What is approved, and what is still under investigation
This is the article a clinic has no interest in writing. We write it because the full map is the only way you can decide, and because anyone who hides it from you is telling you something about themselves.
There is a sentence that goes around a lot: "stem cell therapy is approved." And there is another that goes around just as much: "stem cell therapy is illegal." Both are false, and both are false for the same reason: they treat an enormous set of different procedures, with different regulatory frameworks in different countries, as a single thing.
Separating them out is tedious and takes ten minutes. It is also the most useful thing you will read before spending money on this.
First axis: what is approved as a medicine
In the United States, the market almost every quoted figure comes from, the regulator approves specific products for specific indications. And in the case of mesenchymal cells the number of approved indications is notably small.
One. Not a list. And it is not an aesthetic, sporting or anti-aging indication: it is a serious complication of a bone marrow transplant that does not respond to standard treatment.
That does not mean everything else is smoke. It means everything else is in another category: research, use under country-specific frameworks, or unapproved practice. And the difference between those three is the one worth learning to tell apart.
Second axis: exosomes are a separate case
Exosomes — those vesicles that appear in the article on the paracrine mechanism — have become a highly visible commercial product. The regulatory fact is worth keeping straight:
Zero. And it is not a passive omission: the agency has been sending warning letters to clinics marketing exosome products, with documented cases in several states through 2024, 2025 and the first quarter of 2026. Among the adverse events reported with unapproved products of this kind are serious infections and allergic reactions.
That the global exosome market is counted in tens of billions of dollars does not change the fact above. They are two independent facts, and only one of them tells you anything about what you are going to be given.
A large market is not evidence. It is a large market.
Third axis: Colombia is not governed by the FDA
This is where almost every article on the subject goes wrong, including those written in Colombia: they apply the United States framework to a country that has its own.
In Colombia the authority is INVIMA. Stem cell therapies are not illegal: they exist and are subject to its supervision, mainly in the field of autologous mesenchymal cell therapies — that is, using the patient's own cells — and some allogeneic applications for specific uses.
And there is a nuance INVIMA itself has acknowledged publicly: advanced therapies do not fit entirely into the three categories Colombian regulation provides for — medicine, anatomical component or medical device — because of their own specificity. The current framework rests on tissue bank rules that were not written with this in mind, and in 2024 a specific advanced therapies law was proposed precisely to close that gap.
Translated: the ground is regulated, but the framework is still being built. Knowing this is not a reason to rule anything out. It is a reason to ask more.
The seven questions
If you are evaluating a cell therapy — here, in Medellín, or in any other city — these are the questions whose answers tell you who you are talking to. A clinic that works well answers them without discomfort.
- What exactly are you going to give me: cells, a cell derivative, exosomes? They are not synonyms and they do not share a regulatory framework.
- Where does the material come from: from me (autologous) or from a donor (allogeneic)? With what traceability?
- Under what regulatory figure is it applied in this country, and who supervises it?
- Is this a treatment or is it research? If it is research, is there a protocol, an ethics committee and written informed consent?
- What outcome is expected, measured with what, and over what period? If the answer is "you will feel better," that is not an outcome.
- What are the known risks, and what happens if something goes wrong?
- What evidence is there for MY specific condition, not for cell therapy in general?
Why we would rather write this
Because the alternative — talking about cell therapy as though the map did not exist — works in the short term and fails exactly when it matters: when someone travels from another country, undergoes a procedure, and afterwards finds out that what they were told was not what the evidence supports.
At PROFIT7 the Precision Assessment exists, among other reasons, for this: so that the conversation about whether a therapy makes sense in your case happens with your own data in front of you, and not with a brochure.
Where the evidence stands
What the evidence supports
- That as of 2026 the only FDA-approved indication for mesenchymal cells is steroid-refractory acute graft-versus-host disease in pediatric patients.
- That as of 2026 there is no exosome product approved by the FDA for therapeutic use in humans.
- That the FDA has issued warning letters to clinics for marketing unapproved exosome products, and that adverse events have been reported with unapproved cell and tissue products.
- That in Colombia these therapies exist under INVIMA supervision, and that INVIMA itself has stated that advanced therapies do not fit entirely into the current regulatory categories.
What it does not yet
- The specific Colombian framework for advanced therapies is still being built: there is a 2024 legislative proposal, not a closed regulation.
- What is correct or safe in one country cannot be deduced from another country's regulatory framework.
- That a therapy is legal in one jurisdiction says nothing about its efficacy for a specific condition.
- This article describes general public frameworks; it does not replace direct verification of the permits and protocols of any center, ours included.
Sources
- FDA — Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues The agency's official warning on unapproved cell and tissue products.
- INVIMA — Terapias avanzadas: una mirada desde el contexto colombiano Document from the Colombian regulator itself on how advanced therapies fit the regulation.
- From bench to bedside: translating mesenchymal stem cell therapies through preclinical and clinical evidence Review covering the state of approvals and clinical indications.
- CDC — Stem Cell and Exosome Products Documentation of safety problems associated with unapproved products.
This article is general information. It does not replace a medical assessment, and none of its statements should be read as an indication for treatment.
Your data, not an average.
Everything explained here only means something when it is applied to one specific person. That is the starting point.
See the Precision Assessment
