Alexander Seifalian, UCL’s Persian Scapegoat

Alexander Seifalian, UCL’s Persian Scapegoat

The London university UCL has now completed the investigation into the affair around their past honorary professor and now disgraced thoracic surgeon Paolo Macchiarini and the trachea transplants. Subject of the investigation were: the two plastic tracheas UCL produced (one sent to Karolinska Institutet and implanted in patient Andemariam Beyene in Stockholm, another used by UCL laryngologist Martin Birchall to treat Keziah Shorten, who previously received a cadaveric trachea from Macchiarini as requested by UCL) as well as four more cadaveric trachea transplants, namely the very first such intervention organised by Macchiarini and Birchall in Barcelona in 2008, on patient Claudia Castillo, as well as the three trachea transplants which took place under UCL oversight in London, on paediatric patients Ciaran Lynch, Shauna Davison and a 3-year old child who was transplanted just in May 2017 at the same Great Ormond Street Hospital (GOSH). The offhand revelations about the last transplant in this UCL report came as surprise, since it was otherwise kept secret.

No information is provided by the investigative report on how that child is doing now, in fact it seems no evidence like laboratory books, research data or patients’ medical files was ever requested and the committee relied solely on the opinions provided by the very people they were supposed to investigate: Paolo Macchiarini, Martin Birchall and GOSH paediatric surgeon and past director Martin Elliott. In fact, the report seems to become very nebulous or even creative with its use of alternative facts to avoid implicating Birchall in anything unethical at all. The only guilty party in this medical scandal is incidentally also the only non-clinician and the only non-white character in the entire Macchiarini affair: the nuclear physicist Alexander Seifalian, a Persian-Armenian and dual citizen of Iran and UK, whose lab manufactured two plastic tracheas. He was already sacked by UCL in July 2016, accused of bribery. Seifalian is also bowel cancer survivor, which did not prevent UCL of accusing him of failing to oversee the abroad clinical application of his produce just when he was receiving chemotherapy.

These are the results of UCL investigation in the nutshell:

  • All UCL-employed clinicians involved in trachea transplants, in particular UCL’s chief trachea transplanter Martin Birchall, are fully acquitted from any suspicion of misconduct or clinical wrongdoing. Even Macchiarini seems partially exonerated from the gist of the UCL report, because:
  • The maker of the two plastic tracheas, Alexander Seifalian, is to take all the UCL-related blame for the failed  transplants (as well as other plastics implants in India, Iran and Switzerland). His fault is to have manufactured these products though his UCL lab lacked GMP (Good Manufacturing Practice) certificate. Only this lack of GMP-quality seal was what apparently made plastic tracheas too dangerous to implant in humans.
  • All five cadaveric trachea transplants under the scope of investigation were considered ethically, medically and scientifically justified. Deaths of the patients were explained with new discoveries of recurrent cancer, or demands of other patients for the same hospital bed.
  • Birchall’s clinical trials with cadaveric tracheas (phase 1/2a INSPIRE, and by extension, also EU-wide phase 2 TETRA) are to go ahead as planned and to recruit patients. Same positive recommendation for Birchall’s related trial RegenVox on cadaveric larynx, decellurised and “regenerated” with same technology as tracheas.

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Macchiarini’s trachea transplant patients: the full list

Macchiarini’s trachea transplant patients: the full list

This article lists all known (including those not officially declared) patients of the scandal surgeon Paolo Macchiarini, who received from him a cadaveric or plastic trachea. All these grafts were “regenerated” with bone marrow and epithelial cells, in some cases a bioreactor was used to incubate cells on the trachea carcass, in some cases a “bionic” method was applied,  where cells were brought straight into the open patient, together with growth factors like EPO. Not all patients are named in my list, though names of all are available, certainly at the hospitals where they were treated. One of my sources is a patients list from the Careggi Hospital in Florence, Italy, which the Corriere Fiorentino journalist Alessio Gaggioli sent me.  Some of the patients I already described in an earlier article.

This now is a full list, and it will be updated whenever I receive any new evidence. All Macchiarini trachea transplant patients are listed in the chronological order of their operation. The 2003 operated patient (story here), who received from Macchiarini (together with Heike and Thorsten Walles) a small “regenerated” tracheal patch of pig intestine, is not included here, as it was not a trachea transplant as such. There is a total of 17 patients, at least 11 are dead, the rest, if alive, were left mutilated.

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Ciaran’s success story

Ciaran’s success story

Trachea is a very difficult organ to transplant, because its blood supply happens through many tiny blood vessels and it is practically impossible to connect them all (same is true also for the oesophagus). An organ transplanted without blood supply will die, and this is where the regenerative medicine of Paolo Macchiarini and Martin Birchall comes in: a treatment with stem cells and growth factors will somehow magically ensure quick vascularization and bring the dead tissue to life. There is no independent evidence for this, and most patients died as the consequence or became dangerously ill when their new tracheas, made from plastic or from dead, decellurised cadaveric organs predictably failed.  One boy has survived: Ciaran Lynch. His current clinical state is not too rosy, even by Birchall’s own admittance, but nevertheless the sole fact that Ciaran (unlike almost all other trachea transplant patients) is alive, sufficed for Birchall to have one or two more patients operated (both dead) and to push through a clinical trial in UK with a much larger follow-up trial EU-wide. The difference though: that boy never had much choice anyway, since he had no real trachea in the first place. He received very early on a pickled trachea homograft from dead human donor tissue which functioned very well for many years, but at some point urgently needed replacement in order to save his life. Now Birchall however wishes to remove the live airways of stable patients outside any life danger, who suffer from tracheal stenosis, and replace them with his regenerated dead ones (see this report). Noone seems to wonder why these tracheas are to be prepared in a radically different way from that of the sole success, Ciaran Lynch: Birchall’s bioreactor vs so-called “bionic” method of Macchiarini.

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