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CONTACT: 847/378-0517Heather Monroe ([email protected])

Neurosurgeons Use Adult Stem Cells for Treatment of Parkinson's Disease

CHICAGO (April 8, 2002) - Neurosurgeon scientists have discovered that adult neural stem cells taken directly from a patient's own tissue can aid in the treatment of Parkinson's disease. The study, "Autologous Transplantation of Adult Human Neural Stem Cells and Differentiated Dopaminergic Neurons for Parkinson's Disease: A One Year Post-Operative Clinical Outcome," will be presented by Michel F. Levesque, MD, FRCS, FACS, a neurosurgeon at Cedars-Sinai Medical Center, and Toomas Neuman, PhD, on Monday, April 8, from 10:30 a.m. to 12:25 p.m., during the 70th Annual Meeting of the American Association of Neurological Surgeons (AANS).

Dr. Levesque is a principal investigator for Celmed BioSciences, poised to start a Phase Two trial using this technology.

The researchers report on their original methodology of isolating adult neural stem cells, expanding them in vitro (outside the living body), inducing them to differentiate into dopamine-secreting neurons, and selectively delivering them back to targets within the patients. This is accomplished all without the patient requiring immunosuppression (the need to suppress natural immune responses). Dopamine is a crucial neurotransmitter, a substance which is deficient in people who suffer from Parkinson's disease.

"Previous animal studies have already indicated that transplantation of neural stem cells and stem cell-derived neurons not only reverses the effects of dopamine cell loss in the Parkinson's disease rat, but also reveals evidence of long-term survival," said Levesque, an author of the study and AANS member. "Neural transplantation for Parkinson's disease focuses on replacing the loss of essential neurons."

The study reported today followed a 57-year old, right-handed patient who was diagnosed with idiopathic (from an unknown cause) Parkinson's disease at age 46. He first was treated with drugs that stimulate the production of dopamine, which initially improved his symptoms of rigidity, bradykinesia (extreme slowness of movements and reflexes) and tremor.

However, as the patient's symptoms worsened, the researchers worked with him to control his rapidly progressing symptoms. A single stereotactic craniotomy (burr hole) was performed while the patient remained awake. During this procedure, the patient's stem cells were isolated and then expanded in vitro in the laboratory over the course of several months. The patient was kept on his medication and sent home two days after surgery.

The patient then entered the clinical study for autologous neural stem cell transplantation for idiopathic Parkinson's disease. Post-operative clinical assessments were performed at three, six, nine and 12 months by "blinded" neurological examinations (the evaluators were unaware of the transplantation).

Post-transplantation studies at three months and 12 months, with the patient off and on medication, were undertaken. At that time, researchers tracked the patient's motor scores. At three months post-operatively and while on medication, the patient's motor scores improved by 37 percent, and other studies reflected a 55.6 percent increase in dopamine uptake. At one year post-operatively, the patient's overall Unified Parkinson's Disease Rating Scale (UPDRS) improved by 81 percent, while "on" medication and 83 percent while "off" medication.

"One of the most significant findings of this study was the patient's continued clinical improvement over time," said Levesque. "After six months of the transplantation, we observed a progressive regression of motor deficits."

Autologous neuronal transplantation has numerous advantages as a treatment for Parkinson's disease. This approach eliminates immune reactions at the site of implantation and improves the likelihood of survival of surgically implanted cells. It also minimizes risks of transmission of infectious disease, and does not require immunosuppressants or steroids. Finally, it does not involve the controversial use of fetal tissue or immortalized embryonic cell lines.

In summary, the study revealed that adult neural stem cells harvested from a patient's own tissue can be used as a source of dopamine neurons. The restorative procedure appears safe and effective as a treatment for Parkinson's disease, with the patient experiencing regression of motor symptoms. "This form of treatment has the potential for making neural stem cell therapy acceptable and available to a large number of patients," added Levesque.

For more information on Parkinson's disease, visit www.neurosurgery.org.

Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons is a scientific and educational association with nearly 5,500 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system including the spinal column, spinal cord, brain and peripheral nerves.

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Media Representatives: If you would like to cover the meeting or interview a neurosurgeon - either on-site or via telephone - please contact the AANS Communications Department at (847) 378-0517 or call the Annual Meeting Press Room beginning Monday, April 8 at (312) 949-3201 (3202).