HomeStem Cells & Exosomes in Oklahoma: FDA Rules and Legal AccessFDA-Approved Stem Cell Therapies: The Complete List

FDA-Approved Stem Cell Therapies: The Complete List

By Alvin Philipose, DC (Ret.), Clinic Director · Part of our guide to Stem Cells & Exosomes in Oklahoma

The FDA publishes a list of every approved cellular and gene therapy product. Most of them are gene therapies or engineered immune cells for cancer. Only a handful are stem cell or tissue-repair cell products, and each is approved for a narrow use. Here they are, current as of October 2026.

Cord blood (blood-forming stem cell) products

These licensed products contain hematopoietic progenitor cells from donated umbilical cord blood. They are approved for unrelated-donor transplantation in patients with disorders affecting the blood-forming system, given at qualified transplant centers.

  • Allocord (SSM Cardinal Glennon Children’s Medical Center)
  • Clevecord (Cleveland Cord Blood Center)
  • Ducord (Duke University School of Medicine)
  • Hemacord (New York Blood Center)
  • HPC, Cord Blood (Clinimmune Labs, University of Colorado Cord Blood Bank)
  • HPC, Cord Blood – MD Anderson Cord Blood Bank
  • HPC, Cord Blood – LifeSouth Community Blood Centers
  • HPC, Cord Blood – Bloodworks
  • Regenecyte (StemCyte)

Omisirge (Gamida Cell) is a processed cord blood product approved for certain patients with blood cancers who are planned for cord blood transplantation.

Mesenchymal stromal cell product

Ryoncil (remestemcel-L, Mesoblast), approved December 2024, is the first FDA-approved MSC therapy. Its approval is limited to steroid-refractory acute graft-versus-host disease in pediatric patients.

Other cell-based tissue products

  • MACI (Vericel): the patient’s own cultured cartilage cells on a collagen membrane, for knee cartilage defects.
  • Lantidra (CellTrans): donor pancreatic islet cells for certain adults with type 1 diabetes who have recurring severe low blood sugar.
  • Gintuit (Organogenesis) and Stratagraft (Stratatech): cell-based products for specific oral and burn wound applications.
  • Laviv (Fibrocell): the patient’s own fibroblasts for nasolabial folds.

What is not on the list

  • Any exosome product
  • Any umbilical cord, Wharton’s jelly or amniotic injection for joints, back pain or chronic illness
  • Any stem cell product for long COVID, autoimmune disease, neuropathy, autism, COPD or anti-aging
  • Stromal vascular fraction (SVF) from fat

If a clinic calls one of these “FDA-approved” or “FDA-registered,” ask for the specific approval. Registering an establishment with the FDA is not product approval.

What this means for you

Outside the approved uses above, stem cell products are investigational. That doesn’t always put them out of reach. Patients can lawfully access investigational products through clinical trials, expanded access, the federal Right to Try Act and, for individualized treatments, Oklahoma’s SB 933 starting November 1, 2026. See how each pathway works.

Questions? Call (405) 848-7246 for a free 15-minute discovery call.

Source: FDA, Approved Cellular and Gene Therapy Products (accessed October 2026). Approved indications are summarized; see each product’s prescribing information for the full approved use. Educational information only.