Human embryonic stem cell therapy is being tried on a human for the first time in a new clinical trial. This is the first clinical trial of its kind in the world. The trial is designed to test the safety of the treatment, not how well it works. Nonetheless, this is a huge step for regenerative medicine, embryonic stem cell research and science in general!
Working in a handful of medical centers around the country, the biotech firm Geron is treating eight to 10 recent paraplegics. The patients will receive an injection of neurons to the site of the damage, followed by a short treatment of anti-rejection drugs. The first patient is reported as a patient in an Atlanta spinal cord and brain injury rehabilitation hospital. To take part in the study, the patient had to have suffered a spinal or brain injury that resulted in paralysis from the chest down. This patient was injected with cells derived from human embryonic stem cells obtained from a fertility clinic. Researchers are optimistic that this human embryonic stem cell therapy will not only help alleviate the symptoms of the injury, but permanently repair the damage that caused the paralysis from the spinal cord injury.
Embryonic stem cell-derived neural cells have been used by researchers to treat nervous system disorders in animal models. In the case of spinal cord injuries, neural cells derived from animal embryonic stem cells and injected into the spinal cord injury site produced significant recovery of the animal’s ability to move and bear weight.
To apply those observations to humans, Geron had derived oligodendrocyte progenitor cells (GRNOPC1) from Human Embryonic Stem Cells (HESCs). “Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” said Thomas B. Okarma , Geron’s president and CEO. “When we started our work back 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.”
Stem cells have attracted huge scientific and public interest, not only because they bear the promise of miracle cures for age-related diseases, but also because their medical use is so appealing: stem-cell therapies like those that have recently begun could augment the human body’s own regenerative capacity, which declines as we grow older. The appropriate source of cells for these applications is hotly debated, but the technical feasibility of generating replacement tissues and organs is now within realistic projections.
Read more about the human embryonic stem cell therapy clinical trials
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