Cardiac Safe Transplants for Systemic Sclerosis

Summary

This study is designed to treat systemic sclerosis (scleroderma) patients with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy that is less toxic to your heart.

Conditions

• Systemic Sclerosis
• Scleroderma

Interventions

DRUG

Rituximab

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

DRUG

Fludarabine

A chemotherapy medication commonly used in the treatment of leukemia and lymphoma

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

• Northwestern University

  lead OTHER

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

2018-05-17

Primary Completion

2019-10-03

Completion

2019-10-09

FDA Drug

Yes

Countries

• United States

Study Locations