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Maximizing Outcome of Multiple Sclerosis Transplantation

NCT03342638 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-01-11

Study results available
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Summary

Randomized study of autologous un-manipulated peripheral blood hematopoietic stem cell transplant (HSCT) comparing two regimens: (1) cyclophosphamide and rabbit anti-thymoglobulin (rATG) versus (2) cyclophosphamide, rATG, and Intravenous Immunoglobulin (IVIg).

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Cyclophosphamide

Potent immunosuppressive agent; an alkylating agent

DRUG

Mesna

Medication used to decrease the risk of hemorrhagic cystitis prophylaxis

DRUG

rATG

A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells

DRUG

Methylprednisolone

Steroid

DRUG

G-CSF

Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream

BIOLOGICAL

IVIg

Sterile, purified immunoglobulin G (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG, which has intact Fc-dependent effector functions and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM).

BIOLOGICAL

Autologous Stem Cells

Infusion of participant's own stem cells

Sponsors & Collaborators

Principal Investigators

  • Richard Burt, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2019-07-23
Completion
2019-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03342638 on ClinicalTrials.gov