Paolo Macchiarini, M.D., Ph.D., is Professor of Regenerative Medicine at Karolinska Institutet in Stockholm (Sweden), as well as director of the ACTREM (Advanced Center for Regenerative Medicine) in the same Institute. He is also Honorary Professor at London University College. He is a pioneer in the field of Regenerative medicine and has patented his own "synthetic scaffolds and airway transplantations" to create replacement tracheas using a patient's own stem cells.:51
He was previously the head and chairman of the Hospital Clínic (Barcelona Metro) de Barcelona, University of Barcelona in Barcelona, Spain, as well as professor of surgery at the University of Barcelona in Spain, and at the Hannover Medical School in Hannover, Germany.
- 1 Education
- 2 History-making surgeries performed
- 3 Resistance and challenges
- 4 Criticism and accusations of scientific misconduct, omitting ethical approval and informed consent
- 5 Other activities
- 6 References
- 7 External links
Macchiarini completed his residency in thoracic surgery at the University of Pisa in Pisa, Italy. He completed a fellowship in the department of thoracic surgery at the University of Alabama at Birmingham in Birmingham, Alabama, with an additional fellowship completed in the department of thoracic and vascular surgery and heart-lung transplantation, Hôpital Marie-Lannelongue, Paris-Sud University, Le Plessis Robinson, France.
History-making surgeries performed
Claudia Castillo: First transplant using patient's stem cells
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 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.
Ciaran Finn-Lynch: First child
March 2010: Ciaran Finn-Lynch 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 (surgeon), 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.
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."
Andemariam Teklesenbet Beyene: First synthetic trachea
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 man with late-stage tracheal cancer. The synthetic windpipe was made at University College London, by Professor Alexander Seifalian.
Christopher Lyles: First U.S. citizen to receive synthetic trachea
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 4-year-old daughter. 'I’m just thankful for a second chance at life.'" Sadly, Mr. Lyles died in March 2012, nearly four months after the surgery. Mr. Lyles' family continue to be supportive of the therapy, stating "Christopher was a recipient and strong advocate of stem cell therapy.… We hope his bravery will pave the way for further research and development and acceptance of stem-cell-based therapies in the United States."
Hannah Warren: First baby to receive synthetic trachea
Hannah Warren of Korea was born in August 2010 with an underdeveloped trachea. She survived for 2 months 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 9-hour procedure working with local pediatric surgeon Mark Holterman- the parents, a Newfoundland, Canada man and a South Korean woman living in her country), he gave a 3-inch long, bone marrow stem cell-cultured artificial trachea, or windpipe, to 2-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. Sadly, Hannah died a few months later on July 6, 2013. Her family stated: "She is a pioneer in stem-cell technology and her impact will reach all corners of our beautiful Earth. Her new trachea was performing well, but her lungs went from fairly good, to weak, to poor."
Resistance and challenges
In July 2011, Macchiarini came to the United States and interviewed Rachel Phillips, a former Royal Ballet of London dancer, to assess the potential of using this procedure to help with her severe case of tracheobronchomalasia brought on by ElhersDanlos Syndrome complications. Dr. Macchiarini approved Ms. Phillips for the treatment, but she continues to struggle as the therapy has not yet been approved for the United States, and it would not be covered by health insurance. Ms. Phillips is raising funds and awareness at her website "Help Rachel Breathe".
Criticism and accusations of scientific misconduct, omitting ethical approval and informed consent
In 2012 Prof. Macchiarini was accused by Italian legal authorities of demanding money from patients "under the desk", and he was placed under house arrest. Furthermore, during the same year professor Macchiarini had a scientific paper retracted because of scientific misconduct. This was followed by an ongoing investigation regarding falsified scientific results in a paper published in The Lancet  and cited in Nature. Also, professor Macchiarini was recently accused of having performed operations without informed consent (required by the Helsinki convention). These have been appraised in several publications in November and December 2014. The Karolinska Institutet has launched an internal investigation since a thorough analysis of the publications and medical records of the patients operated by Prof. Macchiarini revealed that there are severe inconsistencies. As supporting evidence, four doctors produced an analysis of six of Macchiarini’s papers. Each one lists inconsistencies and inaccuracies, including:
-Inquires have been unable to identify any application for synthetic tracheal transplantation filed at the Regional Ethical Review Board.
