CellPro and Northwestern University to treat multiple sclerosis with bone marrow transplantation.
MS is caused by an immunological attack on the myelin sheath that covers many of the nerve fibers in the central nervous system. This attack is thought to be caused by T cell-mediated immune destruction of the myelin. Malignant MS is a progressive disease resulting in deteriorating neurological function and a median life expectancy of five years from time of diagnosis.
Principal investigator on the research study is Richard Burt, MD assistant professor of medicine at the school and head of the allogeneic BMT program at Northwestern Memorial Hospital. Dr. Burt was the first investigator in the United States to demonstrate that BMT may induce remission of MS in animal models. He is considered a pioneer in the use of BMT for the treatment of autoimmune diseases.
BMT has been used successfully for approximately 30 years to treat a number of cancers and severe immunodeficiency disorders following its original development to treat leukemia. Northwestern's protocol for treating MS includes the use of cyclophosphamide and total body irradiation to ablate (destroy) the patient's faulty immune system.
Myeloablation will be followed by blood and immune system rescue through a T cell-depleted, autologous BMT. This procedure requires aspirating, marrow tissue from the patient prior to myeloablation and positively selecting the stem cells (mother cells responsible for producing all other blood and immune cells) with a CellPro CEPRATE(R) SC Stem Cell Concentration System.
Positive selection significantly depletes the mature T cells that are presumed to be responsible for the autoimmune disorder. Following infusion into the patient, the naive stem cells repopulate the marrow and reconstitute a new blood and immune system.
As the use of BMT has spread in recent years, there have been reports of patients with co-existing autoimmune diseases, such as multiple sclerosis, lupus, rheumatoid arthritis, psoriasis, or ulcerative colitis, having remission of the autoimmune condition following a BMT for their primary cancer. This trial is designed to demonstrate the safety and efficacy of treating MS with BMT and T cell-depleted autologous stem cells.
Northwestern University Medical School and Northwestern Memorial Hospital are seeking patients for this ground-breaking trial. To qualify as candidates for the study, patients must be younger than 55 and have a clinical diagnosis of MS with a disease duration of less than five years from onset of disease.
Prospective patients must have normal kidney, liver, lung and heart function, a Kurtzke Extended Disability Status Scale (EDSS) of 4.0 to 7.5, with a progression of two Kurtzke points over one year and a stable examination for 90 days. A magnetic resonance image showing at least one gadolinium-enhancing lesion and prior treatment with corticosteroids is also required. Patients, or referring physicians, may call 312/908-8400, or fax 312/908-0028, for additional information on this study.
Located in Bothell, Wash., CellPro Inc. is a biotechnology company specializing in the development, manufacturing and marketing of proprietary, continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications.
Its CEPRATE SC Stem Cell Concentration System is approved for sale in 18 European countries and Canada. Its pre-marketing approval application for use in bone marrow transplantation in the United States was recently deemed approvable by the U.S. Food and Drug Administration, however, it is still experimental in the United States.
Lee Parker, 206/485-7644, (http://www.cellpro.com)
NWU Medical School
Elizabeth Crown, 312/503-8928
NW Memorial Hospital
Kelly Gibbard, 312/908-7432
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|Date:||May 28, 1996|
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