Medicine

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. It will be updated whenever I receive any new evidence.

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 information comes from the 2015 “docu-novel” Megagrant, by Macchiarini’s Russian biographer and project manager.

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 20 patients, only 3 are known to be alive. Only one of them still has the graft.

Last update: 1.11.2018

  1. Claudia Castillo, born 1977, suffered from tuberculosis-damaged airways. Operated on 12.06.2008 at Hospital Clinic Barcelona, Spain. She received a cadaveric trachea graft which was implanted as a bronchus transplant, with the use of bioreactor for the purpose of regeneration. The organ was prepared without the knowledge of authorities in the veterinary lab of  Martin Birchall at the University of Bristol, Macchiarini’s student Philipp Jungebluth was part of the process (see my report for details). The operation was published in The LancetMacchiarini et al 2008. A follow-up Lancet paper Gonfiotti et al 2014 reported the highly fragile patient travelling from January 2010 on for three years every 3-4 months from Barcelona to Florence, to be examined and to receive stents at Careggi, while always found in good health by Macchiarini and his partners. She was referred to Oriol Sibila at Hospital de la Santa Creu i Sant Pau in Barcelona in June 2013 by Jungebluth. Claudia’s real medical state was very serious at all times, due to infections and debris from poorly-biodegradable stents.  she returned to Hospital Clinic Barcelona and asked to remove her left lung, which happened in 2016. She is now doing well, given the circumstances.

    doctor-paolo-macchiarini-junto-claudia-castillo-primera-trasplantada-traquea-hospital-clinic-barcelona-2008-14553640052591
    Claudia Castillo, with Macchiarini. Photo: Hospital Clinic of Barcelona
  2. According to a witness report (of another former Macchiarini patient), a 45-50 year old woman of a Middle Eastern origin was assigned to the private clinic BarnaClínic and operated by Macchiarini with a trachea transplant at the associated Hospital Clínic of Barcelona in the fall of 2008. She died at the ICU either around Christmas 2008 or in the first trimester of 2009. Hospital Clinic however was unable to find any records of a matchign patient.
  3. D.D., female, born 1953. Diagnosis unknown (but likely no cancer). She was operated by Macchiarini on her airways twice before she was transplanted in October 2009 at  Institut Dexeus in Barcelona. Prior to that, the Hospital Clinic forbade Macchiarini to transplant more patients (despite a queue), and now denies all knowledge of DD. Jungebluth was present at that operation, as part of his studies. This patient received a cadaveric trachea, which was smuggled from the Hospital Clinic, and according to Macchiarini’s lecture from 2010, was regenerated using so-called bionic method (no bioreactor) which Macchiarini developed together with his German partner Augustinus Bader (see my article here). In an unpublished manuscript however, Macchiarini claimed same bioreactor-assisted method as with Claudia Castillo was used (see here).  The patient was afterwards emergency treated 13 times in thoracic surgery because of dyspnoea (difficulties of breathing) caused by collapse of the graft, “without final resolution”. A tracheostomy was opened in 2012, according to this unpublished manuscript, “due to severe laryngeal stenosis”. My source however stated that the graft detached soon after the transplantation, causing infection, tracheostoma was opened to save this patient’s life (read here). She likely died: in a 2014 lecture (min 12:30) Martin Elliott declared that “out of 10 patients worldwide” who received a cadaveric trachea “only 2 are alive”.

    DD Dexeus
    Patient DD, at Dexeus
  4. Ciaran Lynch, born 2000 without functional trachea, received a homograft from Martin Elliott which functioned for 10 years. The boy received on 15.03.2010 from Macchiarini a trachea transplant (prepared in a lab at Royal Free Hospital, London, provenance however officially assigned to Italy) at Great Ormond Street Hospital in London. It was a cadaveric trachea in full, regenerated by bionic method (no bioreactor). Martin Elliott, but also Martin Birchall, were involved in the operation. Published in as Elliott et al, Lancet, 2013, a later follow-up as Hamilton et al 2015. See my article for details.

