“Me llamo Paloma Cabeza Jiménez”: Macchiarini victim speaks out

“Me llamo Paloma Cabeza Jiménez”: Macchiarini victim speaks out

English version, and a secret of yet another dead trachea transplant patient below.

Me llamo Paloma Cabeza Jiménez,

tengo 43 años y vivo en Alicante aunque nací en Madrid (España)

Con tan solo 10 años, tuve un accidente doméstico con un caustico.

En aquella época (1986) no se manejaban con buen acierto ni criterio las lesiones traqueales.

Mi lesión primaria era de tan solo dos centímetros de longitud y a causa de malas decisiones médicas y pocos recursos… aquellos dos centímetros degeneraron en una lesión que abarcaba la longitud total de la tráquea, lo cual me obligó a la colocación de una prótesis de silicona tipo “T” llamada Montgomery en 1992 (el verano que cumplía 18 años)

Tras años de múltiples recambios de Mongomerys para evitar la colonización por bacterias, se dieron cuenta que esas mismas manipulaciones (cada 3-6 meses) en quirófano estaban favoreciendo y provocando la aparición de nuevas bacterias por contaminación y sumada a esta realidad la propia manipulación destrozaba la regeneración natural de la mucosa traqueal.

Asi mismo, las reiteradas manipulaciones con fibrobroncoscopio rigido y aspiraciones…dañaron parcialmente mi bronquio principal izquierdo, quedándose con una estenosis estable de diámetro entre 6-7mm. Calibre compatible con una calidad de vida normal si no pretendes ser deportista profesional. Continue reading ““Me llamo Paloma Cabeza Jiménez”: Macchiarini victim speaks out”

Macchiarini victim’s family sues trachea makers for wrongful death

Macchiarini victim’s family sues trachea makers for wrongful death

Yesim Cetir was a young woman from Turkey, whose vulnerability the scandal surgeon used to test his plastic trachea (twice), a third such operation he performed at the hospital of the Karolinska Institutet in Sweden, and his fifth plastic trachea recipient. Like almost all the at least 17 patients whom Paolo Macchiarini experimented upon with either cadaveric or plastic trachea, Yesim died. Her suffering was long and horrible, her father Hayrullah Cetir dedicated all his waking hours to caring for his daughter. He died himself soon after her, from a neglected cancer.

Since April 2017, Yesim’s family (or in US legalese, the Estate of Yasim Cetir) is suing the company Harvard Bioscience, which spin-off Biostage (in turn formerly known as Harvard Apparatus) produced the bioreactors and the second plastic trachea graft used by Macchiarini on Yesim. Also the manufacturer of her first plastic trachea, Nanofiber Solutions, is being sued at the Suffolk County Superior Court in Massachusetts, USA, case number 1784CV01174. An article in Boston Business Journal indicated that even Macchiarini himself might be subject to the wrongful death lawsuit:

“Now, the estate of one of the deceased patients is pursuing wrongful death claims against both Biostage and Macchiarini”

Continue reading “Macchiarini victim’s family sues trachea makers for wrongful death”

Birchall’s two dead pigs to prove trachea transplants are safe

Birchall’s two dead pigs to prove trachea transplants are safe

Imagine you are Martin Birchall, laryngologist and ENT surgeon, star of regenerative medicine at UCL and trachea transplant enthusiast. You and your business partner Videregen need to explain to EU bureaucrats why your technology of decellurised cadaveric trachea is perfectly safe, what with all the dead patients of yours and your former best friend Paolo Macchiarini. Preclinical animal tests? Good idea indeed, though you have already published some very shady pig studies with Macchiarini in 2010, after you operated your first human patient in 2008 (whom you keep parading as success story of your stem cell magic superpowers, despite heavy complications which almost killed your research subject).

To distance yourself from that horrid Macchiarini, you do new preclinical tests. Enter three more pigs, which you decide transplant with a cadaveric decellurised human trachea. One trachea turns out to have been dirty not just with human “stem” cells, but also with pathogenic bacteria. So that one piggy got lucky and was set free. The unlucky other two: dead “of respiratory compromise”, one already after 12 days, the other suffered for a whole month after trachea transplant. You now have 100% preclinical mortality rate, and you still manage to convince the bureaucrats that the method works and 48 human patients must experience same, in the EU-funded phase 2 clinical trial TETRA. Thing is, that trachea transplant trial was supposed to help tracheal stenosis patients, by ridding them of burdensome stents and bronchoscopies, and not to euthanise them. Continue reading “Birchall’s two dead pigs to prove trachea transplants are safe”

Los secretos de Macchiarini en Barcelona

Los secretos de Macchiarini en Barcelona

English version below.

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”

Trachea transplanters: Round 2 at UK Parliament

Trachea transplanters: Round 2 at UK Parliament

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”

UCL fibs Parliament about trachea transplants

UCL fibs Parliament about trachea transplants

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 LévyThe 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”

Image reuse, the new low of UCL trachea transplanter Martin Birchall?

Image reuse, the new low of UCL trachea transplanter Martin Birchall?

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.

The UCL laryngologist uses the technology which developed with his former partner, the scandal trachea transplant surgeon Paolo Macchiarini. The method is to strip the cadaveric donor organ of all cells (in a process called decellurisation) and then bring it back to life as recipient’s own organ using the magic of bone marrow cells. In Birchall’s own words, those magic cells recognise the decellurised organ by its shape and know what to do then: Continue reading “Image reuse, the new low of UCL trachea transplanter Martin Birchall?”