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: Not yet recruiting

Phase of Trial: Phase II/III

Latest Information Update: 19 Sep 2025

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At a glance

06 Jun 2025 According to a RESTEM media release, the Company will present an oral presentation of the rationale and study design of Phase 2/3 IIMPACT study at the European Alliance of Associations for Rheumatology's (EULAR) 2025 Congress, to take place June 11-14 in Barcelona, Spain.
10 Jan 2025 According to a RESTEM media release, The study will initially enroll 40 participants to evaluate the safety and efficacy of Restem-L and may be expanded up to 150 patients starting at 8 months for Phase 3 enrollment.
10 Jan 2025 According to a RESTEM media release, company Received IND approval from the FDA for a Phase 2/3 clinical study in IIM.

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