The New York Times-20080129-Questioning the Allure Of Putting Cells in the Bank

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Questioning the Allure Of Putting Cells in the Bank

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Can a woman's period save her life years later?

A company called Cryo-Cell International says that it can -- that menstrual fluid contains stem cells that might one day be used for medical treatments.

The company has not published research verifying the claim. But using the slogan Your monthly miracle, it has begun offering, for a fee, to collect and store cells from the fluid for a woman's future use.

Cryo-Cell, in Oldsmar, Fla., is one of several companies trying to make a business out of banking stem cells. Although businesses that store umbilical cord blood have operated for years, the new services have a potentially broader appeal, to people who are not having babies at the moment.

There are companies that offer to extract and store stem cells from adult blood, from fat removed by liposuction, from children's baby teeth after they fall out and from leftover embryos at fertility clinics.

But some experts say consumers should think twice before spending hundreds or thousands of dollars on such services, because it is not clear how useful such cells will be.

In the stem cell area, we have a problem with truth in advertising, said Christopher Scott, director of the Program on Stem Cells in Society at Stanford. Some of these companies are skirting right on the edge of what's truthful and what's vaporware.

The companies, some of them small and financially shaky, are capitalizing on the excitement surrounding stem cells. The ventures portray themselves as a form of biological insurance. Cells collected from a person could one day be used to treat that person without immune system rejection. There are potentially scores of applications that could emerge over time, said Mercedes Walton, chief executive of Cryo-Cell.

The fee for collection and processing the cells ranges from $499 to $7,500, depending on the company. There is also a yearly fee of $89 to $699 for storing the cells in liquid nitrogen.

The services urge people not to wait. Cryo-Cell says that even if a woman will be menstruating for years to come, cells from younger women will be more robust.

Some people buying the services say there is little to lose from doing so except money, even if the chance that the cells will be needed or useful is slim.

The idea is just to have them, said Stephanie Seidman, a patent lawyer in San Diego with a doctorate in molecular biology. Once you get sick, it's too late. Ms. Seidman had cells collected from her blood at an anti-aging clinic, using a service sold by NeoStem Inc. of New York.

Scientists say it is quite unlikely a person will ever need such cells. And the technology could change so much that cells stored now may not be needed if a person falls ill in 10 or 20 years. Recently, scientists found a way to turn skin cells into cells that behave like embryonic stem cells. That might allow a person of any age to have customized tissue created on the spot.

The companies' Web sites often talk about all the diseases that may one day be treated with stem cells. But experts say it could be years, if ever, for such treatments to become available.

The main use of stem cells now is to reconstitute the immune system after strong chemotherapy or radiation treatment for certain cancers of the blood. The cells are generally blood-forming stem cells from the bone marrow or bloodstream. Transplants of such cells, often called bone marrow transplants, are used for other metabolic and immune system diseases, as well.

But much of the excitement about stem cells is their possible use to create other tissues like nerve cells to treat Parkinson's disease or insulin-producing cells for diabetes. The main focus there has been on human embryonic stem cells, which are created from embryos and can potentially turn into all types of tissue in the body.

One cell bank, StemLifeLine, offers to make such embryonic stem cells from the embryos couples have left over after undergoing in vitro fertilization. The cells, which would cost a couple at least $4,000, would not be a complete genetic match either to either parent or to any of their children, which could conceivably limit their usefulness.

Other cell banks are working with adult cells, which are present in the body throughout life. There is evidence that some of these cells can turn into a diverse range of tissues, but the question is unsettled.

Stem cells in the pulp of baby teeth can clearly turn into part of the teeth. But contentions that the cells can also form other types of cells, like nerve cells, are more controversial.

There's never been a demonstration that these cells actually form nerve cells that can function as nerve cells, said Pamela Gehron Robey, who headed the lab at the National Institutes of Health, where the baby-teeth stem cells were discovered.

Yet the services offering to store baby teeth talk about all the diseases that stem cells might treat one day. One day, the Tooth Fairy could save your child's life is the slogan of BioEden Inc. of Austin, Tex., which says the cells might be used in the future for numerous diseases, including neurological ones like Parkinson's and spinal cord injury.

BioEden has more than 1,000 customers, said Jeff Johnson, its president and co-founder. It charges $595 a tooth for extraction and collection and $89 for yearly storage.

BioEden solicits dentists, elementary schools and PTAs to help spread its message and collection kits. It will pay dentists or schools $100 a tooth.

