El 12 de junio de 2008, el cirujano torácico y entusiasta de la medicina regenerativa Paolo Macchiarini operó a su paciente Claudia Castillo en el Hospital Clínic de Barcelona. La paciente recibió parte de una tráquea de un cadáver. El injerto fue despojado de todas sus células mediante un proceso llamado descelurización, y luego fue incubado dentro del llamado biorreactor junto con muestras de células de médula ósea y epitelio de las vías respiratorias de Claudia recogidas previamente, las cuales se esperaba que regeneraran el injerto muerto y lo hicieran cobrar vida, para convertirse en parte de su organismo. Esto desencadenó lo que hasta hace poco era una historia de éxito de hasta 19 trasplantes de tráquea artificial realizados por Macchiarini, ahora considerado por algunos como uno de los mayores crímenes en la historia reciente de la medicina.
A pesar del bombo de publicitario, Claudia no recibió un trasplante de tráquea. Tan sólo una parte de su bronquio izquierdo fue reemplazada, se la retiró un segmento delimitado de 2,75 centímetros de longitud debido a una infección tuberculosa y se le reemplazó con un injerto descelurizado. El trasplante tampoco resulto un éxito. La razón por la que Macchiarini reemplazo el bronquio de Claudia con un fragmento de la tráquea de cadáver fue que Claudia no tomó correctamente los dilatadores metálicos que dilataban las vías respiratorias. Justo medio año después, su injerto reblandeció y necesitó mantenerse constantemente abierto con una cánula. Después de que Macchiarini terminara de publicitar ese supuesto éxito en dos artículos The Lancet (Macchiarini et al 2008 y Gonfiotti et al 2014), en julio de 2016 el pulmón izquierdo de Claudia fue amputado junto con el injerto podrido, con el fin de salvar su vida. Actualmente está viva pero no gracias al trasplante de tráquea de Macchiarini sino más bien a pesar de él. Si el milagroso cirujano hubiera reemplazado su tráquea en vez de uno de sus bronquios, la paciente muy probablemente habría muerto, ahogada por el colapsado del injerto, tal y como ocurrió en la mayoría de los receptores de tráqueas de cadáver que Macchiarini trató después de Claudia. De hecho, esto es exactamente lo que sucedió en 2009, cuando Macchiarini operó a otro paciente barcelonés suyo, en otro hospital de Barcelona, el Institut Dexeus, y sin ni siquiera intentar obtener ningún permiso ético. En Barcelona, al menos dos pacientes más estaban esperando para recibir un trasplantae, pero Hospital Clinic denegó el permiso y se deshizo de Macchiarini. El cual, en enero de 2010, fue a Florencia, Italia, y trasplantó allí a otros 5 pacientes con injertos de tráquea de cadáver durante ese mismo año. Todos murieron. Continue reading “Los secretos de Macchiarini en Barcelona”→
The Science and Technology Committee of the British House of Commons is now dealing with the trachea transplants performed by the scandal surgeon Paolo Macchiarini and his former parter at UCL, Martin Birchall as part of its inquiry into Research Integrity. Two UK scientists from Liverpool initiated this with their written submission from November 21st 2017 which I previously re-published: Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit, and Raphael Lévy, senior lecturer in nanotechnology. Their concerns were not just the past trachea transplants, but also the present clinical trials with bioengineered trachea and larynx which UCL is most keen to start with, following the recommendation of an investigative commission from last year. UCL’s problem is however, that the two phase 1 UK trials are suspended by the UK authorities, and the big phase 2 EU-sponsored trial cannot begin recruiting patients without the results from phase 1.
By now it looks like UCL and their laryngology professor Birchall are in a pickle. Their own reply to the letter by Murray and Levy was not really honest when describing past UCL trachea transplant patients to the Parliament committee. On top of it, it turned out Birchall was reusing data from same old experiments on 16 pigs across different publications which were meant to show separate studies. This, and many more inconsistencies of UCL’s reply to the House of Commons are addressed in the re-published new letter by Murray and Levy from January 30th 2018 below. Continue reading “Trachea transplanters: Round 2 at UK Parliament”→
The esteemed London university UCL seems to live in its own world. There, the regenerative medicine magic thrives, living organs miraculously grow in labs, while stem cell-made trachea transplants proved a blessing for humanity, despite the negative vibes from UCL’s former honorary professor Paolo Macchiarini. UCL’s own laryngology professor and regenerative medicine enthusiast Martin Birchall cured several patients already, and it is imperative that he is allowed to save more lives with his tracheas and voiceboxes, regenerated from dead decellurised carcasses using patient’s own bone marrow cells. Scientific evidence and research integrity are nothing but cumbersome bureaucracy, which restrain the genius of Birchall, whose educated guess alone should suffice as solid proof.
