![]() ![]() “For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.” This is a cord blood product that can be used in a similar fashion to bone marrow or hematopoietic stem cell transplants. ALLOCORD (HPC, Cord Blood), SSM Cardinal Glennon Children’s Medical Center.List of FDA approved stem cell therapies in 2022 Infographic of FDA clinical trial approval process. In 10 years I predict it’s going to be a much longer list. It’s interesting to speculate on how different this list might be in as short as 5 years given the exciting clinical trials that are ongoing now. I’m going to update this post as the agency updates their list. The current list is up to date as of September 1, 2022. The formal FDA list of approved drugs made from stem cells is called, appropriately enough, “ Approved Cellular and Gene Therapy Products.” You can see a help infographic below that my intern Mina made of the clinical trial approval process. RMATs still have to go through the trial approval process but get special consideration. This is also reflected in their Regenerative Medicine Advanced Therapy (RMAT) designation program, which contains both types. Even better news is that there are more approved cell therapies than last time I tried to tackle this topic.Īn interesting side note is that the agency for several years now has been combining together cell and gene therapies into one category. 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
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