Rheumatoid Arthritis
Rheumatoid arthritis (RA) causes joint inflammation and pain. It happens when the immune system doesn’t work properly and attacks the lining of the joints, called the synovium. The disease commonly affects the hands, knees or ankles, and usually the same joint on both sides of the body, such as both hands or both knees. But sometimes RA causes problems in other parts of the body as well, such as the eyes, heart and circulatory system and/or the lungs.
The Phase 2 clinical trial is a randomized, double- blinded, placebo-controlled, parallel-group safety and efficacy trial of Restem’s ULSC therapy compared to placebo, in patients with rheumatoid arthritis.
Approximately 80 patients will be enrolled in the Phase 2 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 proportion of participants showing a 20% symptom remission according to the American College of Rheumatology ACR20/50/70 scale at Month 4.
Secondary endpoints involve either changes in the requirements for standard therapies for disease management, or changes in biomarker signals relating to biochemical effects that may be found to represent surrogate markers of efficacy in the patient population.
