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Geron Corp. (GERN) and Advanced Cell Technology, Inc. (ACTC.OB) Offering Hope to Paralysis and Stargardt’s Macular Dystrophy Patients

Earlier this month, a historic moment happened; human embryonic stem cells were used to treat a patient in Atlanta. Geron Corporation received the first United States Food and Drug Administration (“FDA”) license to use its stem cells and technology to treat a patient with a spinal cord injury at Shepard Center in Atlanta, Georgia to set precedent for what could be the beginning of the revolutionary, albeit controversial, age of stem cells as a therapeutic discipline.

While details are still being kept undisclosed, Geron did state that “Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.” Shepard Center is a 132-bed rehabilitation hospital and clinical research center. Northwestern University in Chicago is another facility prepared to enroll patients for further clinical studies in the trial.

Although there has been continuous debate in our nation’s Capital regarding the use of stem cells, this clinical study will help provide valuable insight as to the effectiveness of stem cell therapies and may prove to sway legislation with regards to embryos being used that are left over from fertility treatments. Once a company such as Geron or Advanced Cell Technology receives the embryos, they are scientifically manipulated to fit the targeted area. In the case of this groundbreaking study, the cells are treated to become precursors to certain types of nerve cells.

In the case of spinal cord injuries, a common scenario is that when an incident happens, there is trauma to the nerve cells which can result in them being stripped of their myelin, an insulating sheath of fat and protein which protects the nerve cells. Without myelin, a nerve’s ability to conduct an electrical impulse is drastically impaired. As time progresses, further degeneration occurs resulting in the death of the damaged fibers. The stem-cell therapy is designed to address both of these issues by restoring the critical myelin and simultaneously releasing large amounts of growth factors that assist in repairing the damaged tissue and prevent the death of the damaged neurons.

While research has been done and proven to be effective in animal studies, this research on human patients is crucial to the possibility of stem cell therapies providing viable hope to spinal cord patients and victims suffering from paralysis. It is important to understand that the qualifications to be eligible for this initial trial are very specific. Geron is only working with people with recent spinal injuries, with the target range specifying that the damage was incurred more than one week, but less than two weeks prior. Being that this is a phase one study, it is primarily safety oriented. The trial will enroll no more than 10 patients and then follow their neurological condition for one year. Researchers will not only be observing the effectiveness, but will be watching closely to see whether the therapy causes tumors or pain. Tumors can result from transplants containing undifferentiated stem cells, which should be eliminated through a purification process by Geron, but still provide a medical risk until verified in patients.

While Geron is breaking the ground in spinal treatments, Advanced Cell Technology, Inc., a Santa Monica, CA-based company with a distinguished history in pioneering stem cell therapies, has asked the FDA for permission to proceed with clinical trials of a therapy derived from human embryonic stem cells as well. Advanced Cell is prepared to test its lab-grown retinal pigment epithelium cells in patients with a rare eye disorder called Stargardt’s macular dystrophy, a childhood version of macular degeneration.

To quote the American Macular Degeneration Foundation, “Stargardt Macular Dystrophy begins to damage both eyes somewhere between the ages of 6 and 20, although visual impairment may not be apparent until as late as ages 30 to 40. Children first notice difficulty in reading, complaining of gray, black or hazy spots in the center of their vision. They report that a longer length of time is needed to adjust between light and dark environments.

Vision loss is usually slow until the 20/40 level, then rapidly progressing to the 20/200 (legal blindness) level. Unfortunately, in some cases, vision can degenerate to 10/200 in a period of months. Peripheral vision and night vision are not lost for most people but color vision will be affected in the later stages.”

Stargardt’s macular dystrophy affects over 25,000 Americans and occurs in approximately one in 10,000 children.

As Advanced Cell Technology continues research while awaiting an approval from the FDA, the Geron clinical trials will be moving forward. To those that suffer from such debilitating diseases and conditions, this is the first historic step in offering some bona fide hope of one day finding a cure.

More information on Geron Corporation can be found at www.geron.com.

More information on Advanced Cell Technology, Inc. can be found at www.advancedcell.com.

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