("The study reported "no clinically useful improvements" — even
though most patients believed they were better. Five developed
complications such as meningitis."
China Offers Unproven Medical Treatments
Published 01/5/2008 | January 2008
By CHRISTOPHER BODEEN and ALAN SCHER ZAGIER
BEIJING (AP) — They're paralyzed from diving accidents and car
crashes, disabled by Parkinson's, or blind. With few options
available at home in America, they search the Internet for
experimental treatments — and often land on Web sites promoting stem
cell treatments in China.
They mortgage their houses and their hometowns hold fundraisers as
they scrape together the tens of thousands of dollars needed for
travel and the hope for a miracle cure.
Paralyzed after a diving accident almost a year ago, 15-year-old
Celine Lyon receiving treatment at the Tiantan Puhua Hospital in
Beijing, China, Thursday, May 24, 2007. Tiantan Puhua, a joint
venture between Asia's largest neurological hospital and American
Pacific Medical Group, specialize in using stem cells injections to
treat diseases ranging from stroke and spinal cord injuries to
cerebral palsy and Ataxia. Since opening its treatment to foreigners
last year, the hospital has been attracting increasing interest from
overseas patients, the latest breed of medical tourists. (AP Photo/Ng
Han Guan)
Kazakstan's Serik Ananchiev, 27, right receiving treatment at the
Tiantan Puhua Hospital in Beijing, China, Thursday, May 24, 2007.
Tiantan Puhua, a joint venture between Asia's largest neurological
hospital and American Pacific Medical Group, specialize in using stem
cells injections to treat diseases ranging from stroke and spinal
cord injuries to cerebral palsy and ataxia. Since opening its
treatment to foreigners last year, the hospital has been attracting
increasing interest from overseas patients, the latest breed of
medical tourists.(AP Photo/Ng Han Guan)
Kazakstan's Serik Ananchiev, 27, left paralysed in a car accident and
Zhao Jionghao, 2 at right receiving treatment at the Tiantan Puhua
Hospital in Beijing, China, Thursday, May 24, 2007. Tiantan Puhua, a
joint venture between Asia's largest neurological hospital and
American Pacific Medical Group, specializes in using stem cells
injections to treat diseases ranging from stroke and spinal cord
injuries to cerebral palsy and ataxia. Since opening its treatment to
foreigners last year, the hospital has been attracting increasing
interest from overseas patients, the latest breed of medical tourists.
(AP Photo/Ng Han Guan)
Angela Im at right looks over as her husband, William T. Gillespie ,
left talks about her treatment to repair damage to her Brain stem
caused initially by lupus at the Tiantan Puhua Hospital in Beijing,
China, Thursday, May 24, 2007. Tiantan Puhua, a joint venture between
Asia's largest neurological hospital and American Pacific Medical
Group, specializes in using stem cells injections to treat diseases
ranging from stroke and spinal cord injuries to cerebral palsy and
ataxia. Since opening its treatment to foreigners last year, the
hospital has been attracting increasing interest from overseas
patients, the latest breed of medical tourists.(AP Photo/Ng Han Guan)
Chris Hrabik, 21, works on his customized 1993 Nissan 240SX as his
wheelchair sits near by Thursday, Aug. 2, 2007, in Oak Ridge, Mo.
More than a year after his return from China where he received stem
cell therapy, Hrabik says he has nearly complete use of his left hand
and improvement in the right, reversing paralysis caused by a car
accident near his 18th birthday. (AP Photo/Jeff Roberson)
A number of these medical tourists claim some success when they
return home:
Jim Savage, a Houston man with paralysis from a spinal cord injury,
says he can move his right arm. Penny Thomas of Hawaii says her
Parkinson's tremors are mostly gone. The parents of 6-year-old Rylea
Barlett of Missouri, born with an optical defect, say she can see.
But documentation is mostly lacking, and Western doctors warn that
patients are serving as guinea pigs in a country that isn't doing the
rigorous lab and human tests that are needed to prove a treatment is
safe and effective.
Noting the lack of evidence, three Western doctors, undertook their
own limited study. It involved seven patients with spinal cord
injuries who chose to get fetal brain tissue injections at one
hospital in China. The study reported "no clinically useful
improvements" — even though most patients believed they were better.
