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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Keziah’s deadly trachea transplant: UCL hospital’s secret

Keziah’s deadly trachea transplant: UCL hospital’s secret

Keziah Shorten was a 19-year old teenager from England and officially Paolo Macchiarini 3rd patient receiving a cadaveric trachea transplant. She suffered from a slow growing form of cancer and received a cadaveric trachea transplant from Macchiarini at the Careggi hospital in Florence. After life-threatening complications ensued, her second transplant, a plastic trachea made and implanted at UCL and its UCL hospital (UCLH) in London, failed also. Keziah died one and a half years after her first operation. With new evidence provided to me by a source close to the patient, I present here a version of Keziah’s story which is very much different from the official one. This makes UCL and UCLH at least in part responsible for her death, from the very beginning. It was their decision to treat Keziah with the first cadaveric transplant, which sealed her fate.  Next to the UCL honorary professor Macchiarini himself, the British doctors, who according to my source promised Keziah a complete cure and initiated this transplant, were UCL professors and surgeons Martin Birchall and Paul O’Flynn. Keziah was even supposed to be operated at UCLH, but once Macchiarini got an ethics permit in Italy, she was moved there. O’Flynn followed her and joined Macchiarini in the transplant operation. Afterwards, it was an ongoing catastrophe which was exacerbated by an apparent botched intervention at UCL Hospital. Death seemed a relief after terrible suffering imposed on Keziah by fame-seeking doctors worshipping their own magic of regenerative medicine. Continue reading “Keziah’s deadly trachea transplant: UCL hospital’s secret”

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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The vexatious life-saving question of cadaveric tracheas

The vexatious life-saving question of cadaveric tracheas

As we learned it from the Swedish documentary „Experimenten“, the scandal trachea surgeon Paolo Macchiarini didn’t much like to operate on sick cancer patients: they died too quickly after receiving a trachea transplant. This is why Macchiarini was said to have moved on to patients outside of any life-threatening conditions, like the Russian car accident victim Yulia Tuulik. She died because of the plastic trachea which Macchiarini implanted into her. Yesim Cetir, young victim of a botched operation, was slightly luckier to survive the plastic trachea, but only because it was removed and because of constant emergency care and multiple organ transplants (she is presently in very grave state). However, it seems that even Macchiarini’s cancer patients could have led a relatively long life, had they not agreed to receive his trachea transplants. And I am not speaking about the lethal plastic ones. In fact, the “biological” grafts made of decellurised dead donor tracheas were not such a great success either, and seem to have brought suffering and have shortened lives instead of prolonging them. The British UCL and its hospital UCLH are preparing their own clinical trial with cadaveric tracheas, while busily covering up their role in the Macchiarini scandal.

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Birchall’s trachea transplant trial at UCL suspended by health authorities

Birchall’s trachea transplant trial at UCL suspended by health authorities

The British laryngologist and UCL professor Martin Birchall is in trouble now, despite all his constant attempts to turn claims into facts and declare the “stem cell”-based cadaveric trachea transplant technology (which he initially developed together with Paolo Macchiarini) a full success. Birchall’s own little trachea transplant trial INSPIRE (see background here), where the method was about to be applied once again, and on four patients outside of any life-threatening conditions, has been now suspended indefinitely by the NHS Health Research Authority and its South Central – Oxford A Research Ethics Committee (REC), as I report exclusively below. Meanwhile, the Information Commissioner’s Office (ICO) is investigating Birchall’s employer UCL Hospital for providing me with inappropriate and misleading information about that trial under Freedom of Information Act (see email here). Also, the Human Tissue Authority (HTA) is investigating a suspected loss of laboratory documentation at the veterinary department of Bristol University, where their former professor, his Bristol colleagues and Macchiarini’s student Philipp Jungebluth generated in 2008 a trachea transplant for Macchiarini’s patient Claudia Castillo in Barcelona (for background, see my report here). Continue reading “Birchall’s trachea transplant trial at UCL suspended by health authorities”

