Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis

ICT-13080-122206

The goal of this research study is to establish chimerism with the goal to halt disease progression in patients with Multiple Sclerosis.

2007-07-01

2024-12-01

2024-12-01

Withdrawn

Early phase I

Inclusion Criteria: * Clinically definite MS according to the McDonald criteria * Confirmed diagnosis of relapsing-remitting MS. * Age between 18 and 55 years * Extended Disability Status Score (EDSS) between 0 and 5.0 * Independently ambulatory (eligible for inclusion if subject was acutely non-ambulatory within the previous year and return of function is substantiated with EDSS score.) * Relapse within the last year or sustained disability progression of 1.0 for six months * Treatment with high dose, high frequency Interferon-β therapy, or failure to tolerate Interferon-β therapy * Diffusing capacity of the lung for carbon monoxide (DLCO)\> 50% (unless cleared by physician) * Ejection fraction (EF) \> 40% (unless cleared by cardiologist) * Required initial laboratory data (obtained within 30 days prior to transplant, unless otherwise specified) * HIV-1,2 antigen and antibody negative * HBsAg negative (chronic hepatitis B carriers without clinical evidence of liver disease can be considered on an individual basis if it is determined that the added risk is justified by the prognosis and lack of treatment alternatives) * Hepatitis C antibody negative (positive antibody allowed if antigen (RNA)-negative and no clinical evidence of cirrhosis) * Cytomegalovirus (CMV), hepatitis B, Human T-lymphotropic virus (HTLV)-1,2, Epstein-Barr virus (EBV), and Herpes antibody status known * Pregnancy test negative (women of childbearing potential only) * No life-threatening organ dysfunction. * Uncontrolled or severe cardiovascular disease, including recent (\<6 months) myocardial infarction, angina (symptomatic despite optimal medical management), life-threatening arrhythmia or hypertension * Able to give informed consent Exclusion Criteria: * Women who are of child bearing potential must have a negative pregnancy test (serum pregnancy test - human chorionic gonadotrophin (HCG)) within 48 hours of initiating total body irradiation and agree to use reliable contraception for 1 year following transplant. * Concomitant severe diseases (respiratory, renal, liver, cardiac failures, psychiatric disorders, neoplasms) * Recurrent urinary, pulmonary infections. * Active bacterial, viral, or fungal infection * Active peptic ulcer disease * Previous treatments with total lymphoid irradiation or total body irradiation * Interferon-neutralizing antibody positive with a titer greater than 20 * Relapse in the month preceding enrollment * Poor compliance

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2023-10-12