Rheumatoid Arthritis and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 11 records for HSCT in Rheumatoid Arthritis: 2 recruiting now, 1 labelled Phase 3 or 4, across 12 countries. Snapshot 2026-08-29.
Why this is studied in Rheumatoid Arthritis
Rheumatoid arthritis is autoimmune synovial inflammation causing joint erosion. Mesenchymal cells are studied for immunomodulation, generally in disease refractory to conventional and biologic therapy. As with psoriasis, effective established treatments define the comparison — the question is not whether cells do something, but whether they beat what already works.
What HSCT means in this table
Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.
The numbers
Every figure below comes from one reproducible query (rheumatoid arthritis x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 11 |
| Interventional studies in the sample | 8 |
| Recruiting right now | 2 |
| Completed | 5 |
| Terminated, withdrawn or suspended | 2 |
| Phase 3 or Phase 4 records | 1 |
| Countries with at least one site | 12 |
| Median planned enrolment | 24 participants |
| Largest single planned enrolment | 2,663 participants |
| First / most recent start year | 1997 — 2020 |
How mature is this evidence?
A small later-stage tail exists (1 of 11 records at Phase 3 or 4); the centre of gravity is still Phase 1 and 2 work sized for safety rather than proof of benefit.
Of those, 5 are marked completed and 2 were terminated, withdrawn or suspended — a stop rate of 18%, worth weighing when a clinic quotes 'ongoing research' as reassurance.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 5 | 38% |
| Not applicable | 4 | 31% |
| Phase 2 | 3 | 23% |
| Phase 3 | 1 | 8% |
Median planned enrolment is 24 participants (largest single study: 2,663). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
The work is distributed across 12 countries; United States alone accounts for about 47% of mentions, so 'internationally researched' can still mean concentrated in a few regulatory environments.
| Country | Studies with a site there |
|---|---|
| United States | 8 |
| Iran | 1 |
| Denmark | 1 |
| Germany | 1 |
| Italy | 1 |
| Moldova | 1 |
| Norway | 1 |
| Poland | 1 |
| Portugal | 1 |
| Romania | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is academic (4 academic or hospital, 3 commercial among the most frequent lead sponsors).
- Paul Szabolcs — 2 records
- Royan Institute — 1 record
- Fairview University Medical Center — 1 record
- National Institute of Dental and Craniofacial Research (NIDCR) — 1 record
- Tuberculosis Network European Trialsgroup — 1 record
- National Cancer Institute (NCI) — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT01962415 — Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT | Phase 2 | Recruiting | 100 | Paul Szabolcs | 2014-02-04 |
| NCT04528355 — Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC | n/a | Recruiting | 50 | Paul Szabolcs | 2020-08-20 |
| 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 |
| NCT02759731 — Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation | Phase 1, Phase 2 | Completed | 24 | National Cancer Institute (NCI) | 2016-11-01 |
| NCT03067870 — Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis | Phase 1 | Unknown | 100 | Stem Cells Arabia | 2016-11 |
| NCT00282412 — Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism | Phase 1 | Terminated | 4 | Northwestern University | 2002-09 |
| NCT00010335 — Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Ste | Phase 1 | Completed | 6 | Fred Hutchinson Cancer Center | 2000-11 |
| NCT00278551 — Stem Cell Support in Patients With Rheumatoid Arthritis | Phase 1 | Terminated | 10 | Richard Burt, MD | 1997-06 |
| NCT02639936 — New Generation IGRA in Immunocompromised Individuals | n/a | Completed | 2,663 | Tuberculosis Network European Trialsgroup | 2015-12 |
| NCT00023491 — Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells | n/a | Completed | 10 | National Institute of Dental and Craniofacial Research (NIDC | 2001-09 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many HSCT studies for Rheumatoid Arthritis are recruiting right now?
2 of 11 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is HSCT an approved treatment for Rheumatoid Arthritis?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 11 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Rheumatoid Arthritis?
1 of 11 records carry a Phase 3 or Phase 4 label and 5 are marked completed. Registrations run from 1997 to 2020.
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
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.