April 25, 2014 12:55 p.m. ET
Before giving birth two years ago,
went back and forth trying to decide whether to save the blood from her baby’s umbilical cord, a peculiar but increasingly common American birth ritual.
Like every new parent, Ms. Ferrarese worried about the health of her firstborn. It was a long shot, but maybe stem cells from the cord blood held a miracle cure for a disease that might strike her baby in the years ahead.
Ms. Ferrarese trawled online message boards, where some mothers say it is a lifesaver and others call it snake oil. She and her husband talked it over with their doctor, friends and family before agreeing to pay $1,900 for a company to process and store the cryogenically frozen cord blood of their daughter, Iris.
“In the back of my head, I thought, ‘If we don’t do it, something’s going to happen and we’ll need it,’ ” said Ms. Ferrarese, of Houston. Since then, she said, many of her friends have done the same, and the 32-year-old mother plans to store the cord blood of a second daughter, expected in June.
The question of whether to pay for storage of a baby’s cord blood is now routinely asked of expectant parents in obstetrician offices and hospital delivery rooms. Many states have passed laws requiring that doctors tell expectant parents their options for cord blood: discard it; bank it privately; or donate it to a public bank, which like a blood or organ bank helps people in need. The harvesting and storage of stem cells from the blood of umbilical cords has surged in the past decade to a $4 billion global industry.
But a Wall Street Journal analysis of government inspections and a review of lawsuits in the U.S. found problems in the loosely regulated cord-blood-banking business, including dirty storage conditions, leaky blood samples and firms going out of business.
Some private cord-blood banks are essentially marketing websites that lure customers, collect fees, then outsource the processing and storage of what is touted as biological life insurance for children.
The pitch for private storage is compelling to expectant parents. A child’s stem cells—a kind of genetic building block that may repair damaged blood, tissue or organs—are less likely to be rejected by the body than someone else’s cells. Researchers say chances are slim for finding a perfect match at public banks, which last year stored a total of 193,418 samples nationwide.
Stem cells from cord blood were first successfully transplanted into a 5-year-old boy,
to treat a rare blood disorder in 1988. He received his sister’s umbilical-cord blood cells, and his condition improved.
There have since been more than 30,000 cord-blood transplants world-wide to treat more than 70 diseases, according to estimates from Be The Match, a Minneapolis nonprofit bone marrow registry. Research is under way to see if stem cells can be used to treat brain injuries and some types of diabetes, the nonprofit said. Most of the transplants have been between donors and unrelated patients, using matching cord blood from public facilities, said
Dr. Pablo Rubinstein,
director of Howard P. Milstein National Cord Blood Program, a public cord bank, at New York Blood Center, and the longtime survival rate is about 50%.
Actions Against Cord-Blood Banks
The Monterey County District Attorney filed a civil complaint alleging unfair business practices against cord-blood bank BioBancUSA in California state court in 2012. The complaint was triggered by a client worried about the availability of her son’s cord blood.
The FDA ordered the cord-blood bank Newborn Blood Banking Inc. to stop receiving or forwarding blood samples in February 2010, after an inspector months before reported finding dirt and dust in the room where cord blood was processed and stored, along with a dead bug on the floor.
In September 2009, the FDA ordered Vista Cord LLC to stop receiving new cord-blood samples and stop sending out samples for use, after the agency had discovered a number of violations, including, among other things, missing records, a hole in the facility’s ceiling and trash throughout the processing and storage areas.
Most U.S. medical authorities support giving to public banks because the donated cord blood has a much higher likelihood of helping someone who is a close match, compared with the chances of children needing their own.
Private banks say they offer parents the security of holding on to their child’s cord blood in the rare instance it is needed—by some estimates, 1 in 2,700. The roughly three dozen private banks in the U.S. that store and freeze a newborn’s cord blood usually charge $2,000 or so up front, often with annual payments of about $125.
