Paolo Macchiarini (born 22 August 1958) is a convicted felon, thoracic surgeon and former regenerative medicine researcher who became known for research fraud and manipulative behavior. He was convicted of research-related crimes in Italy and Sweden.
Previously considered a pioneer for using both biological and synthetic scaffolds seeded with patients' own stem cells as trachea transplants, Macchiarini was a visiting professor and director on a temporary contract at Sweden's Karolinska Institutet (KI) from 2010. Macchiarini was convicted of unethically performing experimental surgeries, even on relatively healthy patients, resulting in fatalities for seven of the eight patients who received one of his synthetic trachea transplants.
Articles in Vanity Fair and Aftonbladet further suggested he had falsified some academic credentials on résumés.
Urban Lendahl, the secretary of the Nobel Committee for Physiology or Medicine, resigned in February 2016, owing to his involvement in recruiting Macchiarini to KI. Shortly afterwards KI's vice chancellor, Anders Hamsten, who in 2015 had cleared Macchiarini of misconduct, resigned. KI terminated its clinical relationship with Macchiarini in 2013 but allowed him to continue as a researcher; in February 2016, the university announced it would not renew his research contract, which was due to expire in November, and terminated the contract the following month. After being dismissed from KI, Macchiarini worked at the Kazan Federal University in Russia until that institution terminated his project in April 2017, effectively firing him.
After a one-year medico-legal investigation, the Swedish Prosecution Authority announced in October 2017 that Macchiarini had been negligent in four of the five cases investigated, due to the use of devices and procedures not supported by evidence, but a crime could not be proven because the patients might have died under any other treatment given. Macchiarini was convicted of causing bodily harm, but not assault. He received a suspended sentence in June 2022. However, a year later his sentence was increased to two years and six months imprisonment by an appeals court. An appeal to the Supreme Court was rejected in October 2023, and Macchiarini began serving his sentence in Spain in September 2024.
Sweden's Expert Group on Scientific Misconduct found evidence of research fraud by Macchiarini and his co-authors in six papers and called for them to be retracted. As of 2023, 11 of his research papers have been retracted, four others have received an expression of concern, and three others have been corrected.
Education and career Macchiarini obtained his medical degree (equivalent to MD) at the Medical School of the University of Pisa (UniPi) in 1986 and a Master of Surgery in 1991. He was an assistant professor at UniPi from 1990 to 1992. He claimed he was a fellow for approximately two years in the Department of Thoracic Surgery at University of Alabama at Birmingham in 1989. This was later refuted by the university as they did not have a department of thoracic surgery, though they do have a department of cardiothoracic surgery. He was, however, a fellow for 6 months in their Hematology/Oncology department. Macchiarini obtained degree certificates—a masters in organ and tissue transplantation dated 1994 and a doctorate in the same dated 1997—from University of Franche-Comté in France. According to Germany's Hannover Medical School, he never had a salaried position there, but was head of the department of thoracic and vascular surgery at the Heidehaus Hanover hospital between 1999 and 2004. Macchiarini was an investigator at the Institut d'Investigacions Biomèdiques in Barcelona, Spain, from 2006 to 2009; he was affiliated with but not an employee of the University of Barcelona and was apparently an employee at the Hospital Clínic de Barcelona during this time. He had an honorary appointment as a visiting professor from 2009 to 2014, at University College London. He was a consultant and project manager at University Hospital Careggi (AOUC) starting in 2010.
Later in 2010, Macchiarini was appointed as a visiting professor at the Karolinska Institute (KI) in Stockholm and as a part-time position as surgeon at the affiliated university hospital. In 2013, his clinical relationship with KI was terminated, but Macchiarini was able to continue his research at the institute. In February 2016, the university announced that it would not renew Macchiarini's research contract, which was due to expire in November, and terminated the contract the following month. KI published the incomplete results of its verification of Macchiarini's CV in February 2016.
Macchiarini made ties in Russia after he gave a master class in 2010, at the invitation of politician Mikhail Batin; a few months later he did a trachea transplant there which was widely covered in Russian media. This led to Macchiarini's 2011 appointment at Kuban State Medical University along with an honorary doctorate. In 2016, he moved to Kazan Federal University and the grant money moved with him. In April 2017, the university terminated Macchiarini's research project there.
Notable trachea surgeries
Claudia Castillo In June 2008, Macchiarini conducted a transplant of a donated trachea colonized with the stem cells of the recipient, Claudia Castillo; the tissue was used to replace her left bronchus, which had been damaged by tuberculosis, and her left lung had collapsed. The trachea came from a cadaver, and was stripped of its cells and seeded with cells taken from Castillo's bone marrow. The bone marrow cells were cultured at the University of Bristol, the donor trachea was stripped at University of Padua, the stripped trachea was seeded with the cultured cells at Polytechnic University of Milan, and the trachea was transplanted by a team led by Macchiarini at Hospital Clinic in Barcelona. She underwent a lung amputation in July 2016.
