Idiopathic Inflammatory Myopathy
Idiopathic inflammatory myopathy (IIM) is an autoimmune disorder that causes chronic inflammation of the muscles used for movement. The main symptom of IIM is muscle weakness that develops gradually over time. Polymyositis is a type of IIM that causes inflammation and weakness of the skeletal muscles responsible for movement.
Dermatomyositis is a form of polymyositis that also causes skin rash, in addition to muscle inflammation. Both disorders can significantly compromise quality of life and are very challenging to treat.
The Phase ⅔ clinical trial is a randomized, adaptive, double-blinded, dose-repeating, crossover registrational trial to evaluate the safety and efficacy of Restem’s ULSC therapy compared to placebo, in patients with IIM. Approximately 80 patients will be enrolled in the Phase 2 stage of the trial and will increase to up to 150 patients to complete the Phase 3 stage of the clinical trial. Patients are anticipated to be randomized in a 1:1 ratio to receive Restem’s ULSC or placebo. Primary endpoint will be to evaluate safety and efficacy based on the average total improvement score as compared to placebo. Secondary endpoints include average improvement in physician and patient global disease scores well as average improvement in manual muscle testing as compared to placebo.
