Is stem cell therapy legal in Mexico?

Licences exist, but the rules behind them were never written. Mexican law has licence types for stem cell banks and regenerative medicine clinics, and an application is treated as granted if COFEPRIS does not answer within 45 working days.^[3]^[4]

The standard that was meant to set what those licences require, NOM-260, was cancelled in 2018 and never replaced.^[1] COFEPRIS says stem cell treatments lack authorisation because their efficacy is not proven, and that it has approved no clinical protocol for any stem cell treatment.^[2]^[5] The only use the health ministry has called approved is umbilical cord cells for children with blood diseases.^[6]

Selling cells is a crime under Mexican law, but clinics may charge for collecting, processing and supplying them, which is how treatments are priced.^[3]^[7]

How to check a clinic yourself

There is no public register of licensed clinics in Mexico. In a 2019 survey of 110 Tijuana clinic websites, 13 claimed to be licensed and only one matched the licensing information researchers could find.^[8]

Does the clinic hold a health licence? Ask for the licence number and the COFEPRIS form it was issued under. Where: COFEPRIS, by information request.

Is the cell product registered? A registered medicine has a registro sanitario number. Where: COFEPRIS registry.

Is there a stem cell committee? Required since 2026 for clinics that infuse stem cells. Where: Ask the clinic to show it.

Is it a real trial? Ask for the protocol number and ethics approval. Where: COFEPRIS; ClinicalTrials.gov.

Infections after treatment in Mexico

A patient who travelled from Colorado for spinal stem cell injections developed a bacterial meningitis, and US health investigators traced a cluster of the same infection to stem cell clinics in Baja California in 2022.^[9]^[10] In our review of patient accounts, 5 of 7 first-hand infection reports followed treatment in Mexico.^[11]

Conditions treated in Mexico

Knee3 clinics · from USD 2,325

Multiple sclerosis4 clinics · from USD 11,500

Back pain3 clinics · from USD 1,425

Autism0 clinics

Diabetes3 clinics · from USD 11,500

Questions to ask a clinic in Mexico

What is your COFEPRIS licence number, and which form was it issued under?
Who is your responsable sanitario?
Is the cell product registered? If not, is this a research protocol with ethics approval?
Which lab made the cells, and can I see the certificate for my batch?
For spinal injections: what do you do to prevent infection?
Who follows me up after I fly home, and how?

Sources

11 references

Secretaría de Economía, Dirección General de Normas, Comisión Nacional de Normalización. SUPLEMENTO del Programa Nacional de Normalización 2018. Diario Oficial de la Federación, 2018. Link
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). La COFEPRIS suspendió clínica del D.F. que ofrecía tratamientos con Células Madre sin aval científico. Gobierno de México, COFEPRIS (press release, Comunicado 114), 2015. Link
Congreso de la Unión, Estados Unidos Mexicanos. Ley General de Salud (texto vigente, última reforma publicada DOF 07-06-2024). Diario Oficial de la Federación / Orden Jurídico Nacional, Secretaría de Gobernación, 2024. Link
Secretaría de Salud, Estados Unidos Mexicanos. ACUERDO por el que se modifica el diverso por el que se dan a conocer los trámites y servicios, así como los formatos que aplica la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios, inscritos en el Registro Federal de Trámites y Servicios de la Comisión Federal de Mejora Regulatoria, publicado el 28 de enero de 2011. Diario Oficial de la Federación, 2016. Link
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). AVISO A LA POBLACIÓN: Terapias con células madre para la cura de la enfermedad asociada a COVID-19. Gobierno de México, COFEPRIS, 2020. Link
Secretaría de Salud, Gobierno de México. 318. Uso de células madre contará con marco regulatorio. Gobierno de México, Secretaría de Salud (press Release No. 318), 2018. Link
Mansilla-Olivares A, et al. Posición de la Academia Nacional de Medicina de México con el fin de regular el uso de células troncales y de embriones humanos para fines terapéuticos o de investigación. Gaceta Médica de México, 2018. Link
Chavez J, et al. Online marketing practices of regenerative medicine clinics in US-Mexico border region: a web surveillance study. Stem Cell Research & Therapy, 2021. Link
Wolf AB, et al. Mycobacterium abscessus Meningitis Associated with Stem Cell Treatment During Medical Tourism. Emerging Infectious Diseases, 2023. Link
Nguyen MH, et al. Notes from the Field: Potential Outbreak of Extrapulmonary Mycobacterium abscessus subspecies massiliense Infections from Stem Cell Treatment Clinics in Mexico - Arizona and Colorado, 2022. MMWR. Morbidity and Mortality Weekly Report, 2024. Link
StemFinder review of first-hand patient accounts on Reddit and patient forums, 2026. Method

Stem cell therapy in Mexico.

6 clinics in Mexico.