Print

Print


FROM:  AScribe Newswire
 April 9, 2002 Tuesday

HEADLINE: Penn Researchers Confirm Safety, Effectiveness of Cloned
Neurons Used in Stroke Therapy

   PHILADELPHIA, April 9 [AScribe Newswire] -- It appears that a little
foreign
culture is safe for the mind, particularly if it is a culture of cloned
neurons.
Researchers at the University of Pennsylvania School of Medicine
performed the
first postmortem examination of a brain implanted with cloned human
neurons to
treat damage due to stroke. It is hoped that the grafted neurons will
re-establish brain circuitry damaged by stroke in order to restore lost
motor
and cognitive function. Their findings, presented in the April issue of
the
American Journal of Pathology, give further evidence that adult human
neurons,
cloned and grown in culture, can make a safe and effective therapy to
reverse
the neurological effects of stroke.

   "Our findings show that these implanted neurons survived for more than
two
years without causing any harm to the patient whatsoever," said John Q.
Trojanowski, MD, PhD, professor in the department of Pathology and
Laboratory
Medicine and co-director of Penn's Center for Neurodegenerative Disease
Research
[CNDR]. In the Phase I clinical trial, six of the twelve participants
showed
marked improvements after implant surgery. The patient in this study,
however,
did not show improvement.  The patient, a 71-year-old man, died from a
heart
attack 27 months after implant. The grafted cells were human NT2N neurons
[hNT]
developed by Trojanowski and his colleagues at Penn from the well-studied
Ntera2
[NT2] teratocarcinoma cell line.

   "Since these cells were cloned and grown in culture, there is a
concern that
they may continue to reproduce like cancer cells," said lead author,
Peter
Nelson, MD, a Penn neuropathology fellow. "However, none of the cells
near the
implantation site appeared cancerous."

   Stroke affects more than half of a million in the United States each
year
and, while less than a third are fatal, about 60 percent of victims are
affected
by a decline in muscle control and cognitive function. As yet there is no
proven
therapy for treating lasting damage from stroke.

   "As the population ages, strokes and neurodegenerative diseases, such
as
Alzheimer's and Parkinson's, will become more prevalent," said
Trojanowski.
"Grafted hNT cells show remarkable promise in their ability to restore
stroke
damage."

   Unlike cells derived from embryonic stem cells, the use of cloned
adult cells
does not pose any ethical or legal problems. In addition, they do not
harbor
known human pathogens or potentially infectious agents as might be found
in
transplants from other species. The safety of hNT cells is well
documented and
has been used previously in normal rodents as well as animal models of
stroke,
Huntington's disease, Parkinson's Disease, and trauma, with encouraging
results.
The cells have been extensively characterized in vitro, and are amenable
to
genetic engineering.

   "What is potentially most important is that NT2 neurons can be grown
in
unlimited quantities," said Trojanowski. "These cells represent a
relatively
inexpensive and limitless source for therapy."

   The Phase I clinical trial was conducted at the University of
Pittsburgh
Medical Center. The trial leaders there sent the brain to Penn's CNDR for
study
and comparison to other brains in their extensive brain bank.
Trojanowski's
group was unable to find a tumor anywhere in the brain and, furthermore,
the
researchers were unable to find evidence of complications due to implant
surgery.  The clinical use of hNT cells is currently undergoing a Phase
II trial
at the University of Pittsburgh Medical Center.

   This study, and the clinical trial, was supported by Layton
Bioscience, Inc.
Trojanowski and Virginia M.-Y. Lee, PhD, are the founders of - and
consultants
for - Layton Bioscience, and hold equity in the company.  The University
of
Pennsylvania is also a part owner of the company.

   The University of Pennsylvania Health System is distinguished not only
by its
historical significance - first hospital [1751], first medical school
[1765],
first university teaching hospital [1874], first fully integrated
academic
health system [1993] - but by its position as a major player on the world
stage
of medicine in the 21st century. Committed to a three-part mission of
education,
research, and clinical excellence, UPHS excels in all three areas.

CONTACT:
Greg Lester, University of Pennsylvania, 215-349-5658;
[log in to unmask]

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn