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A Phase 2-Phase 3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess the Safety and Efficacy of Allogeneic ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM)

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Trial Profile

A Phase 2-Phase 3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess the Safety and Efficacy of Allogeneic ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 06 Feb 2026

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At a glance

Most Recent Events

  • 03 Feb 2026 Planned number of patients changed from 80 to 150.
  • 03 Feb 2026 According to a RESTEM media release, company look forward to sharing the interim readout in the second half of 2026 and Based on the interim findings, the trial may be expanded to enroll up to 150 patients, if necessary, to achieve the appropriate statistical significance and support registration.
  • 03 Feb 2026 According to a RESTEM media release, A portion of patients will be included from the Phase 1 trial, who also continue to be followed to reinforce the safety and efficacy data generated to date. The study design includes a planned interim analysis at the midpoint to assess safety and efficacy.

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