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FDA Approves Clevecord for Stem Cell Transplants

doi: 10.1097/01.COT.0000505534.78469.5e
FDA Updates
FDA; Clevecord

FDA; Clevecord

The 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.

The organization's cord blood collections represent a diverse cross-section of donor ethnicity to support transplant needs, including patients in the underserved African-American community.

“It's all about the possibility of saving lives,” explained Executive Director Marcie Finney. “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 percent of parents giving birth in our partner hospitals donate their baby's umbilical cord blood, a rate well above the national average. “

Cleveland Cord Blood Center cord blood stem cell units are searched and accessed through registries, including the National Bone Marrow and Donor Program and Bone Marrow Donors Worldwide.

Wolters Kluwer Health, Inc. All rights reserved.
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