CAR-T Clinical Trial in Mexico: What Cofepris Teaches Us

On October 1, 2026, Cofepris authorized a CAR-T clinical trial: protocol CARLLA-B1, number 7192, to be carried out by UANL at its University Hospital. It is the first clinical trial in Mexico using CAR-T cells of domestic manufacture. The case helps illustrate something that is often confused: what separates an authorized investigation from a treatment offered in the clinic, and why that difference matters for patients and physicians.

01What Cofepris authorized in this CAR-T clinical trial, and what it did not

The protocol aims to evaluate the preliminary safety and efficacy of the MB-CART19.1 therapy, a type of T cells modified with a chimeric antigen receptor, in adults with acute lymphoblastic leukemia that has returned after treatment or did not respond to it. Participation is limited to those who meet the protocol criteria and agree to enter the study.

It is worth stressing what the authorization does not mean. It does not turn these cells into a treatment available to any patient with leukemia. The therapy remains experimental within the project, and the hospital will oversee the entire process: obtaining lymphocytes, genetic modification, quality control and administration.

02From the laboratory to the patient's bedside

Cofepris describes UANL's development as a sequence of stages. Each one serves a different function, and none can be skipped if the goal is a serious therapy.

1. 1Transfer and standardizationThe technology is adopted and procedures are set so they can be repeated. In 2023, UANL obtained the first import permit in Mexico for a lentiviral vector for this purpose.
2. 2Validation of manufacturing and quality controlIt is demonstrated that the process produces the same product, with the same tests, batch after batch.
3. 3Preclinical evidenceThe product is studied before being administered to people, to generate data on safety and activity.
4. 4Protocol reviewCofepris reviews the scientific, technical and ethical aspects of the study before authorizing it.
5. 5Clinical trial with monitoringThe product is applied only to patients who meet the criteria, under regulatory supervision and with safety measures in place.

The sequence reduces uncertainty step by step. When a stage is missing or not documented, the risk to the patient rises, even if the product seems promising.

03Authorized research is not the same as an available therapy

The table is a general guide. Each case must be evaluated by a physician, and results can vary from one person to another. No protocol guarantees a benefit.

04How Cofepris regulates cell research

Cofepris is the federal agency that authorizes health research protocols in Mexico. The National Center for Blood Transfusion takes part by proposing policies for the safe use of stem cells. Studies must also pass the review of the ethics committee of the institution where they are carried out.

The authority had already warned about the risk of quackery. In 2020, during the pandemic, it alerted the public to fraudulent stem cell therapies and noted that it had not authorized any clinical protocol supporting treatments with those cells.

A legal analysis published several years ago describes that the authorized use of stem cells in Mexico was limited to specific applications, such as some hematological diseases, and mentions a draft standard (NOM-260-SSA1-2017) that was still in process. Before citing it, verify its current status in official sources.

What documents a physician can request from a provider

A reputable provider should not be bothered by these questions. Depending on the product and its use, request:

• The health authorization number for the protocol or study, when the product is used in research.
• Proof of approval from the ethics committee of the institution where it is applied.
• The current health license of the facility that manufactures or processes the product.
• Quality certificates and batch records that allow the product to be traced from its origin to administration.
• The protocol for monitoring and managing adverse events, with the contact details of the responsible person.
• Clear information on the available evidence, its limits and the regulatory status of each indication.

05Why regulation protects the patient and strengthens the physician

Cofepris notes that this project will help build a specific regulatory framework for advanced therapies, with criteria for quality, safety, traceability and monitoring. For the patient, it means an independent committee reviewed the protocol before it touched their health. For the physician, it means being able to explain clearly what is known, what is not known, and which documents support what is being offered.

At Regene Global, medical-grade products are manufactured at Regene Labs under GMP and ISO standards. This is an important quality foundation, but it does not replace the health authorizations required for each use. That is why we also recommend requesting this documentation from us.

06Frequently asked questions

1. 1

   Does the authorization of CARLLA-B1 mean that CAR-T therapy is already available in Mexico?

   No. The authorization allows the study to begin with patients who meet strict criteria. It does not mean general availability as a treatment.

2. 2

   Does an authorized trial guarantee results?

   No. A trial seeks to answer questions about preliminary safety and efficacy. Results may vary, and no protocol guarantees a benefit.

3. 3

   What should I do if I am offered a cell therapy without documentation?

   Request the information listed above and consult your physician before deciding. A lack of traceability is a signal to stop and review.

4. 4

   Can stem cells cure any disease?

   No. Cell therapies are studied for specific indications and with clear limits. None should be presented as a general cure.

Sources

• Cofepris authorizes first clinical trial with CAR-T cells produced in Mexico
• Health authority approves first clinical trial with CAR-T cells manufactured in Mexico (Infobae)
• Cofepris approves UANL clinical trial against lymphoblastic leukemia; it is the first in Mexico (ABC Noticias)
• CAR-T cells in Mexico: Cofepris authorizes clinical trial against cancer developed by UANL (MVS Noticias)
• Cofepris authorizes first clinical trial with CAR-T cells in Mexico (Consultorsalud)
• Mexico prepares clinical trial of CAR-T cells to treat leukemia in adults after Cofepris endorsement (Infobae México)
• Regulation of Stem Cell Research in Mexico (Ecija)
• Cofepris warns about stem cell therapies to cure COVID-19 (Excélsior)

This article is for informational and educational purposes and does not replace a physician’s evaluation. Results of any treatment vary from patient to patient.