also the view that emerges when going through the memoranda from the meeting. The claim that patients would have been selected for transplantation in Russia in this context is something that the Swedish participants do not confirm. This was also the only video conference arranged as it was established that the current technology did not enable the displaying of x-ray images, for example.

Vice Chancellor Hamsten is referring to this document: International Videoconference Report 2012-02-16: http://www.circare.org/info/pm/report_videoconf_eng.pdf

Imaging looks fine here: http://regmedgrant.ksma.ru/pict/foto7_7.jpg Yes, this is the videoconference, see smaller image here: http://regmedgrant.ksma.ru/pict/videoconf.jpg

This is KI's response to reports of Paolo Macchiarini's arrest during investigation of allegations he demanded large sums of money from vulnerable severely ill patients to operate on them in private clinics, falsely claiming operations couldn't be done for free in timely manner. By the way suspected criminal conduct is not mainly matters of healthcare administration, rather it goes to the heart of a phyician's duty to put his patients' welfare before his own interests:
KI monitors Italian legal case Karolinska Institute Press Release 2012-09-28 http://ki.se/en/news/ki-monitors-italian-legal-case
It has been reported in the Swedish and international media that an employee of Karolinska Institutet is suspected of criminal conduct in Italy. The KI management is monitoring developments in the case - which mainly concerns matters of healthcare administration - but is taking no further action for the time being.
At present we have no reason at all to doubt our colleague or the research he does here, says university director Bengt Norrving. We're in regular touch with him and are keeping a watchful eye on how the legal case against him in Italy unfolds.

[vile KI rubbish] Synthetic trachea save (sic) the lives of dying patients Annika Lund Karolinska Institute Medical Science 2013 https://issuu.com/karolinska_institutet/docs/medical_science_2013/42

Letter to Anders Hamsten et al. RE: A New Investigation of Misconduct in Research on Artificial Tracheae Drs. Corbascio, Grinnemo, Simonson, and Fux 2016-02-05: http://www.sjukhuslakaren.se/visselblasande-kirurgernas-egna-ord-om-kis-agerande/#svpol%23Macchiarini%23KIgate

The Macchiarini case: New document from the whistleblowers Sjukhusvärlden 2016-03-04 [in English] http://www.sjukhuslakaren.se/the-macchiarini-case-new-document-from-the-whistleblowers/

Notification of Suspected Research Misconduct RE: Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study (Dnr 2-2184/2014) submitted to Karolinska Institutet on 2016-05-09 http://www.circare.org/info/pm/notification-20150509.pdf

Letter to the Vice-Chancellor Karin Dahlman-Wright RE: 2-723/2016 Suspicion of Scientific Misconduct, submitted to Karolinska Institutet on 2016-03-03 (Dnr 2-2184/2014) http://www.circare.org/info/pm/notification-20160303.pdf

Appendix 1, Letter to the Vice-Chancellor Karin Dahlman-Wright RE: 2-723/2016 Suspicion of Scientific Misconduct, submitted to Karolinska Institutet on 2016-03-03 (Dnr 2-2184/2014) http://www.circare.org/info/pm/notification-appendix1-20160303.pdf

[This notification number 5 in case anyone is counting ] Notification of Suspected Research Misconduct, by 4 Macchiarini-whistleblowers Leonid Schneider For Better Science Blog 2016-05-23 https://forbetterscience.wordpress.com/2016/05/23/notification-of-suspected-research-misconduct-by-4-macchiarini-whistleblowers/

(No. 6) Notification of Appeal for Investigation of Scientific Misconduct RE: Poster Publication: First in Man Synthetic Nanofiber Trachea. Jed Johnson, Philipp Jungebluth, Paolo Macchiarini Nanofiber Solutions LLC, Columbus, Ohio, Karolinska Institutet, Stockholm, Sweden, Aug 2012. 2016-08-30 http://www.circare.org/info/pm/appeal-misconduct-20160830.pdf

Central Ethical Review Board Expert Group for Misconduct in Research Statement Ref. no. 01-2016, 2016-09-06 Macchiarini et al., Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats. Nat Comm (2014;5:3562) http://www.circare.org/info/pm/O1-2016-statement-expert-group-for-misconduct-in-research-160906-eng.pdf

Eva Ekblad, Ph.D. CEPN Review Assignment 0-2016 2016-07-09 http://www.circare.org/info/pm/ekblad-review-01-2016-20160709.pdf

