A clinical trial using embryonic stem cells on patients with Grade A thoracic spinal cord injuries has enrolled its first patient, the Geron Corporation has announced. The Phase I study is aimed at testing the safety and tolerability of GRNOPC1 – human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells. Any new trial participant must receive GRNOPC1 within two weeks of their injury.

The first trial participant is being treated at Shepherd Center, Georgia, Atlanta, a 132-bed hospital and research center specialized in spinal cord and brain injury rehabilitation. Geron informs that there are seven potential centers in the USA which could participate in the trial and take on patients.

Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO, said:

Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies. When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial.

Donald Peck Leslie, M.D., medical director, Shepherd Center, said:

We are pleased to have our patients participating in this exciting research. Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.

David Apple, M.D., Shepherd Center’s medical director emeritus and principal investigator of the trial at Shepherd Center, said:

This clinical trial represents another step forward in Shepherd Center’s involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care.

Information on centers that will enroll patients for the trial will be listed on the Patient Information Pages of Geron Corporation’s web site, as well as on the NIH clinical trials registry.

Spinal Cord Injury, or SCI occurs when there is trauma to the spinal cord, causing loss of locomotion, sensation or bowel and bladder control. A hard impact on the spine can dislocate or fracture vertebrae, resulting in bone fragments or material from the disc damaging the nerve fibers as well as the cells that insulate the spinal cord nerve fibers (glial cells). In the majority of human SCI cases there are bruises (contusions) rather than the severing of the nerve fibers. In the USA about 12,000 people experience a spinal cord injury annually. CSIs can be caused by gunshot wounds, sports injuries, bad falls, and vehicle accidents.

In a communiqué, Geron Corp wrote:

GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury.

Preclinical studies showed that administration of GRNOPC1 significantly improved locomotor activity and kinematic scores of animals with spinal cord injuries when injected seven days after the injury. Histological examination of the injured spinal cords treated with GRNOPC1 showed improved axon survival and extensive remyelination surrounding the rat axons.

“Phase I Trial of GRNOPC1”
Geron Corp.

Written by Christian Nordqvist