The Obama administration today approved the second trial involving the use of human embryonic-derived stem cells on patients despite significant problems in animal studies.
Advanced Cell Technology, a cloning and stem cell research firm, received approval from the Food and Drug Administration to use derivatives of embryonic stem cells in patients with Stargardt disease, a rare eye disease than can lead to blindness.
The approval for the California firm to move forward comes one month after the FDA approved a request from Geron Corporation to try embryonic-like cells in patients with spinal cord injuries.
The new trials will also involve healthy scavenger cells, created in a laboratory from human embryonic stem cells but that are not embryonic stem cells. Embryonic stem cells still can’t be used because they cause significant problems such as tumor formation and are rejected by the immune system when injected into animals in studies.
ACT indicates 12 patients will receive the treatments.
“We’re also hoping to see some improvement in visual acuity, but that’s a bonus,” said Dr. Robert Lanza, ACT’s chief scientific officer.
Dr. David Prentice, a former Indiana State University biology professor who is a fellow at the Family Research Council, emailed LifeNews.com in response to the news.
“Few details are available at this point, although Robert Lanza, ACT’s chief scientist, has said that this series of experiments could begin after the first of the year,” he said. “[The study] will include up to 12 patients and will test the safety of injecting cells into one of the patient’s eyes, with increasing doses of cells on successive patients. He also hopes to see some results within six weeks of injecting a patient’s eye.”
Prentice said the embryonic stem cell derivatives are not necessarily safe for patients.
“Of course, one big concern regarding safety is the distinct possibility of tumor formation by embryonic stem cells, since that is their real forte,” he said. “No details are available on whether ACT did large animal studies, purity of their experimental cell preparation, or how well the cells retain differentiation versus growing.”
Contrary to media reports about the Geron study, Prentice explained that Geron is not injecting growing embryonic stem cells into a patient. They inject cells made from embryonic stem cells; in this case cells called “oligodendrocyte progenitors.”
“Oligodendrocytes form a sheath around nerve fibers, like insulation. The injected ESC-derived cells are progenitors or precursors, only partly specialized; theoretically the cells will grow, migrate and specialize around the spinal cord, creating a sheath around nerves and also perhaps secreting nerve growth factors to enhance nerve survival,” he explained.
“From the total of two published rat studies on which the human experiment is based, Geron already knows that their ESC-derived cells will not work on chronic spinal cord injury; patients must be recruited and injected within the first 14 days after their injuries. They also know that the patient must be juiced with immunosuppressive drugs, so that the injected cells are not rejected by the immune system, since they are foreign to the body,” he said.
Despite the overwhelming success of adult stem cells for patients, few have heard the good news, Prentice says.
“Adult Stem Cells have already shown published scientific evidence documenting effective treatment for spinal cord injury,” he said.
“That peer-reviewed evidence includes not only safety but also improvement of chronic spinal cord injuries, including in patients up to 15 years after their injury,” he added.