Regulatory Status of Regenerative Products by Product and Indication

How to read a regulatory statement

A regulatory status is only meaningful with four details: the country or region, the exact product, the exact use (indication), and the date. "Approved" for one product and one indication does not carry over to similar-sounding products or other uses. A clinic offering a treatment, a trial registration, or a company registration does not establish approval. The FDA says a firm registering and listing a product does not mean it is legally marketed. [1] Laws change, and this page is information, not legal advice. All sources were read on 2026-10-22.

Examples of approved regenerative products

The FDA's list of approved cellular and gene therapy products (content current as of September 17, 2026) also includes cell-based gene therapies for cancers and blood disorders, which are outside this page's topic. [6] Each product has its own indication; read the label before assuming anything about use.

For Holoclar, the EMA states that the authorization was first conditional and was switched to standard after the company provided additional requested data. [5] It must be given by a trained eye surgeon in a hospital to the patient whose own cells were used. [5]

What is not approved

• Exosome products (US): the FDA says there are currently no FDA-approved exosome products. [7]
• Stem cell, fat-derived, cord blood, amniotic fluid and Wharton's jelly products for common conditions (US): the FDA says none of these regenerative products have been approved for the treatment of orthopedic conditions such as osteoarthritis or back pain, neurological disorders such as MS, ALS, Alzheimer's or Parkinson's, cardiovascular or lung diseases, autism, macular degeneration, chronic pain or fatigue. [8] That alert is dated 2020; check the FDA for any later approvals. For example, the later Ryoncil approval concerns a single blood-transplant complication in children, not those conditions. [3]

United States: HCT/P rules in plain terms

Human cells, tissues and cellular and tissue-based products are called HCT/Ps. The regulation defines them as articles containing or consisting of human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient. [9] An HCT/P is regulated "solely under section 361" (a lighter set of tissue rules) only if it meets all of these criteria: [10]

• It is minimally manipulated.
• It is intended for homologous use only.
• It is not combined with another article, with limited exceptions such as water or storage agents.
• Either it has no systemic effect and does not depend on living cells' metabolic activity for its main function, or, if it does, it is for autologous use, a first- or second-degree blood relative, or reproductive use.

"Homologous use" means repair, reconstruction, replacement or supplementation with an HCT/P that performs the same basic function in the recipient as in the donor. [9] Minimal manipulation for cells means processing that does not alter their relevant biological characteristics. [9]

HCT/Ps that do not meet all criteria are regulated as drugs, devices or biological products and are subject to premarket review unless an exception applies. [11] One exception in the regulations covers an establishment that removes HCT/Ps from a person and implants them into the same person during the same surgical procedure. [12] The FDA has published guidance on how it reads these terms, including on minimal manipulation, homologous use and that exception. [13] We did not read those guidance texts in full, so this page does not apply them to any specific procedure.

Example of application: in May 2026 the FDA told one firm that its cord blood product did not meet the homologous-use criterion and so was not regulated solely under section 361. [11] That is the FDA's position in a warning letter, not a court ruling.

RMAT designation is not approval

A drug can qualify for Regenerative Medicine Advanced Therapy (RMAT) designation if it is a regenerative medicine therapy (such as a cell therapy or tissue-engineered product), intended to treat a serious or life-threatening condition, and preliminary clinical evidence suggests potential to address unmet needs. [14] The request is made with an Investigational New Drug application. [14] The FDA describes expedited programs for regenerative therapies, including RMAT, in its framework. [13] Designation therefore describes a development program, not a marketed or proven product.

European Union, United Kingdom and Canada

• European Union (EMA): advanced therapy medicinal products are gene therapies, somatic cell therapies and tissue-engineered medicines. [15] Under the EU ATMP Regulation, a marketing authorization must be obtained before an ATMP is marketed, and approved ATMPs are authorized centrally through the EMA. [15]
• United Kingdom (MHRA): the MHRA is the competent authority for ATMPs. Unlicensed ATMPs can be made available by the hospital exemption (for non-routine preparation for a specific patient in a hospital) or the "specials" scheme, both requiring a manufacturer's licence. [16]
• Canada (Health Canada): in a May 2019 notice, Health Canada said all cell therapies are considered drugs, and listed Prochymal, Kymriah and Yescarta as authorized at that time. [17] That notice is old; check Health Canada's Drug Product Database for current authorizations. A July 2019 notice said platelet-rich plasma is not a cell therapy under its autologous cell therapy policy, that its preparation by physicians for the same patient is regulated provincially, and that Health Canada had not reviewed evidence for PRP therapeutic uses. [18]
• Australia and other countries: not verified. Proper evidence not found in readable regulator pages this session; the TGA site could not be reached.

What to check for any product

1. Which regulator, which product name, which indication, and which date?
2. Is it an approved product, a product in an authorized clinical trial, or neither? See cell-therapy clinical trials vs commercial treatments.
3. Do the marketing claims match the approved indication?

Related guides

Concepts are in what is regenerative medicine, mesenchymal stromal cell research and established blood stem-cell transplantation. Risks of unapproved offerings are in unapproved clinics and medical tourism.