Questioning the Allure of Putting Cells in the Bank

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Questioning the Allure of Putting Cells in the Bank

By ANDREW POLLACK

http://www.nytimes.com/2008/01/29/health/29stem.html?

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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 , 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 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 , 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.

, 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. 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. "