Is Stem Cell Therapy Legal in Colombia? FDA vs INVIMA Explained

Patients from the United States and Canada usually ask this question for two reasons: they have read that stem cell therapy is not FDA approved, and they want to know whether going abroad means going outside the law. This guide explains how Colombia regulates cells and tissues, how that compares with the FDA, and what you can verify yourself before booking a trip. It is general information, not legal advice.

How Colombia regulates human cells and tissues

Colombia does not have one single “stem cell law”. Cells used in therapy fall under the rules for human anatomical components, which INVIMA, the national health regulator, summarizes in its own document on advanced therapies. The core pieces are:

• Law 9 of 1979 and Law 73 of 1988: the sanitary code and the rules on donation and use of organs and anatomical components for transplant or other therapeutic uses.
• Law 919 of 2004: prohibits the commercialization of human anatomical components for transplant and makes their trafficking a crime. What a patient pays for is the medical service, not the cells.
• Decree 2493 of 2004: regulates the obtaining, processing and use of anatomical components.
• Resolution 5108 of 2005: the Good Practices manual for tissue and bone marrow banks, which INVIMA inspects and certifies.
• Law 1805 of 2016: updated the donation rules and opened a restructuring of this framework.

On top of that, every clinic must be a registered health provider. The Ministry of Health keeps a public registry of providers (REPS) and of licensed health professionals (ReTHUS), and local health secretariats inspect facilities.

What is still missing

INVIMA itself describes advanced therapies as an area where the regulatory framework is still being developed: the existing rules were written mainly for tissue banking and transplants, not for every way cells are processed and used today. A reform of the donation and transplant law that explicitly includes cell therapies and tissue engineering advanced in Congress in 2025 (bill 155 of 2024 Senate, 428 of 2025 House). In practice this means the quality of a clinic depends heavily on its own standards, which is why the checks below matter.

FDA vs INVIMA: the key differences

One point is often misunderstood: the FDA has no authority over medical care delivered in another country. Being treated in Colombia does not make a procedure FDA approved, and it does not make it illegal for a US citizen either. You can read more in our guide Is Stem Cell Therapy FDA Approved?

7 things to verify before you travel

1. The facility’s REPS registration. Ask for the provider code and look it up on the Ministry of Health portal.
2. The physician’s license. Every doctor in Colombia must appear in ReTHUS. Ask who will actually perform the procedure.
3. The cell source. Your own cells (autologous) or donor cells (allogeneic), and from which tissue.
4. Where the cells are processed and, if they come from a bank, its INVIMA certification.
5. A written informed consent in a language you understand, with risks, alternatives and the level of evidence.
6. A plan for complications: who answers the phone after you fly home.
7. Honest candidacy. A serious clinic tells you when you are not a candidate. Be wary of any promise of a cure.

How we approach it at Stem Cell Medellin

Treatment is led by Dr. Catalina Henao, a physician trained at Universidad CES with an ISSCA certification in regenerative medicine. Before you travel she reviews your history and imaging, and you can ask our team for any of the information above. If you want to see how a plan is structured, start with our treatment protocols or the pages for knee, hip and shoulder pain.

Frequently asked questions

Is stem cell therapy legal in Colombia?

Yes. Stem cell procedures are not banned in Colombia. They are performed by licensed physicians in health facilities registered with the Ministry of Health, under the rules for human tissues and cells. Legal does not mean approved: there is no approved stem cell product for joint or back pain in Colombia or the United States.

Is stem cell therapy in Colombia FDA approved?

No. The FDA only approves products for use in the United States and has no authority over care delivered in Colombia. A procedure done abroad is neither FDA approved nor illegal for a US citizen.

Who regulates stem cells in Colombia?

INVIMA oversees tissue and cell banks and health products, the Ministry of Health and local health secretariats register and inspect health providers, and physicians must be registered in ReTHUS.

Can a clinic in Colombia sell stem cells?

No. Law 919 of 2004 prohibits commercializing human anatomical components. Clinics charge for the medical service, not for the cells themselves.

How do I check if a clinic in Colombia is legitimate?

Ask for its REPS provider code, the ReTHUS registration of the physician, the source of the cells, the certification of the lab or bank, and a written informed consent before you travel.