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New clinical research study evaluates novel cell therapy

CHICAGO- Physicians at Rush University Medical Center are testing whether a novel cell therapy using retinal pigment epithelial (RPE) cells attached to tiny gelatin bead microcarriers implanted in the brain can improve the symptoms of Parkinson's disease.

The investigational cellular product (Spheramine), which is being evaluated in a new clinical study called STEPS1, consists of RPE cells attached to microcarriers. RPE cells produce levodopa, the precursor of dopamine. Dopamine is a neurotransmitter produced by nerve cells in the brain that progressively declines as the disease progresses. The RPE cells, which are normally found in the back of the eye, are cultured under standardized conditions and attached to the microscopic beads prior to implantation. The microcarriers are necessary for the cells to survive in the brain. The implanted cells serve as a new potential source of levodopa to enhance dopamine production where it is most needed.

An earlier pilot clinical study at Emory University implanted six advanced Parkinson's patients with cells on one side of the brain. These six patients experienced sustained improvements in motor function, averaging 41 percent at 24 months following treatment. In addition, there have been no safety concerns more than two years post treatment, according to neurosurgeon Dr. Roy A.E. Bakay, now at Rush and member of the Chicago Institute of Neurosurgery and Neuroresearch (CINN) medical group, who performed the surgical implantation for the study.

Along with Bakay, Rush neurologist Dr. Leonard Verhagen is the principal investigator for the Chicago site for this new Phase IIb, blinded STEPS study. Recruitment for the 68 patients for the study has recently begun. Each patient will be followed for approximately two years.

While the pilot study evaluated treatment on just one side of the brain, the STEPS research study will implant cells bilaterally, as Parkinson's affects both sides of the brain. Half of
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Contact: Mary Ann Schultz
Mary_Ann_Schultz@rush.edu
312-942-7816
Rush University Medical Center
16-Sep-2003


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