First state license to retain cord blood for transplant issued in New Jersey.
CAMDEN, N.J. - The first-ever state license to collect and store the cord blood of newborns for therapeutic transplant was issued in December to the Coriell Institute for Medical Research here. The move comes amid the increasing interest from researchers in storing cord blood rich in stem cells, which can divide and make new blood and immune-system cells.
The New Jersey Department of Health gave the go-ahead to Coriell President David P. Beck, PhD, whose institute houses arguably the world's largest collection of living human cells for research. The Institute has been involved in the storage of cells since 1964, according to Dr. Beck.
"This is a new technology on the scene," he said. "Only in the last few years have we known that these cord stem cells can be used for transplantation - to replenish the bone marrow." (See January 1996 "News Worthy," MLO, p. 8.)
To store the blood left in the umbilical cord and placenta after birth, parents will have to pay an up-front fee of $1,500 for the collection of the blood at birth and its shipment to CorCell, a sister company to the Institute. CorCell will have the Institute test the blood to ensure its viability, and store it for one year. The company intends to charge an annual storage fee of $100 thereafter.
"We are going to be informing physicians of our service," said Frank Giordano, president and CEO of Cor-Cell, in a published report. "We'll also be marketing directly to pregnant mothers."
Stored cord blood from a baby would contain stem cells that are a 100% match for that baby, and children can be treated for a variety of diseases with their own cord blood. But the procedure is not without its unanswered questions, among them: how long cells can be kept, what happens if new blood tests come along after the blood is stored, and the accessibility of genetic information about the donor.
"It has been demonstrated that cord blood can be stored for 15 years; and transplants have been done with blood stored for as long as eight years," Dr. Beck said. Moreover, his Institute has been storing white blood cells isolated from whole blood for 44 years, "and they have remained viable," he said. "Those white blood cells have been stored under the same conditions as we will store the stem cells from cord blood, so we have every reason to believe that the technology we use, developed by Coriell, will be successful in preserving stem cells in cord blood for therapeutic purposes for a very long time," he said. "But there is no guarantee."
Dr. Beck cited a series of articles on cord blood in the New England Journal of Medicine that "locked down and demonstrated the feasibility of this technology." He emphasized, "Cord blood stem cells can be used for therapeutic use after criogenic storage."
To ensure the Institute can take advantage of any blood tests that may surface in the future, Dr. Beck explained, "We will store a vial or two of the blood separately, which can, if necessary, be thawed and used for parallel testing. We also store a sample on a Guthrie Card to give us multiple layers of back-up for identifying and matching the blood to the patient. We have this quality control program to assure the identity of the blood before it's actually thawed. This way, should it be necessary, we can go back and visit that blood sample without actually thawing the whole package itself."
Regarding its data management, "We make great efforts to protect the privacy of the information learned in the processing of this material," said Dr. Beck. "In the handling of cord blood, if the baby has an infectious disease such as hepatitis or HIV, we will not store that sample. If there are other, less severe infectious diseases, however, we will go ahead and store the sample," he said.
"We do not do any testing that will reveal the presence of any genetic diseases that would have any downstream deleterious effect on the child," Dr. Beck continued. "In fact, even if we did, the privacy of genetic information is protected according to new legislature in New Jersey. It is the strongest protection in the nation."
In its application for a license, the Institute had to document all its procedures for collection, storage, and quality control. The New Jersey Department of Health then conducted a rigorous review that took more than two months, according to Dr. Beck.
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|Publication:||Medical Laboratory Observer|
|Date:||Feb 1, 1997|
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