|Born||Basel, SwitzerlandAugust 22, 1958 in|
|Known for||Scientific misconduct; synthetic trachea|
Previously he was considered a pioneer in the field of regenerative medicine using both biological and synthetic scaffolds seeded with patients' own stem cells as trachea transplants, and he was a visiting researcher on a temporary contract at Karolinska Institutet in Sweden from 2010.:51 Macchiarini has been accused of research misconduct and unethically performing experimental surgeries, even on relatively healthy patients. Seven of the eight patients who received one of his synthetic trachea transplants have died. Also, an article in Vanity Fair suggested that Macchiarini had falsified some of his academic credentials on résumés. Similar accusations have been published in the Swedish newspaper Aftonbladet according to which Macchiarini's claim to have been a professor at universities in Hannover and Barcelona has turned out to be false.
The secretary of the Nobel Committee for Physiology or Medicine, Urban Lendahl, resigned in February 2016, owing to his involvement in recruiting Macchiarini to Karolinska Institutet in 2010. Shortly afterwards the vice chancellor, Anders Hamsten, who in 2015 had cleared Macchiarini of scientific misconduct also resigned. Macchiarini's employment by Karolinska was due to end in November 2016 following a decision by the institution not to renew his contract. On March 23, 2016 the Staff Disciplinary Board at KI announced that his employee relationship with the institute had been effectively terminated. After being dismissed from Karolinska, he works at the Kazan (Volga region) Federal University in Russia. Since June 2016, Macchiarini is under legal investigation by the public prosecutor's office on a suspicion for manslaughter and grievous bodily harm based on the material leading to death of the three patients operated in Sweden released from the scientific inquiry. The decision concerning a possible indictment will be made in 2017 pending medico-legal assessment by the Swedish National Board of Health and Welfare. A full list of all known (including those not officially declared) patients of Macchiarini, who received from him a cadaveric or plastic trachea, has been collected by Leonid Schneider.
Macchiarini obtained his medical degree (equivalent to MD) at the Medical School of the University of Pisa, Italy in 1986. He subsequently followed his residency in thoracic surgery at the same university between 1986 and 1992. He completed a fellowship at the departments of thoracic and vascular surgery and heart-lung transplantation of the Marie Lannelongue hospital (University of Paris-Sud, Le Plessis-Robinson, France) in 1993. In 1997, he obtained a PhD degree at the University of Franche-Comté. When the University of Barcelona appointed him as associate professor in 2005, the Medizinische Hochschule Hannover awarded him an additional contract (adjunct professorship) to ensure that Macchiarini would continue to teach and operate four days a month in Hannover. From 2010 Macchiarini was consultant and later Director of International Research, Clinical and Educational at the Center of Regenerative Medicine of Kuban State Medical University, Krasnodar, Russia. In 2010, he was appointed to a visiting professorship in surgery at Karolinska Institutet and a part-time position as surgeon at the affiliated university hospital. An investigation of Macchiarini's CV by Karolinska Institutet in 2016 prior to his dismissal in March 2016 revealed a number of inconsistencies and misrepresented employments and positions. From 2016 he is a supervisor of the Bioengineering and Regenerative Medicine OpenLab at Kazan Federal University. On 20 April 2017 Kazan Federal University decided to close the project led by Paolo Macchiarini.
In June 2008, Macchiarini conducted the world's first transplant of a donated trachea colonized with the stem cells of the patient, Claudia Castillo. "After a severe collapse of her left lung in March, Castillo needed regular hospital visits to clear her airways and was unable to take care of her children." The only treatment left to her following conventional medicine "was a major operation to remove her left lung which carries a risk of complications and a high mortality rate." Macchiarini proposed tissue engineering.
A team from Spain, the UK and Italy, collaborated on the surgery, which took place at Spain's Hospital Clinic of Barcelona. They stripped the donated organ of its cells and MHC antigens (involved in helping the body recognize foreign tissues). They used the remaining structure as a scaffold for the patient's own cells, which were cultured onto it.
