Are the stem cells used in Mexico for treatment, different from those used in the United States?

What differs is how each country regulates cell therapies, and therefore which products patients can actually access in a clinic. In the United States, culture-expanded donor MSCs are regulated as biological drugs that require FDA approval for each specific use, and so far only one MSC product has been approved, for a rare pediatric transplant complication. As a result, most U.S. clinics outside clinical trials can only offer minimally processed products from the patient's own body, or tissue products that often contain few or no living cells. In Mexico, establishments that obtain, process or apply stem cells operate under sanitary licenses from COFEPRIS, and licensed laboratories can prepare culture-expanded MSCs for clinical use. At Stem Cell Mexico, we use allogeneic MSCs derived from Wharton's jelly (umbilical cord tissue), expanded in a licensed laboratory.

Understanding these differences helps you compare options honestly and ask the right questions, wherever you choose to be treated.

Same cell, different rules

Scientists use common criteria to define MSCs regardless of where they are produced. The International Society for Cellular Therapy (ISCT) established minimal criteria in 2006: the cells must stick to plastic in culture, carry certain surface markers (CD73, CD90 and CD105) and lack others (such as CD34, CD45 and HLA-DR), and be able to become bone, cartilage and fat cells in the laboratory. These criteria are used by laboratories and researchers internationally.

What changes between countries is the regulatory pathway that decides how a cell product can be manufactured, marketed and administered.

How the United States regulates cell products

The U.S. Food and Drug Administration (FDA) classifies human cells and tissues (called HCT/Ps) into two main groups:

• Lower-risk products (often called "361" products) that are minimally manipulated, intended for homologous use (performing the same basic function in the recipient as in the donor), and not combined with other substances. These do not require pre-market approval.
• Higher-risk products (often called "351" products) that are more than minimally manipulated, used for a different function, or have systemic effects. These are regulated as biological drugs and require clinical trials and FDA approval.

Culture-expanded MSCs fall into the second group. The FDA's guidance on minimal manipulation and homologous use explains this distinction in detail.

In December 2024, the FDA approved the first MSC therapy in the United States: remestemcel-L (Ryoncil), a bone-marrow-derived MSC product for children with steroid-refractory acute graft-versus-host disease, a serious complication of bone marrow transplantation. This approval is an important milestone, but it applies only to that product and that specific use.

What this means in U.S. clinics

Because of these rules, many U.S. regenerative clinics outside clinical trials offer:

• Bone marrow aspirate concentrate (BMAC): the patient's own bone marrow, concentrated the same day. It contains a small percentage of MSCs along with many other cells.
• Adipose-derived products: the patient's own fat, minimally processed. More extensively processed fat products, such as enzymatically isolated stromal vascular fraction, have been the subject of FDA enforcement actions.
• Amniotic or cord tissue "allografts": donor tissue products that, depending on processing, may contain few or no living cells.
• Exosome products, none of which are FDA-approved.

The FDA has repeatedly warned consumers that no stem cell or exosome products are approved for orthopedic, neurological or many other conditions, and that some products are marketed illegally.

How Mexico regulates cell therapies

In Mexico, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) oversees cell therapies under the General Health Law. Establishments that obtain, process, store or apply stem cells require a specific sanitary license, and they must comply with requirements such as ethics committee oversight, transplant committee involvement and reporting to the national blood transfusion center. An overview published by the International Society for Cell and Gene Therapy (ISCT) in 2025 describes this framework, notes that Mexico has moved toward stricter oversight, and points out that some aspects of regenerative medicine regulation are still being developed.

It is important to understand what a license means. A sanitary license authorizes a facility to handle and apply cells under defined standards; it is not the same as a drug approval proving that a therapy works for a specific disease. Responsible clinics explain this clearly rather than describing their treatments as "approved" for a condition.

