Quick answer
Stem cell therapy in Mexico is legal when the product comes from a laboratory licensed by COFEPRIS, Mexico's federal health regulator, and is applied by a physician after a medical review. These therapies are not approved by the U.S. FDA for these uses, and the FDA has reported serious harms from unregulated products. In clinical trials, the most common side effects are temporary pain and swelling at the injection site. Before treatment anywhere, ask for the laboratory's licence, the batch certificate of analysis and the evidence for your condition.
It's the right question to ask. Regenerative medicine is a legitimate field of research, and also one where unregulated products and exaggerated promises have harmed patients.
How it is regulated in Mexico
In Mexico, cell products are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the federal health regulator. Laboratories that collect and bank stem cells need a sanitary licence.
Longevity Clinic works with Stem Biotech S.A. de C.V., which holds:
- 24-TR-25-006-0001, as a collection centre of progenitor or stem cells.
- 24-TR-25-006-0002, as a bank of progenitor or stem cells.
Each vial comes with a certificate of analysis identified by batch. Longevity Clinic is not a laboratory; the licences belong to Stem Biotech.
What the FDA says
The FDA has not approved mesenchymal stem cell, exosome or growth factor therapies for orthopedic, aesthetic or most other uses, and it warns consumers about unapproved products, including reports of blindness, infections and tumors linked to unregulated clinics. We share that warning openly: it's the reason to choose carefully.
Known risks
In a 2026 meta-analysis of 28 knee trials, the most frequent adverse effects were temporary injection-site pain and joint swelling, more often than with control injections. As with any injection, there is a small risk of infection or allergic reaction. Products without quality control add risks such as contamination, which is why traceability matters.
What to ask any clinic
- Who reviews my case, and what are their credentials?
- Which laboratory makes the product, and can I see its licence?
- Can I see the certificate of analysis of my batch?
- What do clinical trials show for my condition, including negative ones?
- What are the risks, and what does the total cost include?
Full checklist: questions to ask before stem cell therapy.
What we don't do
We don't offer cell therapies for neurological diseases or cancer, we don't promise cures, and we don't apply anything without a prior medical review. Meet our medical director.
Frequently asked questions
Can I see the product's documents before treatment?
Yes. At Longevity Clinic you can ask for the laboratory's COFEPRIS licence numbers and the certificate of analysis of the batch that will be applied to you. Any serious clinic should show them.
What happens if I have a reaction?
The physician monitors you during and after the application. Once home, you keep direct contact with the medical team by WhatsApp, and for any urgent symptom you should seek local care right away.
Who should not receive these therapies?
People with active infection or active cancer, pregnant women and anyone whose condition has no supporting evidence, among others. The doctor reviews your history before proposing any protocol.
Sources
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies.
- Awad G, et al. Efficacy and safety of intra-articular mesenchymal stem cell-based therapies in knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Clinical Rheumatology, 2026.
- International Society for Stem Cell Research (ISSCR). A Closer Look at Stem Cells: patient resources.