Umbilical cord blood may be 'biological insurance'

BIOMEDICINE: It is experimental and controversial – but a local hi-tech lab bets on the future of stem cells from umbilical cord blood.
   
   By Anuradha Raghunathan
   The Times Herald-Record
   araghunathan@th-record.com
   

It is the proverbial once-in-a-lifetime opportunity, says Middletown urologist David Cohen.
Within minutes after birth, you either collect the blood from your child's umbilical cord or you don't.
But if you do collect it, Cohen offers to store it in liquid nitrogen at his Town of Wallkill lab at -345 degrees Fahrenheit.
   That is almost three times as cold as the coldest temperature that was ever recorded on the surface of the earth.
   All for an up-front cost of $1,050 and a recurring charge of $75 per year for storage.
   Cohen runs a private umbilical cord blood bank called CORD (Cryobank for Oncologic and Reproductive Donors Inc.) – one of the 11 private cord blood banks in the country.
   The bank on Crystal Run Road has nearly 1,000 samples of cord blood stem cells. These were extracted from cord blood, collected from newborns all over the country in the last three years.
   But why hang onto umbilical cord blood at this cost?
   Private cord blood banks call it a form of biological insurance. Cord blood stem cells can be used to treat blood cancer, anemia and several genetic disorders.
   Research shows that these units can be successfully stored in sub-Antarctic conditions for 10-20 years. But the field itself is only 15 years old and if there any surprises, researchers have to uncover them along the way.
   The idea behind a private cord blood bank like CORD is that parents retain the right to use the cord blood stem cells if and when the need arises.
   For instance, if a child whose sample is stored – or if anyone in the immediate family, such as a sibling or parent – ever needs a blood stem-cell transfusion, say for treating blood cancer, this stored unit could become the life-saver.
   Doctors can retrieve the sample and conduct a transplant. The cord blood unit is expected to generate healthy blood stem cells to treat the condition.
   While cord blood stem cells are also stem cells, they are different from embryonic stem cells that are at the center of the cloning controversy. Embryonic stem cell research has been criticized because the cells are harvested from human embryos, which are destroyed.
   Cord blood stem cells, however, are taken after the baby is delivered and do not harm the child or the mother.
   Nevertheless, cord blood stem cells are entangled in a controversy all their own.
   Some researchers say that cord blood stored for family purposes may never be used. The American Academy of Pediatrics says there is no strong evidence "to recommend routine cord blood banking for an infant's future use."
   But, unaffected by these debates, millions of blood stem cells sit in vials in the Town of Wallkill lab, awaiting the next big wave in research.
   In the future, cord blood stem cells may be used to treat patients with Parkinson's and Alzheimer's diseases, spinal cord injuries and even stroke.
   Even today, patients, who could never have dreamed of a normal life are getting a new lease on life with blood stem-cell transplants. Take, for instance, the nationally recognized case of Keonne Penn.
   This 15-year-old boy was stricken with a painful, genetic blood disease called sickle cell anemia when he was just 6 months old. He was felled by stroke at the age of 5 because of the sickle cell disease.
   In 1998, Keonne received a cord blood stem-cell transplant from an unrelated donor who had contributed to a public bank in New York. The transplant saved the teen-ager's life. It is cases like Keonne's that make private blood bank owners believe that cord blood banking is a growing field.
   "What happens in 2005, when, say, diabetes can be cured with a cord blood stem-cell transplant?" asked Cohen. "In another five years, I believe cord blood would become more commonplace."
   But if and when it does become commonplace, there would be no way of going back and collecting cord blood samples from those born in 2001.
   "You miss the chance if you decide to throw out the cord blood," said Dr. Joy Traille, lab director at CORD.
   