The number of cord-blood samples they store has quadrupled since 2004 to 1.7 million, a number expected to keep growing, according to BioInformant Worldwide LLC, a research firm. Last year, there were 1,102 cord-blood transfusions from public banks in the U.S., according to the Department of Health and Human Services. There are no similar figures for private banks.
While acknowledging that stem-cell science is still in its early stages, private cord-bank operators say it holds the potential to transform medicine.
“Talk to one of the thousand families or so who have had their own stem cells used on their child for cerebral palsy or autism in a clinical trial who feel they have seen drastic improvement in that kid, and ask them if it was worth it,” said
chief executive officer of Cord Blood Registry, the largest private bank in the U.S., storing about 500,000 cord-blood samples.
Cord-blood handling is a delicate process. After doctors collect the blood—three ounces is average, they say—it is shipped in insulated containers to arrive within 48 hours at a lab where workers separate the stem cells.
The blood is placed into sterile bags or vials and stored at about minus 320 degrees Fahrenheit, frozen in the vapors of liquid nitrogen. If accidentally thawed, the blood can’t be refrozen without spoiling the sample, researchers say, raising the stakes on proper storage.
a leading cord-blood researcher and clinician, said in the past few years she has rejected several hundred samples of cord blood from the estimated 2,000 she has received from private banks to use in clinical studies. Some of the samples weren’t sterile or hadn’t been tested for contaminants or diseases, she said; others didn’t have enough cells to be useful.
In one case at Duke,
was ready to drive her 18-month-old son, Luke, to join in a 2009 clinical study of cord blood for the treatment of cerebral palsy. Their suitcases were packed when the phone rang with bad news: The toddler’s cord blood had arrived mislabeled, a nurse said, and there was no telling whose it was. Luke couldn’t participate in the study.
“It felt like death,” Ms. Bays said. “You have all these hopes and you feel like you have a chance. You never get that chance back.”
When Ms. Bays signed up with the company CorCell in 2007 to store her son’s cord blood the private bank didn’t have its own lab. Luke’s cord blood bounced from one blood bank to another, according to a lawsuit filed by the Bays against CorCell in a West Virginia federal court. The family has since dropped the suit, and CorCell, which has become a subsidiary of Cord Blood America Inc., has denied any wrongdoing. CorCell currently operates its own storage freezers.
Luke Bays, now 7 years old, has learned to walk, his mother said, but still suffers the symptoms of cerebral palsy.
The Food and Drug Administration each year inspects roughly a fifth of the approximately 2,700 facilities in the U.S. that store blood, sperm and other human tissue. The FDA’s monitoring of private cord-blood banks is focused on preventing the spread of infectious diseases, rather than making sure the banks can deliver on what they promise.
The government requires public banks to license the cord blood, which entails copious documentation on processing, storage and sterility—and a site inspection before opening. By contrast, the FDA requires private banks only to register their company name and address, and say what they intend to do with the blood.
“We don’t have a particular goal or statutory requirement” for private banks, said
director of the FDA’s office of compliance and biologics quality, who noted the companies are expected to follow rules for safely handling the cord blood.
The agency carries out surprise inspections on public and private banks, but it is difficult for consumers to see those results. The FDA’s online database offers scant details about its inspection findings. They also can be confusing. Some entries, for example, are listed under a company’s corporate owner rather than the name of the bank. Detailed information can be obtained only through an open-records request, the FDA said.
A limited number of inspection reports reviewed by the Journal reveal problems. In July 2009, for example, FDA investigator
walked into the private cord-blood bank Vista Cord LLC in Starkville, Miss., and found dead insects, dirt and trash where cord blood was processed and stored.
In a notice to the company, the FDA said freezer temperatures weren’t routinely monitored, and it was unclear whether equipment had been cleaned after processing cord blood. There were no records whether some donors had been tested for diseases, the notice said. Mr. Abel also found a hole in the ceiling above the area where blood was processed.
Vista Cord’s owner, Aubrey
said the inspector arrived the day he was moving his lab into a bigger space and he wasn’t processing any blood at the time. The FDA’s findings were wrong, he said: “From the report, it looks like a horror story. My own child’s cord blood was in there.”
