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PARKINSN  October 2005, Week 4

PARKINSN October 2005, Week 4

Subject:

FDA approves first brain stem cell transplant

From:

"M.Schild" <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange Network <[log in to unmask]>

Date:

Mon, 24 Oct 2005 23:41:59 +0200

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (152 lines)

Friday, October 21, 2005; Posted: 9:33 a.m. EDT (13:33 GMT)



 Food and Drug Administration (FDA)
 Health Organizations
 Medical Research

SAN FRANCISCO, California (AP) -- Federal regulators on Thursday approved what
would be the first transplant of fetal stem cells into human brains, a
procedure that if successful could open the door to treating a host of neural
disorders.


The transplant recipients will be children who suffer from a rare, fatal
genetic disorder.


The Food and Drug Administration said that doctors at Stanford University
Medical Center can begin the testing on six children afflicted with Batten
disease, a degenerative malady that renders its young victims blind,
speechless and paralyzed before it kills them.


An internal Stanford review board must still approve the test, a process that
could take weeks.


The stem cells to be transplanted in the brain aren't human embryonic stem
cells, which are derived from days-old embryos. Instead, the cells are
immature neural cells that are destined to turn into the mature cells that
makeup a fully formed brain.


Parkinson's disease patients and stroke victims have received transplants of
fully formed brain cells before, but the malleable brain cells involved here
have never before been implanted.


Batten disease is caused by a defective gene that fails to create an enzyme
needed in the brain to help dispose of brain cellular waste. The waste piles
up and kills healthy cells until the patient dies. Most victims die before
they reach their teens.


The idea is to inject the sick kids with healthy, immature neural stem cells
that will "engraft" in a brain that will direct them to turn into cells able
to produce the missing enzyme.


Such an experiment showed promise in Batten-afflicted mice, but such an
ethically charged test has never been tried before in humans.


"I'm sure there is no threat to anyone's identity," said Arthur Caplan,
director of the University of Pennsylvania's Center for Bioethics. "But we
are starting down that road."


What's more, some of the brain cells to be implanted will be derived from
aborted fetuses, which Caplan also said raised ethical concerns for some.


Concern expected


Stem Cells Inc., the Palo Alto, California biotechnology company developing
the Batten disease treatment, said it receives its fetal tissue from a
nonprofit California foundation that also collects tissue from miscarriages
and other surgical processes. Stem Cells chief executive Martin McGlynn
declined to name the foundation.


Stem Cells Inc. first applied for the human test last December, but the FDA
demanded more information in February and put the application on hold. An FDA
spokeswoman didn't return telephone calls or an e-mail inquiry.


McGlynn said the FDA wanted more information on where the transplanted brain
cells were expected to go in the brain and other related health issues such
as the chances the transplant might cause tumors. McGlynn also said the
agency wanted more information on its manufacturing process and more details
about the design of the six-patient test.


He said the FDA's concern was expected.


"This endeavor is unique. It's pioneering and no one has ever proposed to do
what we are attempting," McGlynn said. "Once you put those stem cells in, you
can't get them back."


Stanford University neurosurgeon chief Dr. Stephen Huhn will bore small holes
through each child's skull and inject the neural cells into the patients'
brains. The children will be given drugs to ensure the patients immune system
doesn't attack the new cells and they will be closely monitored for a year.


Huhn said the initial Batten trial will primarily test whether the millions of
new cells each child receives is safe for them. Ultimately, more tests with
many more patients over several years will be needed to determine whether the
transplanted cells help Batten patients.


Human testing


If there is success, people afflicted by other brain disorders could benefit
from such treatment.


"This may be what the future may hold for regenerative medicine," Huhn said.


Stem Cells Inc. was founded by Stanford University researcher Irving Weissman.
The company's stock closed up 11 cents to $4.96 in trading Thursday on the
Nasdaq Stock Market.


McGlynn said Batten disease was chosen because mice genetically engineered
with the disease were readily available and because it's a brutal, fatal
disease with no cure -- a fact the FDA considered when weighing whether to
approve such a novel human experiment.


McGlynn said the stem cells had to be tested in humans.


"You cannot ask a mouse how it's feeling," he said.


For Marcus Kerner, a federal prosecutor in Santa Ana, California with a
Batten-afflicted son, the FDA's approval Thursday gave him hope his child may
actually survive.


He said he will apply to have his 5-year-old son Daniel enrolled in the
experiment.


"It is a horrific, terrible way to watch a child die and there is currently
nothing available to stop it," Kerner said. "I think this is going to be a
major medical breakthrough that will save Daniel's life."


