Is this a certified stem cell treatment center?

In Mexico, establishments that obtain, process, store or apply stem cells must hold a specific sanitary license, and the laboratory that prepares our cells, which come exclusively from Wharton's jelly (donated umbilical cord tissue), operates under a COFEPRIS sanitary license and Good Manufacturing Practice (GMP) standards. It is equally important to understand what a license means and what it does not: a sanitary license authorizes a facility to handle and apply cells under defined standards, but it is not the same as a drug approval proving that a therapy works for a specific disease. License numbers can be reviewed in person at our facilities, and you can request more information at info@stemcellmexico.org.

Because "certified" is used loosely in the stem cell industry, this guide explains how regulation works in Mexico, what you can verify yourself and which questions protect you when choosing any clinic.

Who regulates stem cell treatment in Mexico

COFEPRIS is the federal agency responsible for protecting the population against health risks. Under Mexico's General Health Law, it oversees medicines, medical devices, health establishments and the use of human cells and tissues. For cell therapy, a 2025 regulatory update published by the International Society for Cell and Gene Therapy (ISCT) describes the main requirements:

• A sanitary license for establishments that handle human cells.
• Oversight by an institutional ethics committee and a hospital transplant committee.
• Reporting to Mexico's national blood transfusion center.

The same update notes that Mexico has moved toward stricter oversight in recent years, that some aspects of regenerative medicine regulation are still being developed, and that some private clinics have misrepresented a banking or establishment license as approval of their treatments. That last point is exactly why we prefer to explain the difference clearly.

The Mexican government lists the procedure to obtain a sanitary license for health establishments that handle stem cells (COFEPRIS-09-026-B) among its official procedures, which confirms that a specific license is required for this activity.

What "licensed" means, and what it does not

What a license means

• The facility has been authorized to perform defined activities with human cells.
• It must meet requirements for infrastructure, personnel, processes and record-keeping.
• It is subject to inspection and oversight by the health authority.

What a license does not mean

• It does not mean that a specific therapy has been proven effective for a specific disease.
• It does not replace clinical evidence, informed consent or individual medical judgment.

A responsible clinic explains this distinction and does not describe its treatments as "approved to cure" a condition.

How the laboratory fits in

The quality of a cell therapy depends heavily on the laboratory that prepares the cells. Our cells are prepared by a stem cell laboratory with a biosafety level 2 (BSL-2) facility, a COFEPRIS sanitary license and GMP standards. In practice, this involves:

• Donor screening and infectious disease testing of donated umbilical cord tissue.
• Controlled processing: isolation and expansion of mesenchymal stromal cells (MSCs) under defined conditions.
• Release testing: identity, cell count, viability and sterility before cells are used.
• Traceability: batch records linking each treatment to its documentation.

Our cell product

• Source: exclusively Wharton's jelly from umbilical cords donated with consent after healthy, full-term births.
• Screening: donor history review and infectious disease testing.
• Preparation: isolation and controlled expansion to the dose prescribed by your doctor.
• Release testing: identity, cell count, viability and sterility.

We use a single, well-characterized source rather than offering multiple cell types, so preparation, documentation and protocols remain consistent.

What GMP and BSL-2 mean in plain terms

Good Manufacturing Practice (GMP) is a quality system used worldwide for producing medicines and biological products. It requires written procedures for every step, trained personnel, controlled clean environments, validated equipment, quality testing before release and detailed records, so that each batch is made the same way and any problem can be traced. Biosafety level 2 (BSL-2) describes laboratory containment practices for working safely with human biological materials that may carry moderate risks, including protective equipment, controlled access and proper waste handling. Together, these standards are designed to protect both the product and the people who handle it. They do not by themselves prove that a therapy is effective, but they are an important foundation for a consistent, documented cell product.

Who performs the treatment

Treatments are reviewed and performed by specialists in the relevant field rather than by general practitioners alone, for example pain medicine and interventional specialists for joint and spine procedures. In Mexico, every physician must hold a professional license (cédula profesional), and specialists hold an additional specialty license. These can be verified in the national professional registry of Mexico's Secretariat of Public Education (SEP). We encourage patients to ask for the name of the physician who will perform their procedure and to verify their credentials.

International patients and logistics

Most of our patients travel from the United States and Canada. Our location in Tijuana, minutes from the San Diego border, allows patients to fly into San Diego International Airport and be driven to our facilities by our team. Coordinators help with travel documents for crossing the border, recommend nearby hotels, arrange transportation between San Diego and the clinic and plan departure times that allow a final check-up before you leave. A medical pass is arranged when applicable to make the return crossing easier. Communication is available in English and Spanish by phone, email and messaging. Because care often continues at home, we provide documentation in a format your local doctors can review.

