We have released coverage of this week’s stem cell industry activity that I am excited to share with you. It was a major week for stem cells, with CDI launching Opsis Therapeutics, Provia Laboratories expanding its stem cell product portfolio, CCBC getting a FDA Biologics License for CLEVECORD™, STEMCELL Technologies exploring genomic instability in an upcoming webinar, and iPSCs turning 10. [Read more…]
FDA Approves the Cleveland Cord Blood Center’s CLEVECORD™ for Stem Cell Transplants
CLEVELAND, Sept. 12, 2016 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for CLEVECORD™, a stem cell product (HPC, Cord Blood) derived from umbilical cord blood. Under this license, CCBC is authorized to manufacture CLEVECORD, for use in unrelated hematopoietic cell transplantation in patients with disorders affecting the hematopoietic system such as leukemia, lymphoma and immune system disorders.
“Obtaining FDA licensure for CLEVECORD is reflective of the Cleveland Cord Blood Center’s dedication to meeting the highest quality standards in the industry for distribution of our cord blood products to transplant centers throughout the U.S. and around the world,” said Wouter Van’t Hof, the CCBC’s Cord Blood Bank Director. “The ability to meet such standards is indicative of the commitment of our organization to providing high quality transplant options to patient populations that are underserved in hematopoietic transplantation. It also stages the pursuit of new life-saving and life-enhancing research and product development opportunities.”