Copyright 2005 The Associated Press. All rights reserved.This material may not
be published, broadcast, rewritten, or redistributed.

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December 2002, Week 4
December 2002, Week 3
December 2002, Week 2
December 2002, Week 1
November 2002, Week 5
November 2002, Week 4
November 2002, Week 3
November 2002, Week 2
November 2002, Week 1
October 2002, Week 5
October 2002, Week 4
October 2002, Week 3
October 2002, Week 2
October 2002, Week 1
September 2002, Week 5
September 2002, Week 4
September 2002, Week 3
September 2002, Week 2
September 2002, Week 1
August 2002, Week 5
August 2002, Week 4
August 2002, Week 3
August 2002, Week 2
August 2002, Week 1
July 2002, Week 5
July 2002, Week 4
July 2002, Week 3
July 2002, Week 2
July 2002, Week 1
June 2002, Week 5
June 2002, Week 4
June 2002, Week 3
June 2002, Week 2
June 2002, Week 1
May 2002, Week 5
May 2002, Week 4
May 2002, Week 3
May 2002, Week 2
May 2002, Week 1
April 2002, Week 5
April 2002, Week 4
April 2002, Week 3
April 2002, Week 2
April 2002, Week 1
March 2002, Week 5
March 2002, Week 4
March 2002, Week 3
March 2002, Week 2
March 2002, Week 1
February 2002, Week 4
February 2002, Week 3
February 2002, Week 2
February 2002, Week 1
January 2002, Week 5
January 2002, Week 4
January 2002, Week 3
January 2002, Week 2
January 2002, Week 1
December 2001, Week 5
December 2001, Week 4
December 2001, Week 3
December 2001, Week 2
December 2001, Week 1
November 2001, Week 5
November 2001, Week 4
November 2001, Week 3
November 2001, Week 2
November 2001, Week 1
October 2001, Week 5
October 2001, Week 4
October 2001, Week 3
October 2001, Week 2
October 2001, Week 1
September 2001, Week 5
September 2001, Week 4
September 2001, Week 3
September 2001, Week 2
September 2001, Week 1
August 2001, Week 5
August 2001, Week 4
August 2001, Week 3
August 2001, Week 2
August 2001, Week 1
July 2001, Week 5
July 2001, Week 4
July 2001, Week 3
July 2001, Week 2
July 2001, Week 1
June 2001, Week 5
June 2001, Week 4
June 2001, Week 3
June 2001, Week 2
June 2001, Week 1
May 2001, Week 5
May 2001, Week 4
May 2001, Week 3
May 2001, Week 2
May 2001, Week 1
April 2001, Week 5
April 2001, Week 4
April 2001, Week 3
April 2001, Week 2
April 2001, Week 1
March 2001, Week 5
March 2001, Week 4
March 2001, Week 3
March 2001, Week 2
March 2001, Week 1
February 2001, Week 4
February 2001, Week 3
February 2001, Week 2
February 2001, Week 1
January 2001, Week 5
January 2001, Week 4
January 2001, Week 3
January 2001, Week 2
January 2001, Week 1
December 2000, Week 5
December 2000, Week 4
December 2000, Week 3
December 2000, Week 2
December 2000, Week 1
November 2000, Week 5
November 2000, Week 4
November 2000, Week 3
November 2000, Week 2
November 2000, Week 1
October 2000, Week 5
October 2000, Week 4
October 2000, Week 3
October 2000, Week 2
October 2000, Week 1
September 2000, Week 5
September 2000, Week 4
September 2000, Week 3
September 2000, Week 2
September 2000, Week 1
August 2000, Week 5
August 2000, Week 4
August 2000, Week 3
August 2000, Week 2
August 2000, Week 1
July 2000, Week 5
July 2000, Week 4
July 2000, Week 3
July 2000, Week 2
July 2000, Week 1
June 2000, Week 5
June 2000, Week 4
June 2000, Week 3
June 2000, Week 2
June 2000, Week 1
May 2000, Week 5
May 2000, Week 4
May 2000, Week 3
May 2000, Week 2
May 2000, Week 1
April 2000, Week 5
April 2000, Week 4
April 2000, Week 3
April 2000, Week 2
April 2000, Week 1
March 2000, Week 5
March 2000, Week 4
March 2000, Week 3
March 2000, Week 2
March 2000, Week 1
February 2000, Week 5
February 2000, Week 4
February 2000, Week 3
February 2000, Week 2
February 2000, Week 1
January 2000, Week 5
