The product
Medipost's product is an allogeneic (donor-derived) culture-expanded mesenchymal stem cell preparation from umbilical cord blood, delivered with a hyaluronic acid scaffold into cartilage defects during arthroscopic surgery. It received Korean approval in 2012 for knee cartilage defects and has accumulated more than a decade of post-marketing data there. The current US program, run under a large investment, is a Phase 3 comparison against microfracture.
What earlier phases showed
- Cartilage repair on arthroscopic and MRI assessment at one to five years in the treated group
- Improvement in pain and function scores, sustained in long-term Korean follow-up
- A safety profile without tumor formation or serious immune reactions in the reported cohorts
- Important limitation: the product is applied surgically to defined cartilage defects, not injected into a diffusely arthritic joint
What Phase 3 success would mean
If the trial meets its endpoints and the FDA grants a Biologics License, roughly the 2028 to 2029 window, the United States would have its first approved cell product for a joint indication. That would be a milestone, but a narrow one:
| Would change | Would not change |
|---|---|
| A specific product, applied surgically, for focal cartilage defects becomes FDA-approved | Office-based injections of unrelated cells for diffuse osteoarthritis remain unapproved |
| Insurers begin evaluating coverage for that indication | Clinic claims about IV drips, bone-marrow injections, or exosomes gain no support |
| A reference standard exists for cell count, processing and delivery | Bone-on-bone (Kellgren-Lawrence 4) knees are not the target population |
Why this matters when you read a clinic's brochure
A well-funded developer with a decade of foreign approval data still needs a multi-year randomized trial against a surgical comparator to earn the right to claim efficacy in the US. A clinic that tells you its cells "regenerate cartilage" based on testimonials is making a claim that the best-resourced company in the field is spending years and hundreds of millions of dollars to test. Calibrate accordingly. Our guide to clinic success percentages covers what those numbers usually hide.
How this relates to what is offered in Colombia
Colombian clinics offer expanded MSC injections for knee osteoarthritis, some from bone marrow or fat (autologous) and some from umbilical or Wharton's jelly sources (allogeneic). None is the Medipost product, and none is delivered with its surgical scaffold method. The relevant Colombian evidence base is the broader MSC-injection literature, which is L2 to L3 for pain and function improvement in mild-to-moderate OA and weaker for structural repair; see knee OA evidence 2026. If you are considering Colombia, ask specifically how the clinic's product and delivery method compare with the trial designs it cites.
How to follow the trial
Search ClinicalTrials.gov for the product name and "knee." Trial registrations list enrollment status, sites, and endpoints. If you live near a site and meet criteria, enrolling is free and is the most rigorous access to this technology that exists. See finding legitimate trials.
Regulatory status: FDA vs INVIMA
United States (FDA): No stem cell product is FDA-approved for orthopedic, neurologic, or systemic use. Minimally manipulated same-day autologous procedures are marketed under a narrow exemption; culture-expanded cells and most umbilical products are unapproved biologics and the FDA's authority over them was reaffirmed in federal court in 2024. Florida's 2025 law permits certain treatments under state rules but does not create FDA approval.
Colombia (INVIMA): Cell therapies are regulated as advanced-therapy products. Clinics require INVIMA habilitation for the facility and, for laboratory-processed products, product-level authorization or an approved research protocol. Ask to see the INVIMA registration number and verify the treating physician on ReTHUS. "INVIMA registered" for the clinic is not the same as an authorized product.
Frequently asked questions
Is Medipost's knee product FDA approved?
Not as of 2026. It is approved in South Korea and in a US Phase 3 trial.
Would approval make stem cell injections for arthritis legal in the US?
It would approve one product, delivered surgically for cartilage defects. It would not approve unrelated injected products for general osteoarthritis.
Can I get the Medipost product in Colombia?
No. Colombian clinics use different autologous or allogeneic MSC preparations, with a different and generally weaker evidence base for structural repair.
Weighing a knee protocol in Colombia?
Send your X-ray report and KL grade. We will tell you honestly whether the evidence supports an injection for your knee and which clinics document their products.
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