List of FDA approved stem cell therapies in 2022
ALLOCORD (HPC, Cord Blood), SSM Cardinal Glennon Children’s Medical Center. “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.
BREYANZI. Juno Therapeutics, Inc., a Bristol-Myers Squibb. This is a CAR-T-cell therapy for adults with relapsed or refractory large B-cell lymphoma that has failed to respond to at least 2 other therapies.
CLEVECORD (HPC Cord Blood), Cleveland Cord Blood Center. Similar to ALLOCORD.
Ducord, HPC Cord Blood, Duke Med School, Similar to ALLOCORD.
GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), Organogenesis. The FDA says as to uses, “Is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.” This is hard to understand though. In a nutshell this product treats receding gums, which can be a serious problem. Traditional approaches are painful and don’t always work so this product fills a nice niche. Note that it is an acellular scaffold.
HEMACORD (HPC, cord blood), New York Blood Center. This and the four HPCs that follow are similar to ALLOCORD.
HPC, Cord Blood, Clinimmune Labs, University of Colorado Cord Blood Bank.
HPC, Cord Blood – MD Anderson, MD Anderson.
HPC, Cord Blood – LifeSouth, LifeSouth Community Blood Centers, Inc.
HPC, Cord Blood – Bloodworks, Bloodworks.
IMLYGIC (talimogene laherparepvec), BioVex, subsidiary of Amgen. An oncolytic gene therapy product for treatment of melanoma.
KYMRIAH (tisagenlecleucel), Novartis. CAR-T cell therapy for B-cell acute lymphoblastic leukemia (B-Cell ALL).
LAVIV (Azficel-T), Fibrocall Technologies. It is used for treatment of the deep wrinkles some of us get as we age to the sides of our noses.
LUXTURNA, Spark Therapeutics. A gene therapy for the treatment of Leber congenital amaurosis, an eye disorder that affects the retina and causes vision loss from a young age.
MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane), Vericel. An autologous therapy (the product uses a processed form of your own cartilage cells) for treatment of damaged cartilage.
PROVENGE (sipuleucel-T), Dendreon Corp. An immunotherapy against prostate cancer. The FDA calls it, “an autologous cellular immunotherapy designed to stimulate a patient’s own immune system against cancer.” As a prostate cancer survivor myself it really hits home how few options there can be for advanced cases.
TECARTUS (brexucabtagene autoleucel), Kite Pharma. A CAR-T therapy for treatment of adult patients with relapsed/refractory mantle cell lymphoma.
YESCARTA (axicabtagene ciloleucel), Kite Pharma. CAR-T for large B-cell lymphoma that hasn’t responded to other therapy.
ZOLGENSMA (onasemnogene abeparvovec-xioi), AveXis. Also known as Nusinersen, this is drug is related to Spinraza. It was the first therapy approved for SMA or spinal muscular atrophy. As an antisense oligonucleotide therapy, it is a novel approach. You can see a video from the MDA about this above.
List of FDA approved stem cell clinics