MSC vs HSCT for Scleroderma (Systemic Sclerosis): what the registries show
For Scleroderma (Systemic Sclerosis), the registry holds 11 MSC records against 24 HSCT records. HSCT carries the larger research programme; neither column is a head-to-head efficacy result. Snapshot 2026-08-29.
Side by side
| Metric | MSC | HSCT |
|---|---|---|
| Registered studies | 11 | 24 |
| Recruiting now | 2 | 3 |
| Phase 3 or 4 records | 0 | 4 |
| Completed | 5 | 10 |
| Stopped early | 0 | 7 |
| Countries with sites | 9 | 7 |
| Median planned enrolment | 20 | 20 |
| First registration year | 2,009 | 1,999 |
The condition underneath the comparison
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.
MSC: what it is
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.
HSCT: what it is
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.
Maturity difference
MSC has 0 Phase 3/4 records and 5 completed studies; HSCT has 4 and 10. Where both sit early on the ladder, the honest answer to "which works better" is that registrations cannot tell you.
Leading MSC studies
| 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 |
Leading HSCT studies
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT05029336 — Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Phase 2 | Recruiting | 20 | Stephan Grupp MD PhD | 2026-03 |
| NCT06619561 — A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) | Phase 2 | Recruiting | 48 | Deciphera Pharmaceuticals, LLC | 2024-11-21 |
| NCT03630211 — Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Phase 2 | Recruiting | 8 | Paul Szabolcs | 2018-07-31 |
| NCT04380831 — TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | Early Phase 1 | Active Not Recruiting | 15 | City of Hope Medical Center | 2022-02-24 |
| NCT04464434 — Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis | Phase 4 | Completed | 60 | UMC Utrecht | 2020-09-17 |
The honest comparison
Head-to-head trials putting these two approaches in the same protocol are rare or absent for most conditions. Comparing counts from separate registry queries shows where research effort went — driven by cost, regulation and sponsor interest as much as by biology. Anyone presenting one column of this table as proof of superiority is overreading it.
Frequently asked
Is MSC better than HSCT for Scleroderma (Systemic Sclerosis)?
The registries cannot answer that. They show research volume and maturity, not comparative effectiveness: 11 vs 24 registered records (2026-08-29).
Which has more late-stage research for Scleroderma (Systemic Sclerosis)?
MSC: 0 Phase 3/4 records. HSCT: 4.
Can a clinic offer both?
Some do, which is itself worth questioning — a provider offering every modality for every condition is describing a business model, not a treatment rationale.
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