The operation was reported as an immediate success. "The graft immediately provided the recipient with a functional airway, improved her quality of life, and had a normal appearance and mechanical properties at 4 months. The patient had no anti-donor antibodies and was not on immunosuppressive drugs." The latter aspect was a significant advantage, as immunosuppressive drugs can "increase the risks of infection, malignancy, cardiovascular disease and bone marrow suppression." "The technique raises the prospect of transplants for patients whose organs are damaged by cancer, who then cannot take the drugs as they increase the risk of cancer returning."
Martin Birchall, then Professor of Surgery at the University of Bristol, commented on the importance of the operation's success: “Surgeons can now start to see and understand the very real potential for adult stem cells and tissue engineering to radically improve their ability to treat patients with serious diseases. We believe this success has proved that we are on the verge of a new age in surgical care."
Castillo was reported to be in good health six years after the surgery. There are, however, conflicting statements that Castillo has had continuous, severe, complications after the surgery, with reports that "No graft found, serious complications, need for a pneumectomy but still reported as a major success by Macchiarini and Birchal" by her treating doctors in Barcelona on April 28, 2014. To keep her trachea from collapsing multiple biodegradable stents have had to be inserted.
March 2010: Ciaran Finn-Lynch of Ireland is the first child to receive stem cell organ treatment, and also had the "longest airway that has ever been replaced." He was 10 years old when an earlier transplanted trachea (with metal stents) started to cut into his aorta, the main blood vessel coming out of his heart. After several operations, there was still bleeding from the stents. With no other options in sight, the team leader thought of Macchiarini's earlier success with Castillo.
Macchiarini joined colleagues at London's Great Ormond Street Hospital during the operation, which was led by Martin Elliott, and included Martin Birchall of University College London. Macchiarini seeded the child's stem cells to the donated trachea and applied growth factor chemicals. He explained, "We told the cells to differentiate and transform naturally into the layers that make up the airway."
Due to the urgency of the child's condition, surgeons weren't able to wait for the patient's stem cells to develop into trachea cells in the lab. Martin Birchall said: "To minimise delays, we bypassed the usual process of growing cells in the laboratory over a period of weeks, and instead opted to grow the cells inside the body, in a similar manner to treatments currently being trialed with patients who have had heart attacks." Using this technique, "the boy's trachea was ready to be implanted in just four hours." The entire operation lasted nearly nine hours.
The operation was successful. On March 20, 2010, team leader Martin Elliott said, "The child is extremely well. He's breathing completely for himself and speaking, and he says it's easier for him to breathe than it has been for many years." After six months, his trachea looked almost normal, and his progress continued.
In April 2013, then 14-year-old Finn-Lynch was honoured with a Pontifical Hero Award for his courage, during the Second International Adult Stem Cell conference at the Vatican. He was the second person to receive the award. In July 2016, Ciaran Finn-Lynch was finally discharged from hospital after a complicated recovery at the UCL university hospital under the supervision of Professor Martin Elliott
Macchiarini believed that the implications for future treatments went beyond organ replacement, to the healing of damaged organs with stem cell therapy. "We need to change our philosophy…. The question is do we really need to transplant the entire organ and put the patient on immunosuppression, or can we stimulate stem cells to make it function again?" Martin Birchall said that more clinical trials were needed, but was hopeful that the technique could "allow not just highly specialized hospitals to carry out stem cell organ transplants."
Keziah Shorten was diagnosed with trachea cancer adenoid cystic carcinoma in 2010 leading to breathing obstructions. Maccharini operated on the patient at the Azienda ospedaliero-universitaria Careggi in Florence, transplanting a human trachea subject to his new cell treatment. It appears that no specific process was used, the cells were simply smeared on the transplant during surgery. The patient was also subject to Intraoperative Radiation Therapy by Macchiarini. The transplant collapsed in April 2011 under much suffering from the patient. In September 2011, the patient was operated again by Prof. Martin Birchall at the University College Hospital replacing the collapsed transplant with a synthetic trachea. As for other patients, like Beyene below, the synthetic transplant separated quickly at the base, leading to severe complications. Dr Birchall stated in the SVT Documentary : "“The two ends of the trachea were very loose, they had not integrated at all. There were sutures holding it in place, but very loosely. She remained on the intensive care unit at UCL for another six weeks- but then was able to be discharged back to Brighton to be with her family for a few months. Keziah’s condition worsened, and shortly afterwards she passed away”. Keziah Shorten died from hospital-acquired pneumonia in January 2012.
