NCT03593902

Cardiac Safe Transplants for Systemic Sclerosis

Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The autologous hematopoietic stem cell transplant used in this research study is an investigational procedure that uses cyclophosphamide and fludarabine (chemotherapy), rabbit anti-thymocyte globulin (rATG) (a protein that kills the immune cells that are thought to be causing your disease), and rituximab (a biologic drug that targets B cells of your immune system). After use of these treatments, the patient will receive their own previously collected blood stem cells (autologous stem cell transplant). The ability of these experimental treatments to stop relapses and progression (worsening) of your systemic sclerosis will be assessed.

Conditions

• Systemic Sclerosis
• Scleroderma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-17
• Primary completion: 2019-10-03
• Completion: 2019-10-09
• First posted: 2018-07-20
• Last updated: 2020-08-12
• Results posted: 2020-08-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study