Does this suggest the Nat Comm paper was rejected by Nature Medicine? challenge met not. Reference 10. Sjoqvist S, Jungebluth P, Lim ML, et al. Tissue engineered esophagus- challenge met. (Nature Medicine, in revision), p. 13/14 Karolinska Institute Decision No. 2-3397/2013 Extension of Paolo Macchiarini's employment 2014-01-14 http://www.circare.org/info/pm/ki-macchiarini-prolongation.pdf

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Harvard Bioscience Inc., and Harvard Harvard Apparatus Regenerative Technology, Inc. (HART)

HART — Harvard Apparatus Gains Recognition on Regenerated Technology 2015-04-29 HART CEO David Green explains it all: how the rotating bioreactor is like a uterus ... https://www.youtube.com/watch?v=60FC8785U34

Note: Harvard Apparatus Regenerative Technology, Inc. (HART) was a subsidiary of Harvard Bioscience, Inc. until November 2013 when it was spun off as an independent public company. Harvard Bioscience CEO David Green resigned to become the CEO of HART. According to SEC filings HART's Initial Public Offering was originally set for December 2012 but was withdrawn and re-filed, becoming effective in November 2013. On 2016-03-31 HART changed its name to Biostage, Inc.

NASDAQ Biostage 33 Month Stock Price Chart http://tinyurl.com/hfkb9ud

NASDAQ Harvard Bioscience 6 Year Stock Price Chart http://tinyurl.com/zopa2w4

David Green, former CEO of Harvard Bioscience and HART salary and compensation 2015 http://www1.salary.com/David-Green-Salary-Bonus-Stock-Options-for-BIOSTAGE-INC.html

[Good for background] Regenerating Organs for Transplant interview with David Green undated https://www.mfoundation.org/blog/interviews/regenerating-organs-for-transplant/

Harvard Bioscience Inc., Regenerative Medicine [index of news, videos, and publications] http://web.archive.org/web/20131207182006/http://www.harvardbioscience.com/regenMed.cfm

Harvard Bioscience Inc. Global Companies http://www.harvardbioscience.com/about-us/global-sites/

World's First Synthetic Nanofiber Trachea Transplant Nanofiber Solutions, Inc. and Harvard Bioscience Inc. [Andemarian Beyene transplant at Karolinksa University Hospital on 2011-06-09] https://www.youtube.com/watch?v=9raYqEPYx9w

[Chris Lyles, transplant at KUS 2011-11-17] Harvard Bioscience's InBreath Bioreactor Used in World's Second Successful Synthetic Trachea Transplant Harvard Bioscience Press Release 2011-11-29 http://investor.harvardbioscience.com/releasedetail.cfm?releaseid=627663

Video: Lyles Transplant Final Draft for Release Harvard Apparatus Nov 23, 2011 (formerly posted on Vimeo) http://www.circare.org/info/pm/Lyles Transplant Final Draft for Release Harvard Apparatus Nov 23, 2011.mp4

[In 2013 Harvard Bioscience began manufacturing its own synthetic trachea scaffold, ending its relationship with NanoFiber Solutions, Inc., which manufactured the synthetic trachea scaffolds for patients C.L and Y.C. at Karolinksa Institute and J.T and A.Z. in Krasnodar] OSU spinoff Nanofiber back-burners IP fight with Harvard Bioscience Carrie Ghose Columbus Biz Insider 2014-01-07 http://www.bizjournals.com/columbus/blog/2014/01/osu-spinoff-nanofiber-back-burners-ip.html

Harvard Bioscience's InBreath Bioreactors Used in World's First Successful Regenerated Laryngotracheal Transplants (NASDAQ:HBIO) Harvard Bioscience Press Release 2012-06-26 Harvard Bioscience Press Release 2012-06-26 http://www.circare.org/info/pm/hbio-pr-20120626.pdf

Harvard Bioscience Inc. Investor Presentation 2012-08-08 https://www.sec.gov/Archives/edgar/data/1123494/000119312512343676/d393304dex991.htm

Harvard Bioscience Inc. Form 10-Q Quartery Report 2012-08-09 https://www.sec.gov/Archives/edgar/data/1123494/000119312512346339/d384277d10q.htm

