Posts Tagged ‘spinal cord injury’

Clinical Trial of Human Embryonic Stem Cell-Based Therapy Now Under Way

Wednesday, October 19th, 2011

On Oct. 11, 2010, Geron Corporation announced the enrollment of the first patient in the company’s clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, Ga. Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.

“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “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.”

“We are pleased to have our patients participating in this exciting research,” said Donald Peck Leslie, M.D., medical director, Shepherd Center. “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.”

In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron’s website and on the NIH clinical trials registry,ClinicalTrials.gov.

Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.

Researchers reportedly regenerate adult spinal cord tissue

Wednesday, October 19th, 2011

The following originally appeared in Action Online, the magazine of the United Spinal Association.

Researchers for the first time have induced robust regeneration of nerve tissue connections in injured adult spinal cord sites that control voluntary movement. These findings provide hope that it may be possible to design therapies for paralysis and other impairments of motor function arising from spinal cord injury.

In rodent studies, the Children’s Hospital Boston, UC Irvine, and UC San Diego team made this breakthrough by turning back the developmental clock in a molecular pathway critical for the growth of nerves in the corticospinal tract. The corticospinal tract is a bundle of nerves connecting the brain and spinal cord. While some degree of nerve regeneration has been achieved in other regions of the mature central nervous system (CNS), adult corticospinal nerves have been particularly resistant to regeneration after injury.

The corticospinal nerve regeneration was achieved by deleting PTEN, an enzyme that acts as a critical brake on cell growth. One of the key growth molecules whose activity can be reined in by PTEN is mTOR. In early stages of life, PTEN activity is low, allowing mTOR to promote developmental growth processes. In later stages, PTEN activity is increased and mTOR activity is decreased so that growth is more restricted.

In looking at how to restore early developmental-stage cell growth in injured CNS tissue, Zhigang He, a neurology associate professor at Children’s Hospital Boston–working with Mustafa Sahin, also of the Children’s Neurology Department–showed in a 2008 study that modulating the PTEN/mTOR pathway enabled regeneration of new connections from the eye to the brain after optic nerve damage. He is now partnered with Oswald Stewart from UCI and Binhai Zheng of UCSD to use the same approach to induce nerve regeneration in injured spinal cord sites. Results of their study appear in the Aug. 8 online edition of Nature Neuroscience.

“Until now, such nerve regeneration has been impossible in the spinal cord,” says Oswald Steward, anatomy & neurobiology professor and director of the Reeve-Irvine Research Center at UCI. “Paralysis and loss of function from spinal cord injury has been considered untreatable, but our discovery points the way toward a pathway to develop a therapy to induce regeneration of nerve connections following spinal cord injury in people.”

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