Are your stem cells certified?

They are prepared by a stem cell laboratory that operates under a sanitary license from COFEPRIS, Mexico's federal health regulator, and under Good Manufacturing Practice (GMP) standards. Each batch goes through donor screening, infectious disease testing, and release testing for identity, cell count, viability and sterility before it is used. "Certified," in this context, means that the cells are produced by a licensed laboratory, meet defined quality criteria and are traceable. It does not mean that a regulator has approved the cells as a cure for a specific disease, and no stem cell product for the conditions we treat has that kind of approval in the United States or Europe.

Because the word "certified" is used loosely in the stem cell industry, this guide explains what quality standards apply to cell products, how our cells are tested and documented, and what questions to ask any provider.

Why certification of the cell product matters

In cell therapy, the product is alive, variable and sensitive to how it is handled. A review in Stem Cells Translational Medicine (Mastrolia and colleagues, 2019) describes how MSC characteristics depend on the tissue source, the donor and laboratory processing, such as culture conditions and the number of times cells are expanded. Two products that are both called "umbilical cord stem cells" can differ in how many cells are alive, how pure the population is and whether they were tested for contamination. Quality standards exist to make the product consistent, safe and traceable.

What standards apply to our cells

Laboratory licensing

In Mexico, establishments that obtain, process, store or apply stem cells require a specific sanitary license from COFEPRIS. Our laboratory holds this license and operates with a biosafety level 2 (BSL-2) facility, which describes containment practices for working safely with human biological materials.

Good Manufacturing Practice (GMP)

GMP is a global quality system for medicines and biological products. It requires written procedures for every step, trained personnel, controlled clean environments, validated equipment, testing before release and complete records, so each batch is produced the same way and any issue can be traced back.

International definition of MSCs

The International Society for Cellular Therapy (ISCT) defined minimal criteria for MSCs in 2006: cells must adhere to plastic in culture, express the markers CD73, CD90 and CD105, lack blood cell markers such as CD34, CD45 and HLA-DR, and be able to become bone, cartilage and fat cells in the laboratory. In 2019, the ISCT also recommended clearer naming and reporting of the tissue source and functional properties. These criteria are the scientific reference for characterizing MSC products.

How our cells are prepared and tested

1. Donor selection and consent: umbilical cords are donated with informed consent after healthy, full-term births.
2. Donor screening and infectious disease testing: maternal history is reviewed and tissue is tested for infections such as HIV, hepatitis B and C and syphilis.
3. Isolation: MSCs are separated from the Wharton's jelly.
4. Controlled expansion: cells are grown to therapeutic numbers under defined conditions, including low-oxygen (hypoxic) culture, with the number of growth cycles (passages) controlled.
5. Release testing: identity, cell count, viability (percentage of living cells) and sterility.
6. Preparation for your date: cells are prepared for your scheduled treatment and handled under controlled conditions until application.

7.

How cells are handled between the laboratory and you

Quality does not end when a batch leaves the laboratory. MSCs are living cells, and their viability can drop if they are exposed to the wrong temperature, delayed too long or handled roughly. For this reason, cells are prepared specifically for your scheduled date, transported under controlled conditions and kept in the appropriate medium until the moment of application. This is also why a deposit is requested in advance and why last-minute cancellations are costly: the batch has already been prepared for you. On the day of treatment, the medical team confirms your identity and the batch information before application, closing the chain of custody that begins with the donor and ends with you.

What documentation you receive

• A record of the cell dose you received.

• Your medical report describing the procedure.

Before booking, you can also ask to see a redacted example of a quality-control certificate so you know what information it contains. For confidentiality and regulatory reasons, some internal documents, such as the laboratory's full legal identity or license numbers, are not distributed electronically, but licenses can be reviewed in person at our facilities.

What certification does not mean

It is important to be precise:

• It is not drug approval. A licensed laboratory and GMP standards mean the cells are produced under quality controls, not that a regulator has approved them for a specific disease.
• It is not an FDA approval. The FDA regulates culture-expanded MSCs as biological drugs that require approval for each use. Only one MSC product has been approved in the United States, in 2024, for a pediatric transplant complication. No MSC product is FDA-approved for orthopedic, neurological, cardiac or wellness uses.
• It is not a guarantee of results. Even a high-quality product will not help every patient.

Statements suggesting that a cell product "operates under FDA standards" or carries U.S. tissue bank accreditation should be verified carefully, because these are specific regulatory statuses. We prefer to describe our product by what can be documented: the source, the laboratory license, the quality system, the testing and the batch records.

Why we use only Wharton's jelly MSCs

Working with a single, well-characterized source allows consistent preparation and documentation. Wharton's jelly MSCs come from young tissue, can be expanded efficiently to defined doses, and do not require any harvesting procedure from you. A comparative study in Scientific Reports (Petrenko and colleagues, 2020) found that Wharton's jelly MSCs grow faster than bone marrow MSCs and secrete high levels of several growth and neurotrophic factors, while all sources studied showed meaningful regenerative potential.

Viability: what the numbers mean

Viability is the percentage of cells that are alive at a given moment. Our laboratory reports viability of up to 98% at release, with only a small expected loss before application. Viability matters because only living cells can release the signals that make MSCs useful. A high number of cells with low viability can deliver fewer active cells than a smaller dose with high viability.

Exosomes and other cell-derived products

Some clinics market exosomes, secretomes or tissue extracts as alternatives to stem cells. These are cell-free products: they may contain signaling molecules released by cells, but they are not living cells. Their manufacturing, testing and evidence are different, and in the United States no exosome product is FDA-approved. When exosomes are used in a protocol at Stem Cell Mexico, they are listed separately from cells in your plan, so you always know exactly what you are receiving.

Red flags in cell products

• No information about the cell source, donor screening or testing.
• Claims of "FDA-approved" stem cells for conditions where no such approval exists.
• Very high cell counts without viability data.
• Products described as "stem cells" that contain few or no living cells, such as some tissue-derived or exosome products.

The FDA has warned consumers about unapproved stem cell and exosome products marketed with unsupported claims, and the International Society for Stem Cell Research (ISSCR) recommends asking detailed questions about any product before treatment.

What the evidence says about safety

Large analyses of randomized trials show that MSCs have a favorable safety profile, with temporary fever as the most consistent side effect of intravenous infusions and no increased rates of infection, thrombosis, cancer or death in controlled trials. Product quality is a key reason these results can be reproduced.

How our team describes the cells

When patients ask us by email where our cells come from, this is our answer:

• Source: allogeneic mesenchymal stem cells from the Wharton's jelly of donated umbilical cords, obtained after healthy, full-term births with the mother's informed consent and donor screening. The cells come from the cord tissue, not from cord blood.
• Only one cell type: we do not use the patient's own cells (fat or bone marrow), and we do not use amniotic products.
• Laboratory: cells are processed in a COFEPRIS-licensed laboratory under Good Manufacturing Practice standards, with quality and safety testing before release.
• Exosomes: when a plan includes exosomes, they are derived from the same umbilical cord MSCs.

This answer is the same for every condition and every patient.

Questions to ask during your evaluation

• Where do the cells come from, and how are donors screened?
• Which licenses and quality standards apply to the laboratory?
• What documentation will I receive after treatment?

Bottom line

Our cells are certified in the sense that matters for quality: they come exclusively from Wharton's jelly, are produced by a COFEPRIS-licensed laboratory under GMP standards, are tested before release and are documented for each patient. Certification is not the same as drug approval or a guarantee of results. A medical evaluation can help determine whether this type of regenerative treatment is appropriate for your condition, goals and medical history.