Registry evidence

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.

Medical review statusMedically reviewedReviewed by: Stem Plus medical teamReviewed on: 2026-08-29Last evidence update: 2026-08-29Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

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.

MetricValue
Registered studies (all statuses)11
Interventional studies in the sample10
Recruiting right now2
Completed5
Terminated, withdrawn or suspended0
Phase 3 or Phase 4 records0
Countries with at least one site9
Median planned enrolment20 participants
Largest single planned enrolment200 participants
First / most recent start year2009 — 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 labelRecordsShare
Phase 1844%
Phase 2739%
Not applicable211%
Early Phase 116%

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.

CountryStudies with a site there
Colombia2
South Korea2
Spain1
France1
Netherlands1
Antigua and Barbuda1
Argentina1
China1
Pakistan1

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.

StudyPhaseStatusPlanned nLead sponsorStart
NCT03211793 — Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic SclerosisPhase 1, Phase 2Recruiting20UMC Utrecht2021-10-06
NCT05016804 — Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic SclerosisPhase 1Recruiting20The Foundation for Orthopaedics and Regenerative Medicine2022-07-04
NCT07535931 — Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic SclerosisPhase 1, Phase 2Not Yet Recruiting21Shenzhen Huishan Biotechnology Co., Ltd.2026-04-10
NCT06888973 — Mesenchymal Stem Cells Infusion in Patients With Autoimmune DiseasesPhase 1, Phase 2Enrolling By Invitation200National Institute of Blood and Marrow Transplant (NIBMT), P2025-02-01
NCT07542067 — Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory PulmoPhase 1, Phase 2Completed1Fundación Neumologica Colombiana2024-05-15
NCT02213705 — Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsPhase 1, Phase 2Completed20Assistance Publique - Hôpitaux de Paris2014-05-06
NCT01745783 — Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple SclerosisPhase 1, Phase 2Completed26Andalusian Initiative for Advanced Therapies - Fundación Púb2013-01
NCT00962923 — Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)Phase 1, Phase 2Unknown20The Affiliated Nanjing Drum Tower Hospital of Nanjing Univer2009-08
NCT03060551 — Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis PatientsEarly Phase 1Completed20Suk-Ho Moon2018-07-01
NCT02975960 — ADMSCs for the Treatment of Systemic Sclerosisn/aCompleted7The Catholic University of Korea2016-10-25

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.

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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.