Unregulated stem cell treatments can be dangerous

Stem cells have been touted as miracle cures for a variety of diseases, but the field is not as advanced as the public believes, according to the report in the Sept. 10 issue of the New England Journal of Medicine.
"Patients need to have a healthy dose of skepticism when considering these treatments," Taylor-Weiner said.
Conservatively, Taylor-Weiner estimates hundreds of clinics perform unapproved stem cell treatments in the United States. In reality, he said, thousands may operate throughout the country.
The U.S. Food and Drug Administration has only approved a few stem cell treatments. The approved procedures utilize cells from bone marrow to treat diseases of the blood or immune system, the report explained.
On the other hand, most of the clinics referred to in the new report use fat cells taken from patients during liposuction, Taylor-Weiner said. The cells are processed, and the stem cells isolated and injected back into the patient. The process is called stromal vascular fraction (SVF).
Adult stem cells have the potential to become almost any type of cell, including heart cells and bone cells, researchers say. The hope of stem cell therapy is that these cells will go where they are needed and repair and replace damaged cells.
But Taylor-Weiner said the SVF cells might travel to parts of the body where they're not needed and perhaps damage healthy organs.
The report calls for tighter federal regulations.
According to a statement from the FDA: "Stem cell therapy is a complex and emerging field of medicine. All human cell and tissue products intended for a human recipient are regulated by the FDA. How a product is regulated and whether it needs premarket FDA approval depends on a number of factors."
Without FDA approval, the SVF treatments aren't covered by insurance, so a patient's costs can run from $5,000 to $50,000, according to the report.
"Stem cell therapies represent tremendous potential for medical advance and offer a legitimate basis for hope in areas where current treatments are woefully inadequate," Katz said.
Health Day

Unregulated stem cell treatments can be dangerous

Stem cells have been touted as miracle cures for a variety of diseases, but the field is not as advanced as the public believes, according to the report in the Sept. 10 issue of the New England Journal of Medicine. Patients need to have a healthy dose of skepticism when considering these treatments, Taylor-Weiner said. Conservatively, Taylor-Weiner estimates hundreds of clinics perform unapproved stem cell treatments in the United States. In reality, he said, thousands may operate throughout the country. The U.S. Food and Drug Administration has only approved a few stem cell treatments. The approved procedures utilize cells from bone marrow to treat diseases of the blood or immune system, the report explained. On the other hand, most of the clinics referred to in the new report use fat cells taken from patients during liposuction, Taylor-Weiner said. The cells are processed, and the stem cells isolated and injected back into the patient. The process is called stromal vascular fraction (SVF). Adult stem cells have the potential to become almost any type of cell, including heart cells and bone cells, researchers say. The hope of stem cell therapy is that these cells will go where they are needed and repair and replace damaged cells. But Taylor-Weiner said the SVF cells might travel to parts of the body where theyre not needed and perhaps damage healthy organs. The report calls for tighter federal regulations. According to a statement from the FDA: Stem cell therapy is a complex and emerging field of medicine. All human cell and tissue products intended for a human recipient are regulated by the FDA. How a product is regulated and whether it needs premarket FDA approval depends on a number of factors. Without FDA approval, the SVF treatments arent covered by insurance, so a patients costs can run from $5,000 to $50,000, according to the report. Stem cell therapies represent tremendous potential for medical advance and offer a legitimate basis for hope in areas where current treatments are woefully inadequate, Katz said. Health Day