Harvard Apparatus Regenerative Technology, Inc. Form S-1 Registration Statement Filed with the US Securities and Exchange Commission 2012-12-11 [Mark Holterman FDA IND February 2012] https://www.sec.gov/Archives/edgar/data/1563665/000114420412067422/v329765_s1.htm

Harvard Apparatus Regenerative Technology Amendment 2 to Form S-1 Registration Statement 2013-02-15 [IP, licensing agreements ]http://www.nasdaq.com/markets/ipos/filing.ashx?filingid=8692525

US Securities and Exchange Commission (SEC) fulltext search, i.e. Mark Holterman or Macchiarini https://searchwww.sec.gov/EDGARFSClient/jsp/EDGAR_MainAccess.jsp

Harvard Bioscience Inc. SEC index of filings http://tinyurl.com/gn3jtqv

Harvard Apparatus Regenerative Technology, Inc. SEC index of filings [now Biostage] http://tinyurl.com/jaau8nf

Harvard Apparatus Regenerative Technology, Inc. Novel Surgery Agreement (Mark Holterman, M.D., OSF Health Care System, Children's Hospital of Illinois, Hannah Warren's synthetic trachea transplant) 2012-05-24 http://www.sec.gov/Archives/edgar/data/1563665/000114420413009734/v334458_ex10-22.htm

Harvard Apparatus Regenerative Technology, Inc. Amendment to Novel Surgery Agreement 2013-04-05 [switching from synthetic trachea scaffold manufactured by Nanofiber Solutions, Inc. for HART to sythetic scaffold manufactured by HART] https://www.sec.gov/Archives/edgar/data/1563665/000114420413042225/v351056_ex10-21.htm

Harvard Apparatus Regenerative Technology, Inc. Novel Surgery Agreement (Dr. Vladimir Porhanov, Regional Clinical Hospital No. 1 after Prof. S.V. Ochapovsky, synthetic trachea transplants in Krasnodar) 2012-05-21 http://www.sec.gov/Archives/edgar/data/1563665/000114420413009734/v334458_ex10-21.htm

Harvard Apparatus Regenerative Technology, Inc. Amendment to Novel Surgery Agreement 2013-06-26 [same as amendment of 2013-04-05 above] https://www.sec.gov/Archives/edgar/data/1563665/000114420413042225/v351056_ex10-22.htm

Harvard Bioscience's InBreath Bioreactors Used in World's First Successful Regenerated Laryngotracheal Transplants Harvard Bioscience Press Release 2012-06-26 http://investor.harvardbioscience.com/releasedetail.cfm?releaseid=686701

Interview with Harvard Bioscience CEO David Green 2012-12-14 https://www.youtube.com/watch?v=r2vrnrxbcfM

Harvard Apparatus Regenerative Technology's InBreath Scaffold and Bioreactor Used in First U.S. Transplant of a Regenerated Trachea Surgery Successfully Implanted Trachea Into Two-Year-Old Harvard Bioscience Press Release 2013-04-30 http://web.archive.org/web/20130504214510/http://www.harvardbioscience.com/releasedetail.cfm?ReleaseID=760507

Harvard Apparatus Regenerative Technology Patent Rights Assignment, Paolo Macchiarini to HART 2012-12-21 https://www.sec.gov/Archives/edgar/data/1563665/000114420413009734/v334458_ex10-18.htm

Schedule 1 Assigned Patent Application(s)
U.S. 61/505,096 ?
U.S. 13/542,218 Application, Continuation of U.S. 13/542,202, Assignee Harvard Apparatus Regenerative Technology Inc. 2015-04-02 [Ed.; faux pas de Case 1?] A synthetic bioengineered matrix, reseeded with autologous undifferentiated stem and (nasal) respiratory cells, of appropriate size and morphology, was prepared for transplantation. The transplant procedure allowed the airway tumor to be completely removed while preserving the right lung and safely reconstructing the airway and giving the patient a chance for cure and a normal quality of life. http://patents.justia.com/patent/20150094808
U.S. 13/542,202 USPTO Assignment 2013-09-02, UCL Business Plc (Abandoned?) http://assignment.uspto.gov/#/search?q=20130066438
PCT PCT/IB2012/001696 WIPO, Applicant UCL Business Plc http://tinyurl.com/zjl3bbw

Seraphin Group Exclusive Interview with David Green CEO of Harvard Regenerative Apparatus Technology (NASDAQ:HART) 2013-09-24 [10:00] https://www.youtube.com/watch?v=EzCdH-zUh7c

