Catherine A Priest1,2, Nathan C Manley3, Jerrod Denham1,4, Edward D Wirth1,3, Jane S Lebkowski1,3. 1. Geron Corporation, 149 Commonwealth St., Menlo Park, CA 94025, USA. 2. California Institute of Regenerative Medicine, 210 King St., San Francisco, CA 94107, USA. 3. Asterias Biotherapeutics Inc., 230 Constitution Drive, Menlo Park, CA 94025, USA. 4. Dark Horse Consulting, 1999 South Bascom Ave Suite 700, Campbell, CA 95008, USA.
Abstract
AIM: To characterize the preclinical safety profile of a human embryonic stem cell-derived oligodendrocyte progenitor cell therapy product (AST-OPC1) in support of its use as a treatment for spinal cord injury (SCI). MATERIALS & METHODS: The phenotype and functional capacity of AST-OPC1 was characterized in vitro and in vivo. Safety and toxicology of AST-OPC1 administration was assessed in rodent models of thoracic SCI. RESULTS: These results identify AST-OPC1 as an early-stage oligodendrocyte progenitor population capable of promoting neurite outgrowth in vitro and myelination in vivo. AST-OPC1 administration did not cause any adverse clinical observations, toxicities, allodynia or tumors. CONCLUSION: These results supported initiation of a Phase I clinical trial in patients with sensorimotor complete thoracic SCI.
AIM: To characterize the preclinical safety profile of a human embryonic stem cell-derived oligodendrocyte progenitor cell therapy product (AST-OPC1) in support of its use as a treatment for spinal cord injury (SCI). MATERIALS & METHODS: The phenotype and functional capacity of AST-OPC1 was characterized in vitro and in vivo. Safety and toxicology of AST-OPC1 administration was assessed in rodent models of thoracic SCI. RESULTS: These results identify AST-OPC1 as an early-stage oligodendrocyte progenitor population capable of promoting neurite outgrowth in vitro and myelination in vivo. AST-OPC1 administration did not cause any adverse clinical observations, toxicities, allodynia or tumors. CONCLUSION: These results supported initiation of a Phase I clinical trial in patients with sensorimotor complete thoracic SCI.
Authors: Victoria M Spruance; Lyandysha V Zholudeva; Kristiina M Hormigo; Margo L Randelman; Tatiana Bezdudnaya; Vitaliy Marchenko; Michael A Lane Journal: J Neurotrauma Date: 2018-04-24 Impact factor: 5.269
Authors: Peggy Assinck; Greg J Duncan; Jason R Plemel; Michael J Lee; Jo A Stratton; Sohrab B Manesh; Jie Liu; Leanne M Ramer; Shin H Kang; Dwight E Bergles; Jeff Biernaskie; Wolfram Tetzlaff Journal: J Neurosci Date: 2017-07-31 Impact factor: 6.167