Stem Cell Treatments
Dr. Bruno’s Original Post: STEM CELLS - THE NEW SNAKE OIL.
Most researchers, including those at the National Institutes of Health, think that efforts to sell therapies involving adult stem cells, which can develop into different types of cells to replenish tissue, have gotten way ahead of the science. Rogue clinics offering other kinds of procedures have flourished, accused of blinding people by injecting cells into their eyes, mixing stem cells with smallpox vaccine to treat cancer or causing severe infections by administering contaminated blood from umbilical cords into patients’ joints or spines.
Stem Cell Treatments Flourish With Little Evidence That They Work
“The F.D.A. has taken an industry-friendly approach toward companies using unproven cell cocktails to treat people desperate for relief from aging or damaged joints.”
By Denise Grady and Reed Abelson May 13, 2019
Article Summary
“Many people have become captivated by the idea of using stem cells to fix their damaged joints, and some claim to have been helped. But there is no clear evidence that these treatments work, and their safety has yet to be established. Most researchers, including those at the National Institutes of Health, think that efforts to sell therapies involving adult stem cells, which can develop into different types of cells to replenish tissue, have gotten way ahead of the science. Even so, hundreds of clinics have popped up around the country to meet the demand. Some of the clinics also inject joints with platelet-rich plasma, a solution of platelets extracted from the patient’s own blood. A few employers have even agreed to provide insurance coverage for the treatments.”
“There is almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets, which are regarded as low risk.”
“In the meantime, rogue clinics offering other kinds of procedures have flourished, accused of blinding people by injecting cells into their eyes, mixing stem cells with smallpox vaccine to treat cancer or causing severe infections by administering contaminated blood from umbilical cords into patients’ joints or spines. In some of the worst cases, patients had already been harmed before the agency took any action, and the patients took legal steps themselves, suing the clinics that injured them.”
“We had our day job clearly cut out for us,” said Dr. Scott Gottlieb, who was the F.D.A. commissioner until April, 2019. There is, he added, a lot of ‘really bad stuff.’ “
Navigating the existing guidelines
“Some stem cell businesses have carefully navigated F.D.A. rules to stay just inside the lines. The agency regulates cell and tissue products, but treatments that use a patient’s own cells do not require the agency’s approval if the cells are “minimally manipulated,” meaning that they have not been cultured or multiplied in a lab, and no drugs or other substances have been added.”
Needed: Real data
“Scientists say that research on stem cells does hold tremendous promise for treating many diseases. But those goals are years away.”
“ ‘There’s not a whole lot you can say definitely about whether these therapies are efficacious,’ said Scott Noggle, the senior vice president of research at the New York Stem Cell Foundation, a nonprofit scientific group. ‘Until you do well-controlled clinical trials showing it works in humans, the question is still up in the air.’ ‘Bone marrow contains many different types of cells, and unless the extracts used to treat patients are analyzed, it is not clear which cells they are receiving’, Dr. Noggle said.”