This is basically how UCL replied to the to request from the Science and Technology Committee of the British House of Commons, following a critique of Birchall’s trachea transplants submitted as RES0022 on November 21st 2017 by the Liverpool scientists Patricia Murray and Raphael Lévy. The undated UCL reply appeared online around the New Year and is a staunch defence of Birchall’s endeavours, while calling the two Liverpool researchers “emotive” and dismissing the evidence on my site as inaccurate. It is authored by UCL Registrar Wendy Appleby, who incidentally was now appointed by UCL to investigate Birchall’s data re-use, where he apparently resurrected long-dead pigs twice, by turning some ancient animal experiment data with regenerated larynx into two fresh and very distinct studies.
The biggest inaccuracy, or barefaced lie (as you prefer), is UCL’s pretence that they had nothing at all to do with a certain lethal transplant of a cadeveric trachea, performed by Macchiarini on July 13th 2010 in Italy on the young British patient Keziah Shorten. I have been protesting to UCL Hospital (UCLH) and the British information authorities for a whole year against the refusal of UCLH to release the information about their involvement into that trachea transplant, and eventually UCLH was forced to reply to me. Even then they only admitted what I already knew, and now they hide this information from the UK Parliament inquiry. I will share it here then. Continue reading “UCL fibs Parliament about trachea transplants”→
With his three trachea transplant clinical trials suspended, the British laryngologist and UCL professor Martin Birchall now tries to pull at least the clinical trial RegenVox, which is about the “regenerated” voice-box (larynx) and upper trachea, out of the bog. In order to get an approval to transplant human patients, UCL’s chief trachea transplanter tries to prove in several papers to his funder MRC that the technology is safe in pigs. For this he seems to be reusing data in his recent papers from 2017, to illustrate utterly different experiments, in fact some of this data is at least 7 years old. One wonders if Birchall fibbed the authorities and the scientific community about the novel nature of his results. Was the confused scientist simply salami-publishing and re-interpreting the preclinical data he actually obtained long before he received MRC funding for RegenVox? The evidence of the larynx transplant data reuse across two recent papers and the grant proposal document from 2010 follows below, background on Birchall’s RegenVox and his trachea transplant adventures is here and here.
More trouble for the German stem cell and DNA damage researcher Karl Lenhard Rudolph (not to be confused this Christmas season with Rudolph The Red-Nosed Reindeer), after his own Leibniz Society found him guilty of misconduct in 8 papers and forced his resignation as director of the the Fritz-Lippmann-Institute (FLI) in Jena (read here). Before that, FLI he used to head was raided by the police for suspected animal abuse, and forbidden to perform any mouse experiments. Today the central German funding agency DFG issued a press release declaring that Rudolph received a written reprimand for data manipulation in 3 of his recent papers, and was barred from DFG funding for 2 years. As usual in Germany, no investigative reports were released, we know no details or which papers or which data is affected. The DFG assures that Rudolph was only responsible by failing to provide oversight, and that no data was faked anyway, though the previous Leibniz Society investigation determined the loss of original data and lab books.
Here I republish the written evidence submitted to by two UK scientists to the Science and Technology Committee of the British House of Commons and its inquiry into Research Integrity, as originally published on November 21st 2017. It deals with the trachea transplants performed by the surgeons Paolo Macchiarini and his former parter at UCL, Martin Birchall. The report’s lead author is Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit. She generously invited me in May 2017 to give a seminar at her department at the University of Liverpool on this topic. Her coauthor is Raphael Lévy, senior lecturer in nanotechnology and imaging at the same university. I wrote about his reproducibility studies on the topic of nanoparticles in this article.
UCL recently investigated Birchall’s past trachea transplants, and recommended to continue with his two current clinical trials to transplant cadaveric decellurised trachea and larynx, regenerated with bone marrow cells, as I reported here. For some reason, UCL Registrar Wendy Appleby, when speaking as witness on November 21st in front of the Parliament Inqury, found herself unable to answer the rather straightforward question whether the UCL investigative commission advised to continue transplanting trachea or not (watch here, from 11:50 on). Appleby and her UCL were instructed by the Inquiry to address the concerns by Murray and Levy in writing.
Both clinical trials Inspire and RegenVox were already placed by the supervising authorities on hold, Murray and Levy now call to stop the dangerous and science-unsupported experimenting on misinformed human patients and to return back to the lab.
The British laryngologist and UCL professor Martin Birchall is one of the two founding fathers of “bioengineered” trachea, the other one being his former partner, the scandal surgeon Paolo Macchiarini. Birchall presently runs three trachea transplant trials clinical trials, two in the UK and one EU-wide. His patients must however wait to be cured, because the two UK trials, Inspire and RegenVox (with the latter primarily about larynx and upper trachea transplant) were both placed on hold, and the EU funded phase 2 trial TETRA is still far from getting an ethics approval and just now lost one potential trial site after the Medical University Vienna jumped ship. The EU Commission refuses to tell me anything about TETRA, except that it has not applied for ethics approval yet. EU’s Transparence department still evade commenting on how to put this scheduled 48 patient clinical trial in context of the 11 cadaveric trachea transplants by Macchiarini and Birchall, most or maybe even all of which left the patients either dead or mutilated.