BioTime presents SCiStar clinical study top-line results

BioTime presents SCiStar clinical study top-line results

Biotime, a biotechnology company developing new cellular therapies, presented the top-line 12-month results from the SCiStar study – “A Phase 1/2a Trial of Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cells (OPC1) in Patients with Subacute Cervical Spinal Cord Injury” at the 26th Annual American Society for Neural Therapy and Repair (ASNTR) Annual Conference in Florida, USA.

Chief Medical Officer of BioTime Dr. Edward D. Wirth said the primary goals of the study have all been achieved.

“We believe the primary goals of the SCiStar Study, which were to observe the safety of OPC1 in cervical spinal cord injury patients as well as other important metrics including related to the optimal timing of OPC1 injection, tolerability of the immunosuppression regimen, engraftment of OPC1 cells, and rates of motor recovery observed among different study subpopulations, have all been successfully achieved,” stated Dr. Wirth. 

“We now are in the process of analysing the full data set from the SCiStar Study to inform how best to proceed with this promising program. We expect to propose a clinical plan to the US Food and Drug Administration later this year and expect to share the outcome of those discussions when they are available.”

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