Autologous Transplant To End NMO Spectrum Disorder

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Neuromyelitis Optica, Devic's Disease, NMO Spectrum Disorder

In brief

This study is designed to treat your disease with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy to reset your immune system and to determine if your disease will go into long-term remission.

Key facts

Study ID

NCT03829566

Run by

Northwestern University

People needed

0

Starts

2019-11-01

Expected to finish

2025-11-28

Last updated by the study team

2019-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Under age of 18 or over age of 65
• Prisoners
• 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).
• Paraplegia or quadriplegia (must be able to use a walker if even for only a few feet)
• Extensive subcortical white matter lesions
• 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
• Women who are breastfeeding
• Untreated life-threatening cardiac arrhythmia on electrocardiogram (EKG) or 24-hour holter
• 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
• Active infection except asymptomatic bacteriuria
• Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have magnetic resonance imaging (MRI) exams
• Known hypersensitivity to mouse, rabbit, or E. coli derived proteins
• Human immunodeficiency virus (HIV) positive
• Hepatitis B or C positive
• Use of natalizumab (Tysabri) within the previous six months
• Use of fingolimod (Gilenya) within the previous three months

Where it is running

• Northwestern University, Feinberg School of Medicine — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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