Five months pregnant, the young Kazakh woman Zjadyra Iglikova was severely injured in a car accident in 2006. During an eight-month coma the patient had been breathing through a tracheostomy, leading to tracheal granulation whereby the airways were progressively narrowed. After testing quarterly laser cleaning in Shanghai and hormonal treatment in Israel in 2010, she was offered a new experimental treatment by Dr Macchiarini through the Petrovsky institute in Moscow. On December 7, 2010, Macchiarini and Prof. Parshin transplanted a human trachea from a cadaver in the then 26-year-old patient. However, the graft was rapidly overgrown by granulation and the implant had to be removed January 21, 2011. Discharged on January 24, 2011, the patient was operated in emergency February 21, 2011 by Prof. Parshin when loose parts of the implant that had not been removed in January caused internal bleeding and risk of life. In March 2011, a stent had to be inserted, only to be removed in April 2011 when a new tracheostomy was made. The case is fully described in a case report concluding that the " transplantation of a donor trachea made and used in clinical practice as described by Professor P. Macchiarini eventually led to the graft’s stenosis due to scarring and granulation tissue formation without signs of preservation of native tracheal structure and function". Discharged from hospital in 2011, Zjadyra Iglikova lives in 2017 in a poor state of health, unable to speak and bedridden, without insurance coverage to finance the regular care of the tracheostomy.
On June 9, 2011 at Karolinska University Hospital in Stockholm, Sweden, doctors including Macchiarini implanted a synthetic windpipe built up with the patient's own stem cells, into a 36-year-old Eritrean man living in Iceland with tracheal cancer treated in 2009. In February 2011, test were taken to investigate a possible reoccurrence of the cancer. The multiple tests did not show any malign cancer, but merely an active inflammation. However, Macchiarini chose anyway to transplant a plastic windpipe, although the surgical notes document that the patient's trachea did not have any tumor. The patient signed the 'informed consent' for Macchiariani 17 days after (!) the transplantation under the false pretext that he was terminally ill and that the transplant was his 'only chance of survival'. The synthetic windpipe was made at University College London, by Professor Alexander Seifalian. The surgery lead to several severe complications. After a brief period discharged the patient was again hospitalized in poor condition from November 2011. The implanted trachea became loose and the patient died in January 2014.
According to information uncovered by the Swedish documentary "Dokument inifrån: Experimenten" (Swedish: "Documents from the Inside: The Experiments") the patient went from suffering an increasingly terrible and eventually bloody cough to dying, intubated, in the hospital. At that point, determined by autopsy, 90% of the synthetic windpipe had come loose. He allegedly made several trips to see Macchiarini for his complications, and at one point had surgery again to have his synthetic windpipe replaced, but Macchiarini was notoriously difficult to get an appointment with. According to the autopsy, the old synthetic windpipe did not appear to have been replaced.
The second person in the world, and the first in the U.S., to receive a synthetic trachea engineered with the patient's own stem cells, was Christopher Lyles of Abingdon, Maryland. He had "exhausted the limited treatment options available in the U.S. for his tracheal cancer." Mr. Lyles was operated on in Stockholm, Sweden, in November 2011, and returned home to Baltimore in January 2012. "'I’m feeling good,' Mr. Lyles said in a telephone interview from his home, where he was playing with his four-year-old daughter. 'I’m just thankful for a second chance at life.'" However, Mr. Lyles died in March 2012, nearly four months after the surgery.
The first patient to receive a synthetic trachea in Russia was a young ballet dancer from Saint Petersburg, Yulia Tuulik, then 33 years old. The patient was living with a tracheostomy as a consequence of a car accident in 2011. There was no clinical reason to operate at the time, but Macchiarini and a group of local doctors convince the patient to join a "clinical trial" to regain full comfort. On June 19, 2012, Yulia Tuulik gets a synthetic trachea operated by Macchiarini at the Kuban State University in Krasnodarsk. Initially discharged although the mucus membrane did not form on the plastic graft, the patient increasing is plagued with chronic coughing, fever and choking. A new surgery is made at the same clinic in August 2013, Macchiarini recognizing that the initial windpipe was too short. However, the conditions did not improve and the patient suffered chronic coughs and choking, in the end coughing pieces of her own tissue together with blue surgical thread. Due to poor evacuation of the lungs and bronchi, the patient was also plagued with chronic inflammation and fungi, essentially rotting from the inside. In September 2014, Yulia Tuulik died.
