Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients

Stopped early · Phase 1

Conditions studied: Scleroderma, Systemic Sclerosis

In brief

Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe SSc.

Key facts

Study ID

NCT00040651

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

15

Starts

2002-07-01

Expected to finish

2007-03-01

Last updated by the study team

2007-12-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status of 0 to 2
• Willing to participate in all portions of the protocol, including pharmacodynamic and immunologic studies and patient care follow-up visits
• Willing to stay in the Pittsburgh area for 100 days post-transplantation
• Willing to use acceptable methods of contraception

You may not qualify if…

• HIV infected
• Hepatitis C virus infected
• Active infection
• Small malabsorption syndrome
• Immunosuppressive therapy other than steroids within 4 weeks of study entry
• Pregnant or breastfeeding

Where it is running

• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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