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Amit Nilkanth Patel is an Indian-American cardiac surgeon and former director of clinical regenerative medicine and tissue engineering at the University of Utah in Salt Lake City. He was a tenured professor of surgery-cardiothoracic at the University of Utah until December 2016.
Patel studied medicine at Case Western Reserve University. [1] In 2002, he led a "breakthrough" study demonstrating that stem cell transplantation could treat congestive heart failure. [2] [3]
He is currently the national lead investigator for Aastrom Biosciences, now Vericel Corp, to treat both ischemic and non-ischemic cardiomyopathy by using adult stem cells. He just completed and published the largest heart failure trial for cell therapy in patients with ischemic heart failure. The trial was published in the journal Lancet and demonstrated a 37% reduction in death and hospitalizations for patients with severe heart failure.
He is also the lead investigator for several trials to use adult stem cells to treat limb ischemia (inadequate blood flow to the leg). He has taught many surgeons around the world in countries such as Thailand and India. Notable patients of his include Hawaiian singer Don Ho; Ho credited Patel's 2005 procedure on him with saving his life and allowing him to return to performing after being forced into retirement for health reasons. [4] [5] He is currently working on programs for type 2 diabetes, burn wound therapies with the U.S. military & arteriocyte, traumatic brain injury, and plastic reconstruction. He has started collaborative programs in Peru, Argentina, Ecuador, Germany, and India. His newest program is to treat heart failure patients with one-day outpatient cell therapies – harvest. Patel has recently developed a stem cell spray for rapid healing of heart surgery and burns. [6] He is also the founder of Xogenex LLC, a gene therapy company for heart failure. The project is code-named the "Bourne-Project" because it has multiple genes to improve heart function which can be regulated and non-virally integrated into patients. He is also the co-founder of Jadi Cell LLC which involves a novel xenofree umbilical cord stem cell that is currently being used in a number of clinical trials.
Patel was involved in a retracted study, authored by Mandeep R. Mehra and Sapan Desai, relating to using hydroxychloroquine to treat COVID-19 during the COVID-19 pandemic, which used suspect data from Surgisphere. It was published in The Lancet which retracted it. He co-authored another COVID-19 study that also used suspect data from Surgisphere and which was retracted by New England Journal of Medicine . Patel and Desai are related by marriage. In June 2020 both journals retracted the study and the University of Utah terminated Patel's position over the papers. Upon further independent investigation, it was determined that it was Patel that called for the retraction of both papers as he could not verify the veracity of the Surgisphere program. He had also already verbally resigned from his volunteer position at the University of Utah long before the story in stat news. [7] Dr. Richard Horton, editor in chief of The Lancet, called the paper a fabrication and "a monumental fraud". Dr. Eric Rubin, editor-in-chief of NEJM, said "We shouldn't have published this." [8]
Additionally, Patel's University of Utah profile claimed 100 publications, nearly two-thirds of which he did not write but were co-authored by other individuals with the same surname. [9]
Extracorporeal membrane oxygenation (ECMO), is a form of extracorporeal life support, providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of oxygen, gas exchange or blood supply (perfusion) to sustain life. The technology for ECMO is largely derived from cardiopulmonary bypass, which provides shorter-term support with arrested native circulation. The device used is a membrane oxygenator, also known as an artificial lung.
The Lancet is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also one of the world's highest-impact academic journals. It was founded in England in 1823.
In academic publishing, a retraction is a mechanism by which a published paper in an academic journal is flagged for being seriously flawed to the extent that their results and conclusions can no longer be relied upon. Retracted articles are not removed from the published literature but marked as retracted. In some cases it may be necessary to remove an article from publication, such as when the article is clearly defamatory, violates personal privacy, is the subject of a court order, or might pose a serious health risk to the general public.
Stephen E. Epstein is the Head of Translational and Vascular Biology Research at the MedStar Heart and Vascular Institute, MedStar Washington Hospital Center and Clinical Professor of Medicine at the Georgetown University School of Medicine.
The Ottawa Hospital Research Institute (OHRI), formerly Ottawa Health Research Institute, is a non-profit academic health research institute located in the city of Ottawa. It was formed in 2001 following the merger of three Ottawa hospitals. The Ottawa Hospital Research Institute is the research arm of The Ottawa Hospital and affiliated with the University of Ottawa.
Paolo Macchiarini is a 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.
Cellular cardiomyoplasty, or cell-based cardiac repair, is a new potential therapeutic modality in which progenitor cells are used to repair regions of damaged or necrotic myocardium. The ability of transplanted progenitor cells to improve function within the failing heart has been shown in experimental animal models and in some human clinical trials. In November 2011, a large group of collaborators at Minneapolis Heart Institute Foundation at Abbott Northwestern found no significant difference in left ventricular ejection fraction (LVEF) or other markers, between a group of patients treated with cellular cardiomyoplasty and a group of control patients. In this study, all patients were post MI, post percutaneous coronary intervention (PCI) and that infusion of progenitor cells occurred 2–3 weeks after intervention. In a study that is currently underway, however, more positive results were being reported: In the SCIPIO trial, patients treated with autologous cardiac stem cells post MI have been reported to be showing statistically significant increases in LVEF and reduction in infarct size over the control group at four months after implant. Positive results at the one-year mark are even more pronounced. Yet the SCIPIO trial "was recently called into question". Harvard University is "now investigating the integrity of some of the data". The Lancet recently published a non-specific ‘Expression of concern’ about the paper. Subsequently, another preclinical study also raised doubts on the rationale behind using this special kind of cell, as it was found that the special cells only have a minimal ability in generating new cardiomyocytes. Some specialists therefore now raise concerns to continue.