January 2000, Week 4
January 2000, Week 3
January 2000, Week 2
January 2000, Week 1
December 1999, Week 5
December 1999, Week 4
December 1999, Week 3
December 1999, Week 2
December 1999, Week 1
November 1999, Week 5
November 1999, Week 4
November 1999, Week 3
November 1999, Week 2
November 1999, Week 1
October 1999, Week 5
October 1999, Week 4
October 1999, Week 3
October 1999, Week 2
October 1999, Week 1
September 1999, Week 5
September 1999, Week 4
September 1999, Week 3
September 1999, Week 2
September 1999, Week 1
August 1999, Week 5
August 1999, Week 4
August 1999, Week 3
August 1999, Week 2
August 1999, Week 1
July 1999, Week 5
July 1999, Week 4
July 1999, Week 3
July 1999, Week 2
July 1999, Week 1
June 1999, Week 5
June 1999, Week 4
June 1999, Week 3
June 1999, Week 2
June 1999, Week 1
May 1999, Week 5
May 1999, Week 4
May 1999, Week 3
May 1999, Week 2
May 1999, Week 1
April 1999, Week 5
April 1999, Week 4
April 1999, Week 3
April 1999, Week 2
April 1999, Week 1
March 1999, Week 5
March 1999, Week 4
March 1999, Week 3
March 1999, Week 2
March 1999, Week 1
February 1999, Week 4
February 1999, Week 3
February 1999, Week 2
February 1999, Week 1
January 1999, Week 5
January 1999, Week 4
January 1999, Week 3
January 1999, Week 2
January 1999, Week 1
December 1998, Week 5
December 1998, Week 4
December 1998, Week 3
December 1998, Week 2
December 1998, Week 1
November 1998, Week 5
November 1998, Week 4
November 1998, Week 3
November 1998, Week 2
November 1998, Week 1
October 1998, Week 5
October 1998, Week 4
October 1998, Week 3
October 1998, Week 2
October 1998, Week 1
September 1998, Week 5
September 1998, Week 4
September 1998, Week 3
September 1998, Week 2
September 1998, Week 1
August 1998, Week 5
August 1998, Week 4
August 1998, Week 3
August 1998, Week 2
August 1998, Week 1
July 1998, Week 5
July 1998, Week 4
July 1998, Week 3
July 1998, Week 2
July 1998, Week 1
June 1998, Week 5
June 1998, Week 4
June 1998, Week 3
June 1998, Week 2
June 1998, Week 1
May 1998, Week 5
May 1998, Week 4
May 1998, Week 3
May 1998, Week 2
May 1998, Week 1
April 1998, Week 5
April 1998, Week 4
April 1998, Week 3
April 1998, Week 2
April 1998, Week 1
March 1998, Week 5
March 1998, Week 4
March 1998, Week 3
March 1998, Week 2
March 1998, Week 1
February 1998, Week 5
February 1998, Week 4
February 1998, Week 3
February 1998, Week 2
February 1998, Week 1
January 1998, Week 5
January 1998, Week 4
January 1998, Week 3
January 1998, Week 2
January 1998, Week 1
December 1997, Week 5
December 1997, Week 4
December 1997, Week 3
December 1997, Week 2
December 1997, Week 1
November 1997, Week 5
November 1997, Week 4
November 1997, Week 3
November 1997, Week 2
November 1997, Week 1
October 1997, Week 5
October 1997, Week 4
October 1997, Week 3
October 1997, Week 2
October 1997, Week 1
September 1997, Week 5
September 1997, Week 4
September 1997, Week 3
September 1997, Week 2
September 1997, Week 1
August 1997, Week 5
August 1997, Week 4
August 1997, Week 3
August 1997, Week 2
August 1997, Week 1
July 1997, Week 5
July 1997, Week 4
July 1997, Week 3
July 1997, Week 2
July 1997, Week 1
June 1997, Week 5
June 1997, Week 4
June 1997, Week 3
June 1997, Week 2
June 1997, Week 1
May 1997, Week 5
May 1997, Week 4
May 1997, Week 3
May 1997, Week 2
May 1997, Week 1
April 1997, Week 5
April 1997, Week 4
April 1997, Week 3
April 1997, Week 2
April 1997, Week 1
March 1997, Week 5
March 1997, Week 4
March 1997, Week 3
March 1997, Week 2
March 1997, Week 1
February 1997, Week 5
February 1997, Week 4
February 1997, Week 3
February 1997, Week 2
February 1997, Week 1
January 1997, Week 5
January 1997, Week 4
January 1997, Week 3