    Stem cell trachea rebuild
    Ciaran Lynch, with Birchall. Photo: UCL
  5. M.K., female, born 1979, from Czech Republic, at the time mother of a 7 month old baby. She had mucoepidermoid carcinoma, was delegated to Macchiarini by her Czech doctor, the thorax surgeon Václav Jedlička. Operated at Careggi Hospital, Florence on 06.07.2010. She received a cadaveric trachea, using bionic method (no bioreactor). She also received chemotherapy in parallel. Sent home with mediastenitis (inflammation of chest cavity) on July 30th, later on fistula formation, cancer recurrence with the necessity of repeated bronchological interventions and chemotherapy was diagnosed, according to this Macchiarini-coauthored conference abstract (Jedlicka et al 2011). The patient died 1 year after diagnosis (which means already in 2010 or early 2011). Czech newspaper sources here and here. Clinicians directly involved at Careggi: Alessandro Gonfiotti, Massimo Jaus.
  6. Keziah Shorten, born 1991, from UK. She had adenoid cystic carcinoma and was operated on 13.07.2010 at Careggi, Florence, with a cadaveric trachea in full, regenerated by bionic method (no bioreactor). She also received intraoperative radiation therapy (IORT). The therapy was according to my information managed by Birchall; Macchiarini’s partner in the Careggi operation theatre was UCL surgeon Paul O’Flynn. The decision to perform the cadaveric trachea transplant in Italy was made at a multidisciplinary team meeting at UCL hospital on June 11th 2010. After the transplant failed, Keziah received from Martin Birchall a second transplant on 29.09.2011, Macchiarini was not involved (he allegedly even opposed this transplant). It was a plastic trachea, made at UCL and regenerated at Royal Free using a bioreactor. Keziah died in January 2012, she is mentioned as patient 2 in Culme-Seymour et al 2015. See my article for details.

    telemmglpict000179398491_trans_nvbqzqnjv4bq0urrf3wjyt3_thktrfbwkz8acnctveebhjfkn_rng0m
    Keziah Shorten, signing the “informed consent”. Photo: Telegraph. under fair use.
  7. G.M, female, born 1987, diagnosed with left-side bronchomalacia (softness of bronchi). She was operated on 28.09.2010 at Careggi, Florence and received a cadaveric trachea graft to replace her left bronchus. Macchiarini’s clinical partners were Gonfiotti, Jaus. As severe complications with the graft ensued 2 months after the operation (aorto-bronchial fistula), she had her left lung removed and suffered “serious permanent brain damage”. Between 2010 and 2011 she underwent 7 interventions after transplantation (see also Corriere article). She likely died: in a 2014 lecture (min 12:30) Martin Elliott declared that “out of 10 patients worldwide” who received a cadaveric trachea “only 2 are alive”.
  8. M.M, female, born 1945, suffered from tracheo-oesophageal fistula, which happened postoperatively after larynx cancer treatment. She was operated on 04.10.2010 at Careggi, Florence with a cadaveric trachea, namely the cervical and media-trachea section. Macchiarini’s clinical partners were Gonfiotti, Jaus. The patient suffered then from venal thromobosis and infection of tracheostomy, transplant became necrotic and she died around one year after hospital discharge (see also Corriere article), according to this unpublished manuscript, in September 2012, “of sudden massive upper gastrointestinal bleeding”.
  9.  Zhadyra Iglikova, born 1984. Russian patient who suffered tracheostomy after a car accident. She was operated by Macchiarini on 07.12.2010 at National Research Center of Surgery in Moscow and received a cadaveric trachea graft, namely cervical and mediastenic trachea section. Vladimir Parshin was Macchiarini’s operation partner. According to this unpublished manuscript, she received “a tracheoplasty with a T-tube” in April 2011, which suggest that the cadaveric graft was removed. An article by Dzemeshkevich 2015 described “graft’s stenosis due to scarring and granulation tissue formation without signs of preservation of native tracheal structure and function”. On 5.06.2018, Zhadyra received another cadaveric trachea transplant in Moscow (with no involvement of Macchiarini). She was sent home to Kazakhstan on June 24th and died on 8.07.2018. See my reporting here and here and this article in Filter.

