For those of you who may be interested following is some latte news Re: PD
and fetal transplant.....ED H
WASHINGTON (AP) -- The Federal government on Tuesday
approved the first grant for fetal tissue research since
President Clinton lifted a 5-year-old ban on studies using
cells from aborted fetuses. The NINDS is giving $4.5
million to three institutions to study the effects of
implanting fetal tissue into the brains of patients with
Parkinson's disease. Dr. Patricia Grady, head of the
federal institute, said there may be more grants this
year, both for Parkinson's and other brain disorders. She
called the Parkinson's research promising."We are
optimistic it will be helpful for at least some of the
patients," she said. Presidents Reagan and Bush banned
such research. But Clinton lifted the ban in one of his
first official acts. Some privately funded research
continued at the University of Colorado and at Yale
University throughout the five-year ban, but experts said
those studies lacked adequate scientific precision.
Parkinson's is a progressive rain disorder that causes
tremors, a shuffling walk, a decreased ability to control
speech and facial muscles, and a gradual loss of
functional control. Its precise cause is unknown, but it
is connected to the death of brain cells that produce
dopamine, a chemical key to communication within the
brain. About 500,000 Americans, most of them over 60, have
Parkinson's. There is no cure, but treatment with
levodopa, or L-dopa, a chemical that partially mimics
dopamine, slows the progression in some patients. Under
the new grant, 40 Parkinson's patients now under treatment
at the Columbia-Presbyterian Medical Center in New York
will be evaluated to determine the exact extent of their
disease. They will be videotaped and their movements
measured by computer The patients also will undergo a
brain imaging technique called PET at the North Shore
University Hospital on Long Island. The technique
measures the function of the brain cells that produce
dopamine. The patients then will get fetal tissue
transplants at the University of Colorado health Sciences
Center in Denver, a pioneer in the transplants. During the
ban, researchers there injected fetal brain cells into 16
Parkinson's patients. Colorado scientists reported last
November that about a third improved significantly, a
third showed some improvement and a third had no
measurable benefit. "Some of them were dramatically
better," said Dr. Curt Freed, head of the Colorado
project. Some recovered their ability to speak and to
drive cars and some who were home-bound invalids were able
to travel," said Freed. In the new study, Freed said only
half of the patients will actually receive fetal tissue
implants. The others will receive placebos or fake
injections. Neither the patients nor the doctors will
know who gets the fetal tissue. The procedure will enable
for the first time a precise measurement of the effects of
fetal tissue transplants. Previously, no patients would
{agree to help pay for such a study since only half of them
actually received transplants," Freed said. Tissue used
in the transplants comes from fetuses aborted after seven
to eight weeks of gestation when the fetus is about an
inch long. Doctors then remove a brain structure about
the size of a grain of rice and extract about a half
million cells to be injected into brains of the patients.
Freed said the target of t he injections are two
structures -- one on each side of the brain -- that are
called putamen. These structures are about the size of the
last thumb joint and are the source of dopamine. Eight
injections will be made into each putamen in each patient.
End - Paul Recer (AP)
<MORE>
This is a very important first step into federal
funding of fetal tissue transplantation. According to Dr.
Matt Kurth of the Barrow Neurological Institute in
Phoenix, AZ, the federal government prefers a double
blind, placebo controlled study of this nature before it
will consider further research funding. Once this study
has been successfully completed proposals for studying
enhancements and alternatives to existing procedures can
be considered. Most studies of this nature cost about $15
million and involve many patients. (DATATOP involved 800
patients.) This study involves only forty patients and at
one third the cost. This study has been carefully
designed, possibly over designed, to assure proposed
federal guidelines in tissue accusation are used.
According to Dr. William Langston, President of The
Parkinson's Institute in Sunnyvale, CA, the scientific
design of this research study sets a new standard in
medical research. Very careful controls have been
included to rem ove any bias in the evaluation. An
obvious example is that Dr. Stanley Fahn will be doing the
evaluation of Dr. Curt Freed's surgical results. This
removes any implied bias that Dr. Freed's group would have
if they were to perform the post surgical evaluations. Jim
Maurer of the YPSN of Massachusetts recently interviewed
Dr. Curt Freed. The full interview will be published in
the Young and the Restless, the newsletter of YPSN of MA.
Dr. Curt Freed's transplant history shows that one third
of his fetal tissue transplant patients show great
results, one third are showing marginal results and one
third are showing no appreciable change. For patients
under 60, the success rate is better than for those over
60. Also for patients with complications like dementia or
other psychiatric problems this surgery could be harmful.
Thus patient selection will be carefully controlled. There
is a very large placebo effect in transplantation therapy.
It has been estimated that patients can actually have
improvements in their symptoms for as long as six months,
yet have received nothing more than a lot of good
attention. This often shows in pill studies. The study's
duration of one year and other design considerations hope
to minimize the placebo effect or at lease allow
researchers to identify it and reduce its influence on the
study results. My hat is off to those patients who are
willing to participate in this study. Dr. Fahn had
discussed this study with a number of patients for their
input. Initially, he said, there was concern about not
all getting the fetal tissue transplantation. But there
is a pot of gold at the end of their rainbow. Those
patients receiving the placebo will be given a fetal
tissue transplantation by Dr. Curt Freed's group at the
end of the study. The burr hole previously drilled will
be the site of the real transplant this time. And all
this is at no cost to the participant. Considering the
patients condition, the fact that all will have access to
the transplantation in the end and all at no cost, the
patients agreed that the conditions were acceptable. All
of these considerations do not change the participant's
expectations. We as patients and/or caregivers always set
our expectations at full recovery from PD. This can't be
changed, we all want freedom from the bondage of
Parkinson' s disease. Knowing that all will have the
fetal tissue transplant available in the end will help
resolve many of the emotional problems of waiting. Finally
this study will determine a lot of the future of not just
fetal tissue transplantation, but almost all forms of
transplantation surgery including genetic re-engineering
of our own cells for transplantation. For over five
years, this promising research has been banned. Time has
been lost. This study is a one year study. Lets get on
with this study so that federal funding of the many
proposed studies surrounding this therapy can also get
funded.
End of Message.....
