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)
Latest Information Update: 10 Oct 2025
At a glance
- Drugs Umbilical cord derived mesenchymal stem cell therapy-RESTEM (Primary)
- Indications Dermatomyositis; Myositis; Polymyositis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms IIMPACT
- Sponsors RESTEM
Most Recent Events
- 22 Sep 2025 Planned End Date changed from 1 Apr 2029 to 1 May 2029.
- 22 Sep 2025 Planned primary completion date changed from 1 May 2028 to 1 Jun 2028.
- 22 Sep 2025 Planned initiation date changed from 1 Sep 2025 to 1 Oct 2025.