TerminatedPhase 1

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

United States15 participantsStarted 2002-07

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Non-hematologic toxicity experienced

Timeframe: Measured within 3 weeks after transplant

Trial details

NCT IDNCT00040651

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

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2007-03

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