Geron Corporation Commences the World’s First Human Stem Cell Trials
On Jan. 23, 2009, Geron Corporation was granted clearance by the Food and Drug Administration (FDA) to start its human clinical trial of GRNOPC1, a human embryonic stem cell (hESC)-based therapy for the treatment of acute spinal cord injury. This trial is said to be the first in the world.
Geron Corporation considers this development as one of its most significant accomplishments so far because through this, they are now able to conduct the world’s first federally approved study of hESC-based therapy for humans. If successful, this will be a major milestone not just for the company but also for the fields of embryonic stem cell research and medical therapeutics.
According to Geron Corporation president and CEO Dr. Thomas Okarma, the clearance of the GRNOPC1 trial serves as a gateway to a new level of healing wherein restoration of organs and tissues is achieved through the injection of healthy replacement cells. Dr. Thomas Okarma added that the goal for the use of GRNOPC1 is “to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s spinal cord.”
The initial phase I study will focus on the safety of the cell therapy, although researchers will also try to find signs whether the therapy works. The company has selected seven medical centers to participate in the trial, with the study subject to approval from their internal review boards.
Geron Corporation is an American biotechnology company that specializes in the development of biopharmaceuticals designed to treat cancer and chronic degenerative ailments including heart failure, diabetes, and spinal cord injury. Headquartered in Melo Park, California, Geron Corporation was founded by Dr. Michael D. West. It was incorporated in 1990 and began its operations in 1992. Geron Corporation is considered to be the leading embryonic stem cell developer in the world as it holds exclusive rights on several cell types. Since its incorporation, Geron Corporation has been granted more than 260 patents.
The corporation also helped fund the researchers at the University of Wisconsin when human embryonic stem cells were first isolated in 1998.
Geron Corporation has subsidiaries, namely: Geron Bio-Med Limited, which is wholly owned and located in Edinburgh, Scotland; and TA Therapeutics, Limited in Hong Kong, which is majority-owned.
Geron Corporation is centered on the creation of drugs based on telomere and stem cell research. Geron Corporation is currently advancing an anti-cancer drug (GRN163L) that inhibits the enzyme telomerase. Geron Corporation is also conducting multiple trials at Duke University Medical Center in its efforts to develop a telomerase vaccine (GRNVAC1) for the treatment of prostate cancer in patients. Additionally, Geron Corporation is developing cell-based therapeutics derived from human embryonic stem cells (hESC) to treat different health conditions associated with cell aging, injury, and degenerative diseases. Moreover, Geron Corporation is engaged in the initial development of telomerase-based treatment for HIV named TAT0002 and taken from Astragalus plant.
Due to Geron Corporation’s advancement in telomerase drugs, the pharmaceutical company Merck invested considerably in the biotechnology corporation in 2005.
- Official site of Genron Corporation.
- Forbes profile of Dr. Thomas B. Okarma.
- The National Institute of Health offers some basic facts on stem cell research.
