Cord Blood: From Medical Waste to Award-winning Product

Zosia Chustecka

November 10, 2014

Umbilical cord and placentas were considered "medical waste" until the realization, about 25 years ago, that they provide a rich source of hematopoietic stems cells. That led to the development of cord blood for use as an alternative to bone marrow for transplants in patients with serious blood disorders, such as acute leukemia and sickle cell anemia.

Now, the first hematopoietic stem cell product licensed by the Food and Drug Administration, Hemacord, has won the Best Biotechnology Product Award from Prix Galien USA.

The Prix Galien award recognizes "biomedical products that advance the human condition," and is considered the biomedical industry's highest accolade. This year, nine products were entered for the award. Entry was restricted to products that had been approved by the US Food and Drug Administration within the previous 5 years; Hemacord was approved in November 2011.

Hemacord was developed at the New York Blood Center's National Cord Blood Program (NCBP).

Dr Pablo Rubinstein

"This breakthrough was made possible through the visionary leadership and tireless research of NCBP Director Dr Pablo Rubinstein," commented New York Blood Center chair Howard Milstein.

"Dr Rubinstein's innovative concept of transforming umbilical cord blood, previously considered medical waste, into a clinically useful, noncontroversial source of stem cells has saved tens of thousands of lives worldwide," Milstein commented in a statement.

The New York Center's NCBP was the first public umbilical cord blood bank. It was established in 1992 with funding from the National Institutes of Health.

Since its inception, it has provided almost 5000 cord blood units for transplantation worldwide.

Cord blood retrieval. Courtesy of the New York Blood Center.

In an interview with Medscape Medical News, Dr Rubinstein recalled the early days of setting up the umbilical cord bank. Mothers who were approached for donations were at first "surprised and then fascinated" by the idea that the "waste products" of childbirth could find such a therapeutic use, and once the concept was explained to them they donated readily, he said.

The first transplant using the umbilical cord as a source of stem cells was carried out in 1989, and the patient is still alive and well today, Dr Rubinstein said. That first transplant used cord blood from a relative; the material was collected from a newborn sibling of the patient, he explained. The first transplant using cord blood from an unrelated source was made in 1993, and was also successful. That was a world first, Dr Rubinstein said.

Since then, the procedure has become a standard clinical practice, and a recent study in the New England Journal of Medicine (2014;371:1685-1694) estimated that umbilical cord blood has been used as a source for stem cells in about 30,0000 transplants worldwide.

Cord blood processing. Courtesy of the New York Blood Center.

Dr Rubinstein said that the New York Center's NCBP has around 60,000 units of cord blood ready for transplantation, but he added that there are now other banks all over the world, including Australia, Canada, Europe, Japan, and Mexico. The others followed the lead of the NCBP, he suggested: "Ours was the first one, and we had a number of seminars, which were attended by researchers from around the world keen to learn what we were doing."

Very Effective Alternative to Bone Marrow

"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," Dr Rubinstein commented.

There is less of a need for close matching with cord blood than there is for bone marrow transplants, where patients need to find a related or matched donor, he explained. "It is less demanding of close HLA matching, importantly, reducing the barrier for recipients of infrequent HLA types and patients of minority ethnic groups."

He estimates that cord blood is the source of hematopoietic stem cells in about 20% of all such transplants currently carried out in the United States. In Europe, generally speaking, it may be a little less, maybe about 15%, and in other geographic areas, it may be even less.

"There are reasons for this," Dr Rubinstein said. In Europe, the ethnicity of the populations is relatively homogenous, he explained, and so it is easier to find matched donors. But it is quite difficult to find matched donors for some ethnic groups, for example South American Indians and Asians, he said, and so there is an increased need for cord blood in countries where there are mixed ethnicities, such as the United States.

"With cord blood, there is less of a need for exact matching," Dr Rubinstein commented. "We can do transplants that approximately match, and they work quite well," he said.

In addition, when cord blood is used as a source, there is less of a risk for graft vs host disease and, therefore, less need for chemotherapy induction before the transplant and immunosuppression afterward. The regimens that are used are milder than those used when bone marrow is the source. This means that the whole process of cord blood transplantation is less of a shock to the system, and so these transplants are now being considered in elderly patients who would have been considered too frail for bone marrow transplants, he commented.

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