FDA Inspects Just Fraction of Umbilical Cord Blood Banks

Businesses in California and across the country have set up private banks and labs that store a child’s umbilical cord blood for a fee. It’s a multibillion-dollar industry that has grown tremendously in the last 20 years.

The blood from an umbilical cord contains stem cells, a rich resource that can be used to treat certain diseases, including leukemia, lymphoma, aplastic anemia, and severe sickle cell disease. More science is emerging to support the potential of these stem cells in future cell therapies.

But private cord blood banks are only lightly regulated, and it may not be clear what happens to the cord blood if the banks go out of business.

Crystal Prince chose to spend $2,000 to bank her son’s cord blood at Monterey-based BioBanc in 2009. “You want the best for your children,” Prince said. “You plan for the future, you see it as a type of insurance and savings account and we pictured that cord blood to be an extra life insurance policy.”

Prince thought of that insurance policy when her 14-month-old daughter Trinity became sick.

“She might have a genetic disease,” Prince said. “You go into panic mode. What can I do to help my child?” She says she immediately thought of her son’s stored cord blood as an option, but when she called BioBanc, she couldn’t get through.

“This went on, phone calls after phone calls and I even tried different times throughout the day in case they were working odd hours,” Prince said.

She soon discovered the business was on the brink of closing. She had no idea where her son’s umbilical cord blood was being stored and if it was even viable. “That life insurance policy that I got for my kids, I feel like it was ripped away from us,” Prince said.

Crystal Prince couldn't access her son's cord blood when her 14-month-old daughter Trinity became ill

Regulating Umbilical Cord Blood Banks

The Food and Drug Administration is in charge of inspecting and regulating umbilical cord blood banks. According to the FDA, 310 facilities are registered in the United States to store umbilical cord blood banks, but unlike nail salons and restaurants, there’s no law that says how often private cord blood banks must be inspected.

The FDA declined to be interviewed but in an email, stated it "has been averaging approximately 30 inspections of cord blood establishments each year," both private and public. Inspection records reveal serious problems at many private banks around the country.

In 2009, at Florida-based Newborn Blood Banking Inc., inspectors found dead insects near areas used for cord blood processing and freezing.

The NBC Bay Area Investigative Unit contacted Newborn Blood Banking. The man who answered the phone confirmed the bank continues to store samples, but is not enrolling new customers at this time. He hung up when asked further questions.

During a 2006 inspection at Las Vegas-based CellFreeze, inspectors found no “quality program for cord blood” and “no established procedures for cleaning and sanitation.”

At another blood bank, Mississippi-based Vista Cord, the FDA inspection revealed a laundry list of violations, including “dust, dirt, trash and various dead insects…found throughout the processing and storage areas.

CellFreeze closed in 2009. VistaCord was acquired by another umbilical cord blood bank, Family Cord, in 2010. In a statement, Richard Jennings, president of Family Cord, said the company “conducted proxy testing that confirmed the quality of the stem cells.”

As for BioBanc USA, where Prince stored her son’s cord blood, a 2009 FDA inspection found several violations, including failing to screen mothers for communicable diseases.

The FDA didn’t return to BioBanc for another two years, when Prince contacted the agency about her missing cord blood. Then, the FDA found more problems. Inspection documents show that the bank was storing samples improperly and that the owners admitted that they “had no medical or scientific training.”

“They’re not held to the same standard as the public banks,” said Jon Walker, co-director of umbilical cord blood collection at UC Davis.

The UC Davis Health System administers California's public system for collecting cord blood.  California is one of a handful of states, including New York, Missouri and Texas, where parents who deliver at certain hospitals can donate their child’s cord blood to a public bank where it can be used in a transplant or for research.

Walker said parents who choose private banking have to ask what happens if the bank goes out of business and who oversees it.

“The first thing you want to ask is, 'Are they accredited by anyone?'” Walker said.

Parents should also verify how the banks collect and preserve samples.

“You want to make sure there are enough cells to actually do something if you use it,” Walker said.

The FDA says it "uses a risk-based approach when deciding how often private cord banks are to be inspected.

The FDA would not explain why the agency did nothing after the 2009 inspection. In an email, an FDA spokeswoman wrote, “We have no additional information to provide regarding BioBanc other than what is contained in the inspection reports.”

The former owners of BioBanc did not respond to the Investigative Unit's multiple requests for comment.

Prince eventually tracked down her son’s cord blood, and it is now stored in a private bank in Southern California, but she doesn’t know if it’s still viable.

“It’s so heartbreaking today, knowing everything you’ve gone through, it still may not have been enough,” Prince said.

She wants parents to know what she didn’t: that the business of private cord blood banks is not regulated as stringently as they might think. It’s what she believes led to the sloppy handling of her son’s cord blood.

Prince's daughter Trinity is now a happy 5-year-old, but she still doesn’t have a diagnosis.

“I think I will always wonder until the day I die, was the cord blood good?" she said. "Will we have to use it and will it save my kid’s life if needed?”

If you have a tip for the Investigative Unit email theunit@nbcbayarea.com or call 888-996-TIPS.

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