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Date: =09Friday, May 29, 1998 9:08:32 PM From: [log in to unmask] Reply-To: [log in to unmask] Organization: Parkinson's Action Network, Mike Claeys "Volunteers Needed to Participate in a Parkinson=92s Transplantation Stud= y Volunteer patients are needed for a clinical trial to evaluate an investigational therapy for the treatment of Parkinson=92s disease. The therapy under investigation involves the transplantation of fetal porcine (pig) brain cells into the areas of the brain that control movement. The results of an ongoing Phase I study sponsored by Diacrin Inc. and Genzyme Tissue Repair in 10 evaluable patients with Parkinson=92s disease showed a favorable safety profile and provided preliminary evidence of effectiveness which was measured as an improvement in the performance of an variety of movements as measured by the unified Parkinson=92s Disease Rating Scale, a standard clinical rating measure. The first of three Phase II/III trials will measure the effects of porcine fetal cells surgically implanted into both sides of the brain in advanced Parkinson=92s disease patients. In this first trial, patients will receive cyclosporin and the safety of transplanted porcine cells and their effects on Parkinson=92s disease symptoms will be compared to a control group that will not receive porcine cell transplantation. The total number of patients required is 36. Patients enrolled in the control groups will be offered the opportunity to receive fetal porcine cells following completion of the trial. This study will last approximately 21 months. Study participants must be willing and able to travel to the recruitment sites for frequent clinical evaluations, and to the surgical and neuroimaging study centers. Each participant in the study must: =B7 Be 40-70 years old (male or female) =B7 Have had idiopathic Parkinson=92s disease for at least 5 years (from onset of symptoms) =B7 Be responsive to L-Dopa =B7 Have fluctuations in response to medication (dyskinesias and off-periods) =B7 Not have had prior brain surgery Study centers are located in Tampa, Florida; Altanta, Georgia and Boston, Massachusetts. Interested participants are encouraged to discuss the study with the physician contact and Physician and Patient Services at 1-800-453-6948 to request additional information to assess suitability for participation in this trial." =09 Fri, 29 May 1998 21:08:31 -0400 (EDT) Received: (qmail 17126 invoked from network); 30 May 1998 01:09:49 -0000 From: "Parkinson's Action Network" <[log in to unmask]>