-Unapproved informed consent form signed 17 days after the transplantation.
-Serial fabrication and omission of biopsy findings.
-Serial fabrication and omission of bronchoscopic findings.
-Fabrication and omission of clinical status. 
Even though Prof. Macchiarini has attracted global attention, it has been neglected and concealed that many of the patients have suffered devastating complications and died in very inhumane conditions. 
The analysis of the six papers published by Prof. Macchiarini´s research group is available here
The results of the aforementioned investigation are awaited in Feb 2015.
With the current success of regenerative medicine via stem cell research and continued success of treating patients diagnosed with non-treatable diseases through traditional medicine the non-profit foundation "Change a Life - Regenerate a Life" was founded in February 2012 by Macchiarini, Alex Roberts and Luis Coronas. The main objective is to raise awareness of RM, (regenerative medicine) giving patients and their families hope of a better quality of life including life itself. The raising of funds will also help to further the research and development of RM via stem cells, including helping patients who are met with financial difficulties for such procedures where their medical insurance companies will not cover the expenses.
- "Qualifications portfolio for teachers and researchers at Karolinska Institutet: Curriculum vitae", Feb. 4, 2010.
- "Transplant first a giant leap for surgery: Patient's stem cells used to engineer new organ; UK scientists involved in pioneering technique", Sarah Boseley, The Guardian, 19 November 2008.
- "Doctors give woman a new windpipe, using her own stem cells", The Associated Press, New York Daily News, Nov. 19, 2008.
- "Adult stem cell breakthrough", University of Bristol, 19 November 2008.
- "Once doctors had a donor windpipe, scientists at Italy's University of Padua stripped off all its cells, leaving only a tube of connective tissue. Meanwhile, doctors at the [UK's] University of Bristol took a sample of Castillo's bone marrow from her hip. They used the bone marrow's stem cells to create millions of cartilage and tissue cells to cover and line the windpipe. Experts at the University of Milan [Italy] then used a device to put the new cartilage and tissue onto the windpipe. The new windpipe was transplanted into Castillo [at Spain's Hospital Clinic of Barcelona] in June.""Doctors give woman a new windpipe, using her own stem cells", The Associated Press, New York Daily News, Nov. 19, 2008.
- "Clinical transplantation of a tissue-engineered airway", Paolo Macchiarini et al, The Lancet, Volume 372, Issue 9655, Pages 2023 - 2030, 13 December 2008, Published Online: 19 November 2008.
- "Long-term management of patients taking immunosuppressive drugs", Denise C. Hsu et al, Australian Prescriber (vol. 32, no. 3, June 2009), summary.
- "A Leap Of Faith Recap: Dr. Macchiarini & Pioneering Regenerative Medicine (6/27/14)", Eileen Rillera, Nerdles: News for Nerds, June 27, 2014, reporting on the NBC news report which aired the same date (see External Links).
- "Boy's windpipe replaced in pioneering stem cell operation", Sarah Boseley, The Guardian, March 19, 2010.
- "Vatican honors boy for courage during trachea transplant", Estefania Aguirre, Catholic News Agency, April 12, 2013.
- "Ciaran Finn-Lynch's windpipe transplant success", BBC News Northern Ireland, 26 July 2012.
- "'Milestone moment' as boy undergoes transplant to regenerate trachea", BioCentre, accessed July 1, 2014.
- "Windpipe transplant success in UK child", BBC News, March 19, 2010.
- Macchiarini P (2011). "Bioartificial tracheobronchial transplantation. Interview with Paolo Macchiarini". REGENERATIVE MEDICINE 6 (6 Supplement): 14–15. doi:10.2217/rme.11.81. PMID 21999257.
- "Using a Lab-Grown Trachea, Surgeons Conduct the World's First Synthetic Organ Transplant", Clay Dillow, Popular Science, 07, 07, 2011
- "First U.S. Patient Gets Stem Cell Trachea Transplant", Lara Salahi, ABC News via World News, January 13, 2012.
- "Synthetic Windpipe Is Used to Replace Cancerous One", Henry Fountain, The New York Times, January 12, 2012.