Anil Potti is a physician and former Duke University associate professor and cancer researcher, focusing on oncogenomics. He, along with Joseph Nevins, are at the center of a research fabrication scandal at Duke University. On 9 November 2015, the Office of Research Integrity (ORI) found that Potti had engaged in research misconduct. According to Potti's voluntary settlement agreement with ORI, Potti can continue to perform research with the requirement of supervision until year 2020, while he "neither admits nor denies ORI's findings of research misconduct." As of 2024 Potti, who is employed at the Cancer Center of North Dakota, has had 11 of his research publications retracted, one publication has received an expression of concern, and two others have been corrected.
Human HGF plasmid DNA therapy of cardiomyocytes is being examined as a potential treatment for coronary artery disease, as well as treatment for the damage that occurs to the heart after MI. After MI, the myocardium suffers from reperfusion injury which leads to death of cardiomyocytes and detrimental remodelling of the heart, consequently reducing proper cardiac function. Transfection of cardiac myocytes with human HGF reduces ischemic reperfusion injury after MI. The benefits of HGF therapy include preventing improper remodelling of the heart and ameliorating heart dysfunction post-MI.
The University of Louisville School of Medicine at the University of Louisville is a medical school located in Louisville, Kentucky, United States. Opened as the Louisville Medical Institute in 1837, it is one of the oldest medical schools in North America and the 9th oldest in the United States.
High-dose chemotherapy and bone marrow transplant (HDC/BMT), also high-dose chemotherapy with autologous bone marrow transplant, was an ineffective treatment regimen for metastatic breast cancer, and later high-risk breast cancer, that was considered promising during the 1980s and 1990s. With an overall idea that more is better, this process involved taking cells from the person's bone marrow to store in a lab, then to give such high doses of chemotherapy drugs that the remaining bone marrow was destroyed, and then to inject the cells taken earlier back into the body as replacement. It was ultimately determined to be no more effective than normal treatment, and to have significantly higher side effects, including treatment-related death.
Mandeep R. Mehra is The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and a professor of medicine at Harvard Medical School. He is the medical director of the Brigham Heart and Vascular Center in Boston, Massachusetts, and specializes in advanced heart failure, mechanical circulatory support and cardiac transplantation.
Annarosa Leri is a medical doctor and former associate professor at Harvard University. Along with former professor Piero Anversa, Leri was engaged in biomedical research at Brigham and Women’s Hospital in Boston, an affiliate of Harvard Medical School. Since at least 2003 Anversa and Leri had investigated the ability of the heart to regenerate damaged cells using cardiac stem cells.
Ischemic cardiomyopathy is a type of cardiomyopathy caused by a narrowing of the coronary arteries which supply blood to the heart. Typically, patients with ischemic cardiomyopathy have a history of acute myocardial infarction, however, it may occur in patients with coronary artery disease, but without a past history of acute myocardial infarction. This cardiomyopathy is one of the leading causes of sudden cardiac death. The adjective ischemic means characteristic of, or accompanied by, ischemia — local anemia due to mechanical obstruction of the blood supply.
Remote ischemic conditioning (RIC) is an experimental medical procedure that aims to reduce the severity of ischaemic injury to an organ such as the heart or the brain, most commonly in the situation of a heart attack or a stroke, or during procedures such as heart surgery when the heart may temporary suffer ischaemia during the operation, by triggering the body's natural protection against tissue injury. Although noted to have some benefits in experimental models in animals, this is still an experimental procedure in humans and initial evidence from small studies have not been replicated in larger clinical trials. Successive clinical trials have failed to identify evidence supporting a protective role in humans.
Surgisphere is an American healthcare analytics company established in 2008 by Sapan Desai. Originally a textbook marketing company, it came under scrutiny in May 2020 after it provided large datasets of COVID-19 patients that were subsequently found to be unreliable. The questionable data were used in studies published in The Lancet and The New England Journal of Medicine in May 2020, suggesting that COVID-19 patients on hydroxychloroquine had a "significantly higher risk of death". In light of these studies, the World Health Organization decided to temporarily halt global trials of the drug hydroxychloroquine to treat COVID-19. After the studies were retracted, the WHO trials were resumed and then discontinued shortly after.
Sapan Sharankishor Desai is an American ex-physician, and the owner of Surgisphere, originally a textbook marketing company that claimed to provide large sets of medical data on COVID-19 patients. This data and the research using it has been discredited, and two papers Desai co-authored that used this data were retracted after being published in prominent medical journals.
Chloroquine and hydroxychloroquine are anti-malarial medications also used against some auto-immune diseases. Chloroquine, along with hydroxychloroquine, was an early experimental treatment for COVID-19. Neither drug has been useful to prevent or treat SARS-CoV-2 infection. Administration of chloroquine or hydroxychloroquine to COVID-19 patients, either as monotherapies or in conjunction with azithromycin, has been associated with deleterious outcomes, such as QT prolongation. As of 2024, scientific evidence does not substantiate the efficacy of hydroxychloroquine, with or without the addition of azithromycin, in the therapeutic management of COVID-19.
Roberto Ferrari is an Italian cardiologist who holds the position of Emeritus Professor at the University of Ferrara, where besides he was the chair of the Cardiology in the School of Medicine until the 2019–2020 academic year.
The University of Utah has "mutually agreed" to terminate the faculty appointment of Amit Patel, who was among the authors of two retracted papers on Covid-19 and who appears to have played a key role in involving a little-known company that has ignited a firestorm of controversy.