The FDA rejected the company’s plan to correct the problem. In September 2009, the agency ordered Vista Cord to stop receiving new cord-blood samples or sending out samples.
Mr. Allen and the FDA worked with another private bank, FamilyCord, to take over storage of Vista Cord’s 500 samples in 2010. Soon after, FamilyCord hired Mr. Allen to promote cord-blood storage at obstetricians’ offices.
Around the same time, the FDA took similar action against Newborn Blood Banking Inc., a private cord-blood bank located on the same acre of land as the owner’s house in Land O’ Lakes, Fla. The FDA in a letter reported dust and dirt in the room where cord blood was processed and stored, as well as a dead bug by the liquid-nitrogen-cooled freezer. Donor records were incomplete, the agency noted, and the firm was missing written procedures for cleaning or long-term storage.
The FDA ruled the violations posed a “danger to health” and ordered Newborn to stop receiving or forwarding blood samples. Newborn owner
said in an interview the FDA action was a surprise, and he was working with the agency to become compliant again. The FDA allowed Newborn to continue storing cord blood, he said, and none of his customers moved to other banks.
Reliability became an issue for
when her 14-month-old daughter, Trinity, stopped speaking in 2011 and lost movement in one leg. Doctors said the young girl might have a terminal genetic disease. “The first thing I thought was, ‘What about the cord blood?’ ” Ms. Prince said.
She began phoning BioBancUSA, where she had paid about $2,000 to store the cord blood of Trinity’s older brother. For days, no one answered.
Ms. Prince eventually learned the Monterey, Calif., company was going out of business. There was no longer a trained or certified laboratory technician monitoring the temperature-controlled tank for the frozen cord blood, according to a 2012 civil complaint filed by the Monterey County District Attorney in California state court. The complaint, triggered by Ms. Prince’s situation, alleged unfair business practices.
Ms. Prince said her son’s cord blood was transferred to FamilyCord, which conducted tests from samples of other BioBancUSA clients. The samples were found to be unspoiled, but Ms. Prince said there was no way to know for sure the condition of her son’s blood.
A lawyer for BioBancUSA chief executive officer
said the cord blood was never at risk and denied any wrongdoing alleged in the civil complaint, which is pending.
Private bank Cord Blood Registry stores its half million cord-blood samples at a laboratory in Tucson, Ariz., lined with bullet-resistant glass. The company advertises that ongoing investments in its lab and storage facility “help ensure the long-term safety and viability of your newborn’s stem cells.”
An FDA inspector found that some cord-blood samples had arrived at the lab in 2008 and 2009 leaking blood, posing a contamination threat. Doctors or nurses in a handful of cases apparently put the blood in bags they had inadvertently sliced in the delivery room, according to an FDA inspection report. Other times, blood bags had faulty sealing, the agency noted.
Mr. Crouse, the company’s chief executive, said the problem has been addressed.
In 2005, a newborn’s cord-blood sample en route to Cord Blood Registry was destroyed on the tarmac at a Dallas airport when a gust of wind blew the container off a luggage cart and a truck ran over it. “Sometimes this stuff is going to happen and we empathize with our clients,” Mr. Crouse said, noting that such problems were rare and the company now uses crush-proof boxes.
Ms. Malarkey, of the FDA, said the government in 2009 had found problems in the industry, but it has since improved. At the time, Ms. Malarkey voiced concerns about the reliability of long-term storage at private banks. The FDA these days encourages parents to donate cord blood to a public bank if they aren’t going to store it for their own use.
The American Academy of Pediatrics has cautioned its doctor members to be wary of unsubstantiated claims about the healing power of cord blood.
Dr. Bertram Lubin,
an author of the academy’s policy on the issue, said: “I encourage families to use that money that you would use for private banking for a good stroller or car seat.”
—Jeremy Singer-Vine contributed to this article.
Write to Christopher S. Stewart at firstname.lastname@example.org
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