- "Christopher Lyles, Got Synthetic Trachea, Dies at 30", Henry Fountain, The New York Times, March 7, 2012.
- "Harvard Bioscience tracheal transplant patient dies", Julie M. Donnelly, Boston Business Journal, March 6, 2012, updated Dec. 28, 2012.
- "Recipient of synthetic trachea dies: Family of Abington father still wants people to support stem cell research", Andrea K. Walker, The Baltimore Sun, March 06, 2012.
- "Youngest Girl Given Bio-Engineered Windpipe Dies". nbcbayarea.com. NBCUniversal Media. Retrieved 2 October 2013.
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.
- "Hannah Warren Dead: Toddler Who Received Windpipe Made From Stem Cells Dies", Karla K. Johnson, Huffington Post, 07/08/13.
- "Arrestato il superchirurgo Macchiarini «Approfittava della fragilità dei malati»", Corriere Fiorentino 27 settembre 2012 (modifica il 28 settembre 2012).
- , Retraction Watch Tracking retractions as a window into the scientific process 'Misconduct' leads to retraction from Italian 'super surgeon' under house arrest".
- , Leading Surgeon Is Accused of Misconduct in Experimental Transplant Operations, New York Times, November 25, 2014, on page A11 of the New York edition.
- , Investigations launched into artificial tracheas The Karolinska Institute is carrying out two inquiries into an experimental transplant procedure Nature 516, 16–17 (04 December 2014) doi:10.1038/516016a
- , "Surgeon Faces Misconduct Allegations The scientist who implanted artificial windpipes into several patients is being accused of conducting the procedures without proper ethical review. The Scientist By Bob Grant | December 1, 2014.
- , Retraction Watch “Super-surgeon” who created artificial tracheas facing new misconduct allegations
- , Retraction Watch Tracking retractions as a window into the scientific process Revealed: Complaint lodged against Macchiarini, 'super-surgeon under investigation".
- Paolo Macchiarini, M.D., Ph.D. profile from the Cardiothoracic Surgery Network
- "A Leap of Faith: Desperate Patients Look to Lab-Grown Organs", Linda Carroll, NBC News, June 27, 2014.
- "Full Episode: A Leaf of Faith", NBC News, June 27, 2014.
- "How artificial tracheas are made", Dateline, June 26, 2014. "David Green, President of Harvard Apparatus Regenerative Technology, explains how the tracheas are made in the lab."
- "Paolo Macchiarini: crossing frontiers", David Holmes, The Lancet (Volume 379, Issue 9819, Page 886), 10 March 2012
- Paolo Macchiarini - link to search of other articles mentioning Dr. Macchiarini in The Lancet
- "The regeneration of tissues of the airways and lung", Kuban State Medical University, 2012 (original in Russian language, translation provided by computer)
- "Biography: Paolo Macchiarini, MD,PhD"
- "Qualifications portfolio for teachers and researchers at Karolinska Institutet: Curriculum vitae", Feb. 4, 2010, 86 pages in length with many links and references.
- "Leading Surgeon Is Accused of Misconduct in Experimental Transplant Operations" New York Times, November 25, 2014, on page A11 of the New York edition.
-  "Investigations launched into artificial tracheas" Nature 516, 16–17 (4 December 2014) doi:10.1038/516016a.
- "Retraction Watch Tracking retractions as a window into the scientific process 'Misconduct' leads to retraction from Italian 'super surgeon' under house arrest"
- "Arrestato il superchirurgo Macchiarini
«Approfittava della fragilità dei malati»" Corriere Fiorentino > Firenze > Cronaca > Arrestato Il Superchirurgo Macchiarini«Approfittava Della Fragilità Dei Malati» 27 settembre 2012 (modifica il 28 settembre 2012).
- "Retraction Watch Tracking retractions as a window into the scientific process Revealed: Complaint lodged against Macchiarini, 'super-surgeon under investigation".
- "Retraction Watch “Super-surgeon” who created artificial tracheas facing new misconduct allegations"
- "Surgeon Faces Misconduct Allegations The scientist who implanted artificial windpipes into several patients is being accused of conducting the procedures without proper ethical review. The Scientist By Bob Grant | December 1, 2014"