On August 28, The National Public Radio and The New York Times, published a very interesting article that we at the Stem Cells Transplant Institute want to make you aware of. The FDA announced a crackdown on stem-cell clinics in the United States that are offering an “unapproved and potentially dangerous” treatment.
A very valuable aspect of the Stem Cell Institute in Costa Rica, is we provide only legally approved therapies. The lack of approval and regulation on stem cell treatments in the USA can lead to fraudulent and unsafe practices. The Stem Cells Transplant Institute provides treatments that have data showing positive results and great promise for the eventual approval by the FDA.
Three of the clinics implicated in the article are StemImmune Inc., California Stem Cell Treatment Centers and Stem Cell of Sunrise.
The key points of the article are highlighted below:
U.S. marshals raided San Diego-based StemImmune Inc. and seized the vaccine, which the FDA said had been combined with stem cells derived from fat to create an unapproved product. The concoction was injected intravenously and directly into patients’ tumors at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the agency said.
FDA said it had “serious concerns” about how StemImmune obtained the smallpox vaccine, which is not commercially available. The vaccine typically is reserved for people at high risk for smallpox, such as members of the military.
StemImmune obtained at least some of the vaccines from the Centers for Disease Control and Prevention, which controls the civilian supply. Thomas Skinner, a CDC spokesman said that the company had requested the vaccine to inoculate researchers who were doing cancer research involving the vaccinia virus.
In recent years, the vaccine, which was used to stamp out smallpox, has increasingly been tested as an anti-cancer tool, including as a way to prompt the immune system to attack malignancies.
In a separate enforcement action, the agency on Monday posted a warning letter issued last week to U.S. Stem Cell of Sunrise, Fla., saying that recent FDA inspections of the clinic found that it was processing stromal vascular fraction —to supposedly treat a variety of serious diseases or conditions, including Parkinson’s disease, ALS, and heart and lung disease.
The FDA said it has not approved any products manufactured by U.S. Stem Cell and that it had documented “significant deviations” from current good manufacturing practices in at least 256 lots of stem cell products. The agency also said the clinic tried to impede the FDA’s investigation by refusing to allow entry except by appointment and by denying FDA investigators access to employees.
The clinic in March was the subject of a New England Journal of Medicine article that said three women with age-related macular degeneration were blinded or had their vision badly damaged after stem cells were injected into their eyeballs.
In a statement, U.S. Stem Cell said that “the safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws” of the FDA. It said that it has never had a “breach of sterility and our facility has demonstrated sterile surgical techniques as required by the state medical boards.”
FDA has approved only a few therapies, mostly for blood disorders in the USA.
Gottlieb, in the statement about the regulation of stem-cell therapies, said that the emerging field of cell-based and so-called regenerative medicine holds “significant promise for transformative and potentially curative treatments” for serious illnesses but that “a small number of unscrupulous actors” is putting the field at risk. He said he is launching a new working group at the FDA “to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health.”
At the same time, he said, the agency will develop a framework to more clearly describe the “rules of the road” for the field and to allow responsible developers of stem-cell treatments to more easily win FDA approval. “The FDA must advance an efficient and least burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation,” he said.
He said, for example, that FDA might not require advance approval for treatments where cells or tissues are extracted and given back to the same individual or when the materials do not undergo significant manufacturing and are intended to perform the same basic functions as they did originally.
A bioethicist at the University of Minnesota said there are hundreds of clinics offering unapproved treatments for a slew of diseases and that patients are being injured. “The question is,” he said, “will the FDA take action on hundreds of these clinics?”
The article highlights a concern about the lack of regulations and the “ethical limits” of many clinics in the USA.
We encourage patients to look for government regulated therapies. The Stem Cells Transplant Institute only provides treatments that have been approved by the Costa Rican government based on data showing positive results and great promise for the eventual approval by the FDA. They just have not reached the stage of FDA approval. Our approach is based on data from trials that have already shown great promise. We are not “experimenting” with completely new procedures that have not been studied or have no data showing positive results. We are a conservative, but cutting edge, stem cell clinic. This is how Dr. Mesen was trained during his stem cell studies in the US. We will be more than happy to give you more information about stem cells therapies. Contact us today.