Harvard Bioscience [questionable] Second Quarter 2013 Earnings Conference Call 2013-08-13 https://www.sec.gov/Archives/edgar/data/1123494/000117184313003216/exh_991.htm

[Forget something? Aide-memóire:] P 213 Artificial Tracheo–Laryngeal Complex Transplantation in Patients with Tracheal Diseases. Early Results (A 6–Month Follow–up Period). Krasnodar (Russian Federation) Experience Polyakov I, Macchiarini P et al. Interact CardioVasc Thorac Surg (2013) 17 (suppl 1): S55-S56 http://icvts.oxfordjournals.org/content/17/suppl_1/S55.4.abstract

[Andemarian Beyene, whom Green touts as a success, died several weeks earlier] Ex-Harvard Bio Prez Leads Spin-Off's Plan to Make Engineered Organs Ben Fidler Xconomy 2014-02-18 http://www.xconomy.com/boston/2014/02/18/ex-harvard-bio-prez-leads-spin-offs-plan-to-make-engineered-organs/

Harvard Apparatus Regenerative Technology Collaborator Successfully Transplants Regenerated Esophagus into Rat Study Results by Dr. Paolo Macchiarini and Research Team Published in Nature Communications HART Press Release 2014-04-15 http://www.businesswire.com/news/home/20140415006188/en/Harvard-Apparatus-Regenerative-Technology-Collaborator-Successfully-Transplants

REGENMED Investor Days David Green, HART CEO, video presentation 2014-03-30 https://www.youtube.com/watch?v=zEXdm6Fhh0g

Consultation Harvard Pilgrim Health Care Ethics Advisory Group David Green, CEO HART 2014-05-28 [discussion of value and pricing for HART synthetic trachea transplant; advisory group favorably impressed] http://tinyurl.com/goystsl

HART: From Lab Hardware to Implantable Organs (Interview) Michael Batista MedGadget 2014-08-12 http://www.medgadget.com/2014/08/hart-from-lab-hardware-to-implantable-organs-interview.html

Harvard Apparatus Regenerative Technology, Inc. [questionable] Investor Teleconference Script Dec. 23, 2014 https://www.sec.gov/Archives/edgar/data/1563665/000114420414075522/v397428_ex99-1.htm

HART CEO David Green on the transformative potential for regenerative medicine MassDevice Brad Perriello 2014-09-03 http://www.massdevice.com/hart-ceo-david-green-transformative-potential-regenerative-medicine/

FDA Orphan Drug Designation Harvard Apparatus Regenerative Technology, Inc., inBreath airway transplant system 2014-09-04 http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=419813

HART Reports Significant Confirmatory Results for its 2nd Generation Bioengineered Esophagus, Trachea and Bronchus Implants Harvard Apparatus Regenerative Technology, Inc. Press Release 2015-11-12 http://www.sec.gov/Archives/edgar/data/1563665/000114420415064789/v424594_ex99-2.htm

Harvard Apparatus Regenerative Technology, Inc. Annual Report for the Period Ending December 31, 2015 Item 1 Business http://www.sec.gov/Archives/edgar/data/1563665/000114420416091643/v435009_10k.htm#a_002

The company previously collaborated with Paolo Macchiarini gives a nice painted picture of what had happened to the generally healthy patients who got plastic throats in Russia, shows Dagens Medicin review. Carl-Magnus Hake Dagens Medicine 2016-02-17 http://tinyurl.com/hsgwj7s

Harvard Apparatus Regenerative Technology (HART) Changes Name to Biostage, Inc. (NASDAQ: BSTG) Harvard Apparatus Regenerative Technology, Inc. Press Release 2016-03-31 http://www.prnewswire.com/news-releases/harvard-apparatus-regenerative-technology-changes-name-to-biostage-inc-nasdaq-bstg-300243888.html

Biostage Successfully Regenerates Esophagus in Groundbreaking Pre-Clinical Work with Mayo Clinic; Data Provides Proof of Concept to Seek FDA Approval for Clinical Trials Biostage Inc. Press Release 2016-05-16 http://www.prnewswire.com/news-releases/biostage-successfully-regenerates-esophagus-in-groundbreaking-pre-clinical-work-with-mayo-clinic-data-provides-proof-of-concept-to-seek-fda-approval-for-clinical-trials-300267404.html

