How strong is the evidence for stem-cell therapy in Rheumatoid Arthritis?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: the registry holds 44 records, 14 completed, 2 at Phase 3 or 4, and 5 stopped early (11%). MSC-specific work accounts for 22 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 Rheumatoid Arthritis
Credible outcomes are DAS28 or ACR response rates and radiographic progression at six to twelve months against an active comparator. Morning-stiffness improvement reported openly, in a disease that flares and remits, is not a substitute.
What we can say from registrations alone
- Volume: 44 registered studies since 1997.
- Maturity: 2 confirmatory-phase records.
- Delivery: 14 completed; 5 terminated, withdrawn or suspended.
- Scale: median planned enrolment 33 participants, largest 2,663.
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 |
|---|---|---|---|---|---|
| NCT02639936 — New Generation IGRA in Immunocompromised Individuals | n/a | Completed | 2,663 | Tuberculosis Network European Trialsgroup | 2015-12 |
| 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 |
| NCT01413061 — Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft | n/a | Completed | 140 | AlloSource | 2010-06 |
| 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 |
| NCT01663116 — Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients | Phase 1, Phase 2 | Completed | 53 | Tigenix S.A.U. | 2011-03 |
| NCT05528809 — Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis | n/a | Completed | 40 | University Hospital, Montpellier | 2022-09-27 |
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 "Rheumatoid Arthritis 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 Rheumatoid Arthritis?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: 44 registered records, 2 at Phase 3/4 and 5 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Check the regulator's own register for the exact product name. Marketing frequently blurs approval for one narrow indication into approval in general.
Why do clinics cite hundreds of studies?
Because counting registrations is easy and sounds authoritative. The number that matters is how many controlled studies reported a clinically meaningful outcome for the product being sold.
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