In a landmark study, the Geron Corporation of Menlo Park, CA today announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells; proprietary designation GRNOPC1. For the first time ever in the United States, a patient has been treated with embryonic stem cells under FDA approval. Experimental stem cell treatments have already taken place in China under their government auspices.
The primary objective of this FDA approved 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.
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.
This clinical trial follows years of non-clinical laboratory work and many millions of dollars invested by Geron in their spinal cord-stem cell research program. Despite an unhealthy climate in the USA for embryonic stem cell research, Geron has steadily worked on this program through private financing. Two weeks ago Senators Tom Harkin and Arlen Specter (and others) held a subcommittee meeting in support of embryonic stem cell research, which is hoped to propel the US to support embryonic stem cell research and better enable the development of stem cell therapeutics by Geron and other companies in the USA.
Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.