Why this booking needs its own checklist
Most medical bookings involve a procedure with a recognized name and a known evidence base. "Stem cell treatment" can mean very different things:
- cells taken from your own fat or bone marrow and reinjected the same day
- donor material from umbilical cord or placental tissue
- cells grown in a laboratory over weeks
- products that contain few or no living cells at all
Price, risk and legal status differ for each. A booking line that just says "stem cell therapy, knee" leaves out nearly everything that matters.
The US FDA's patient page lists stem cells, stromal vascular fraction, umbilical cord blood, amniotic fluid, Wharton's jelly, ortho-biologics and exosomes among the products being marketed without approval. It says the only stem cell products FDA has approved are blood-forming cells derived from umbilical cord blood, for disorders affecting blood production (FDA, 2024). FDA regulates the US market, not Colombian clinics. But the harms it reports, including blindness, tumor formation and infections, are about the biology, and the biology doesn't change at the border.
Verification 1: product identity
Ask the treating physician, in writing:
- Source. Are the cells or material your own (autologous) or from a donor? Which tissue do they come from?
- Processing. Is the product minimally processed in the procedure room on the same day, or expanded in a laboratory? Who does the processing, and where?
- Composition. If cells are involved, what is counted and how? If the product is cell-free, such as exosomes or a "secretome," what exactly does it contain?
- Route. Will it be injected into a joint, infused into a vein, or delivered some other way? Ask the physician to explain the specific risks of that route, not of "stem cells" in general.
- Dose and sessions. What dose, how many sessions, and on what basis was that decided?
Verification 2: testing and manufacturing
FDA lists contamination during processing, and products not tested for infections such as hepatitis and HIV, among the safety concerns with unapproved regenerative products (FDA, 2024). For donor-derived material especially, ask:
- How was the donor screened, and which infectious-disease tests were run?
- Is each batch tested for sterility before release, and can you see the results?
- Who manufactured the product, and will the lot number be recorded in your medical file?
- What happens to your booking and deposit if a batch fails testing?
For same-day treatment with your own cells, ask where the harvest and processing happen, and who handles the material between the two steps.
Verification 3: regulatory status in Colombia
Ask the clinic to state in writing whether this product, for this use, is authorized by Colombian health authorities, or whether it is offered within a registered research protocol with ethics approval. Ask for the name or reference number of that authorization or protocol. "It's legal here" is not an answer you can check.
Be careful with trial language. FDA notes that a listing on clinicaltrials.gov, or a firm being registered with FDA, does not make a product legally marketed. It also says that if you are charged for these products outside an FDA-overseen trial, you are likely being deceived (FDA, 2024). That statement is about the US system, but the lesson carries over. Find out whether you would be a research participant, with a consent process and ethics oversight, or a paying customer. The two are not the same thing.
Verification 4: evidence for your diagnosis
FDA lists conditions for which regenerative medicine therapies are not approved. They include osteoarthritis, tendonitis and back, knee or shoulder pain; neurological conditions such as MS, ALS, Parkinson's disease and stroke; heart and lung disease; autism; and macular degeneration. FDA also flags the risk of the therapy failing when approved treatments exist (FDA, 2024).
Ask the clinic for published studies that match your condition, the product type and the route. Testimonials and before-and-after videos are not studies. Ask your home specialist to read the evidence with you, and to tell you which standard treatments you would be postponing.
How to read what the clinic sends
When a clinic sends an evidence packet, sort each item before you're persuaded by the volume. Ask four things of each one:
- Is it a published study, a conference abstract, a brochure or a testimonial?
- Did it study the same product type, prepared the same way, and given by the same route you've been offered?
- Did it include people with your diagnosis, and did it compare them with a group that didn't get the treatment?
- Was it run by the clinic selling you the treatment?
Material that fails most of these tests may still be interesting, but it doesn't support a deposit. Bring the sorted list to your home specialist rather than the whole pile.
Verification 5: people and place
Check the treating physician in ReTHUS, Colombia's registry of health professionals authorized to practice (MinSalud, ReTHUS). If the treatment involves a harvest, such as fat removal or bone-marrow aspiration, that is a procedure in its own right. Ask where it happens, who gives the anesthesia or sedation, and whether that site is a registered health provider for those services. Our verification chain guide walks through clinician, facility and service checks in order.
The deposit terms that matter here
| Term | What to ask |
|---|---|
| What the deposit reserves | Is it holding a date, ordering a product or paying for a laboratory slot? |
| Pre-treatment evaluation | What is refunded if the physician finds you unsuitable on arrival? |
| Product failure | What is refunded if a batch fails release testing or isn't delivered? |
| Multiple sessions | Are later sessions sold up front, and are they refundable if you stop? |
| What's included | Harvest, imaging, anesthesia or sedation, facility fees and follow-up |
Our deposit due-diligence checklist covers the general terms. In this field, the refund conditions for product problems deserve particular attention.
Sales tactics that don't belong in this booking
- Scarcity claims, such as "only a few doses left in this batch"
- Discounts for prepaying several sessions
- One product said to treat many unrelated diseases. FDA says broadly marketed products making such claims need approval before they can be marketed
- Patient testimonials offered in place of published data
- Discouraging you from involving your home doctor
After treatment: the records you'll need
Ask for a written record of the product type, source, lot number, dose, route and date, plus the note for any harvest procedure. Give copies to your home clinicians. FDA invites US patients who have been treated and want to report side effects to contact the agency or use its MedWatch program (FDA, 2024). Our guide to post-treatment follow-up at home explains how to set up that handoff before you leave.
Before any regenerative-treatment deposit
- Product type, source and processing described in writing
- Route, dose and number of sessions explained by the treating physician
- Donor screening and batch testing documented (if donor-derived)
- Colombian authorization or research-protocol status named
- Clear answer on whether you're a research participant or a paying customer
- Published evidence for your diagnosis, reviewed with your home specialist
- Physician checked in ReTHUS; harvest site and anesthesia identified
- Refund terms for unsuitability and product failure in writing
- No prepaid multi-session package required
- Lot number and treatment record promised for your file
The Colombia Medical network
Ready to organize the booking?
Send your diagnosis, what you've been offered (product, route and number of sessions) and any documents the clinic has given you. We can help you organize the verification questions before any deposit is paid.
Start Booking on WhatsAppFrequently asked questions
Are stem cell treatments legal in Colombia?
It depends on the product, how it is made and what it is used for, so there is no single answer. Ask the clinic to name the specific authorization or research protocol that covers your treatment, and treat a vague answer as unverified.
Is using my own cells automatically safer than donor material?
Not automatically. Using your own cells removes donor-screening questions. But FDA's list of concerns still includes reactions at the collection or injection site, contamination during processing and unwanted immune or inflammatory responses. How the cells are handled matters as much as where they come from.
The clinic says the treatment is part of a clinical trial. Should I still be paying?
Ask for the protocol's name, the ethics committee that approved it and the consent document, and ask why participants are charged. A trial listing on its own is not approval. FDA notes that a clinicaltrials.gov listing does not make a product legally marketed.
What should my home doctor see before I book?
Show them the written product description, the proposed route and dose, the evidence the clinic provided and the full quote. Ask which standard treatments you would delay and how they would handle any complications after you return.
How do I report a problem after treatment?
Tell your home clinicians first and get care for any symptoms. US patients can also report side effects to FDA, which lists a contact email and its MedWatch program on its regenerative medicine page.