Karen Midthun, M.D., director, FDA's Center for Biologics Evaluation and Research, said:
"The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders."
According to the FDA, HEMACORD is indicated for:
".. use in unrelated donor hematopoietic progenitor cell transplantation procedures... in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment."
Myeloablative treatment refers to treatment that results in the severe or complete depletion of bone marrow cells.
HEMACORD contains HPCs - hematopoietic progenitor cells - from cord blood.
- Hematopoietic means - pertaining to the formation of blood or blood cells.
- Progenitor cells means - early descendants of stem cells that can only differentiate, they cannot renew themselves anymore, like stem cells can. Differentiate means to change during development to more specialized forms. In other words, progenitor cells are not stem cells, but they can become, turn into (differentiate) certain types of mature cells.
- Cord blood
- Bone marrow
- Peripheral blood
President and CEO of the New York Blood Center, the makers of HEMACORD, Christopher D. Hillyer, MD, said:
"We are thrilled to be the first public cord blood bank with an FDA-licensed
product for transplantation."
In 2009, the FDA issued the "Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications." The aim being to help creators and marketers of certain cord blood units submit their products for approval. A two-year-phase-in period was instituted for manufacturers to submit either an investigational new drug application or a license application. The phase-in period expired on October 20th, 2011. Such applications must now be submitted.
A boxed warning comes with HEMACORD which warns doctors and patients about the risks regarding GVHD (Graft Versus Host Disease), infusion reactions, graft failure, and engraftment syndrome - each of them is potentially life-threatening.
The FDA says that individuals receiving HEMACORD require close monitoring.
The Agency added:
"A risk benefit assessment, unit selection and administration of HEMACORD should be done under the direction of a physician experienced in hematopoietic stem cell transplantation."
The New York Blood Center Vice President and Program Director of NCBP (National Cord Blood Program), Pablo Rubinstein, MD, said:
"The application process has been a rigorous and educational one for all of us at the National Cord Blood Program. We have always understood that providing high quality cord blood units for clinical use requires thorough scientific and technical definitions of methods, detailed analysis of results, and hard work.
Achieving systematic compliance with FDA Good Manufacturing Practices and Good Tissue Practices offers further assurance of the consistency, potency, purity, safety and efficacy of NCBP cord blood units."
Cord blood is collected by syringing out the placenta through the umbilical cord during childbirth, after the newborn has been detached from the umbilical cord.