Scleroderma (Systemic Sclerosis): cell-therapy evidence by therapy class
Across every stem-cell intervention, ClinicalTrials.gov holds 44 registered records for Scleroderma (Systemic Sclerosis) — 6 recruiting, 5 at Phase 3 or 4, in 16 countries. Snapshot 2026-08-29.
The condition, and why cells are proposed
Systemic sclerosis combines vascular injury, autoimmunity and progressive fibrosis of skin and internal organs. Autologous haematopoietic transplantation has controlled trial evidence in severe rapidly progressive disease — with real treatment-related mortality — making this an indication where risk-benefit must be stated explicitly rather than implied.
Therapy classes side by side
Counts come from separate registry queries per class; a study testing two interventions can appear in more than one row, so rows do not sum to the all-interventions total.
Geography of the research
United States accounts for about 49% of country mentions among sampled studies; 16 countries host at least one site.
| Country | Studies with a site there |
|---|---|
| United States | 19 |
| France | 7 |
| Netherlands | 2 |
| Colombia | 2 |
| Italy | 2 |
| Canada | 2 |
| South Korea | 2 |
| Spain | 1 |
The largest registered studies
Sorted by planned enrolment — size is not quality, but a 300-participant trial can answer questions a 12-participant series cannot.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT06888973 — Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases | Phase 1, Phase 2 | Enrolling By Invitation | 200 | National Institute of Blood and Marrow Transplant (NIBMT), P | 2025-02-01 |
| NCT02516124 — EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients | n/a | Completed | 82 | European Society for Blood and Marrow Transplantation | 2012-12 |
| NCT00114530 — Scleroderma: Cyclophosphamide or Transplantation | Phase 2, Phase 3 | Completed | 75 | National Institute of Allergy and Infectious Diseases (NIAID | 2005-06 |
| NCT05960058 — Acceptance and Effectiveness of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Vaccination in Systemic Sclerosis Patients Treated by Aut | n/a | Unknown | 72 | Assistance Publique - Hôpitaux de Paris | 2023-07 |
| NCT05482594 — Stem Cell Factor, a Potential Biological Marker of Skin Involvement in Systemic Sclerosis? | n/a | Unknown | 65 | Brugmann University Hospital | 2022-01-11 |
| NCT03444805 — EBMT ADWP Prospective Non-interventional Study: Post-AHSCT Management in SSC Patients (NISSC-2) | n/a | Unknown | 60 | European Society for Blood and Marrow Transplantation | 2019-07-01 |
Most recently registered
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07650565 — Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs) | n/a | Not Yet Recruiting | n/a | University Hospital, Montpellier | 2026-09 |
| NCT07734012 — Mycophenolate After Stem Cell Transplant for Systemic Sclerosis | n/a | Not Yet Recruiting | n/a | Ottawa Hospital Research Institute | 2026-08 |
| NCT07535931 — Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis | n/a | Not Yet Recruiting | n/a | Shenzhen Huishan Biotechnology Co., Ltd. | 2026-04-10 |
| NCT05029336 — Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | n/a | Recruiting | n/a | Stephan Grupp MD PhD | 2026-03 |
| NCT07301164 — Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases | n/a | Not Yet Recruiting | n/a | Peking University Third Hospital | 2025-12-11 |
Reading this honestly
A registry is a plan repository. Counting entries tells you what people intended to study, which is a weaker thing than what they found. For Scleroderma (Systemic Sclerosis) specifically, the practical question is which registered study — if any — matches the product a provider is offering, and what its outcome measures actually are.
Frequently asked
How many stem-cell trials exist for Scleroderma (Systemic Sclerosis)?
44 registered records mention a stem-cell intervention for this condition (2026-08-29 snapshot), of which 6 were recruiting.
Which therapy class is furthest along for Scleroderma (Systemic Sclerosis)?
Ranked by Phase 3/4 records: HSCT (4), MSC (0), exosomes (0), PRP (0).
Does a recruiting trial mean I can be treated?
No. Trials have eligibility criteria, and joining one is not the same as buying a treatment. Paying a clinic for an unproven intervention outside a registered study gives you neither the protections nor the data collection of a trial.
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
- Scleroderma (Systemic Sclerosis): cell-therapy evidence and registered trials
- How much does stem cell therapy for Scleroderma (Systemic Sclerosis) cost? (2026)
- Scleroderma (Systemic Sclerosis) stem cell therapy — your questions answered (2026)
- MSC vs HSCT for Scleroderma (Systemic Sclerosis): 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.