Medical expert of the article
New publications
FDA approves first cord blood product for stem cell transplantation
Last reviewed: 01.07.2025
All iLive content is medically reviewed or fact checked to ensure as much factual accuracy as possible.
We have strict sourcing guidelines and only link to reputable media sites, academic research institutions and, whenever possible, medically peer reviewed studies. Note that the numbers in parentheses ([1], [2], etc.) are clickable links to these studies.
If you feel that any of our content is inaccurate, out-of-date, or otherwise questionable, please select it and press Ctrl + Enter.
The product, known as Hemacord, is intended for use during hematopoietic stem cell transplantation in patients with diseases of the hematopoietic (blood-forming) system, namely certain types of blood cancer, inherited metabolic disorders and immune system disorders.
"Using cord blood in hematopoietic stem cell transplant procedures could save the lives of many patients with these diseases," said Dr. Karen Midthun, director of the FDA's Center for Disease Control and Prevention.
Hemacord contains hematopoietic progenitor cells from human cord blood. A study published last year found that cord blood was effective in treating acute leukemia in adults.
In 2009, the agency issued formal guidance to help manufacturers obtain licenses for cord blood products. Under that framework, the FDA spent two years reviewing data from manufacturers and new studies on the drug.
Hemacord's approval was based on safety and efficacy data supported by clinical trials.
The product will contain instructions that will warn about the risks of graft-versus-host disease, transplant rejection and other effects that can even lead to death, the agency said.
"Patients receiving Hemacord should be closely monitored by a physician experienced in hematopoietic stem cell transplantation with a risk/benefit assessment," the FDA noted.
Hemacord is produced by New Blood-York Centre, a company located in New York City.
[