Autologous Transplant To End NMO Spectrum Disorder

Korábbi kezelés

• Use of natalizumab (Tysabri) within the previous six months
• Use of fingolimod (Gilenya) within the previous three months
• Use of dimethyl fumarate (Tecfidera) within the previous three months
• Use of alemtuzumab (Lemtrada/Campath) within previous 12 months
• Use of rituximab (Rituxan) or ocrelizumab (Ocrevus) within previous six months
• Prior treatment with mitoxantrone (Novantrone)

Más betegség

• Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible, or any adult who is unable to consent (for adults cognitively impaired due to disease, consent may be obtained from the closest living relative).
• Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment
• Myocardial infarction within the last 12 months. If longer than 12 months, must pass a dobutamine stress test and be cleared by cardiology.
• Active systemic lupus erythematous, Sjogren's, myasthenia gravis, or another autoimmune disease
• Sickle cell disease, sickle cell disease, or coagulopathy
• Prior history of malignancy that required any radiotherapy, chemotherapy, or biological therapy
• Positive pregnancy test, inability or unable to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
• Untreated life-threatening cardiac arrhythmia on electrocardiogram (EKG) or 24-hour holter
• Active infection except asymptomatic bacteriuria
• Known hypersensitivity to mouse, rabbit, or E. coli derived proteins
• Human immunodeficiency virus (HIV) positive
• Hepatitis B or C positive

Laborértékek

• Left ventricular ejection fraction (LVEF) <50%
• Tiffeneau-Pinelli index (FEV1/FVC) <70% of predicted after bronchodilator therapy (if necessary), or diffusing capacity of lung for carbon monoxide (DLCO) hemoglobin corrected <70 % predicted
• Serum creatinine >2.0 mg/dl
• Liver cirrhosis, transaminases >2x of normal limits, or bilirubin >2.0 mg/dl unless due to Gilbert's disease
• Major hematological abnormalities such as platelet count < 100,000/μl or absolute neutrophil count (ANC) < 1000/μl

Életkor

• Under age of 18 or over age of 65

Egyéb

• Prisoners
• Paraplegia or quadriplegia (must be able to use a walker if even for only a few feet)
• Extensive subcortical white matter lesions
• Women who are breastfeeding
• Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have magnetic resonance imaging (MRI) exams
• Use of teriflunomide (Aubagio) unless cleared from the body (plasma concentration <0.02mcg/ml) following elimination from the body with cholestyramine 8g three times a day for 11 days

• Age 18 - 65 years old at the time of pre-transplant evaluation
• An established diagnosis of NMOSD (with or without aquaporin 4 (AQP4)-IgG antibody)