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Hematopoietic Stem Cell Transplant in Devic's Disease

NCT00787722 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-02-28

Study results available
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Summary

This study is designed to examine whether treating Devic's disease patients with high dose cyclophosphamide together with rabbit antithymocyte globulin (rATG)/rituximab (drugs which reduce the function of the immune system), followed by return of previously collected patient's stem cells will result in improvement in Devic's disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in patient's immune system, which may be causing his/her disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack patient's body. The purpose of study is to examine the safety and efficacy of this treatment. The drugs used in this study treatment are drugs for commonly used for immune suppression.

Conditions

  • Devic's Disease

Interventions

PROCEDURE

Hematopoietic Stem Cell Transplantation

Infusion of participant's own stem cells

DRUG

Cyclophosphamide

A medication used as chemotherapy and to suppress the immune system

DRUG

G-CSF

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

DRUG

rATG

A rabbit polyclonal antibody to lymphocytes

DRUG

Mesna

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

DRUG

Rituximab

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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

Principal Investigators

  • Richard Burt, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-10-10
Primary Completion
2018-11-30
Completion
2018-11-30
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 NCT00787722 on ClinicalTrials.gov