Five developed complications such as meningitis.
Experts in the West have theories about why some people think they've
improved when the evidence is thin. Some are often getting intensive
physical therapy, along with the mysterious injections; the placebo
effect may also be a factor.
John Steeves, a professor at the University of British Columbia who
heads an international group that monitors spinal cord treatments,
has another theory. Some patients may be influenced by the amount of
money they paid and the help they got from those who donated or
helped raise money.
"Needless to say, when they come back, what are they going to report
to their friends and neighbors? That it didn't work?" said
Steeves. "Nobody wants to hear that."
He and other experts have written a booklet advising patients who are
considering such treatments.
Western doctors discourage their patients from seeking such
treatments. They note that it's impossible to gauge the safety and
effectiveness of the treatments, or even know what's in the
injections put into brains and spinal cords.
Patients and their families say they accept those risks. They simply
don't have time to wait for more conclusive evidence. For many, the
trip to China is a journey of hope.
"It's one of the only games in town," said Savage, 44, a lawyer who
suffered severe spinal cord injuries after a canoe trip 25 years ago.
Savage spent 2 1/2 months in late 2006 and early 2007 at a hospital
in the southern China city of Shenzhen to get what he was told were
stem cell injections in his spine from umbilical cord blood. He made
the arrangements through Beike Biotechnology Co., which offers the
treatments at a number of hospitals in China.
Afterward, Savage said he was able to move his right arm for the
first time since his diving accident; a video made at the hospital
appears to show slight movement. He also said he noticed greater
strength in his abdomen and more sensation on his skin.
Just how many foreigners like Savage are coming to China for
treatment isn't known; and China is only one of several countries
where such techniques are being offered.
Many Chinese doctors don't wait for results of rigorous testing
before treating patients and they offer what they say are stem cell
or other cell treatments to those willing to pay.
What is known about the procedures being performed comes from
material on their Web sites or from patients who give detailed
accounts of their visits. Little has been published in scientific
journals for other doctors to scrutinize.
The use of stem cells for treatments isn't new. For decades, doctors
around the world have been using adult stem cells from blood and bone
marrow — and more recently from umbilical cord blood — to treat
cancers of the blood like leukemia and lymphoma and blood diseases
like sickle cell anemia.
Scientists have been exploring whether such adult stem cells and
other cells such as those from the retina or fetal brain tissue could
be used to replace cells lost because of injury or disease. And they
are trying to figure out if there's a way to stimulate the body's own
stem cells to make repairs.
But those strategies are still being investigated in the lab in
animals; there have been very limited tests in people.
Whether any clinics in China are using the more controversial
embryonic stem cells — doctors in some other countries claim to be —
isn't clear. These stem cells are taken from days-old embryos. They
can develop into all types of cells, but research into their
usefulness is in early stages.
Patients seek out these unproven treatments after hearing about them
from other patients, patient groups or Web sites for the medical
companies. The patients' stories posted on the Internet usually tell
of some kind of improvement from the treatments — slight movements in
arms or legs, fewer spasms or tremors, a feeling of sensation, an
ability to sweat.
Chris Hrabik, 21, has been disabled since a 2004 car crash left him
with limited use of his hands and legs. His father took out a second
mortgage on their Oak Ridge, Mo., home to help pay for $20,000 worth
of stem cell injections at a Beike facility in China.
More than a year after returning home, Hrabik says he has nearly
complete use of his left hand, with improvement in the right. He can
work on his customized 1993 Nissan 240SX, a modified number complete
with hand controls and racing seats.
He said he was able to move his left fingers within days of that
first injection of umbilical cord stem cells into his spinal cord.
There's been little progress since he left China, but he called the
incremental changes significant.
"I just wanted something back, no matter what it was," said Hrabik,
who attributes some of the changes to the Physical Therapy that he
had in China.
Beike founder Sean Hu, who returned from abroad in 1999 with a
doctorate in biochemistry, said the company has treated more than
1,000 patients, including 300 foreigners from 40 different countries.
The only side effects have been slight fevers and headaches among a
small percentage of patients, according to Hu.