    moscow_23dec2010
    Zhadyra Iglikova, with Parshin on her right and Macchiarini on her left. Photo: journal NakedScience, under fair use.
  10. F.F., male, born 1938, diagnosed with squamous neoplasia of trachea. Operated on 25.01.2011 at Careggi, Florence, received a cadaveric trachea graft, in full, with neocarena. Macchiarini’s clinical partners were Gonfiotti, Jaus. The patient died very soon after, on 22.02.2011 (see also Corriere article), after “massive pulmonary embolism”.
  11. Andemariam Beyene, born 1973. Diagnosed in Iceland with mucoepidermoid carcinoma, operated on 09.06.2011 at Karolinska University Hospital, Stockholm. He received a plastic trachea made at UCL and bioreactor regenerated at Karolinska Institutet (KI). This and other bioreactors came from the company Harvard Apparatus (now re-branded as BioStage). Icelandic surgeon Tomas Gudbjartsson referred Beyene to Macchiarini, and was also participating in the operation. Philipp Jungebluth “regenerated” the trachea, took care of the patient and organised postoperative sample acquistion. Beyene died 30.01.2014, his story is told in Bosse Lindquist’s documentary “Experimenten“. Published as Jungebluth et al, Lancet 2011. See my reporting here and here.

    91073465_barkaigraedsla-radstefna-2-vefur
    Andemariam Beyene, left, with David green, CEO of Harvard Apparatus, and Macchiarini. Photo: University of Iceland, made during a show Symposium to celebrate the anniversary of operation.
  12. Christopher Lyles, born 1981, US American, diagnosed with adenoid cystic carcinoma. Operated on 17.11.2011 at Karolinska University Hospital, Stockholm. He received a  plastic trachea made by Nanofiber Solutions (bioreactor regenerated). Involved was Philipp Jungebluth, who “regenerated” trachea and even operated the patient without a Swedish licence to practice medicine. Chris Lyles died on 5.03.2012. His family raised $200,000 for the operation. See my reporting here.

    f85e2829-44d1-415f-b903-3e6feffec420_w650_r0_s
    Macchiarini with Chris Lyles. Photo public domain.
  13. Yulia Tuulik, born 1979, Russian, suffered from tracheostomy after a after car accident. Operated on 19.06.2012 at Kuban Medical University, Krasnodar. She received a plastic trachea from Nanofiber Solutions (bioreactor regenerated), and a second graft on August 2012. Macchiarini’s Russian surgery partners were Vladimir Porkhanov and Igor Polyakov. Philipp Jungebluth “regenerated” trachea and discussed operation). Yulia died in September 2014, her story is told in “Experimenten“. See also my article here and Alla Astakhova’s report.

    f20120728
    Yulia Tuulik, with Macchiarini. Photo KP.ru, under fair use.
  14. Alexandr Zozulya, born 1984, suffered from tracheostomy after car accident. This patient was an alcoholic and smoker, nevertheless operated on 21.06.2012 at Kuban Medical University, Krasnodar with a plastic trachea from Nanofiber Solutions (bioreactor regenerated). He received his second graft in November 2013. Macchiarini’s Russian surgery partners were Vladimir Porkhanov and Igor Polyakov. Philipp Jungebluth “regenerated” the trachea. Sasha Zozulya had several operations to improve his state, but died on 21.02.2014 due to mass bleeding, allegedly “from the area unrelated to trachea”, after “a bicycle accident”  (referenced in Megagrant).