On June 21, 2012, Macchiarini makes a second synthetic transplantation at the Kuban State University in Krasnodar and on a 28-year old Russian man with tracheostomy resulting from a car accident. The condition of the patient was not critical at the time, the patient expressed discomfort when speaking through a voice box. The effects from the first implant in 2012 prompted a second surgery in November 2013. The patient apparently stayed at the hospital until February 2014 when he allegedly died in a bicycle accident.
Then a 22-year-old student in Turkey, Yesim Cetir underwent a routine surgery in 2012 to cure her sweating hands, but due to an error her trachea was severely injured and the left lung non-functional. Macchiarini accepted to treat her injury by inserting a plastic trachea in July 2012 at Karolinska Institute. The treatment was highly ineffective, the original transplant was leaking and frequently collapsing. Macchiarini performed a second replacement of the plastic trachea, but the condition of the patient deteriorated, leading also to blood clotting and kidney failure and removing the oesophagus. The plastic trachea was removed and a large number of surgeries followed. Yesim Cetir remained in intensive care in Sweden for three years, the airways had to be cleared every four hours to avoid asphyxiation. Finally, in May 2016 the patient was transferred to a clinic in the USA for a major transplant from living human donors, including the left lung, the trachea and the oesophagus. Yesim Cetir died in March 2017, 26 years old.
Hannah Warren of Korea was born in August 2010 with an underdeveloped trachea. She survived for two years thanks to a tube inserted in a bronchus through the oesophagus and an aesophagus-broncus fistula. In April 2013, at the Children's Hospital of Illinois at OSF Saint Francis Medical Center (in a nine-hour procedure working with local paediatric surgeon Mark Holterman- the parents, a Newfoundland, Canada man and a South Korean woman living in her country), he gave a 3 inches (76 mm) long, bone marrow stem cell-cultured artificial trachea, or windpipe, to two-year-old Hannah Warren, who had until then spent all her life in the Seoul National University Hospital in Seoul, South Korea, and was initially not expected to survive. She was the youngest patient yet to undergo that procedure, and only about 50,000 people in the world have her condition. Hannah died a few months later on July 6, 2013. Her family stated: "Her new trachea was performing well, but her lungs went from fairly good, to weak, to poor."
Little is known about the third patient of Macchiarini, Sadiq Kanaan of Jordanian descent who received a synthetic trachea at the Kuban State University in Krasnodar in August 2013. According to some sources the patient returned to Jordan and does not respond to email, possibly deceased.
Then 18 years old, the Kerch resident Dmitri Onogda was victim of an accident in 2007 leading to a tracheal stenosis. In 2012 Dmitri and his parents collected funds for a tracheal transplantation with Macchiarini. In June 2014, the surgery was made at the Kuban State University in Krasnodar, a synthetic trachea was implanted. The complications led to life-threatening conditions and the implant was removed at the Regional Clinical Hospital №1 by Dr Ochapovsk six months later. In 2017, Dmitri Onogda was reported alive and living with a tracheostomy.
In 2012, Italian newspapers reported stories of transplant patients accusing Macchiarini of asking for money to expedite their procedures.
In two separate filings in June and August 2014 Macchiarini was accused by four former colleagues and co-authors of having falsified claims in his research. The Karolinska Institute appointed an external expert (Bengt Gerdin) to review the charges, comparing the results reported to the medical record of the hospital. His investigation was presented in May 2015 finding Macchiarini guilty of research misconduct and that he had exaggerated the outcome of his operations in six of the seven articles reviewed. After considering the findings and a lengthy rebuttal provided by Macchiarini, vice-chancellor of Karolinska Institute Anders Hamsten decided to clear Macchiarini of the allegations. The journal The Lancet, which published Machiarini's work, also quickly published an article defending Machiarini. Only after the scandal received wide attention did The Lancet publish a letter from the Swedish Royal Academy of Sciences reiterating investigator Bengt Gerdin's findings.
