FDA Approves First Embryonic Stem Cell Study in Humans
The first trial of embryonic stem cells as a therapy for humans has been approved by the Food and Drug Administration.
Researchers at Geron Corp., a California biotech company, will assess the safety of the cell therapy in a small group of people with spinal cord injuries. Embryonic stem cells are cells derived from an embryo that have the capacity to develop into any cell type found in the body.
Stem cells such as the ones Geron researchers are working with may someday be used in people with type 1 diabetes. The biotech firm is actively researching embryonic stem cell therapies for type 1 as well as heart disease.
The hope is that the insulin-producing cells in the pancreas (beta cells) destroyed in type 1 could be replaced by embryonic stem cells, effectively curing diabetes.
The initial trial will begin this summer and enroll 8 to 10 people with spinal cord injuries that affect their leg mobility but not their arms. Embryonic stem cells will be injected at the point of injury within two weeks of the participant's being hurt.
While the purpose of this trial will be to assess the cell therapy's safety, Geron scientists will also look for any improvements in the neurologic defects that resulted from the spinal cord injury.