Celavie Biosciences

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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.

Phase I Clinical Trial for Parkinson’s Disease in Mexico

  •  Purpose: To evaluate the safety of OK99 stem cells in treating patients suffering from Parkinson’s disease
  •  Conduct: Hospital Angeles del Pedregal, Mexico City. Study approved by the Federal Commission for Protection against Sanitary Risks (COFEPRIS – Mexico’s FDA equivalent)
  •  Methodology: 8 patients with moderate to severe PD not adequately controlled with medication were selected for the study. OK99 stem cells were injected into putamen. Patients were immunosuppressed with Cyclosporine for one month after injection. Patients were examined with Positron Emission Tomography (PET) using 3 radio markers (two per patient) to fully evaluate relevant molecular changes in the brain after transplantation. The patients were divided into 2 groups: one was given dihidrotetrabenazine (DTBZ) and raclopride; and the other DTBZ and fluoro-L-DOPA.
  •  Time frame: 2014-Ongoing
  • Results: Results are pending. To date, no tumors or lasting severe adverse effects have been reported.
  • Status: Ongoing
    • Evaluations to be repeated 2 and 3 years after transplantation
    • Two-year follow up to be published in 2017
    • In the process of obtaining FDA pre-IND guidance for conducting larger controlled single-blinded randomized trial in US
    • Dr. Oleg Kopyov and Dr. Christopher Duma are designing protocol for larger controlled single-blinded randomized trial
  • Publication: Trial registered at ClinicalTrials.gov

Controlled Single-blinded Randomized Trial in US

  • Purpose: To evaluate the safety of OK99 stem cells in treating patients suffering from Parkinson’s disease
  • Conduct: Hoag Memorial Hospital Presbyterian, Newport Beach, CA
  • Time frame: 3 years
  • Methodology:  The trial is planned as a randomized, single-blinded study in which 66 patients (based on statistical power analysis) with advanced to moderate PD will receive bilateral implantations of undifferentiated OK99 cells into the brain’s putamen, with 66 patients serving as controls. All independent raters will be blinded to the condition of the patient. 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, 2 and 3 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.

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