CellPro and Northwestern University to treat multiple sclerosis with bone marrow transplantation.
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CPRO Connecticut Peer Review Organization, Inc. ) today announced that it and Northwestern University Medical School were initiating the nation's first clinical trial to use T cell-depleted autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.
1. (self) bone marrow transplantation Bone Marrow Transplantation Definition
The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. (BMT BMT bone marrow transplantation.
n.pr See bone marrow transplant.
BMT Bone marrow transplant, see there ) to treat malignant multiple sclerosis (MS).
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 myelin /my·elin/ (mi´e-lin) the lipid-rich substance of the cell membrane of Schwann cells that coils to form the myelin sheath surrounding the axon of myelinated nerve fibers. . 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
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 cyclophosphamide /cy·clo·phos·pha·mide/ (-fos´fah-mid) a cytotoxic alkylating agent of the nitrogen mustard group; used as an antineoplastic, as an immunosuppressant to prevent transplant rejection, and to treat some diseases and total body irradiation Total Body Irradiation (TBI) is a radiotherapy technique used to ablate the bone marrow and immune system prior to bone marrow transplantation or peripheral blood stem cell transplantation. It may be used as part of high-dose treatment of some leukaemias and lymphomas. to ablate ab·late
To remove or destroy the function of.
to remove, especially by cutting.
ablate verb To remove; excise (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 EDSS Expanded Disability Status Scale
EDSS Equine Digit Support System
EDSS Executive Decision Support System
EDSS Equipment Deployment and Storage System
EDSS Electronic Document Storage System
EDSS Electronic Data Storage System
EDSS Electronic Document Submission System ) 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