StemCyte gets FDA green light to continue studying spinal cord injury treatment stem cells: 5 takeaways


The FDA granted StemCyte permission to proceed with its phase 2 investigational new drug application for the Allogenic Human Leukocyte Antigen-Matched Umbilical Cord Blood Mononuclear Stem Cells (MC001).

Here are five takeaways:

1. MC001 is a regenerative cell therapy drug designed to treat spinal cord injuries.

2. StemCyte has proven MC001 is efficacious, safe and well tolerated in a phase 2 trial in China.

3. Dr. Wise Young of Rutger's University in Kunming, China, led the phase 2 trial to test the regenerative drug's safety and efficacy.

4. Various centers in New Jersey will be a part of the phase 2 U.S. study. StemCyte aims to introduce the new treatment option in early 2019.

5. "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.

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