    screenshot_2018-07-25-d0bcd0bdd0bed0b3d0bed182d0bed187d0b5d187d0bdd0b0d18f-d0b2d0b8d0b4d0b5d0bed0bad0bed0bdd184d0b5d180d0b5d0bdd186d0b8d18f.jpg
    Videoconference from 15.02.2012, where Macchiarini and his Russian, Italian and US colleagues discussed plastic trachea operations on Yulia Tuulik and Alexandr Zozulya. Present clinicians on Karolinska side, as seen on the screenshot: Macchiarini, Jungebluth, Richard Kuylenstierna, Christer Sylven, and some others. Another key participant (never admitted by KI) was Vladimir Parshin (right corner, with moustache), who performed both trachea transplant operations on Zhadyra Iglikova in 2010 and 2018.
  15. Yesim Cetir, born 1990, Turkish, suffered from a damage to her trachea and lung drainage, after botched operation to fix hand sweating, but her quality of life was restricted. . Operated at Karolinska University Hospital, Stockholm, on  24.07.2012, where her right lung was removed, so a plastic trachea could be inserted on 7.08.2012. It was manufactured by Nanofiber Solutions and bioreactor regenerated. Yesim received a second plastic trachea graft on 9.07.2013, which was also removed. Philipp Jungebluth likely “regenerated” the plastic trachea, and transported a cadaveric trachea from Gothenburg as a possible replacement. Yesim died on 19.03.2017, after a lung-trachea transplant in Temple University hospital in Philadelphia failed to save her life. See also my reporting here and here.

    cperprhwoaa7rbw
    Yesim Cetir, with her father. Photo: his, on Twitter. .  
  16. Hannah Warren, born 2010 born without functional trachea. The little girl was operated on  09.04.2013 at Children’s Hospital of Illinois with a plastic trachea from Harvard Apparatus. Macchiarini’s surgery partner was Mark Holterman, Philipp Jungebluth regenerated the trachea. Little Hannah died on 6.07.2013. She was supposed to be the very first plastic trachea recipient, but FDA repeatedly refused approval. Macchiarini then saw his previous plastic trachea patients as tests for Hannah’s transplant, and indeed, FDA eventually conceded based on those “successes” (referenced in Megagrant).
    hannah2-size-custom-crop-788x650
    Hannah Warren, photo Jim Carlson for 
    Children’s Hospital of Illinois, under fair use.

     

  17. Sadiq Kanaan, Jordanian. Born 1971, doctor by profession. Suffered from trachea stenosis due to complications from a 20 year-old trauma from car accident. Operated on 9.08.2013 Kuban Medical University, Krasnodar plastic trachea from Harvard Apparatus. Macchiarini’s Russian surgery partners were Vladimir Porkhanov and Igor Polyakov. Kanaan left Krasnodar a month after operation, allegedly against “prognosis” of surgeon Igor Polyakov. Died in 2014, according to Macchiarini on alcoholism (2015 book Megagrant), exact date unknown.

    1378993046_616130_93
    Sadiq Kanaan, being operated by Macchiarini’s team. Source: Smartnews.ru/Kokurina

18. Dmitri Onogda, born 1987, Ukrainian citizen of annexed Crimea. Suffered from tracheostomy after a car accident.  Operated on 4.06.2014 at Kuban Medical University, Krasnodar, with a plastic trachea from Harvard Apparatus. Macchiarini’s Russian surgery partners were Vladimir Porkhanov and Igor Polyakov. Dmitri’s graft could be removed after 6 months when it started collapsing, he now lives with tracheostomy. See this RFEL report by Sergei Dobrynin.

