Stem cell transplant shows promise for scleroderma patients

NCT ID NCT04464434

Completed Disease control Sponsor: UMC Utrecht Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two treatment strategies for people with early, severe scleroderma: a stem cell transplant using their own cells versus standard immunosuppressive drugs. The trial enrolled 60 adults with diffuse cutaneous systemic sclerosis. The goal was to see which approach better prevents death, organ failure, and disability. Results could help doctors decide the best timing for stem cell transplant.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: autologous hematopoietic stem cell transplant (using the patient's own stem cells) and immunosuppressive drugs (cyclophosphamide and mycophenolate mofetil)
What this could lead to: If successful, this could show that early stem cell transplant is better than standard drugs for controlling scleroderma and preventing organ damage.
What could go wrong: This is a small, completed Phase 4 trial with only 60 participants, so results may not apply to everyone. Stem cell transplant carries serious risks like infection and organ damage.

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma scleroderma systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AUTOLOGOUS STEM CELL TRANSPLANTATION CYCLOPHOSPHAMIDE MYCOPHENOLATE MOFETIL SCLERODERMA SCLERODERMA, DIFFUSE SYSTEMIC SCLEROSES, DIFFUSE SYSTEMIC SCLEROSIS TREATMENT STRATEGY

Contacts and locations

Locations

Amsterdam Rheumatology Centre

Amsterdam, Netherlands
Gaetano Pini-CTO

Milan, Italy
Ospedale San Raffaele

Milan, Italy
Radboudumc Nijmegen

Nijmegen, Netherlands
Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom
University Hospital Rome

Roma, Italy
University Medical Centre Leiden

Leiden, Netherlands
University Medical Centre Utrecht

Utrecht, Netherlands

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