How strong is the evidence for stem-cell therapy in Scleroderma (Systemic Sclerosis)?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 44 records, 17 completed, 5 at Phase 3 or 4, and 8 stopped early (18%). MSC-specific work accounts for 11 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 Scleroderma (Systemic Sclerosis)
Endpoints are event-free survival, skin score, lung function and mortality over years. Any presentation of transplantation for scleroderma that omits treatment-related mortality is not describing the published evidence.
What we can say from registrations alone
- Volume: 44 registered studies since 1999.
- Maturity: 5 confirmatory-phase records.
- Delivery: 17 completed; 8 terminated, withdrawn or suspended.
- Scale: median planned enrolment 20 participants, largest 200.
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 |
|---|---|---|---|---|---|
| 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 |
| NCT04464434 — Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis | Phase 4 | Completed | 60 | UMC Utrecht | 2020-09-17 |
| NCT01895244 — Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis | Phase 2 | Completed | 44 | University Hospital Tuebingen | 2012-09 |
| NCT01347008 — Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis | Phase 3 | Completed | 41 | Federal University of São Paulo | 2011-04 |
| 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 "Scleroderma (Systemic Sclerosis) 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 Scleroderma (Systemic Sclerosis)?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 44 registered records, 5 at Phase 3/4 and 8 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
That has to be checked per product with the regulator that governs where you would be treated. A clinic's own claim of approval is not verification.
Why do clinics cite hundreds of studies?
Volume is the cheapest form of credibility. Ask instead for the controlled studies of the specific product, and read what outcome they measured.
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)
- Scleroderma (Systemic Sclerosis): cell-therapy evidence by therapy class
- MSC vs HSCT for Scleroderma (Systemic Sclerosis): what the registries show