Biostage Files for FDA Orphan Drug Designation for Cellspan™ Esophageal Implant Biostage Inc. Press Release 2016-06-29 http://www.prnewswire.com/news-releases/biostage-files-for-fda-orphan-drug-designation-for-cellspan-esophageal-implant-300291770.html

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Nanofiber Solutions, LLC

what's new Notification of Appeal for Investigation of Scientific Misconduct RE: Poster Publication: First in Man Synthetic Nanofiber Trachea. Jed Johnson, Philipp Jungebluth, Paolo Macchiarini Nanofiber Solutions LLC, Columbus, Ohio, Karolinska Institutet, Stockholm, Sweden, Aug 2012. 2016-08-30 http://www.circare.org/info/pm/appeal-misconduct-20160830.pdf

[In 2013 Harvard Bioscience began manufacturing its own synthetic trachea scaffold, ending its relationship with NanoFiber Solutions, Inc., which manufactured the synthetic trachea scaffolds for patients C.L and Y.C. at Karolinksa Institute and J.T and A.Z. in Krasnodar] OSU spinoff Nanofiber back-burners IP fight with Harvard Bioscience Carrie Ghose Columbus Biz Insider 2014-01-07 http://www.bizjournals.com/columbus/blog/2014/01/osu-spinoff-nanofiber-back-burners-ip.html

[Chris Lyles, transplant at KUS 2011-11-17] Harvard Bioscience's InBreath Bioreactor Used in World's Second Successful Synthetic Trachea Transplant Harvard Bioscience Press Release 2011-11-29 http://investor.harvardbioscience.com/releasedetail.cfm?releaseid=627663

Cell culture startup's scaffold used in 2nd-ever synthetic trachea transplant Brendon Glenn MedCityNews 2011-11-30 http://medcitynews.com/2011/11/cell-culture-startups-scaffold-used-in-2nd-ever-synthetic-trachea-transplant/?edition=ohio

Cell culture company sees promise in making scaffolds for artificial organs Brandon Glenn MedCityNews 2012-01-23 http://medcitynews.com/2012/01/cell-culture-company-sees-promise-in-making-scaffolds-for-artificial-organs/
The scaffolds are scheduled to be used in several other trachea transplants this year. The company's technology has not been approved by the U.S. Food and Drug Administration, but is able to be used in humans because of a humanitarian device exemption, Johnson said.

Tissue on Demand Columbus Business First Carrie Ghose 2012-05-18 http://tinyurl.com/j6n7fjq

Regenerative Medicine News, Press Release, Nanofiber Solutions, Ross Kayuha, CEO, 2012-06-26 [TinyURL used due non-SGML characters in URL] http://tinyurl.com/hmgs4qq

Nanofiber Solutions: Our Technology is the Future Will Schmidt Tech.co 2013-11-05 http://tech.co/nanofiber-solutions-technology-future-2013-11

Nanofiber Solutions, Inc., Jed Johnson, Philipp Jungebluth, Paolo Macchiarini First in Man Nanofiber Synthetic Trachea 2012-08-02 http://www.circare.org/info/pm/NFS-First_in_man_nanofiber_trachea.pdf

Nanotechnology for Defense Conference Nov 4-7, 2013, Tucson, US. Poster Award Winners at the 2012 Conference: First in man Synthetic Nanofiber Trachea, Dr. Jed Jonson, Nanofiber Solutions : https://www.usasymposium.com/nano/13%20Nano/posters.htm

Poster Award Presentation Aug 8, 2012 at the Nanotechnology for Defense Conference, Las Vegas, US, Aug 6-9, 2012. Agenda, page 3 (1330-1830), 4 (1710-1830), 7: First in Man Synthetic Nanofiber Trachea, Dr. Jed Johnson, Nanofiber Solutions https://www.usasymposium.com/nano/docs/2012%20NT4D%20Agenda%2019%20Jul%2012.pdf

Nanotechnology for Defense Conference, Las Vegas, US, Aug 6-9, 2012 https://www.regonline.com/builder/site/Default.aspx?EventID=1047321

Alliance for Regenerative Medicine Nanofiber Solutions Ross Kayuha, CEO 2012-11-25 https://www.youtube.com/watch?v=P1NyHXOPNp0