Related to the findings that emerged in the investigation Swedish MPA (Medical Products Agency) and the Health and Social Care Inspectorate decided to press charges for the three operations performed in Sweden. The charges against him, for which he is still under investigation, are manslaughter and bodily harm.
Professor Emeritus at Uppsala University Bengt Gerdin, who the Karolinska Institute originally brought in to review the case, criticized the vice-chancellor's dismissal of the allegations in an interview on Swedish television. These concerns were echoed by the chairman of the Karolinska Institute, Lars Leijonborg, and the chairman of the Swedish Medical Association, Heidi Stensmyren, calling for an independent investigation that would also look at how the issue was dealt with by the university management.
A story published by Vanity Fair in January 2016 referred to disjunct versions of his academic résumé. The Vanity Fair article paints him as a serial fabulist, describing Macchiarini as "the extreme form of a con man," and remarking that "the fact that he could keep all the details straight and compartmentalize these different lives and lies is really amazing." The article details a courtship and alleged subsequent marriage arrangements from the perspective of a NBC News producer, Benita Alexander. Alexander had been tasked by NBC News to produce a documentary-type programme for Dateline in 2013 called "A Leap of Faith" to portray Macchiarini and she ultimately began an affair with her subject, only to find out later in 2015 that he had been married for thirty years, including the entire period of the courtship. The details recounted in the article include Alexander recounting Macchiarini's alleged lies about being a surgeon to the stars and current and former heads of state, and a planned wedding to Alexander to be the social event of the year (with Pope Francis officiating, Andrea Bocelli singing, Enoteca Pinchiorri catering, and numerous celebrities attending), among other reported falsified details about his C.V. and personal life.
The Karolinska Institute mentioned the alleged discrepancies regarding Macchiarini's résumé(s) as part of its decision to not extend his current contract beyond 2016. Macchiarini is reported to have claimed that Pope Francis had given his personal blessing for the wedding between the couple, both said to be divorcees, and would host the ceremony. The Pope's spokesman said that the Pope had no "personal doctor" named Macchiarini, knew nobody of that name, and would not have officiated.
Sveriges Television investigative TV show Dokument inifrån aired a three-part series in January 2016 titled "Experimenten" where Macchiarini's work was investigated. The documentary shows Macchiarini continuing operations with the new method even after it showed little or no promise, exaggerating the health of his patients in articles as they died one by one. While Macchiarini admitted that the synthetic trachea did not work in the current state, he did not agree that trying it on several additional patients without further testing had been inappropriate. Allegations were also made that patients' medical conditions both before and after the operations, as reported in academic papers, did not match reality. Macchiarini also stated that the synthetic trachea had been tested on animals before using it on humans, something that could not be verified. Following the series, Karolinska Institutet stated that they would investigate his work again.
In October 2016, the BBC broadcast a three-part Storyville documentary, Fatal Experiments: The Downfall of a Supersurgeon, directed by Bosse Lindquist and based on the earlier Swedish programmes about Macchiarini.
In the wake of the SVT documentary, Vice Chancellor Anders Hamsten resigned his Institute position on February 12, 2016.
On September 5, 2016, the Swedish government moved to dismiss the entire board of the Institute. Shortly afterwards Harriet Wallberg and Anders Hamsten were removed from the judging panel that is responsible for annually choosing the Nobel Prize for Medicine, selection of which is additionally overseen by Karolinska Institutet.
Following the detailed revelations concerning medical malpractice for the three cases treated in Sweden, all leading to decease after extensive suffering (one of which, Beyene, was likely operated upon without medical reason and without being properly informed), the public prosecutor's office in Stockholm opened an investigation for manslaughter and grievous bodily harm. Dr Macchiarini was served summons on suspicion in 2015 and heard for the investigation. In March 2017, the prosecutor claimed to wait for a medico-legal assessment by the National Board of Health and Welfare in Sweden before making the decision regarding a possible indictment. In particular, the penal responsibility will depend on the validity of the definition of 'medical urgency' that allegedly justified the interventions by Macchiarini. If prosecuted, Macchiarini risks between 2 and 8 years of prison for manslaughter.
A nearly 3-year-old toddler who was the youngest person ever to receive a bio-engineered organ died Saturday in Illinois, surgeons involved in her treatment said.
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