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Stem cell showdown: can early transplant beat standard care for scleroderma?

NCT ID NCT04464434

First seen Mar 29, 2026 · Last updated Jun 12, 2026 · Updated 15 times

Summary

This study tested whether giving a stem cell transplant early is better than standard immunosuppressive drugs for people with early, severe scleroderma (a rare autoimmune disease that causes skin hardening and organ damage). Sixty adults aged 18-65 were randomly assigned to either upfront stem cell transplant or usual care (cyclophosphamide followed by mycophenolate mofetil, with transplant as a backup). The goal was to see which strategy improves survival, lung function, and quality of life.

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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

Conditions

The condition(s) this trial relates to.

diffuse scleroderma systemic sclerosis

As listed by the trial registrant

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