Nanofiber Solutions Company Presentation, Jed Johnson, Chief Technical Officer 3rd Annual Regen Med Partnering Forum 2013-10-24 https://www.youtube.com/watch?v=dYo-ffZWCzs

Nanofiber Solutions Recognizes Value of NSF Funding in Creating the World's First Successful Nanofiber Tracheal Implant Nanofiber Solutions Inc. Press Release 2011-12-01 http://www.nanofibersolutions.com/Images/contactengine.pdf

Nanofiber Solutions, Inc., Jed Johnson SBIR Phase I: Development of a Tissue Engineered Trachea Jed Johnson 2013-07-01 [start date] http://www.nsf.gov/awardsearch/showAward?AWD_ID=1315524

Nanofiber Solutions, Inc., Jed Johnson SBIR Phase I: Development of a Tissue Engineered Trachea [with Project Report of successful synthetic stem cell trachea transplant in patient] http://grantome.com/grant/NSF/IIP-1315524

Nanofiber Solutions, Inc., Jed Johnson SBIR Phase II: Development of a Tissue Engineered Trachea [award year 2015] https://www.sbir.gov/sbirsearch/detail/878427

SBIR Success Story Nanofiber Solutions 2013-12-19 [shows the trailer for SuperCells, i.e. the miracle in Krasnodar that wasn't] https://www.youtube.com/watch?v=hmFFhMo-YZo

National Science Foundation FOIA Response SBIR Phase 1: Development of a Tissue Engineered Trachea. Jed Johnson, Nanofiber Solutions Award 1315524 Final Project Report 2016-08-26 http://www.circare.org/info/pm/1315524-finalprojectreport.pdf

National Science Foundation FOIA Response SBIR Phase 1: Development of a Tissue Engineered Trachea. Jed Johnson, Nanofiber Solutions Award 1315524 Project Outcomes Report 2016-08-26 http://www.circare.org/info/pm/1315524-projectoutcomesreport.pdf

National Science Foundation FOIA Response SBIR Phase 1: Development of a Tissue Engineered Trachea. Jed Johnson, Nanofiber Solutions Award 1315524 Final Project Report Poster titled Development of a Tissue Engineered Trachea 2016-08-26 http://www.circare.org/info/pm/1315524-poster-tissueengineeredtrachea.pdf

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Research Funding and Clinical Trials

European Commission Community Research and Development Information Service (CORDIS) Horizon 2020 Autologous Stem Cell Seeded Tissue Engineered Trachea Project reference: 681027 [phase 2 trachea transplant trial] http://cordis.europa.eu/project/rcn/198788_en.html

European Commission Community Research and Development Information Service (CORDIS) Biotrachea Project reference: 280584 http://cordis.europa.eu/project/rcn/103069_en.html

Biotrachea Project reference: 280584 KI Form C Financial Statement 2013-04-01 to 2014-09-30 http://tinyurl.com/hn2y6wc

Biotrachea Project reference: 280584 KI Form C Financial Statement 2012-04-01 to 2013-03-31 http://tinyurl.com/j33kz3r

Biotrachea Project reference: 280584 WT2 List of Deliverables http://tinyurl.com/h29mfsx

Information about termination of EU grant, courtesy of Leonid Schneider, For Better Science Blog 2016-03-04: https://forbetterscience.wordpress.com/2016/02/21/macchiarini-and-karolinska-the-biomedical-ethics-meltdown/#comment-445

California Stem Cell Research and a Super Doc: Inside a $4.4 Million Windpipe Grant at UC Davis David Jensen California Stem Cell Report 2016-04-22 http://californiastemcellreport.blogspot.mx/2016/04/california-stem-cell-research-and-super.html

California Institute for Regenerative Medicine Airways for Children Grant Number: DR2-05298 Investigator: Martin Birchall Institution: UC Davis https://www.cirm.ca.gov/our-progress/awards/airways-children

California Institute for Regenerative Medicine Tissue Engineered Recellularized Laryngotracheal Implants Grant Number: DR3-07281 Investigator: Peter Belafsky Institution: UC Davis https://www.cirm.ca.gov/our-progress/awards/tissue-engineered-recellularized-laryngotracheal-implants

Deutsche Forschungsgemeinschaft (DFG) Paolo Macchiarini Development of a bioartificial trachea 2004-2009 http://gepris.dfg.de/gepris/projekt/5419115

