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Advancing CC-101 toward regulatory approval in the US
Clarion Cells is conducting a rigorous clinical development program to evaluate the safety and efficacy of CC-101 for chronic ischemic stroke. Our trials are designed to build on promising early-phase results and bring this therapy to the patients who need it.
Phase 1/2a Safety and Activity Dose-Escalation Study
The Phase 1/2a study, entitled “A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke (ISS),” evaluated the safety and preliminary efficacy of CC-101 in subjects with chronic ischemic stroke and stable motor deficits.
Window of Eligibility
6 months to 5 years post-stroke
Subjects
18 subjects
Primary Endpoint
Safety and tolerability
Status
Completed, with subject transition to long-term follow-up
CC-101 Doses Studied
2.5, 5.0, 10.0, and 20.0 million cells
Key Results
Phase 2b Efficacy and Safety Study
also known as the suNR1se II TrialThe Phase 2b study, entitled “A Phase 2b, Prospective, Randomized, Multi-Center, Double-Blinded, Controlled Trial To Assess the Efficacy and Safety of Stereotactic Intracerebral Transplantation of Allogeneic Neural Stem Cells CC-101 (f/k/a NR1) in Adults with Chronic Ischemic Subcortical ± Cortical Stroke,” is a randomized, controlled trial designed to evaluate the efficacy and safety of CC-101 in a larger population of chronic ischemic stroke patients with motor deficits.
Window of Eligibility
6 months to 7 years post-stroke
Population
Chronic ischemic stroke with stable motor deficits
Design
Randomized, controlled
Primary Efficacy Endpoint
Change in motor function (upper and lower extremity) between baseline and 365 days after treatment
CC-101 Dose
5.0 million cells
Status
Opening to enrollment soon
Information on this page is provided for educational purposes. Clarion Cells does not provide medical advice. Please consult your physician for treatment decisions. Clinical trial participation is subject to eligibility criteria.