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Dmitry Onogda, Photo his own, from public VK social media profile

19. +20. Apparently, two more adult patients were operated in Krasnodar, male and female, both Russian citizens. Their names are currently unknown, as is their fate. Here is the evidence:

Records at ClinicalTrials.gov show that not 4 as officially known, but 6 adult patients received a plastic trachea transplant in Krasnodar: 1 Jordanian and 5 Russian citizens, 2 of them female. All are declared as disease-free survivors.

screenshot-www.clinicaltrials.gov 2017-10-24 09-20-17-302
Source: ClinicalTrials.gov

A conference report Weiss et al 2014 “Tracheal bioengineering: the next steps. Proceeds of an International Society of Cell Therapy Pulmonary Cellular Therapy Signature Series Workshop, Paris, France, April 22, 2014” tells about a presentation by Jungebluth at that meeting on results from Macchiarini group:

“Overall, the experience of this group has been that a number of deaths have occurred with both biologic and synthetic implants (8 of 18 patients have died). Many of these patients were seriously ill at the outset, including some with tracheal malignancies who had undergone previous treatment attempts. As such, most of the implants have been “ compassionate use ” in difficult clinical situations”.

Patient Onogda (Nr 18 above) was not yet operated when that Paris conference took place. Thus, he was apparently actually the last, 19th patient to receive a trachea transplant from Macchiarini (and 11th get a plastic one).

Was Onogda definitely the last? According to this report signed by Macchiarini, a 6-month old child “suffering from serious congenital defects” was operated on June 3rd 2014, “as a preparatory stage for the prearranged tracheal transplantation on the 28th of June 2014”. Nothing else is known about that child. Another Macchiarini patient had a close escape in early July 2014. A 20-year old Italian named Luigi, sufferer of trachea stenosis, was also supposed to receive a plastic trachea transplant in Krasnodar. Ethics permit “in Europe” was refused, according to his mother. An operation by Macchiarini and Porkhanov was reported to have left out the transplant, only a tracheoplasty was performed.


Several patients were operated by Macchiarini in cooperation with his former British partner, the UCL surgeon Martin Birchall. There was only one trachea transplant patient of Birchall’s where Macchiarini had no involvement: Shauna Davison (see here and here). The 15 year old girl received a cadaveric trachea transplant from Birchall’s partner Martin Elliott., on 15th February 2012. 12 patients received trachea transplants at that time point already, several were already dead.  Shauna died on March 6th 2012, according to her obituary she suffocated when her new trachea collapsed. Birchall and Elliott however deny in their publications that her cause of death is known (patient 3 in Culme-Seymour et al 2015). They published this failed transplant experience as Elliott et al 2017. 

shauna-davison-638298292
Shauna Davison, photo Gazette Live, under fair use.

A UCL investigation into trachea transplants revealed on September 30th 2017 that there was an 11th cadaveric trachea recipient: a 3-year old child, transplanted with the involvement of Martin Birchall in May 2017. Her current status was presented in the report as unknown (details here).

Macchiarini also had collaborators at the University of Gothenburg in Sweden: the regenerative medicine researcher Suchitra Sumitran-Holgersson, and her surgeon partners Michael Olausson and  Hasse Ejnell. Their primarily focus was “regenerated” blood vessels, but they also transplanted a decellurised trachea coated with patient’s bone marrow cells, on 2.03.2011. The elderly patient, whose diagnosis was tracheal stenosis, died 23 days later, the case is described here. The Gothenburg group also produced another decellurised trachea, which Jungebluth personally delivered to Karolinska for implantation in Yesim Cetir after her plastic graft failed. It was not used though. This experience qualified Olausson and Ejnell as experts advising the Swedish state prosecutor in Macchiarini case, with the result that all criminal charges against the former KI professor were dropped in October 2017.


 

 

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74 comments on “Macchiarini’s trachea transplant patients: the full list

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  4. Latest development in Sweden, is that the Stockholm prosecutor is now formally discussing with the Solna (the burrough where Karolinska is located) district court to prepare the trial of Macchiarini for aggravated assault (reports only inj Swedish so far):

    https://www.dagensmedicin.se/vardens-styrning/juridik/nu-forbereds-rattegangen-macchiarini-ensam-misstankt-for-grov-misshandel/
    https://www.lifesciencesweden.se/article/view/816349/forberedelser_infor_machiarinis_rattegang_startar_pa_torsdag

    If convicted the minimum sentence is 4 years in jail, and max 10 years.

    Like

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