What research stage is stem-cell therapy for Tendon & Sports Injuries at?
Confirmatory-phase work accounts for 1 of the 13 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 5 | 33% |
| Not applicable | 5 | 33% |
| Phase 1 | 2 | 13% |
| Early Phase 1 | 2 | 13% |
| Phase 4 | 1 | 7% |
What the phase mix means for Tendon & Sports Injuries
Registrations are relatively numerous but small and heterogeneous, with inconsistent preparation protocols. Product variability is the field's central methodological weakness: two studies of 'PRP' may test materially different substances.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT06160427 — Connective Tissue Matrix for Rotator Cuff Tendinopathy | Phase 4 | Active Not Recruiting | 92 | Allegheny Singer Research Institute (also known as Allegheny | 2023-12-04 |
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 30 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 |
|---|---|---|---|---|---|
| NCT02052089 — Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis | n/a | Completed | 231 | CM Chungmu Hospital | 2009-03 |
| NCT03279796 — Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells | Phase 2 | Unknown | 200 | Second Affiliated Hospital, Zhejiang University, School of M | 2018-10-01 |
| NCT03390920 — Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions | n/a | Not Yet Recruiting | 200 | R3 Stem Cell | 2022-01-01 |
| NCT07320378 — Clinical Study on the Safety and Efficacy of Tendon Stem Progenitor Cells Therapy for Rotator Cuff Tears | Early Phase 1 | Not Yet Recruiting | 107 | Second Affiliated Hospital, Zhejiang University, School of M | 2026-05 |
| NCT06160427 — Connective Tissue Matrix for Rotator Cuff Tendinopathy | Phase 4 | Active Not Recruiting | 92 | Allegheny Singer Research Institute (also known as Allegheny | 2023-12-04 |
Frequently asked
What research stage is stem-cell therapy for Tendon & Sports Injuries at?
1 of 13 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.