Clevecord, Umbilical Cord Blood Product for HSCT in Lymphoma Patients, Approved by FDA

Clevecord, Umbilical Cord Blood Product for HSCT in Lymphoma Patients, Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Cleveland Cord Blood Center‘s Clevecord use in hematopoietic stem cell transplants from unrelated donors in patients with leukemia, lymphoma, and immune system disorders and other hematopoietic system disorders. Clevecord is a stem cell product derived from umbilical cord blood.

“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,” Wouter Van’t Hof, the Cleveland Cord Blood Center (CCBC)’s Cord Blood Bank director, said in a press release.

“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,” he said.

Clevecord is a minimally manipulated product of human umbilical cord blood. It contains hematopoietic stem cells that may be used in unrelated donor hematopoietic progenitor cell transplant procedures in patients with hematopoietic disorders that are inherited, acquired, or result from treatments that disrupt a patient’s hematopietic system.

CCBC has an extensive collection of processed umbilical cord blood-derived products whose information can be assessed through registries, including the Bone Marrow Donors Worldwide and National Bone Marrow Donor Program. By including a diverse cross-section of donor ethnicity, the company may be able to support the transplant needs of a number of patients, including the underserved African-American population.

“It’s all about the possibility of saving lives,” said Marcie Finney, the center’s executive director. “Our high standards are implemented from the moment the baby’s cord blood is collected to the delivery of cord blood units to transplant centers. Up to 50% of parents giving birth in our partner hospitals donate their baby’s umbilical cord blood, a rate well above the national average.”

CCBC was founded by Mary J. Laughlin, MD, the doctor who performed one of the world’s first successful umbilical cord blood stem cell transplants on an adult leukemia patient in 1993.

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