![]() Concomitant severe diseases (respiratory, renal, liver, cardiac failures, psychiatric disorders, neoplasms).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.Uncontrolled or severe cardiovascular disease, including recent (Pregnancy test negative (women of childbearing potential only).Cytomegalovirus (CMV), hepatitis B, Human T-lymphotropic virus (HTLV)-1,2, Epstein-Barr virus (EBV), and Herpes antibody status known.Hepatitis C antibody negative (positive antibody allowed if antigen (RNA)-negative and no clinical evidence of cirrhosis).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).Required initial laboratory data (obtained within 30 days prior to transplant, unless otherwise specified) Ejection fraction (EF) > 40% (unless cleared by cardiologist).Diffusing capacity of the lung for carbon monoxide (DLCO)> 50% (unless cleared by physician).Treatment with high dose, high frequency Interferon-β therapy, or failure to tolerate Interferon-β therapy.Relapse within the last year or sustained disability progression of 1.0 for six months.Independently ambulatory (eligible for inclusion if subject was acutely non-ambulatory within the previous year and return of function is substantiated with EDSS score.).Extended Disability Status Score (EDSS) between 0 and 5.0.Confirmed diagnosis of relapsing-remitting MS.Clinically definite MS according to the McDonald criteria.The goal of this study is to evaluate the potential of safely establishing mixed chimerism to interrupt the autoimmune process and end the devastating effects of MS. We believe this study will provide a breakthrough in the treatment of MS. Each patient will receive a cell dose one unit above the dose received by the most recent safely transplanted patient. The study takes a gradual approach to increasing the cell dose to achieve mixed chimerism. ![]() In this study, we will determine the appropriate cell dose to safely establish mixed chimerism following partial conditioning in patients with RRMS. The end result is a marrow system that contains recipient and donor cells, a state called mixed chimerism. The toxicity of conditioning and transplantation is significantly reduced. The transplant product is depleted of GVHD-producing cells but retains tolerance-promoting cells, called facilitating cells, which are intended to ensure the donor and recipient cells coexists peacefully. This study utilizes a new approach to conditioning which leaves the patient's immune system intact. GVHD occurs when donor immune cells recognize the recipient's cells as foreign tissue and attack them. Traditional conditioning destroys the recipient's immune system and requires that the marrow transplant be successful because the patient is unable to fight off infection if the donor cells do not survive. Two factors limit the widespread application of traditional donor stem cell transplant: 1) preparing the patient for transplant (conditioning) and 2) graft-versus-host disease (GVHD). This study is designed to evaluate the safety of a donor transplant procedure as a therapy for relapsing remitting multiple sclerosis (RRMS). The general consensus in the field is that donor transplant is most likely to halt disease progression. Stem cell transplant can be performed using the patient's own cells, or donor cells. Bone marrow stem cell transplantation has been shown to halt autoimmunity. Autoimmunity is a condition where an individual's immune system attacks his/her own cells. While the cause of MS in not known, there is an autoimmune component that destroys nerve cells. Why Should I Register and Submit Results?.
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