Nutrient-rich umbilical cord blood preserved as potential aid to immune system

THE BALTIMORE SUN

The baby's due any day. You've prepared everything at the hospital and at home.

You expect in the years ahead to have such keepsakes as a lock of hair, maybe a bronzed booty or two, lots of snapshots and access to the baby's umbilical cord blood.

Yes. The umbilical cord.

Researchers, physicians and some families are less likely today to throw out such unpleasant items as umbilical cords as they start to view the nutrient-rich blood it contains as a valuable resource to rebuild the immune system in siblings and, potentially, adults.

Those early drops of blood after the baby is delivered contain stem cells, the building blocks of the child's immune system. These cells can be used in later years for bone marrow transplants to fight rare childhood diseases, leukemia, some immune disorders and, in the future, such diseases as sickle cell anemia and multiple sclerosis.

So far, the collection and processing of blood cells from umbilical cords have been done primarily for research purposes by various medical centers.

Now private industry wants to do the collecting, processing, testing, cold storing and marketing to families. And Boston-based ViaCord Inc. is among the first to jump on the wagon.

"We're offering biological insurance," said Cynthia Fisher, the 34-year-old president and founder of ViaCord, which last week formally launched its medical service, making it the nation's third commercial umbilical cord blood banking company.

The fee for ViaCord's service: A one-time $1,500 -- to collect, test and process the fetal blood -- plus a $95 annual fee to keep the stem cells frozen in a University of Cincinnati Medical Center hospital vault.

Ms. Fisher calls her company's technology "a special lifetime baby gift" and "a choice that could save your child's life."

But critics of the procedure say it is costly, unregulated and is likely to appeal to only a small patient population -- that which already has an ill child and can benefit from stem cells taken from a second child.

ViaCord's procedure works this way:

It begins with the obstetrician clamping the umbilical cord once it is removed from the newborn. During the next two to three minutes, about three to four ounces of blood is collected from the umbilical cord and placed into a sterile blood bag. A blood sample is also taken from the mother.

Ms. Fisher said the cord blood and the mother's sample are then sent by air courier to the Hoxworth Blood Center of the University of Cincinnati Medical Center where they are tested for infectious diseases and genetically typed.

Stored in liquid nitrogen

The blood is processed and stored in liquid nitrogen at nearly 200 degrees below zero Celsius. Ms. Fisher said her company guarantees the time between blood collection and freezing will take less than 24 hours.

Stem cells are scarce and difficult to extract from adults and children. But they are abundant and easy to obtain in umbilical cord blood. Should the child need them later to cure a hereditary disease, the stem cells are a perfect match. And there is a one in four chance of a 100 percent match between the donating infant and an ill brother or sister, say some physicians.

When the donating child or a sibling needs the blood, ViaCord arranges to return it to the family.

While ViaCord is just entering the market, its rival, the Stamford, Conn.-based Biocyte Inc., has been harvesting umbilical cord stem cells for nearly two years and storing them in freezers in Pittsburgh. It recently reported having about 130 clients, who pay a one-time collection and processing fee of between $895 and $1,500 and a $75 per year storage fee.

"We find parents subscribing to our service [include those] with one ill child who plan to have a second and see the benefits, to progressive parents who have some medical knowledge and know the value of stem cells," said Mark A. Niles, Biocyte's director of marketing.

Ms. Fisher has spent $1 million of her own money to launch ViaCord nearly two year ago, using funds she obtained from savings and various investments.

Armed with a biophysics degree from Ursinus College in Collegeville, Pa., and a Harvard Business School degree, Ms. Fisher formed the company in June 1993 and spent two years funding university research on stem cell separation. Now entering the commercial phase, Ms. Fisher said the company has started a search for $6 million in private investment funds to build the business.

"A lot of the growth will depend on the education of obstetricians and parents," said Ms. Fisher.

Since 1990, more than 100 patients -- 90 percent of them children -- have received umbilical cord stem cells in transfusions to treat childhood and adult leukemia and such rare disorders as severe combined immune deficiencies (SCIDs) and Fanconi's Anemia. More than 65 percent of the transplants within families (infant donor to brother or sister) have been successful.

Rejection is unlikely

Even without a perfect match, the infant's rich stem cells -- eight to 10 times more prolific in multiplying and dividing to create new blood cells than the stem cells extracted from healthy bone marrow donors -- may still be used in some transplants. Moreover, the chance of the body rejecting the new stem cells is much lower with umbilical cord blood than bone marrow.

And by next year, studies will be launched to determine whether mothers can use their child's cord blood to treat cancer and other immune disorders affecting them. At issue is whether there are enough stem cells in the cord blood to treat an adult.

Although not everyone is convinced that parents will buy into biological insurance, many physicians concede that if parents who are planning to have more children already have a child that could benefit from an infant sibling's stem cells, then parents may find subscribing to a cord program worthwhile.

Although few question the science or the efficacy of cord blood cell transplants, they raise questions about the cost and the practicality for most families who may never come face to face with a rare disease.

Others are concerned about the lack of Food and Drug Administration regulation over cord blood banking systems. Neither ViaCord nor its competitors need FDA approval today, although that is expected to change, according to Ms. Fisher. But without FDA approval, insurance providers may be reluctant to pay for cord blood transplants -- another issue that concerns some.

"It's a rather expensive insurance policy since you are more likely to die in a car accident than you are to develop the kind of cancers where this would be the best of all possible solutions," said Dr. Jed Gorlin, associate director of transfusion services at Boston's Children's Hospital.

One potential impetus for cord blood preservation is to create cord blood centers and collection sites around the country. It would also increase the success rate of minority transplant candidates in finding a donor. That's what the National Institutes of Health hopes to do. It has set an Aug. 15 deadline to receive proposals from medical centers to participate in a five-year, $37 million pilot program to establish two to four blood banking centers, collecting umbilical cords from 20,000 infants -- half of them from African-Americans, Hispanics, Asian-Americans and Native Americans.

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