Before researching any specific condition or treatment on this site, it's worth understanding the regulatory landscape clearly. This isn't a legal disclaimer buried in fine print — it's information that should shape how you evaluate everything else you read.
As of 2026, neither the FDA nor INVIMA (Colombia's regulatory authority) has approved stem cell, PRP, or exosome products specifically for most orthopedic or aesthetic indications. This does not mean these treatments are unsafe or ineffective — it means they operate in a space where clinical evidence and regulatory approval haven't yet aligned. Any provider should be transparent about this distinction.
What this means in practice
Regenerative treatments in this space are generally offered under a physician's clinical judgment within Colombia's regulatory framework, rather than as FDA- or INVIMA-approved treatments for the specific condition being addressed. This is a meaningfully different regulatory position than an approved drug or approved medical device — worth understanding clearly rather than assuming "offered by a licensed clinic" is equivalent to "government-approved for this use."
A responsible provider states this regulatory reality plainly, upfront, without being asked. If a provider's marketing implies these are approved, established treatments without qualification, that's a meaningful gap between what's being communicated and what's actually true.
What IS more established
Not every application in this field carries equal regulatory uncertainty — hematopoietic stem cell transplants (used in certain cancer treatments) have a long-established clinical track record and different regulatory standing than the orthopedic and aesthetic applications most patients researching this site are considering.
How INVIMA governs this space in Colombia
See our dedicated INVIMA guide for how Colombia's regulatory body oversees cell therapy provision, and what that oversight does and doesn't cover.
What this means for your decision-making
This information isn't a reason to avoid these treatments altogether — it's context for making an informed decision, with appropriately calibrated expectations, rather than assuming a level of regulatory certainty that doesn't currently exist for most applications in this field.
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