January 1997, Week 2
January 1997, Week 1
December 1996, Week 5
December 1996, Week 4
December 1996, Week 3
December 1996, Week 2
December 1996, Week 1
November 1996, Week 5
November 1996, Week 4
November 1996, Week 3
November 1996, Week 2
November 1996, Week 1
October 1996, Week 5
October 1996, Week 4
October 1996, Week 3
October 1996, Week 2
October 1996, Week 1
September 1996, Week 5
September 1996, Week 4
September 1996, Week 3
September 1996, Week 2
September 1996, Week 1
August 1996, Week 5
August 1996, Week 4
August 1996, Week 3
August 1996, Week 2
August 1996, Week 1
July 1996, Week 5
July 1996, Week 4
July 1996, Week 3
July 1996, Week 2
July 1996, Week 1
June 1996, Week 5
June 1996, Week 4
June 1996, Week 3
June 1996, Week 2
June 1996, Week 1
May 1996, Week 5
May 1996, Week 4
May 1996, Week 3
May 1996, Week 2
May 1996, Week 1
April 1996, Week 5
April 1996, Week 4
April 1996, Week 3
April 1996, Week 2
April 1996, Week 1
March 1996, Week 5
March 1996, Week 4
March 1996, Week 3
March 1996, Week 2
March 1996, Week 1
February 1996, Week 5
February 1996, Week 4
February 1996, Week 3
February 1996, Week 2
February 1996, Week 1
January 1996, Week 5
January 1996, Week 4
January 1996, Week 3
January 1996, Week 2
January 1996, Week 1
December 1995, Week 5
December 1995, Week 4
December 1995, Week 3
December 1995, Week 2
December 1995, Week 1
November 1995, Week 5
November 1995, Week 4
November 1995, Week 3
November 1995, Week 2
November 1995, Week 1
October 1995, Week 5
October 1995, Week 4
October 1995, Week 3
October 1995, Week 2
October 1995, Week 1
September 1995, Week 5
September 1995, Week 4
September 1995, Week 3
September 1995, Week 2
September 1995, Week 1
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August 1995, Week 4
August 1995, Week 3
August 1995, Week 2
August 1995, Week 1
July 1995, Week 5
July 1995, Week 4
July 1995, Week 3
July 1995, Week 2
July 1995, Week 1
June 1995, Week 5
June 1995, Week 4
June 1995, Week 3
June 1995, Week 2
June 1995, Week 1
May 1995, Week 5
May 1995, Week 4
May 1995, Week 3
May 1995, Week 2
May 1995, Week 1
April 1995, Week 5
April 1995, Week 4
April 1995, Week 3
April 1995, Week 2
April 1995, Week 1
March 1995, Week 5
March 1995, Week 4
March 1995, Week 3
March 1995, Week 2
March 1995, Week 1
February 1995, Week 4
February 1995, Week 3
February 1995, Week 2
February 1995, Week 1
January 1995, Week 5
January 1995, Week 4
January 1995, Week 3
January 1995, Week 2
January 1995, Week 1
December 1994, Week 5
December 1994, Week 4
December 1994, Week 3
December 1994, Week 2
December 1994, Week 1
November 1994, Week 5
November 1994, Week 4
November 1994, Week 3
November 1994, Week 2
November 1994, Week 1
October 1994, Week 5
October 1994, Week 4
October 1994, Week 3
October 1994, Week 2
October 1994, Week 1
September 1994, Week 5
September 1994, Week 4
September 1994, Week 3
September 1994, Week 2
September 1994, Week 1
August 1994, Week 5
August 1994, Week 4
August 1994, Week 3
August 1994, Week 2
August 1994, Week 1
July 1994, Week 5
July 1994, Week 4
July 1994, Week 3
July 1994, Week 2
July 1994, Week 1
June 1994, Week 5
June 1994, Week 4
June 1994, Week 3
June 1994, Week 2
June 1994, Week 1
May 1994, Week 5
May 1994, Week 4
May 1994, Week 3
May 1994, Week 2
May 1994, Week 1
April 1994, Week 5
April 1994, Week 4
April 1994, Week 3
April 1994, Week 2
April 1994, Week 1
March 1994, Week 5
March 1994, Week 4
March 1994, Week 3
March 1994, Week 2
March 1994, Week 1
February 1994, Week 4
February 1994, Week 3
February 1994, Week 2
February 1994, Week 1
February 1994
January 1994
December 1993
November 1993

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