What research stage is stem-cell therapy for Knee Osteoarthritis at?
Confirmatory-phase work accounts for 25 of the 168 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 77 | 36% |
| Phase 1 | 61 | 29% |
| Not applicable | 41 | 19% |
| Phase 3 | 20 | 9% |
| Early Phase 1 | 9 | 4% |
| Phase 4 | 5 | 2% |
What the phase mix means for Knee Osteoarthritis
Knee osteoarthritis carries one of the largest later-phase footprints in the field, which makes it the best available test case for whether cell therapy outperforms saline and hyaluronic acid under controlled conditions.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07106229 — A Study to Investigate the Effectiveness, Safety, and Tolerability of MAG200 Solution for Intra-articular Injection Compared With Placebo in Participa | Phase 3 | Not Yet Recruiting | 573 | Magellan Stem Cells | 2025-11 |
| NCT06570291 — Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis | Phase 3 | Recruiting | 520 | Wuxi Cellular Biopharmaceutical Group Ltd. | 2025-02-28 |
| NCT03818737 — Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES) | Phase 3 | Completed | 475 | Emory University | 2019-03-28 |
| NCT06716281 — Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis | Phase 3 | Recruiting | 398 | Shanghai IxCell Biotechnology Co., LTD | 2024-01-05 |
| NCT07339111 — Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis | Phase 3 | Recruiting | 300 | Medipost, Inc. | 2026-03-11 |
| 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 |
How to read phase labels
The ladder runs from tolerability through signal-finding to a controlled, adequately powered test of benefit. Cell-therapy records frequently carry no phase at all, because observational designs and some tissue-based protocols sit outside the drug framework entirely. Read that as a classification gap, not a verdict.
Median planned enrolment across sampled studies here is 31 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02844751 — Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee | Phase 2 | Recruiting | 4,000 | VivaTech International, Inc. | 2015-07 |
| NCT07106229 — A Study to Investigate the Effectiveness, Safety, and Tolerability of MAG200 Solution for Intra-articular Injection Compared With Placebo in Participa | Phase 3 | Not Yet Recruiting | 573 | Magellan Stem Cells | 2025-11 |
| NCT06570291 — Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis | Phase 3 | Recruiting | 520 | Wuxi Cellular Biopharmaceutical Group Ltd. | 2025-02-28 |
| NCT03818737 — Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES) | Phase 3 | Completed | 475 | Emory University | 2019-03-28 |
| NCT05507099 — Stem Cell Study in Osteoarthritis of the Knee and Hip Joints | Phase 2 | Recruiting | 400 | Grigory Karmy | 2022-08-23 |
Frequently asked
What research stage is stem-cell therapy for Knee Osteoarthritis at?
25 of 168 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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