He said patients with trauma injuries experience the most dramatic
improvements; those with degenerative diseases such as ALS, also
known as Lou Gehrig's disease, tend to improve initially but then
slide back to their former condition within months.
"Patients shouldn't have their expectations too high," Hu said. "For
patients to think they can walk again may be too much at this stage,"
he said.
He's now seeking venture capital to expand his web of treatment
centers, labs and doctors and adapt proprietary techniques from
researchers overseas.
"There is real potential here for China to take the lead in stem
cells," Hu said.
Also offering treatments is Tiantan Puhua in Beijing, a joint venture
between Asia's largest neurological hospital and an American medical
group. Tiantan's sunny, sparkling rooms are a far cry from the dour
facilities and staff at most Chinese hospitals. Diseases treated
there range from stroke and spinal cord injuries to cerebral palsy
and ataxia, a rare neurological condition that can cause slurred
speech.
The hospital says its stem cell injections are combined with daily,
three-hour doses of intravenous drugs designed to stimulate
production of the patient's own stem cells. Physical Rehabilitation
and Chinese medicine are also part of the plan. A standard two-month
course of treatment costs $30,000 to $35,000.
"We want to see actual improvements,
the hospital's management team. "We are giving them another option at
the highest level of safety."
Yang contends that 90 percent of patients show some results, with the
rest suffering disabilities that are too far advanced to respond to
treatment.
"We are making no promises," he added. "It's impossible to say
exactly how any given patient will respond."
Western experts point to the lack of documented evidence that cell
treatments have any benefit for spinal cord injuries or degenerative
diseases like Parkinson's.
"All of us in the so-called Western world, if there was something
valid, we'd be the first to be offering it," said Steeves, the
Canadian professor and director of the International Collaboration on
Repair Discoveries, known as ICORD.
Three other experts were involved in the study that found no
improvement in the seven spinal cord injury patients who went for
fetal brain tissue injections in China. The patients were evaluated
before and after their surgery.
The doctors stressed their observations were no substitute for a
larger, more strict investigation.
"People are looking for a cure," said Dr. Bruce Dobkin, a neurology
professor at the University of California, Los Angeles, School of
Medicine, one of the study's authors. "They may come to do something
based more on a gut feeling. It's like looking for a religious
miracle."
Along with the patients' booklet of advice about exploring
experimental treatments, Steeves and other researchers have drawn up
a set of guidelines on how to do research in spinal cord injuries.
Another researcher, Dr. Wise Young of Rutgers University, is
assembling a network of Chinese medical centers and universities to
train researchers and conduct studies that meet international
standards.
Dr. Michael Okun, medical director of the National Parkinson
Foundation, said his group discourages patients from seeking out
experimental treatments unless they're being done under the most
rigorous research protocols.
"Stem cell therapy ... is a really interesting area that has a lot of
promise for therapeutic approaches. But we're just not ready to be
putting stem cells into people's brains at this point in time," said
Okun.
But such warnings don't dissuade people like Penny Thomas of Captain
Cook, Hawaii. She sought treatment for Parkinson's disease at
Tiantan, where doctors drilled into her skull and injected what she
was told were cells from a donor's retina. One year later, she said
her tremors are almost gone and her medication has been cut to one-
half of a single pill.
"I have no regrets and would do it all over again if need be," said
Thomas, 53.
So would the parents of Rylea Barlett of Webb City, Mo. The family
raised nearly $40,000 from friends and neighbors to spend a month in
China at a Beike facility last summer, hoping treatments would cure
their daughter's blindness. The child was born with an optic nerve
disorder.
Dawn Barlett said her daughter responded to lights shone in her eyes
within a week after the first of a series of five stem cell
injections and can now make out blurry images on TV.
"She had no vision whatsoever before we left," the mother
said. "There was no hope otherwise."
The girl's optometrist, Larry Brothers, said: "It truly is a miracle."
But when pressed for details, he said he detected "subtle
differences" in Rylea's optic nerve after her return from China.
Asked if he would characterize her progress as incremental, he said
that "might be too optimistic."
Associated Press Writer Alan Scher Zagier reported from Missouri; AP
writer Stephanie Nano in New York also contributed to this report.
http://www.thescizo
Medical-Treatments/
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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