How strong is the evidence for stem-cell therapy in Knee Osteoarthritis?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 168 records, 68 completed, 25 at Phase 3 or 4, and 12 stopped early (7%). MSC-specific work accounts for 124 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Knee Osteoarthritis
The bar is a validated pain and function score against a sham or active comparator at twelve months, ideally with structural imaging. Knee pain responds strongly to injection itself: sham arms in orthopaedic trials routinely improve, which is why uncontrolled results are uninformative.
What we can say from registrations alone
- Volume: 168 registered studies since 2007.
- Maturity: 25 confirmatory-phase records.
- Delivery: 68 completed; 12 terminated, withdrawn or suspended.
- Scale: median planned enrolment 31 participants, largest 4,000.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03818737 — Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES) | Phase 3 | Completed | 475 | Emory University | 2019-03-28 |
| NCT03990805 — A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis | Phase 3 | Completed | 260 | R-Bio | 2019-06-11 |
| NCT02539095 — Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection | Phase 4 | Completed | 200 | Cellontech Co., Ltd. | 2014-04 |
| NCT05081921 — Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civil | Phase 1, Phase 2 | Completed | 192 | Jagiellonian University | 2022-01-05 |
| NCT05484856 — Evaluation of Clinical Efficacy of Autologous Adipose Tissue Derived ADSCSs in Treatment of Osteoarthritis (OA) | Phase 1, Phase 2 | Completed | 140 | Dr. Himanshu Bansal Foundation | 2016-05-16 |
| NCT04208646 — Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis | Phase 2 | Completed | 106 | Shanghai AbelZeta Ltd. | 2020-05-16 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Knee Osteoarthritis research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Knee Osteoarthritis?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 168 registered records, 25 at Phase 3/4 and 12 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Approval is product-and-indication specific and changes over time; check the FDA, EMA or your national regulator directly rather than relying on a clinic's summary.
Why do clinics cite hundreds of studies?
Volume is the cheapest form of credibility. Ask instead for the controlled studies of the specific product, and read what outcome they measured.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Knee Osteoarthritis: cell-therapy evidence and registered trials
- How much does stem cell therapy for Knee Osteoarthritis cost? (2026)
- Knee Osteoarthritis stem cell therapy — your questions answered (2026)
- Knee Osteoarthritis: cell-therapy evidence by therapy class
- MSC vs PRP for Knee Osteoarthritis: what the registries show