CHICAGO & MENLO PARK, Calif.–(BUSINESS WIRE)– 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. (Nasdaq:GERN – News). 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, MD, PhD, 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, MD, 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 www.geron.com.
About Northwestern Memorial HealthCare
Northwestern 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 Hospital
Northwestern 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 Medicine
Northwestern 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 www.feinberg.northwestern.edu.
Geron 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.
This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of Geron’s human embryonic stem cell technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, the uncertainty and preliminary nature of clinical trial results or regulatory approvals or clearances, need to raise additional capital, dependence upon collaborators and protection of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron’s periodic reports, including the quarterly report on Form 10-Q for the quarter ended March 31, 2011. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and, except as required by law. Geron disclaims any obligation to update these forward-looking statements to reflect future events or circumstance.