Scleroderma (Systemic Sclerosis) and Mesenchymal stem/stromal cells (MSC): what the trial registry contains
The ClinicalTrials.gov registry holds 11 records for MSC in Scleroderma (Systemic Sclerosis): 2 recruiting now, 0 labelled Phase 3 or 4, across 9 countries. Snapshot 2026-08-29.
Why this is studied in Scleroderma (Systemic Sclerosis)
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.
What MSC means in this table
Mesenchymal stromal cells are the workhorse of commercial cell therapy: easy to source from fat, cord or marrow, easy to expand, and rarely characterised in the same way twice. Their proposed action is paracrine — signalling molecules that damp inflammation — rather than replacement of lost tissue. That matters when reading counts like these, because two studies filed under the same label can test materially different products at different doses by different routes.
The numbers
Every figure below comes from one reproducible query (systemic sclerosis x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 11 |
| Interventional studies in the sample | 10 |
| Recruiting right now | 2 |
| Completed | 5 |
| Terminated, withdrawn or suspended | 0 |
| Phase 3 or Phase 4 records | 0 |
| Countries with at least one site | 9 |
| Median planned enrolment | 20 participants |
| Largest single planned enrolment | 200 participants |
| First / most recent start year | 2009 — 2026 |
How mature is this evidence?
Registration activity is thin and early: 11 records in total, none at confirmatory phase, 2 recruiting.
The delivery record matters as much as the count: 5 completed against 0 abandoned or suspended, or 0% of everything registered.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 8 | 44% |
| Phase 2 | 7 | 39% |
| Not applicable | 2 | 11% |
| Early Phase 1 | 1 | 6% |
Median planned enrolment is 20 participants (largest single study: 200). 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
9 countries host at least one site. Colombia is the largest single contributor at roughly 18% of country mentions in this sample.
| Country | Studies with a site there |
|---|---|
| Colombia | 2 |
| South Korea | 2 |
| Spain | 1 |
| France | 1 |
| Netherlands | 1 |
| Antigua and Barbuda | 1 |
| Argentina | 1 |
| China | 1 |
| Pakistan | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is evenly split (3 academic or hospital, 3 commercial among the most frequent lead sponsors).
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud — 1 record
- Assistance Publique - Hôpitaux de Paris — 1 record
- UMC Utrecht — 1 record
- Fundación Neumologica Colombiana — 1 record
- The Foundation for Orthopaedics and Regenerative Medicine — 1 record
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — 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 |
|---|---|---|---|---|---|
| NCT03211793 — Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis | Phase 1, Phase 2 | Recruiting | 20 | UMC Utrecht | 2021-10-06 |
| NCT05016804 — Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis | Phase 1 | Recruiting | 20 | The Foundation for Orthopaedics and Regenerative Medicine | 2022-07-04 |
| NCT07535931 — Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis | Phase 1, Phase 2 | Not Yet Recruiting | 21 | Shenzhen Huishan Biotechnology Co., Ltd. | 2026-04-10 |
| 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 |
| NCT07542067 — Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmo | Phase 1, Phase 2 | Completed | 1 | Fundación Neumologica Colombiana | 2024-05-15 |
| NCT02213705 — Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells | Phase 1, Phase 2 | Completed | 20 | Assistance Publique - Hôpitaux de Paris | 2014-05-06 |
| NCT01745783 — Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis | Phase 1, Phase 2 | Completed | 26 | Andalusian Initiative for Advanced Therapies - Fundación Púb | 2013-01 |
| NCT00962923 — Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc) | Phase 1, Phase 2 | Unknown | 20 | The Affiliated Nanjing Drum Tower Hospital of Nanjing Univer | 2009-08 |
| NCT03060551 — Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients | Early Phase 1 | Completed | 20 | Suk-Ho Moon | 2018-07-01 |
| NCT02975960 — ADMSCs for the Treatment of Systemic Sclerosis | n/a | Completed | 7 | The Catholic University of Korea | 2016-10-25 |
What this page does and does not tell you
Treat this as a map of research activity. It tells you whether a claim has an evidence programme behind it — not whether the treatment helped anyone.
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 MSC studies for Scleroderma (Systemic Sclerosis) 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 MSC an approved treatment for Scleroderma (Systemic Sclerosis)?
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 MSC for Scleroderma (Systemic Sclerosis)?
0 of 11 records carry a Phase 3 or Phase 4 label and 5 are marked completed. Registrations run from 2009 to 2026.
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
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.