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Autologous Transplant To End NMO Spectrum Disorder

NCT03829566 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2019-11-20

No results posted yet for this study

Summary

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.

Conditions

  • Neuromyelitis Optica
  • Devic's Disease
  • NMO Spectrum Disorder

Interventions

DRUG

Rituximab

Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer

DRUG

Cyclophosphamide

A medication used as chemotherapy and to suppress the immune system

DRUG

Mesna

A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder

DRUG

rATG

A rabbit polyclonal antibody to lymphocytes

DRUG

Methylprednisolone

A corticosteroid medication used to suppress the immune system and decrease inflammation

DRUG

G-CSF

A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream

BIOLOGICAL

IVIg

Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects

BIOLOGICAL

Autologous Stem Cells

Infusion of patient's own stem cells

Sponsors & Collaborators

Principal Investigators

  • Richard Burt, MD · Northwestern University

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
2019-11-30
Primary Completion
2025-01-31
Completion
2025-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03829566 on ClinicalTrials.gov