This is a question that gets asked often here in the United States and the answer has not always been clear. The fact is that the US Food and Drug Administration (FDA) did approve stem cell therapy, but it is a very specific type of stem cell therapy and it can only be used to treat very specific conditions.
According to the “Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes” that was released by the FDA in July 2020, “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. 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.”
Here’s a video recorded by Dr. Paul Knoepfler, Professor at UC Davis School of Medicine, explaining the list of FDA approved stem cell therapies and the diseases that have been approved to be treated.
Potential Risks of Unproven Stem Cell Treatments
The CDC states the following:
- Injection site reaction
- Failure of the cells to work as expected
- Growth of tumors
- Potential for contamination of the product
- The ability of cells to move from placement sites and multiply or change into inappropriate cell types.
FDA Approved Cellular and Gene Therapy Products
Below is a list of the current approved products as listed on the FDA’s website.
- ABECMA (idecabtagene vicleucel)
- ALLOCORD (HPC, Cord Blood)
- CARVYKTI (ciltacabtagene autoleucel)
- CLEVECORD (HPC Cord Blood)
- Ducord, HPC Cord Blood
- GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
- HEMACORD (HPC, cord blood)
- HPC, Cord Blood
- HPC, Cord Blood – MD Anderson Cord Blood Bank
- HPC, Cord Blood – LifeSouth
- HPC, Cord Blood – Bloodworks
- IMLYGIC (talimogene laherparepvec)
- KYMRIAH (tisagenlecleucel)
- LAVIV (Azficel-T)
- MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)
- PROVENGE (sipuleucel-T)
- TECARTUS (brexucabtagene autoleucel)
- YESCARTA (axicabtagene ciloleucel)
- ZOLGENSMA (onasemnogene abeparvovec-xioi)
Medical Conditions Treatable with Hematopoietic Stem Cells
Hematopoietic stem cells are immature cells that can develop into all types of blood cells and, as mentioned earlier, this is currently the only type of stem cell-based treatment that is FDA Approved. Fortunately just this type of treatment alone is able to treat over 80 medical conditions. Such conditions include leukemias, lymphomas, childhood cancers, anemias, sickle cell disease, inherited platelet anomalies, inherited immune system disorders, inherited metabolic disorders, and more.
The great news is that there is an abundance of studies and clinical trials that continue to show promising results and the list of medical conditions and diseases that can be treated with stem cell therapies will only keep on growing.
Here’s an animated video to help you better understand hematopoiesis.
*** All content on NationalStemCellTherapy.com is for informational purposes only. All medical questions and concerns should always be consulted with your licensed healthcare provider.