Regarding the Knut and Alice Wallenberg Foundation and the Macchiarini case in media Press Release 2016-02-16: https://www.wallenberg.com/Kaw/en/press/regarding-knut-and-alice-wallenberg-foundation-and-macchiarini-case-media

Research Council stops the payment of contributions to dishonest researchers Swedish Research Council Press Release 2015-06-22 (via Google Translate from Swedish to English) : http://tinyurl.com/glbqw3x

Russian Federation Megagrant Regeneration of airways and lung Leading Scientist Paolo Macchiarini Kuban State Medical University 2011-2014 http://www.regmedgrant.com/index.php?id=4&lang=eng

Laryngo-Tracheal Tissue-Engineered Clinical Transplantation Paolo Macchiarini Kuban State Medical University https://clinicaltrials.gov/ct2/show/study/NCT01997437?show_desc=Y#desc

Laryngo-Tracheal Tissue-Engineered Clinical Transplantation Results 2016-01-25 https://clinicaltrials.gov/ct2/show/results/NCT01997437

Laryngo-Tracheal Tissue-Engineered Clinical Transplantation History of Changes https://clinicaltrials.gov/archive/NCT01997437

Clinical Trial of Stem Cell Based Tissue Engineered Laryngeal Implants (RegenVOX) Martin Birchall University College London https://clinicaltrials.gov/ct2/show/study/NCT01977911

Clinical Trial of Stem Cell Based Tissue Engineered Laryngeal Implants (RegenVOX) History of Changes https://clinicaltrials.gov/archive/NCT01977911

Laryngeal transplantation Working Party Final Report Royal College of Physicians June 2011 https://www.rcseng.ac.uk/news/docs/rcs_laryngeal_transplant_lo_res%20%282%29.pdf

RegenVOX: phase I/II clinical trial of stem cell based tissue engineered laryngeal implants Project Reference: MR/K026453/1 Research Councils UK http://gtr.rcuk.ac.uk/project/6039BD76-9195-433C-894E-4536CF2FCA74

RegenVOX:Clinical trial of voicebox implants using tissue engineering UK Clinical Research Network Study Portfolio [2 subjects enrolled to date] http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=18788

[Ed.: waffling between plastic or cadaveric scaffold?] World's first clinical trial of stem cell voice box Press Release UCL Hospitals Biomedical Research Centre 2013-03-11 http://www.uclhospitals.brc.nihr.ac.uk/news/world%E2%80%99s-first-clinical-trial-stem-cell-voice-box

University College London Impact case study (REF3b) [trachea transplants, Martin Birchall] 2014: http://www.circare.org/info/pm/ucl-impact-2014.pdf

University College London Impact case study (REF3b) [POSS/PCU synthetic trachea transplants, Alexander Seifalian] 2014 http://tinyurl.com/gu2g3wa

University of Bristol Impact case study (REF3b) [recellulization of cadaveric trachea scaffold, A. Hollander] 2014 http://tinyurl.com/humlxwj

Horizon 2020 awards €6.8m to TETRA consortium for pivotal replacement trachea trial EU study to build on Phase I trial of Videregen product & generate approval application Videregen Ltd Press Release 2015-12-10 http://www.videregen.com/horizon-2020-awards-e6-8m-to-tetra-consortium-for-pivotal-replacement-trachea-trial/

Clinical trial for replacement trachea technology to start next year INSPIRE consortium receives UK MHRA approval for study Videregen Ltd Press Release 2015-111-03 http://www.videregen.com/clinical-trial-for-replacement-trachea-technology-to-start-next-year/

INSPIRE Trial: A Phase I open-label study to assess the safety, tolerability and potential efficacy of a novel tracheal replacement consisting of a tissue engineering decelluarised tracheal scaffold with seeded autologous mesenchymal cells in subjects with severe tracheal stenosis or malacia Participant Information Sheet 2016-01-05 [courtesy of hard work by Leonid Schneider at For Better Science Blog] http://www.circare.org/info/pm/trachea_D00173-CT2013002.pdf

Odds and Ends

Jungebluth P1, Holzgraefe B et al. Autologous Peripheral Blood Mononuclear Cells as Treatment in Refractory Acute Respiratory Distress Syndrome. Respiration. 2015;90(6):481-92. doi: 10.1159/000441799. Epub 2015 Nov 28. http://dx.doi.org/10.1159/000441799


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