Fda Says Parents Needn’t Worry About Umbilical Cord Blood Rules

Panicked parents are flooding the Food and Drug Administration with letters and baby photographs, in fear the agency will outlaw storing their newborns’ umbilical cord blood for future medical use.

Pending regulations “could take a lifesaving option away from Erika and other patients,” wrote Inge Jackson of Audubon, N.Y., whose newborn son’s cord blood might offer her 3-year-old Erika a transplant if her leukemia ever returns.

However, the proposed FDA rules do not forbid parents from saving their newborns’ cord blood - nor forbid any patient from receiving the blood.

The rules instead would force companies that bank babies’ blood to disclose that these transplants are highly experimental and to collect medical data to prove they work. Until then, banks could charge only what it costs to store cord blood - not make a profit off an experiment.

The FDA has received more than 120 letters from parents frightened by one bank’s lobbying against the rules.

“There’s a lot of misinformation that is being disseminated,” said FDA cellular hematology chief Liana Harvath. “We are not stopping the use of material that is needed for patients.”

But the largest cord-blood bank says the FDA doesn’t have to prohibit transplants - its proposed rules will cost too much to stay in business.

Transplants of a newborn’s umbilical cord blood are used as a last resort to treat people dying of leukemia and other diseases, because it is rich in stem cells that are the building blocks of blood.

Only about 250 transplants have been performed worldwide, but companies are promising to freeze newborns’ cord blood in case the child or a relative needs it decades later.

Doctors don’t know which diseases cord blood helps, whether it stays good longer than three years or even which banks properly test it for the AIDS virus or certain genetic diseases.