   A biomedicine bank is born in Orange County
   The birth of CORD was almost serendipitous.
   In 1998, Cohen had teamed up with Dr. Rohit Patel, another urologist in Middletown, to start a sperm bank because there was none serving the mid-Hudson region.
   While the physicians were scouting for semen storage equipment, they learned they needed similar equipment to store umbilical cord blood.
   The two doctors, together with two other doctors in the area, invested nearly half a million dollars and opened a joint facility for semen banking and cord blood banking.
   The lab employs a director and a scientist who test, collect and store samples. It is certified by the New York State Department of Health.
   The business philosophy at the bank is straightforward: The company targets gynecologists and expecting couples. CORD also gets a plug from Lamaze programs in the tri-state area.
   The message is the same – save your child's cord blood; it could be potentially life-saving.
   "There are millions of babies that are born every year in this country," said Cohen. "Even if we got 1 percent of that market, it would be huge."
   The big plus is that while cord blood stem cells have life-saving potential, they do not carry the same ethical issues as embryonic stem cells do.
   However, cord blood stem cells have generated a different kind of controversy. And private banks like CORD are right in the center of it.
   Public cord blood banks are opposed to the commercialization that happens in a private bank, where parents pay a fee and are assured the unit is available exclusively for their use.
   Public cord blood banks, on the other hand, collect cord blood from volunteers and put it into a registry that can be used for anyone in need of a blood stem-cell transplant – as long as there is a match.
   The primary gripe is this: Cord blood units from private blood banks are seldom used.
   In a public policy statement issued in 1999, the American Academy of Pediatrics said that "no accurate estimates exist of the likelihood of children to need their own stored cells. The range of available estimates is from 1 in 1,000 to 1 in 200,000."
   Even at CORD, there has not been a single request for a cord blood unit for treatment in three years.
   The rate of request has been low at other private banks, too. CBR Systems Inc. of San Bruno, Calif., the largest private cord blood bank in the country, has sent out 18 of its 32,000 units, for actual stem-cell transplants.
   However, public cord blood banks have met more than 2,000 requests for cord blood stem cells in the last decade.
   Critics believe that private banks are really practicing "emotional marketing."
   "Private cord blood banks are exploiting people at a time when they are most susceptible to it," said Dr. Pablo Rubinstein,director of the cord blood program at the New York Blood Center, which is the oldest public cord blood center in the world. "These organizations are making money and they are unabashedly saying so themselves."
   Cohen, however, says that private banks are not necessarily exploitative. They are merely providing a different kind of service.
   "We want to provide a place where people can bank cord blood in a world-class facility," he said.
   He says that the chances of a family coming back and retrieving a unit are slim.
   "It is a small chance, but if it's you that has a problem, that's all that matters," he said.
   
   Peace of mind

   Private bank owners and the parents who entrust them with their infants' cord blood are not complaining about ethical issues.
   Diana Loffredo is storing the umbilical cord blood of her 3-year-old son and 18-month-old daughter at CORD.
   Diana's family has a history of breast cancer; her grandmother had the disease, as did her mother and several aunts.
   So the Loffredos decided to take the precaution of banking their children's cord blood.
   "How this is going to end is that God is going to save us and we will never use those specimens," said Thomas Loffredo, Diana's husband.
   But given the unfavorable family history, he wants to do everything he can to be in control of the situation. If his wife or daughter ever need a transplant, they can come back to CORD to claim their sample.
   At $75 a year and a few minutes of inconvenience after child birth, he says the cord blood storage is well worth the investment.
   Other parents do not have a demonstrated medical history but store the blood, just in case.
   Nancy Murphy, who works as an office manager at CORD, has stored her son's cord blood at the bank.
   "It's for the peace of mind," said Murphy, who wishes she had preserved her daughter's sample as well.
   Experts advise that cord blood storage makes most sense for families with mixed ethnic backgrounds because it is hard to find sample matches. It can also be particularly useful in cases of in vitro fertilization from an unknown donor.
   CORD has to meet storage standards set by the state Department of Health and the American Association of Blood Banks. There are unannounced inspections and tons of paper work. The requirements could become steeper once a national body called the Foundation for Accreditation of Hematopoietic Cell Therapy steps in with tougher standards, which are currently being developed.
   Cohen says that CORD is ready for all those challenges. The bank is even looking for venture capital to expand the lab.
   The urologist declares that it is only a question of time before researchers realize what cord blood can do.
   After all, 15 years ago, cord blood was treated as "medical waste" that ended up in hospital dumpsites. Today, there are dozens of public and private banks clamoring to store as little as a half-cup of cord blood.
   Research on blood stem cells began with animal transplants in the early 1980s. In 1988, the first cord blood stem-cell transplant was done on a 6-year-old French boy with an inherited blood disorder called Fanconi's anemia. He received umbilical cord blood stem cells from his sister, and the transplant proved a success.
   Since then, more than 1,000 umbilical cord blood stem-cell transplants have been performed around the world.
   Many cord blood bank owners and researchers believe that the future has a lot to offer and that blood stem cell research is on the cusp of a medical revolution.
   The most exciting breakthrough would be if cord blood stem cells can be made to generate muscle cells or skin cells or any other type of cell that an embryonic stem cell can generate.
   If that happens, stem cell therapy would become less controversial. Blood stem cells could become the source for generating healthy cells.
   But doubts and uncertainties persist.
   "What the future holds is in the future," said Rubinstein. "We don't know."