Dr. Lily Eng, a dentist in Lower Manhattan, said she had learned about the service just in time to send in the last suitable tooth from her son Leo, who is now 12.

I heard some mixed reviews about how viable this option is, Dr. Eng said. But she added that she had regretted not storing the cord blood from Leo's birth, so she decided to try the tooth.

There's no other option left, and I decided to take it, she said.

In contrast to tooth cells, cells from umbilical cord blood are being used in place of bone marrow transplants to treat cancer and other diseases. There is evidence such cells can also turn into neural cells, blood vessels and bone- and insulin-making cells.

Still, last January, the American Academy of Pediatrics, in a policy statement, discouraged private banking of cord blood as biological insurance for a child without a known disease risk. It said there was a small chance -- from 1 in 1,000 to 1 in 200,000 -- that a child would ever need the blood.

Cells collected by NeoStem from adult blood should be suitable for the existing stem cell uses, because they are collected in the way used to obtain cells from donors for such transplants.

The customers take two injections of Neupogen, a drug that stimulates the bone marrow to spill stem cells into the bloodstream. They are then hooked for three or four hours to a machine that draws the blood, extracts the desired cells and returns the rest of the blood to the body.

Patients can experience side effects like bone pain and lung problems from the Neupogen and fatigue and itching from the extraction process. Stem cell donors typically take four or five injections of Neupogen and go through the extraction process for four to six hours. So NeoStem customers are likely to furnish fewer cells. But the company says the number of cells it obtains would be enough for medical uses.

An advantage of the service is that most adults can use it. A disadvantage, besides the side effects, is that it is the most expensive. The cost for the collection and processing is $7,500, plus about $800 for the Neupogen. The yearly storage fee is $699.

NeoStem had only two customers in the quarter that ended Sept. 30, according to its most recent financial report. But Dr. Robin L. Smith, the company's president, said the business was just gearing up, signing up anti-aging clinics and other medical practices in San Diego, Los Angeles, Las Vegas, Pennsylvania and New York.

Some experts say there might be little reason for an adult to store such cells. For patients with some cancers, cells can be collected even after a patient becomes sick. And progress is being made on using cells from only partly matched donors.

The odds of using them are small, and there are ways of getting stem cells from most patients if you need them, or of finding a donor, said Dr. Stephen J. Forman, director of hematopoietic cell transplantation at the City of Hope medical center in Duarte, Calif.

Menstrual fluid is the newest service, and the least is known about these cells. Cryo-Cell has long been in the cord-blood-banking business, but in November it began a service called C'elle for the menstrual blood.

Women receive a silicone menstrual cup that is used much like a tampon. Two samples from the same period are needed, one for infectious-disease testing and one for cell extraction. Each collection takes two to three hours at the peak flow.

The service costs $499 for collection and processing, and $99 a year for storage. The company will not refund the processing fee if it fails to extract viable stem cells, though it might allow the woman to send another sample. The C'elle Web site urges women to store cells from multiple periods, saying it is not clear how many cells will be needed.

One paper on menstrual stem cells was recently published in The Journal of Translational Medicine, not by Cryo-Cell but by a group led by Dr. Xiaolong Meng of the Center for the Improvement of Human Functioning International, a clinic in Wichita, Kan., focusing on holistic medicine.

The stem cells grow very rapidly, Dr. Meng said, a lot more than cord blood or the bone marrow. But some outside experts noted that the paper used a menstrual sample from just one woman.

Rights to the discovery are held by MediStem Laboratories, an Arizona company that has set up a clinic in Costa Rica to offer treatments with stem cells that would probably not be allowed in the United States.

Cryo-Cell said that its cells could turn into various types of tissue. But that is work done mainly by looking at the molecular characteristics of the cells, not by trying the cells in animals. The company is having outside experts evaluate the cells.

One expert, Dr. Camillo Ricordi of the University of Miami, said he had not finished his analysis but added that the cells did proliferate very rapidly.

Dr. Ricordi said he had told his two daughters, ages 19 and 20, about the service. They've been complaining to me that I didn't save the cord blood when they were born, he said. At least this one is not a once-in-a-lifetime opportunity.

[Illustration]ILLUSTRATIONS (ILLUSTRATIONS BY MARNA LUZ); CHART: MARKETING STEM CELLS: Several companies now offer stem cell extraction and storage services, though viable therapies may be years away.
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