Celavie Biosciences Conducts First Clinical Trial for New Stem Cell Treatment
New stem cell technology offers potential to revolutionize regenerative medicine
OXNARD, Calif., Dec. 14, 2015—Regenerative medicine start-up Celavie Biosciences LLC has conducted its first clinical trial to evaluate the safety of their stem cells in treating eight patients suffering from Parkinson’s disease (PD). Seven of the eight patients completed first-year follow-up. No lasting adverse effects or complications over period of more than two years were observed.
“We are thrilled with the progress made by the patients,” said CEO and President Sandy Solmon. “We are hoping that the follow-up trials will help us advance this innovation. We believe that Celavie’s stem cells, with their restorative power and their versatility to become multiple tissues, represent humanity’s best hope for a cure for many unaddressed or underserved degenerative diseases and injuries.”
The clinical trial was conducted at Hospital Angeles del Pedregal in Mexico City and overseen by internationally renowned neurosurgeon Ignacio Madrazo, MD. The study was approved by Mexico’s Federal Commission for Protection against Sanitary Risks (COFEPRIS). Celavie’s OK99 stem cells were injected into each subject’s putamen. In the first evaluation, patients were examined with positron emission tomography (PET) using three radio markers to fully evaluate molecular changes in the brain after transplantation. In following evaluations, one marker was used. PET scans showed trend toward improvement with no evidence of disease progression.
“Celavie is currently working on a larger controlled single-blinded randomized trial. We have filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) and await pre-IND guidance,” said Dr. Oleg Kopyov, Celavie’s Executive Vice President and Chief Scientific Officer. Kopyov is designing the protocol for the study.
Focusing on veterinary applications for the new technology, Celavie’s subsidiary, Celavet Inc., utilizes Celavie’s proprietary technology to transplant undifferentiated allogeneic pluripotent stem cells into the ligaments and tendons of injured horses to enable them to regain their fullest potential as competitors, performers, workers or companions. Celavet has conducted multiple studies to ascertain the capability and potential of their stem cells as a veterinary treatment and have applied for an Investigational New Animal Drug (INAD) with the Center for Veterinary Medicine (CVM).
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 Celavie’s undifferentiated cells to address diseases with complex multifactorial deficiencies in their entirety.