Celavie Biosciences Clinical Trials
Celavie Biosciences and subsidiary Celavet are developing therapies using undifferentiated allogeneic pluripotent stem cells to repair damaged tissues and restore their functions. Celavie and Celavet produce large banks of undifferentiated cells across 4 mammalian lines that are grown in a specialized patented medium allowing uniform qualities and genetic stability. Research in one area leads to innovation in another. Early trials have demonstrated safety and the promise of efficacy.
The first-in-human exploratory study of Celavie stem cells for Parkinson’s Disease in Mexico
Phase 1 Double-blind Placebo Controlled Randomized Trial in US. Application to FDA is in Progress.
- Purpose: To evaluate the safety of Celavie’s stem cells in treating patients suffering from Parkinson’s disease
- Conduct: Hoag Memorial Hospital Presbyterian, Newport Beach, CA
- Time frame: 3 years
- Methodology: This will be a two-part study, wherein Part I is a staggered-start open label longitudinal trial, and Part II is a randomized, two arm, double-blind, controlled, longitudinal trial of Celavie stem cells for the treatment of moderate to advanced Parkinson’s Disease. Stage II will be launched only if 3 month follow up of the patients enrolled and treated in Stage I reveals no permanent, serious adverse events due to treatment. The primary end measure is safety: number and severity of side effects and complications. The secondary end measures include variable neurological, neuropsychological and radiological evaluations (Positron Emission Tomography – PET) established in Core Assessment Program for Intracerebral Transplantations (CAPIT). Evaluations will be performed during on and off medication conditions at baseline, 6 months, 1 and 2 years after transplantation. The neurosurgical facility has state-of-the-art stereotactic equipment, CAT scan, MRI and Positron Emission Tomography.
- Status: To be scheduled
- Filed for pre-IND guidance for trial with FDA.
- Dr. Oleg Kopyov and Dr. Christopher Duma designing protocol.