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Autologous Hematopoietic Stem Cell Transplant in Neuromyelitis Optica

NCT01339455 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-05-02

No results posted yet for this study

Summary

Neuromyelitis Optica (NMO) is a demyelinating and degenerative disorder of the CNS affecting vision and spinal cord function. This disease is rare compared to Multiple Sclerosis (MS), but it is devastating and often leads to accumulating disability with a 5 year-mortality of approximately 30%. Survivors are typically left with severe morbidity secondary to blindness, quadriparesis and respiratory failure. No agent has been found to be highly effective in halting disease activity. Based on recent outcomes of stem cell transplant trials and reports in autoimmune diseases including MS, and based on the mechanisms of NMO, we anticipate that stem cell transplantation may provide lasting disease stability for NMO patients. The hypothesis of the present trial is that autologous hematopoetic stem cell transplantation in patients with NMO will provide lasting benefit in relapse prevention. Specifically, we anticipate a 50% reduction in the proportion of patients experiencing relapse over a three year period. We will be following patients for a total of five years after transplantation.

Conditions

  • Neuromyelitis Optica

Interventions

PROCEDURE

AHSCT

AHSCT Procedure: 1. Mobilization and Harvesting: * Cyclophosphamide * Rituximab * GSCF * Dexamethasone * Apheresis 2. Conditioning and Infusion (3-4 weeks after Mobilization and Harvesting): * Cyclophosphamide * MESNA * Rabbit ATG * Rituximab * Methylprednisolone * Stem Cell infusion * GSCF

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Jodie M Burton, MD,MSc,FRCPC · Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary

  • Jan Storek, MD,PhD · Department of Medicine, University of Calgary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01339455 on ClinicalTrials.gov