Patient gets human stem cells
DOCTORS in the United States have begun treating the first patient to receive human embryonic stem cells, but details of the landmark clinical trial are being kept confidential, Geron Corp said yesterday.
Geron has the first US Food and Drug Administration license to use the controversial cells to treat people, in this case patients with new spinal cord injuries. It is the first publicly known use of human embryonic stem cells in people.
"The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, Georgia," Geron said.
"Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial."
Northwestern University in Chicago is also ready to enroll patients.
Geron's stem cells come from human embryos left over from fertility treatments. They have been manipulated so that they have become precursors to certain types of nerve cells.
The hope is that they will travel to the site of a recent spinal cord injury and release compounds that will help the damaged nerves in the cord regenerate.
The Phase I trial will not be aiming to cure patients but to establish that the cells are safe to use. Under the guidelines of the trial, the patients must have very recent injuries.
Geron said the Shepherd Center would not reveal patient details.
"When we started working with human embryonic stem cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials," Geron President and CEO Dr Thomas Okarma said.
Opponents of their use say it is wrong to use a human embryo to make the cells, and two researchers have sued the National Institutes of Health. A federal appeals court has allowed continued federal funding of the work until the case is heard.
Geron has the first US Food and Drug Administration license to use the controversial cells to treat people, in this case patients with new spinal cord injuries. It is the first publicly known use of human embryonic stem cells in people.
"The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, Georgia," Geron said.
"Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial."
Northwestern University in Chicago is also ready to enroll patients.
Geron's stem cells come from human embryos left over from fertility treatments. They have been manipulated so that they have become precursors to certain types of nerve cells.
The hope is that they will travel to the site of a recent spinal cord injury and release compounds that will help the damaged nerves in the cord regenerate.
The Phase I trial will not be aiming to cure patients but to establish that the cells are safe to use. Under the guidelines of the trial, the patients must have very recent injuries.
Geron said the Shepherd Center would not reveal patient details.
"When we started working with human embryonic stem cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials," Geron President and CEO Dr Thomas Okarma said.
Opponents of their use say it is wrong to use a human embryo to make the cells, and two researchers have sued the National Institutes of Health. A federal appeals court has allowed continued federal funding of the work until the case is heard.
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