Advancing Beyond Mainstream Stem Cell Technology
Celavie Biosciences LLC is a private, emerging-growth medical technology company that develops stem cell-based regenerative therapies for the treatment of disorders of the central nervous system.
Our mission is to deliver effective new restorative treatments for degenerative diseases like Parkinson’s disease and other disabling disorders for which there are no cures.
Advancing beyond mainstream stem cell technology
Our scientists explore therapies that use undifferentiated allogeneic pluripotent stem cells to repair damaged tissues and restore their functions.
The foundational theory of Celavie technology is that undifferentiated stem cells are able to react to the micro-environment into which they are injected and mature into multiple cell types dictated by their new surroundings. Unlike commonly used pre-differentiated cells, this would allow our undifferentiated cells to address diseases with complex multifactorial deficiencies in their entirety.
Our goal is to develop cells that are hypo-immunogenic and do not cause tumors. Unlike embryonic stem cells, OK99 cells have not produced tumors when implanted into immunodeficient rats. An equine open label study with 400 cases treated did not reveal any tumor formation during a three-year follow up. A first-in-human Phase I clinical trial for Parkinson’s disease carried out in Mexico City with permission of COFEPRIS (Mexico’s FDA) just reached its two-year follow up. The Phase I trial on seven patients has not revealed any lasting adverse effects or complications over a period of more than two years. Protocol for a larger controlled single-blinded randomized trial in US is in progress. Preparation of materials for IND application is in progress.