First Human Being Injected with Stem Cells
First Human Being
Injected with Stem Cells
The Geron Corporation announced Monday that they have injected the first human with cells from embryonic stem cells after years of animal trials.
The company is staying relatively tight-lipped about the patient, but have said that he or she was enrolled in the FDA-approved clinical trial at the Shepherd Center, a rehabilitation hodpital in Atl;anta, Georgia that specializes in spine and brain injury recovery. The patient was reportedly injected with the stem cells on Friday.
The trial initially received FDA approval in January 2009, but further research was required before the study could go ahead. Final approval from the FDA was given in July. The intervening time allowed the company to conduct a search for patients who might qualify for the phase 1 clinical trial, and to assure the safety of introducing the cells into a human.
Eligible patients will have suffered what is called a complete thoracic spinal cord injury, meaning they have no movement below the chest. They will still have use of their arms and can breathe on their own, but have no control of their bladder, bowels, or lower appendages (legs). The injury to the spinal cord would have to have occurred between the third and tenth vertebrae and they have to be injected with the stem cell therapy, known as GRNOPC1, within two weeks of sustaining the injury. The cells behave just like they would in the womb, building a spine in a fetus.
Embryonic stem cells are typically just four or five days old and possess the ability to become any type of cell in the human body. Cells that the patient received, however, are not pure embryonic stem cells anymore. They have been coaxed into becoming early myelinated glial cells, a type of cell that insulates nerve cells.
The goal of stem cell therapy is to create hope for patients who suffer severe spinal cord injuries. Whereas before there was nothing physicians could do in these cases, stem cell therapy could create a situation where these patients are able to respond to physical therapy. The purpose of the first clinical trial is to determine whether the therapy will cause any negative side effects or rejection by the patient's body. Only eight to ten patients have been approved for involvement in phase 1 so far, and patients with new spinal cord injuries are being enrolled at seven separate sites across the country.
The cells being injected into the patient were derived from stem cells harvested from leftover embryos at fertility clinics. Because the process destroys the embryo, the research, as well as federal funding for it, have sparked considerable controversy. A spokesman for Geron, however, has said that no federal funding was used in the development of the company's human embryonic stem cell product
The Geron Corporation announced Monday that they have injected the first human with cells from embryonic stem cells after years of animal trials.
The company is staying relatively tight-lipped about the patient, but have said that he or she was enrolled in the FDA-approved clinical trial at the Shepherd Center, a rehabilitation hodpital in Atl;anta, Georgia that specializes in spine and brain injury recovery. The patient was reportedly injected with the stem cells on Friday.
The trial initially received FDA approval in January 2009, but further research was required before the study could go ahead. Final approval from the FDA was given in July. The intervening time allowed the company to conduct a search for patients who might qualify for the phase 1 clinical trial, and to assure the safety of introducing the cells into a human.
Eligible patients will have suffered what is called a complete thoracic spinal cord injury, meaning they have no movement below the chest. They will still have use of their arms and can breathe on their own, but have no control of their bladder, bowels, or lower appendages (legs). The injury to the spinal cord would have to have occurred between the third and tenth vertebrae and they have to be injected with the stem cell therapy, known as GRNOPC1, within two weeks of sustaining the injury. The cells behave just like they would in the womb, building a spine in a fetus.
Embryonic stem cells are typically just four or five days old and possess the ability to become any type of cell in the human body. Cells that the patient received, however, are not pure embryonic stem cells anymore. They have been coaxed into becoming early myelinated glial cells, a type of cell that insulates nerve cells.
The goal of stem cell therapy is to create hope for patients who suffer severe spinal cord injuries. Whereas before there was nothing physicians could do in these cases, stem cell therapy could create a situation where these patients are able to respond to physical therapy. The purpose of the first clinical trial is to determine whether the therapy will cause any negative side effects or rejection by the patient's body. Only eight to ten patients have been approved for involvement in phase 1 so far, and patients with new spinal cord injuries are being enrolled at seven separate sites across the country.
The cells being injected into the patient were derived from stem cells harvested from leftover embryos at fertility clinics. Because the process destroys the embryo, the research, as well as federal funding for it, have sparked considerable controversy. A spokesman for Geron, however, has said that no federal funding was used in the development of the company's human embryonic stem cell product
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