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.”