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.
s 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.
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”
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”
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.
This is a new instalment of my investigation into UK and EU funded clinical trials on trachea replacement by the throat surgeon Martin Birchall at UCL. The method of using bone marrow cells to regenerate a dead decellurised donor trachea was developed by Birchall together with Paolo Macchiarini, and tested since 2008 on several human patients, with catastrophic results. Macchiarini by now is a pariah sacked by his formerly proud employer, the Karolinska Institute in Sweden, but Birchall was given further millions in British and EU money for his human trachea transplant experiments.
I finally obtained the patient information brochure for such phase 1 clinical trial INSPIRE, which was consistently denied to me by all participants. The information therein, or rather the strategic lack of it and the consequential wilful misleading of prospective patients, is truly scandalous. There is no mention whatsoever of any of the previous trachea transplant experiments Birchall performed and the clinical outcome of which he likely misrepresented in order to obtain this very funding and even his current full professorship at UCL (with the help of Macchiarini, see page 43 of his CV). His described strategy of transplant preparation and implantation seems scientifically nonsensical, while suggestive of medical obfuscation and even deceit. Now that I finally received the INSPIRE patient information sheet, I understand why the consortium partners preferred in to be hidden from public scrutiny.
For the scientific and medical ethics background of this complicated case, please refer to my earlier reporting (in chronological order):
- The stem cell faith healers, or magic inside your bone marrow
- EU threatens to terminate TETRA Consortium funding for phase 2 trachea transplant trial
- Brexiting out of EU research and patient rights
Britain voted itself out of the European Union, and with this act UK research will soon be also out of EU funding and EU scientists (or any foreign scientists for that matter, given that the central point of the Brexit vote was immigration). Without freedom of movement, there cannot be any access to EU research funding, as Switzerland had to learn after their citizens also bravely voted in their own referendum against immigration in 2014. Thus, with the genie of racism and xenophobia out of the bottle in UK now, it is highly unlikely that the next Tory government will agree to allow foreign work-seekers onto their precious island. This Brexit out of Horizon 2020, ERC and other European research programmes will hurt, because, as the UK scientist and open science activist Stephen Curry mentioned in an interview: “The UK is a net contributor to the EU overall but ‘wins’ in terms of research funding”. While Scotland might find a way out through another vote on independence, England will be stuck where it is.
Maybe this is actually not that bad, given the interesting attitude British authorities and bureaucracy have to clinical research. Their prime concern goes out not towards the public interest or the patients’ wellbeing, but to the financial profits of biotech and pharma industry. All my inquiries about the most basic documentation or permits granted to the INSPIRE clinical trial on trachea-replacement were ignored or outright rejected, with the simple argument that sharing information with me would hurt the business interests of the commercial participants involved. The INSPIRE trial is about transplanting four patients with donor tracheas, which are prior to this to be decellurised and “regenerated” using a “stem cell” approach developed by Paolo Macchiarini (now accused of involuntary manslaughter for his trachea transplant experiments). Macchiarini’s former partner Martin Birchall, laryngology surgeon at the UCL and UCLH in London, is leading this trial (see my detailed analysis here and here), and the company whose interests need the most careful protection by British authorities is Videregen, which seems to imagine the trachea replacement in humans as similar to that of exchanging a car part. Only much more lucrative of course, Birchall himself put the revenue at up to the mouth-watering $740,000 per patient (Culme-Seymour et al, 2016). Continue reading “Brexiting out of EU research and patient rights”