SEARCH FOR SCI CURE: StemCyte receives Phase II approval from FDA

StemCyte, a company in Southern California, announced that the U.S. Food and Drug Administration (FDA) approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for the treatment of spinal cord injury.

MC001 is a regenerative cell therapy drug, which is designed to regenerate neurons in patients who suffered chronic, severe, stable spinal cord injury. MC001 has already been shown to be efficacious, safe and well tolerated in a Phase II trial conducted by Dr. Wise Young of Rutger’s University in Kunming, China. Starting in early 2019, within the United States, this Phase II study will be performed at a number of clinical centers in New Jersey.

Dr. Young was featured in this article in New Mobility magazine back in July 2016 talking about this approach which wax tested first in China.