Business interests trump patient safety, says EU about trachea transplant trial

The European Union (EU) is firmly determined to see dozens of patients transplanted with “regenerated” tracheas made by the method of Paolo Macchiarini.  Just as soon as one €5.5 Million-funded trial, Biotrachea, was terminated (because the replacement plastic material Macchiarini intended to use was not novel enough), EU gave fresh €7 Million to his former partner and now competitor, the UK throat surgeon Martin Birchall (see my report here). Birchall’s TETRA will be using decellurised cadaveric tracheas, “regenerated” with bone marrow and epithelial cells after the method he developed together with his thorax surgery colleague, Macchiarini. It is a phase II clinical trial, which is rapidly progressing while the Birchall’s corresponding phase I trial, INSPIRE (funded by the public funder Innovate UK), isn’t moving anywhere. In fact, it is about to receive a re-evaluation of its ethics approval on December 2nd 2016, possibly together with Birchall’s other regenerative trial, RegenVox. There, patients are being recruited to have their voice-box replaced with a lab-made one (using same methodology as with trachea); there is also some evidence that the UCL professor already transplanted 3 patients with plastic and cadaveric larynxes even before he applied to the British MRC for the funding of RegenVox in 2012.

I submitted a Freedom of Information (FOI)  inquiry to the EU, asking for the original research proposal of TETRA. My rationale was to compare its science and methodology to that of INSPIRE, which was decried as unscientific and dangerous by the throat surgery specialists I spoke with. The Director-General of the European Commission, Robert-Jan Smits denied my request on the grounds that it lacks an “overriding public interest”, despite the well-known fact that numerous patients have suffered tremendous damage to their health and even died previously when the very same technology was applied by Birchall and Macchiarini. Instead, the EU Commission declared that financial and business interests of the TETRA consortium participants trump all safety concerns about their human research subjects (the full letter can be read here). This is double as scary, also because I am well aware that among my readers are actual prospective patients of Birchall’s. At the same time, the patient information sheet Birchall is using to recruit patients to INSPIRE is highly misinformative (see my report here). Previously, EU ethics commission even approved a much more outrageous patient consent form for Macchiarini’s trachea transplant trial Biotrachea (see my report here). Bottom line: the patients are being duped by the trials’ own consent forms, while the EU has now officially denied these patients and their kin any right to learn from an independent source like my site about what their doctors intend to do to them. Continue reading “Business interests trump patient safety, says EU about trachea transplant trial”

Claudia’s trachea

Claudia’s trachea
This is the English original of my story for Hipertextual, first published in Spanish on 27.10.2016.

What did we learn from the trachea transplant scandal around the miracle surgeon and stem cell pioneer Paolo Macchiarini, who used to conduct his human experiments in Germany, Spain, Italy, Sweden and Russia? That despite the stem cell fairy magic, all his plastic trachea transplants proved deadly for his patients, except of one or two cases where the transplant was removed early enough. These patients were not saved by Macchiarini though: he quickly lost interest in his human Guinea pigs, especially when his miracle cures started to fail. One such patient, a young woman from Turkey, lost several organs in the process, and was only saved so far due to excellent medical care and organ transplants. Macchiarini meanwhile was busy experimenting on humans in Russia, the saddest case was that of another young woman who was tricked into agreeing to an allegedly life-improving plastic trachea, which caused her death soon after.

But it was not only about the lethal plastic, and there were more young women (and some men) who were killed or mutilated by Macchiarini’s trachea transplants, while other options were available to save their lives and health. What often remains unspoken: the technology which Macchiarini used before, that of a dead donor trachea stripped of cells and allegedly reconstituted with stem cells, failed as well. Without exception, but for some reason the method is still being presented as ground-breaking success and in fact there are currently clinical trials happening in UK and soon in the whole EU. These are led by none other than by Macchiarini’s formerly closest ally, the British surgeon Martin Birchall. What the two of them did to their very first patient whom they operated in 2008 at the Hospital Clinic Barcelona, is nothing less but a bankruptcy of basic medical ethics which almost costed that young woman her life. Other Spanish doctors have been rescuing her life ever since, while Macchiarini and Birchall were busy making their fame and careers by parading this utterly failed transplant of a rotting trachea as an epic success story.

The untold story of Claudia Castillo and her trachea transplant features these key points:

  • Patient was neglected by Macchiarini and his Barcelona colleagues prior and after the transplant operation, while her condition deteriorated
  • Standard therapies were not considered or rejected in favour of a totally untested, scientifically unfounded and unrealistic method
  • “Informed constent” of the patient was obtained through deliberate misinformation
  • The transplant was prepared in a British veterinary lab using animal products, in total disregard for elementary safety measures in human medicine. The responsible British authorities were misinformed, the incident soon covered up and all research documentation vanished.

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