StemCyte Receives Phase II Investigational New Drug (IND) Clearance from the U.S. Food and Drug Administration (FDA)
BALDWIN PARK, Calif., Jan. 3, 2019 — StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, 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.
“This is a great achievement by the StemCyte team. As a leading regenerative cell therapy company, the success of the MC001 will put StemCyte in the central position in the emerging stem cell application markets,” said Jonas Wang, StemCyte’s CEO and Chairman. “FDA’s announcement marks StemCyte having successfully reached the major milestone of the advancement of our regenerative cell therapy program. With our highly experienced expert investigators, we plan to bring this new innovative treatment option in early 2019 to this highly unmet medical need in patient populations with chronic, severe, stable spinal cord injury.”
StemCyte’s rich history started with a mission of dedication to helping the world’s physicians save more lives by providing high quality, safe, and effective stem cell transplantation and therapy to all patients in need. Located in the US, India, and Taiwan, StemCyte has supplied over 2,200 cord blood units for a variety of life-threatening diseases to over 350 leading worldwide transplant centers. StemCyte is actively involved in the development of stem cell therapies. StemCyte has also been chosen by the US Department of Health and Human Services to help establish a Public National Cord Blood Inventory. Its headquarters is located in Baldwin Park, CA. To learn more, visit www.StemCyte.com.
For more information call 626.646.2500