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The US Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for Clevecord™ (HPC, Cord Blood), a hematopoietic progenitor cell product derived from umbilical cord blood.
Under this license, CCBC is authorized to manufacture Clevecord at its facility in Warrensville Heights, Ohio.
Clevecord is indicated for use in unrelated donor transplant procedures, in conjunction with an appropriate preparative regimen.
The product can be used for hematopoietic and immunologic reconstitution in patients with disorders that affect the hematopoietic system, whether they are inherited, acquired, or result from myeloablative treatment.
Each Clevecord unit contains a minimum of 5 x 108 total nucleated cells with at least 1.25 x 106 viable CD34+ cells at the time of cryopreservation. The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation.
Clevecord has been approved with a black box warning, which states that use of the product may result in fatal infusion reactions, graft-vs-host disease, engraftment syndrome, and graft failure.
For more details on Clevecord, see the package insert on the FDA website.
“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 US and around the world,” said Wouter Van’t Hof, cord blood bank director at CCBC.
CCBC collects, processes, stores, and distributes umbilical cord blood units for use in transplants and advanced research in cellular therapy.
The organization says its cord blood collections represent a diverse cross-section of donor ethnicity to support transplant needs, particularly in the underserved African-American population.
“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,” said Marcie Finney, executive director of CCBC.
CCBC cord blood units can be searched and accessed through registries, including the National Bone Marrow Donor Program and Bone Marrow Donors Worldwide. 
The US Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for Clevecord™ (HPC, Cord Blood), a hematopoietic progenitor cell product derived from umbilical cord blood.
Under this license, CCBC is authorized to manufacture Clevecord at its facility in Warrensville Heights, Ohio.
Clevecord is indicated for use in unrelated donor transplant procedures, in conjunction with an appropriate preparative regimen.
The product can be used for hematopoietic and immunologic reconstitution in patients with disorders that affect the hematopoietic system, whether they are inherited, acquired, or result from myeloablative treatment.
Each Clevecord unit contains a minimum of 5 x 108 total nucleated cells with at least 1.25 x 106 viable CD34+ cells at the time of cryopreservation. The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation.
Clevecord has been approved with a black box warning, which states that use of the product may result in fatal infusion reactions, graft-vs-host disease, engraftment syndrome, and graft failure.
For more details on Clevecord, see the package insert on the FDA website.
“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 US and around the world,” said Wouter Van’t Hof, cord blood bank director at CCBC.
CCBC collects, processes, stores, and distributes umbilical cord blood units for use in transplants and advanced research in cellular therapy.
The organization says its cord blood collections represent a diverse cross-section of donor ethnicity to support transplant needs, particularly in the underserved African-American population.
“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,” said Marcie Finney, executive director of CCBC.
CCBC cord blood units can be searched and accessed through registries, including the National Bone Marrow Donor Program and Bone Marrow Donors Worldwide.
The US Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for Clevecord™ (HPC, Cord Blood), a hematopoietic progenitor cell product derived from umbilical cord blood.
Under this license, CCBC is authorized to manufacture Clevecord at its facility in Warrensville Heights, Ohio.
Clevecord is indicated for use in unrelated donor transplant procedures, in conjunction with an appropriate preparative regimen.
The product can be used for hematopoietic and immunologic reconstitution in patients with disorders that affect the hematopoietic system, whether they are inherited, acquired, or result from myeloablative treatment.
Each Clevecord unit contains a minimum of 5 x 108 total nucleated cells with at least 1.25 x 106 viable CD34+ cells at the time of cryopreservation. The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation.
Clevecord has been approved with a black box warning, which states that use of the product may result in fatal infusion reactions, graft-vs-host disease, engraftment syndrome, and graft failure.
For more details on Clevecord, see the package insert on the FDA website.
“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 US and around the world,” said Wouter Van’t Hof, cord blood bank director at CCBC.
CCBC collects, processes, stores, and distributes umbilical cord blood units for use in transplants and advanced research in cellular therapy.
The organization says its cord blood collections represent a diverse cross-section of donor ethnicity to support transplant needs, particularly in the underserved African-American population.
“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,” said Marcie Finney, executive director of CCBC.
CCBC cord blood units can be searched and accessed through registries, including the National Bone Marrow Donor Program and Bone Marrow Donors Worldwide.