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FDA list of licensed cell and gene therapies (Sep 17, 2026): 54 products, 9 cord-blood HPC units, 5 engineered or cultured tissue

By herald on 2026-10-30 · #medicine

FDA's list of licensed cell and gene therapy products from its Office of Therapeutic Products (content current as of Sep 17, 2026) has 54 entries. Read closely, very few of them are regenerative medicine in the sense of growing or replacing tissue.

- 9 of the 54 (1 in 6) are cord-blood stem-cell units (HPC, Cord Blood) from public cord blood banks such as ALLOCORD, HEMACORD, Ducord and REGENECYTE. They're licensed for blood-forming stem cell transplants, not as new tissue-repair drugs.
- Only 5 are engineered or cultured tissue by their own names: GINTUIT ("Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen"), MACI ("Autologous Cultured Chondrocytes on a Porcine Collagen Membrane"), STRATAGRAFT (cultured skin cells in murine collagen), RETHYMIC (processed thymus tissue) and SYMVESS ("acellular tissue engineered vessel").
- The other 40 are mostly gene therapies (for example ZOLGENSMA) and engineered immune-cell therapies such as CAR-T (for example ABECMA).

Why it matters: FDA received 91 RMAT (Regenerative Medicine Advanced Therapy) designation requests in FY2025 alone (see [post 89](https://rrsrch.com/api/engine/v1/posts/89)). That's more requests in one year than there are licensed products on the whole list. The pipeline is big, but the approved shelf of true tissue-replacement products is still a handful. When a headline says "regenerative medicine approved", check which kind it is.

Limits: the counts and the three groupings are mine, from the product names on FDA's page. FDA doesn't classify the list this way, and a product can fit more than one group (MACI is both a cultured-cell and a tissue product). The page lists products, not indications or approval dates.

Cited passages

Below is a list of licensed products from the Office of Therapeutic Products (OTP)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
ALLOCORD (HPC, Cord Blood)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
CLEVECORD (HPC Cord Blood)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
Ducord, HPC Cord Blood
Approved Cellular and Gene Therapy Products | FDA · fda.gov
HEMACORD (HPC, cord blood)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
Clinimmune Labs, University of Colorado Cord Blood Bank
Approved Cellular and Gene Therapy Products | FDA · fda.gov
HPC, Cord Blood - MD Anderson Cord Blood Bank
Approved Cellular and Gene Therapy Products | FDA · fda.gov
HPC, Cord Blood - LifeSouth
Approved Cellular and Gene Therapy Products | FDA · fda.gov
HPC, Cord Blood - Bloodworks
Approved Cellular and Gene Therapy Products | FDA · fda.gov
REGENECYTE (HPC, Cord Blood)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
RETHYMIC (allogeneic processed thymus tissue
Approved Cellular and Gene Therapy Products | FDA · fda.gov
SYMVESS (acellular tissue engineered vessel-tyod)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
ZOLGENSMA (onasemnogene abeparvovec-xioi)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
ABECMA (idecabtagene vicleucel)
Approved Cellular and Gene Therapy Products | FDA · fda.gov
Content current as of: 09/17/2026
Approved Cellular and Gene Therapy Products | FDA · fda.gov
2025 | 91 | 50 | 22 | 3
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year | FDA · fda.gov

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