HEMACORD®, the First FDA-Licensed Stem Cell Product, Wins Prix Galien USA “Best Biotechnology Product” Award
October 30, 2014, New York, NY – The New York Blood Center’s Milstein National Cord Blood Program (NCBP) is pleased to announce that HEMACORD®, the first FDA-licensed hematopoietic stem cell product, has been awarded the prestigious “Best Biotechnology Product” Award by Prix Galien USA.
The award recognizes “biomedical products that advance the human condition and which were approved by the U.S. Food and Drug Administration (FDA) during the past five years,” according to the Galien Foundation. HEMACORD® was among nine biotech products nominated for this award.
The Prix Galien Award is considered the biomedical industry's highest accolade and recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and devices.
“Prix Galien’s selection of HEMACORD®, the first FDA licensed stem cell product, heralds an important advancement in the world of medical therapeutics. With this award, the Prix Galien Foundation recognizes cellular “drugs” in its efforts to encourage the development of tools and technologies for Regenerative Medicine, the scope of which is already vast and growing exponentially,” said New York Blood Center Chairman Howard P. Milstein. “This breakthrough was made possible through the visionary leadership and tireless research of NCBP Director Dr. Pablo Rubinstein.”
“Dr. Rubinstein’s innovative concept of transforming umbilical cord blood, previously considered medical waste, into a clinically useful, non-controversial source of stem cells has saved tens of thousands of lives worldwide,” Mr. Milstein added.
Approved by the FDA in November 2011, HEMACORD® is the first FDA-licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy. HEMACORD® uses cord blood stem cells to treat certain disorders of the hematopoietic, or blood forming, system.
Dr. Rubinstein said: “The stems cells in donated cord blood have become an alternative and very effective allogeneic cell therapy for diseases whose treatment requires bone marrow transplants. It substitutes for HLA-matched unrelated donors and is less demanding of close HLA matching, hence importantly reducing the barrier for recipients of infrequent HLA types and patients of minority ethnic groups.”
Dr. Rubinstein added: “The NCBP’s accomplishments – scientific, medical and regulatory – in creating and nurturing cord blood banking, and ultimately HEMACORD®, were made possible by the long tradition of innovation in medical biotechnology at NYBC, the visionary direction of Board of Trustees Chairman, Howard Milstein, the commitment of NYBC’s President, Dr. Christopher Hillyer, and the outstanding dedication of the entire staff.”
More than 20 years ago, Dr. Rubinstein and other scientists at New York Blood Center (NYBC)’s Lindsley F. Kimball Research Institute presented the concept of a public cord blood bank to the National Heart, Lung and Blood Institute of the National Institutes of Health (NHLBI/NIH). Their proposal addressed the practical feasibility of publicly banking donated umbilical cord blood from healthy births as an off-the-shelf source of hematopoietic stem cells – an alternative to bone marrow and peripheral blood stem cell donation. Donated cord blood addressed the critical need of finding appropriate transplants for patients who had no related or matched bone marrow donors and thus no access to stem cell transplantation (lack of match bone marrow donors is often the case with members of ethnic minorities).
Dr. Christopher D. Hillyer, President and CEO of New York Blood Center, said: “Umbilical cord blood contains cells that are ideal for reprogramming to pluripotency – which provides the longest telomeres and highest DNA repair activity – and these cells are being increasingly tapped for a very broad potential role in therapy.”
New York Blood Center established NCBP, the first public cord blood bank in 1992, funded by a research and demonstration grant from NIH. Since its inception, NCBP, part of the Howard P. Milstein Cord Blood Center, has banked more than 60,000 cord blood units and provided over 5,000 cord blood units for transplantation to patients suffering from lethal diseases. The technology developed by Dr. Rubinstein at NCBP has made lifesavings treatments available to more than 100,000 people worldwide. Since 1996, NCBP has operated under an FDA Investigational New Drug (IND) exemption, the first cord blood bank to receive an IND allowing it to collect, process, test, and store and provide cord blood as a stem cell source for use in experimental clinical transplantation. NCBP was also the first cord blood bank accredited by FACT (the Foundation for Accreditation of Cellular Therapy) in 2003.
Transplant outcomes provided evidence of the clinical benefit of cord blood transplantation in the treatment of malignant diseases of the blood, immune system and certain inherited metabolic diseases. Together with NCBP-developed technical procedures and donor-recipient matching facilities, this paved the way for the regulatory recognition of cord blood as a licensable therapeutic agent.
Most mothers at NCBP partner birthing hospitals are happy to donate their placental and umbilical cord stem cells for the public good. In addition to providing stem cells to patients around the world the New York Blood Center, the Howard P. Milstein Cord Blood Center and NCBP support the development of cord blood stem cell and cell therapy research. HEMACORD® will facilitate the future development of cellular therapies that start with an FDA accepted cell source, thus shortening their time to Clinical Trials and medical utilization.