Ciaran Finn-Lynch In March 2010, similar to the one done for Castillo, this was on a ten-year-old Irish boy, Ciaran Finn-Lynch, at Great Ormond Street Hospital in London. The boy was born with a 1 mm diameter trachea, and efforts to widen it had caused life-threatening complications. Unlike the Castillo procedure, in this case, the stripped trachea was seeded with the boy's stem cells just hours before it was implanted.
Keziah Shorten Keziah Shorten had tracheal cancer. In 2010, Macchiarini performed a transplant similar to the earlier two; the transplant failed almost a year later and a synthetic trachea was implanted for palliative care at University College Hospital London in 2011. She was discharged home late October 2011 and re-admitted early November 2011 for a change of tracheostomy tube. She then succumbed to hospital-acquired pneumonia which led to her death in January 2012.
Zhadyra Iglikova In 2010, Macchiarini implanted a seeded donated trachea in a 25-year-old woman in Russia, Zhadyra Iglikova, while working with surgeon Vladimir Parshin. According to her parents as of mid-2016, she had been unable to speak or stand and only left their home to visit health facilities. She died in 2018 due to complications from chronic pneumonia, a tracheoesophageal fistula and severe malnutrition.
Andemariam Teklesenbet Beyene Andemariam Teklesenbet Beyene was a man from Eritrea who was earning a master's degree in Iceland when he was diagnosed with cancer. The cancer was treated with chemotherapy and surgery in 2009, but in 2011 his trachea was obstructed again. Beyene's doctors recommended palliative care, but also reached out to Macchiarini, who was at KI by that time. In this case, Macchiarini collaborated with scientists at University College London to manufacture a fully synthetic trachea, with an engineered scaffold seeded with Beyene's marrow cells, instead of using a donated and stripped trachea, as it had been done before. The operation occurred in June 2011 and was widely covered in the media, including a front page story in The New York Times. By end of the year the implant was failing, and while Beyene was able to complete his Ph.D. in 2012, he died in January 2013 despite undergoing many treatments at KI. The autopsy showed that Beyene had a chronic lung infection, a clot in his lung, and the synthetic trachea had come loose.
Christopher Lyles Christopher Lyles lived in the United States; he had tracheal cancer which was treated with radiation and surgery. He heard about Beyene's treatment and through his doctor asked Macchiarini to do the same for him. Macchiarini obliged, creating a fully synthetic trachea seeded with stem cells from Lyles and implanting it at KI in November 2011. Lyles died suddenly in 2012 after he had returned home; no autopsy was performed.
Yulia Tuulik In June 2012, Macchiarini implanted a fully synthetic seeded trachea in Yulia Tuulik at Kuban State Medical University. Tuulik had a tracheostomy resulting from a car accident, but her life was not in danger. The graft included a cricoid cartilage, part of the voice box, which Macchiarini had not tried before. The trachea later collapsed, and was replaced; she died in 2014. An audit by the Russian government later found that Macchiarini had operated without a Russian medical license.
Alexander Zozulya Also in June 2012, Macchiarini implanted a second synthetic seeded trachea on Alexander Zozulya, who also had a tracheostomy resulting from a car accident and whose life was not in danger. The effects from the first implant in 2012 prompted a second surgery in November 2013. Zozulya died in February 2014 under unclear circumstances.
Yesim Cetir Turkish national Yesim Cetir underwent a routine surgery in 2011 to treat excessive sweating in her hands, but due to an error her trachea was severely injured and her left lung was damaged. She came to Macchiarini at the KI for treatment, and in 2012 he first removed her left lung and replaced her trachea with a pipe, then replaced the pipe with a fully synthetic seeded trachea. The next year the implant collapsed and Macchiarini replaced it with a second one. Cetir had many complications from this procedure, remained in constant need of having her airway cleared, and suffered kidney failure. In 2016 she underwent multiple organ transplants in the U.S., and her trachea was replaced with one from a cadaver. Cetir died in March 2017.
Hannah Warren In April 2013, Macchiarini implanted a fully synthetic seeded trachea in two-year-old Hannah Warren, who had been born without one. The operation was performed at OSF Saint Francis Medical Center in Peoria, Illinois, United States. The operation also involved her esophagus, which did not heal properly and required a second operation in June; she died 6 July 2013, from complications of the second surgery.
Sadiq Kanaan In August 2013 Sadiq Kanaan received a fully synthetic seeded tracheal implant from Macchiarini at Kuban State Medical University. He died later the same year.
Dmitri Onogda In June 2014, Macchiarini implanted a fully synthetic seeded trachea in Dmitri Onogda at the Kuban State Medical University. The implant failed and was removed, and as of 2017 Onogda was still alive with a tracheostomy, having retained part of his natural trachea.
Allegations
University Hospital Careggi patient extortion In 2012, Macchiarini was arrested in Italy and charged with asking patients at AOUC for money to expedite their procedures; the charges were dismissed in May 2015 and the prosecutor's appeal was dismissed in September 2015.
Research misconduct In 2014, Macchiarini was accused by four former colleagues and co-authors of having falsified claims in his research with KI. The following April, KI's ethics committee issued a response to one set of allegations with regard to research ethics and peer review at The Lancet, and found them to be groundless.