How regulation compares with other countries

• United States: the FDA regulates culture-expanded MSCs as biological drugs that require approval for each use. Only one MSC product has been approved so far, in 2024, for a pediatric transplant complication. The FDA has warned consumers about unapproved stem cell and exosome products, including those marketed by U.S. clinics.
• European Union: the European Medicines Agency regulates cell therapies as advanced therapy medicinal products, generally used within trials, hospital exemptions or after approval.
• Mexico: licensed establishments may handle and apply stem cells under COFEPRIS oversight, which is why culture-expanded donor MSCs are available in licensed settings.

No country's license guarantees results. In every system, patients should look for transparency, documentation and evidence.

How to verify a stem cell clinic

The International Society for Stem Cell Research (ISSCR) encourages patients to ask detailed questions before any treatment. Practical steps include:

1. Ask which licenses apply to the facility and to the laboratory, and review them during your visit.
2. Ask who will perform the procedure and verify the physician's professional and specialty licenses.
3. Ask where the procedure will take place, for example a clinic or a hospital for fluoroscopy-guided spine procedures.
4. Ask for the evidence supporting the treatment for your specific condition.
5. Read the consent form and policies for deposits, cancellations and follow-up.
6. Be cautious with guaranteed results, pressure to pay quickly or vague answers.

Red flags in any clinic

• Claims that treatments are "FDA-approved" for conditions where no such approval exists.
• Describing a facility license as proof that a treatment cures a disease.
• Refusing to say who performs the procedure or where cells come from.
• No medical evaluation before quoting.
• Testimonials presented as scientific evidence.

Our commitments to patients

• Honest eligibility: not everyone is a candidate, and we decline treatment when we believe it is unlikely to help or when risks outweigh benefits.
• Transparent pricing: a written quote before any deposit, with inclusions and exclusions clearly listed.
• Clear information about evidence: we distinguish between conditions with maturing evidence and those where research is early.
• Documentation: a medical report and cell documentation after treatment.
• Accessibility: licenses available for review in person, and a team available to answer questions.
• Continuity: structured follow-up after you return home and coordination with your local physicians when you request it.

What the evidence says about safety

Large analyses of randomized trials have found that MSC therapy has a favorable safety profile, with temporary fever as the most consistent side effect after intravenous infusion and no increased rates of serious infection, thrombosis, cancer or death in controlled trials. Effectiveness varies by condition: evidence is most mature for knee osteoarthritis and degenerative disc disease.

What happens if something goes wrong

A trustworthy clinic plans for complications before they happen. Before treatment, you should know who to contact, by phone and email, if you develop symptoms after returning home, and how quickly you can expect a response. During your stay, nursing and medical staff monitor your response, and procedures that require hospital resources, such as fluoroscopy-guided spine injections, are performed in a hospital setting. After treatment, your medical report and cell documentation allow your local doctors to understand exactly what you received. Ask the clinic how adverse events are documented and reported, as transparent reporting is part of responsible practice.

Privacy and patient rights

Your medical information is confidential and protected under Mexican privacy law. It is shared only with the professionals involved in your care and, with your consent, with your own doctors. You have the right to ask questions, to receive information about risks and alternatives, to review your consent documents before signing, to request copies of your medical report and to decline or postpone treatment at any time before the procedure, subject to the deposit and cancellation terms provided in writing.

What this means for you

Choosing a licensed facility is a necessary first step, but it is not the only one. Combine regulatory verification with clear information about the cells, the physician, the evidence and the follow-up plan. A clinic that welcomes these questions is more likely to put your safety first. If you are traveling from another country, it is also wise to tell your own doctor about your plans, bring copies of your records and keep the documentation you receive, so your care continues smoothly once you return home.

Questions to ask during your evaluation

• Which COFEPRIS licenses apply to your facility and laboratory, and can I see them?
• Who will perform my procedure, and what are their credentials?
• What testing is performed on the cells, and what documentation will I receive?
• What evidence supports this treatment for my condition?
• What happens if I have a complication after I return home?

Bottom line

Stem Cell Mexico operates under COFEPRIS sanitary licensing, with cells prepared by a licensed laboratory under GMP standards and treatments performed by specialists. A license confirms that a facility is authorized to handle and apply cells, not that a therapy is guaranteed to work, which is why we encourage every patient to verify credentials and ask about evidence. A medical evaluation can help determine whether this type of regenerative treatment is appropriate for your condition, goals and medical history.