Nation's Second Participant Enrolls in Human Embryonic Stem Cell Trial
CHICAGO, May 10, 2011 /PRNewswire via COMTEX/ -- Northwestern Memorial, the
Feinberg School and RIC continue to forge collaborative strides in an effort to
help people with severe spinal cord injuries
Researchers at Northwestern Memorial Hospital, Northwestern University Feinberg
School of Medicine and The Rehabilitation Institute of Chicago (RIC) recently
enrolled their first subject in a national clinical research trial of a human
embryonic stem cell-based therapy for participants with a subacute thoracic
spinal cord injury. This is only the second enrollment nationwide in the study
sponsored by Geron Corp. (GERN). Northwestern is one of five sites currently open
for subject enrollment. The trial will enroll up to 10 subjects nationally.
"We are very excited to announce the second enrollment in this milestone study,
which is the first to evaluate the effects of cells derived from embryonic stem
cells in subjects with severe spinal cord injuries," said lead national
investigator Richard Fessler, M.D., Ph.D., surgeon at Northwestern Memorial and
professor of neurological surgery at the Feinberg School. "Injection of
oligodendrocyte progenitor cells directly into the spinal cord lesion is a
rational way to attempt to arrest or reverse the structural damage in the spinal
cord caused by severe trauma."
The participant received an injection of cells over the weekend at Northwestern
Memorial and will now undergo a progressive course of rehabilitation care and
intervention at RIC.
"RIC's team of spinal cord injury rehabilitation specialists customize each
patient's rehabilitation care plan, which may include robotic walking therapy and
other procedures to facilitate the participant's neurologic repair and recovery,"
said David Chen, M.D., medical director of the RIC Spinal Cord Injury
Rehabilitation Program. "At RIC, restoring a patient's ability is our objective
and the scientific application of embryonic stem cells offers exciting new hope
for recovery."
The primary objective of the Phase I trial is to assess the safety and
tolerability of special cells called oligodendrocyte progenitor cells, derived
from human embryonic stem cells, when they are injected into the spinal cord
injury of paralyzed subjects. The injuries must have occurred within two weeks
for someone to be eligible for the procedure. In addition to evaluating safety,
the secondary aim of the trial is to see if the stem cells improve neuromuscular
control or sensation in the trunk or lower extremities.
"The first recipient receiving the injection of oligodendrocyte progenitor cells
more than six months ago has not experienced any serious adverse events
attributed to the stem cell transplant to date," said Fessler. "It remains too
early in the trial to determine improvement in neuromuscular control or
sensation."
In previous animal studies, these stem cells have demonstrated the ability to
remyelinate or recoat damaged nerve cells that have lost their ability to conduct
electrical impulses down the axon. The stem cells also have shown nerve-growth
stimulating properties leading to restoration of function in animal models of
acute spinal cord injury.
Subjects eligible for the Phase I trial will have documented evidence of
functionally complete (ASIA Impairment Scale grade A) spinal cord injury with a
neurological level of T3 to T10 spinal segments and agree to have GRNOPC1
injected into the lesion sites between 7 and 14 days after injury. For more
information, go to information pages of Geron's website at geron.com.
About Northwestern Memorial HealthCareNorthwestern Memorial HealthCare is the
parent corporation of Chicago's Northwestern Memorial Hospital, an 854-bed
academic medical center hospital and Northwestern Lake Forest Hospital, a 205-bed
community hospital located in Lake Forest, Illinois.
About Northwestern Memorial HospitalNorthwestern Memorial is one of the country's
premier academic medical center hospitals and is the primary teaching hospital of
the Northwestern University Feinberg School of Medicine. Along with its Prentice
Women's Hospital and Stone Institute of Psychiatry, the hospital comprises 854
beds, 1,603 affiliated physicians and 7,144 employees. Northwestern Memorial is
recognized for providing exemplary patient care and state-of-the art advancements
in the areas of cardiovascular care; women's health; oncology; neurology and
neurosurgery; solid organ and soft tissue transplants and orthopaedics.
Northwestern Memorial possesses nursing Magnet Status, the nation's highest
recognition for patient care and nursing excellence. It is also listed in 12
clinical specialties in U.S. News & World Report's 2010 "America's Best
Hospitals" guide and ranks No. 1 in Chicago in the 2010 U.S. News & World Report
Best Hospitals metro area rankings. For 10 years running, Northwestern Memorial
has been rated among the "100 Best Companies for Working Mothers" guide by
Working Mother magazine. The hospital is a recipient of the prestigious National
Quality Health Care Award and has been chosen by Chicagoans as the Consumer
Choice according to the National Research Corporation's annual survey for 11
years.
About The Rehabilitation Institute of Chicago The Rehabilitation Institute of
Chicago (RIC) is the nation's #1 ranked provider of comprehensive physical
medicine and rehabilitation care to patients from around the world and is the
leader in research and development of the most cutting-edge treatments and
technology in its field. Through aggressive medical protocols, RIC guides the
patient care process toward a better patient outcome-involving repair,
regeneration, and recovery of brain, spinal cord, and musculoskeletal function.
RIC holds an unparalleled market distinction with a record six federal research
designations awarded and funded by the National Institutes of Health and the
Department of Educations' National Institute of Disability and Rehabilitation
Research in the areas of spinal cord injury, traumatic brain injury, stroke,
neurological rehabilitation, outcomes research, and rehabilitation engineering
research.
RIC, founded in 1954, has been designated the "#1 Rehabilitation Hospital in
America" by U.S. News & World Report every year since 1991 and attributes its
leading standard of care in part to its innovative research and discovery,
particularly in the areas of bionic medicine, robotics, neural regeneration, pain
care, and better outcomes. RIC operates its 165-bed flagship hospital in downtown
Chicago, as well as a network of 30 sites of care located throughout the city and
surrounding suburbs that provide additional inpatient care, day rehabilitation,
and outpatient services. RIC also maintains strategic alliances with leading
healthcare providers throughout the state of Illinois and Indiana.
About Northwestern University Feinberg School of MedicineNorthwestern University
Feinberg School of Medicine, founded in 1859, attracts talented individuals to
its faculty, staff, and student body through its cutting-edge research
initiatives, superb clinical facilities, global outlook, and innovative
curriculum. Consistently ranked high on the list of best research medical
schools, Feinberg is part of the vibrant educational and cultural community of
Northwestern University, an independent private institution founded in 1851, and
is a central component of a premier academic medical center, Northwestern
Medicine. Located on the Northwestern campus in the heart of Chicago's
Magnificent Mile, Feinberg has built a national reputation for excellence through
a strong history of collaborative, interdisciplinary medical education and
research. Feinberg's top-rated clinical affiliates include Northwestern Memorial
HealthCare, the Rehabilitation Institute of Chicago, Children's Memorial
Hospital, the Jesse Brown VA Medical Center, the Northwestern Medical Faculty
Foundation, as well as numerous hospitals and clinics across the region. To learn
more, visit feinberg.northwestern.edu.
About GeronGeron is developing first-in-class biopharmaceuticals for the
treatment of cancer and chronic degenerative diseases. The company is advancing
anti-cancer therapies through multiple Phase 2 clinical trials in different
cancers by targeting the enzyme telomerase and with a compound designed to
penetrate the blood-brain barrier. The company is developing cell therapy
products from differentiated human embryonic stem cells for multiple indications,
including central nervous system disorders, heart failure, diabetes and
osteoarthritis and has initiated a Phase 1 clinical trial in spinal cord injury.
SOURCE Northwestern Memorial Hospital |
