What research stage is stem-cell therapy for Rheumatoid Arthritis at?
Confirmatory-phase work accounts for 2 of the 44 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 26 | 45% |
| Phase 2 | 16 | 28% |
| Not applicable | 13 | 22% |
| Phase 3 | 2 | 3% |
| Early Phase 1 | 1 | 2% |
What the phase mix means for Rheumatoid Arthritis
There is a real later-phase presence relative to softer indications, helped by validated composite endpoints. That makes the terminated-study column here worth reading closely alongside the totals.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02378506 — Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects | Phase 3 | Completed | 188 | Pfizer | 2015-04 |
| NCT01873625 — Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis | Phase 2, Phase 3 | Completed | 60 | Royan Institute | 2009-10 |
How to read phase labels
Phase labels describe what a study was designed to answer. A Phase 1 result showing improvement answers a question nobody asked of it, because the design has no control arm and too few participants to distinguish an effect from noise.
Median planned enrolment across sampled studies here is 33 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 |
|---|---|---|---|---|---|
| NCT02639936 — New Generation IGRA in Immunocompromised Individuals | n/a | Completed | 2,663 | Tuberculosis Network European Trialsgroup | 2015-12 |
| NCT02327884 — Characterization of Diseases With Salivary Gland Involvement | n/a | Recruiting | 1,150 | National Institute of Dental and Craniofacial Research (NIDC | 2015-04-03 |
| NCT04449224 — Comparative Effectiveness of Targeted Therapy in RA Patients | n/a | Unknown | 506 | Hanyang University | 2020-04-27 |
| NCT01978639 — Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain | n/a | Unknown | 300 | Arizona Pain Specialists | 2014-01 |
| NCT03798028 — The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis | n/a | Unknown | 250 | Xijing Hospital | 2017-12-26 |
Frequently asked
What research stage is stem-cell therapy for Rheumatoid Arthritis at?
2 of 44 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
- Rheumatoid Arthritis: cell-therapy evidence and registered trials
- How much does stem cell therapy for Rheumatoid Arthritis cost? (2026)
- Rheumatoid Arthritis stem cell therapy — your questions answered (2026)
- Rheumatoid Arthritis: cell-therapy evidence by therapy class
- MSC vs HSCT for Rheumatoid Arthritis: what the registries show