![]() The good news today is that the agency has an actual list that is publicly available. The Alliance for Regenerative Medicine has what we might call an international list of cleared cell and gene therapies here. Note that, of course, the US and the FDA are not the only ones in this arena. This fits with the general boilerplate some of us in the stem cell field have used, as noted earlier. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.” Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. “Stem cell products are regulated by FDA, and, generally, all stem cell products require FDA approval. In mid-2020, they issued an advisory, “ Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes.” In it they wrote: So what does the FDA have to say about what they have approved? FDA has regularly warned about unproven stem cells What this means in English is that the products are not regulated as drugs. In actuality at best what some of them sell is not FDA approved, but rather technically compliant with the rules for 361 products. Too often stem cell clinics claim that what they offer is “FDA approved”. We need to turn to the FDA itself for the clearest answer on where things stand now. What about the products? FDA Approved Stem Cell Therapies, key context Leber congenital amaurosis (a retinal disorder).There’s no approval to treat it with fat stem cells, bone marrow, umbilical cord cells or exosomes. For instance just because damaged cartilage is on the list doesn’t mean anything goes. Note that only very specific products matched with specific forms of these diseases have the FDA OK. What about today in 2022? Before we get to the approved products, I made a short list of the diseases treated by stem cells. List of diseases treated by stem cells & FDA approved Note that you can watch me discuss this post in a new YouTube Video below. ![]() In a way these fit into the broader category of regenerative medicine. ![]() There were, however, cellular therapies approved even if not related to stem cells. Other than what I mentioned above, there was nothing else approved that was an actual stem cell therapy. What is in this article?įDA and cell therapies | List of diseases treated by stem cells | Key Context | Cell & Gene Therapies | List of FDA approved therapies 2022 | FDA approved stem cell clinics?| References FDA and cell therapies Today we have more information and the goal of this post is to fill you in on where things stand. Also, “bone marrow transplantation, while not formally approved, is essentially an approved therapy.” Patients and fellow scientists often asked me, but I couldn’t find a list.Īs a result, the generic answer was, “the FDA has approved umbilical cord blood therapies for cancer or immune disorders”. In the past many of us have wished there was a list of FDA-approved stem cell therapies. ![]()
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