What this means at Stem Cell Mexico

• We use allogeneic MSCs derived from Wharton's jelly, the connective tissue of the umbilical cord, donated after healthy full-term births.
• The cells are expanded in a licensed laboratory to reach therapeutic doses, something U.S. clinics cannot do outside an approved clinical trial.
• Each batch is tested for quality and safety before release.
• Cells are often combined with PRP from your own blood.
• Application follows protocols defined by our medical team, with image guidance when needed.

Why "same cell type" does not mean "same product"

Even when two products both contain umbilical cord MSCs, they can differ in important ways. The donor, the part of the cord used, the culture conditions, how many times the cells were expanded (called passages), how they were stored and transported, and how many cells are alive at the moment of application all influence the final product. A study in Scientific Reports comparing MSCs from bone marrow, adipose tissue and Wharton's jelly found clear differences in growth speed and in the growth factors each type releases, even though all met the standard definition of MSCs. For patients, this means that comparing offers by cell count alone is not enough. Ask where the product comes from and which laboratory prepares it. A provider who is confident in its product will answer these questions openly.

How Europe compares

In the European Union, the European Medicines Agency (EMA) regulates cell-based therapies as Advanced Therapy Medicinal Products (ATMPs), which require centralized authorization based on quality, safety and efficacy data. Like the United States, Europe permits culture-expanded MSCs within clinical trials, specific hospital exemptions or after formal approval.

What the evidence says, regardless of country

The location of treatment does not change the science. Research on MSCs shows:

• A generally favorable safety profile across thousands of trial participants.
• Strongest evidence in areas, such as knee osteoarthritis and degenerative disc disease.
• Growing evidence in neurological, cardiac, autoimmune and healthy-aging uses.

Research also shows that MSC products vary depending on tissue source, donor and laboratory processing. A review in Stem Cells Translational Medicine (Mastrolia and colleagues, 2019) highlights how these factors affect cell behavior and why consistent manufacturing and documentation are essential. This is why it is reasonable for patients to ask detailed questions about the product they will receive.

Advantages and trade-offs for patients

Potential advantages of treatment in Mexico

• Access to culture-expanded donor MSCs at defined doses.
• No need for bone marrow or fat harvesting procedures.
• Lower cost than many comparable programs.
• Proximity to San Diego for U.S. patients.

Trade-offs to consider

• Treatments are not FDA-approved and are generally not covered by U.S. insurance.
• Evidence varies by condition, and outcomes are not guaranteed.
• Patients need to verify licenses, laboratory standards and medical credentials.
• Continuity of care with your home physicians requires good documentation.

Keeping your home doctors informed

Treatment in another country works best when your regular physicians are part of the picture. Before you travel, consider telling your primary care doctor or specialist about your plans, especially if you take blood thinners, immunosuppressants or medications for heart disease or diabetes. After treatment, share your medical report, the documentation of the cells used and your follow-up instructions with them. This helps them interpret any changes, coordinate rehabilitation and respond appropriately if you have questions or side effects once you are home.

Questions to ask any provider, in any country

• What type of cells will I receive, from what source, and are they culture-expanded?
• What sanitary licenses apply to the laboratory and the facility?
• What evidence supports this treatment for my condition?
• What documentation will I receive for my local doctors?

Who may be a candidate

Candidacy depends on your condition and health rather than your country of residence. In general, candidates have a diagnosis that regenerative treatment may reasonably support, no active infection and no cancer history within the past five years.

When patients ask us by email where our cells come from, our answer is always the same: allogeneic mesenchymal stem cells from the Wharton's jelly of donated umbilical cords, processed in a COFEPRIS-licensed laboratory under Good Manufacturing Practice standards. We do not use cord blood, amniotic products or the patient's own cells.

Bottom line

The stem cells themselves are not fundamentally different in Mexico and the United States; the regulations are. U.S. rules limit most clinics to minimally processed or tissue-based products outside trials, while licensed facilities in Mexico can use culture-expanded donor MSCs under COFEPRIS oversight. A medical evaluation can help determine whether this type of regenerative treatment is appropriate for your condition, goals and medical history, and you should always receive clear documentation of the product you are offered.