This clinical trial may be of interest to us, the cells will be
implanted in the basal ganglia-- Key word " mobility ".
................................................................
[Reuters Medical News - for the Professional]
Layton BioSciences' Neurons Enter Phase IIb
Stroke Trial
-------------------------------------------------
NEW YORK (Reuters Health) Mar 15 - A phase IIb
trial is set to test whether implanting nerve
cells manufactured by Layton Bioscience Inc. can
reverse the neurologic effects of stroke in
individuals who are left with limited speech and
mobility.
Surgery In the study, which will take place at the
University of Pittsburgh Medical Center, in
Pennsylvania, investigators expect to implant the
nerve cells into 18 patients aged 18 to 75 years.
Patients in the trial must have had a stroke in
the basal ganglia region of the brain between 1
and 6 years earlier, and the stroke must have
resulted in permanent major weakness or partial
paralysis.
Stroke/CerebrovascularDisease
"We expect to quantify the benefits of the
procedure [by increasing] the number of cells
implanted," Dr. Douglas Kondziolka, principal
investigator of the study, told Reuters Health.
"We'll gather more information on safety, but
[with more cells] we should be able to measure
the benefits."
In a phase I trial completed two years ago,
researchers discovered that half of the 12
patients implanted with Layton's LBS-Neurons
demonstrated improvement in motor function one
year after implantation. PET scan images, used to
measure metabolic activity of the brain around
the area of the stroke, also improved in those
patients.
In the study, patients received between 2 million
and 6 million nerve cells. In the latest trial,
seven participants will receive 5 million cells
while another seven individuals will receive 10
million cells in and around the area damaged by
the stroke.
For every seven patients implanted with the nerve
cells, two will receive no implants. All
participants will undergo 8 weeks of
rehabilitative physical therapy.
As they did with the first trial, researchers
will use the European stroke scale to measure
improvements in motor skills, said Dr.
Kondziolka.
Layton manufactures its LBS-Neurons in cultures
comprising human cancer cells, retinoic acid and
several other chemicals that ultimately help
transform the cancer cells into fully
differentiated, non-cancerous, non-dividing human
neuronal cells, or "pure neurons," according to
Dr. Kondziolka.
The company then freezes the neurons and sends
them to the medical center, where they are thawed
and transferred to a long-needle syringe. Using a
stereotactic frame on the patient's head and a CT
scan as guides, surgeons inject the cells through
an opening in the skull to the site of the
damaged brain tissue. Following implantation,
patients are discharged within 48 hours.
Dr. Kondziolka said that all the operations in
the phase IIb trial should be completed within 6
months. The follow-up evaluation of the 18
patients will last 1 year.
Layton is a privately held company based in
Sunnyvale, California.
-------------------------------------------------
[Reuters] Copyright © 2000 Reuters Ltd.
All rights reserved.
Republication or redistribution
of Reuters content is expressly
prohibited without the prior
written consent of Reuters.
Reuters shall not be liable for
any errors or delays in the
content, or for any actions
taken in reliance thereon.
................................................................
Ray Strand
Prairie Sky Design
-----------------( on the Edge of the Prairie Abyss )---------------
when the sky is clear
the ground is visible
49/dx PD 2 yrs/40? onset/retired
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