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Nonmyeloablative transplant for severe systemic sclerosis

Complete title: Allogeneic Hematopoietic Cell Transplantation after Nonmyeloablative Conditioning for Patients with Severe Systemic Sclerosis

Research Study Number       2067.00
    
Principal Investigator       George Georges, MD
    
Phase       I/II

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Research Study Description

Study Purpose: The major goal of this project is to determine if non-myeloablative stem cell transplantation is an effective treatment for severe systemic sclerosis (SSc). SSc is an autoimmune disease in which a person’s immune system attacks skin and internal organs that leads to scarring and dysfunction. For persons with severe SSc, there exists no effective therapy to halt disease progression, and conventional transplantation is not well tolerated by all SSc patients. Non-myeloablative transplant treatments use lower doses of chemotherapy and radiation than conventional transplant treatments.

Study Sites: Participants will receive treatment at the Seattle Cancer Care Alliance (SCCA) and the University of Washington.

Study Duration and Follow-up: Participation in the active treatment phase of the study (the transplantation) will last approximately 3 months. Following the transplantation, participants will receive regularly scheduled medical evaluations the first year. Thereafter, participants will have follow-up testing once a year through five years.

Eligibility Criteria (must meet the following to participate in this study)

• Males or females

• Ages up to 70

• Severe Systemic Sclerosis with evidence of moderate to severe skin involvement, lung involvement, history of kidney disease and failure of treatment with cyclophosphamide.

• Availability of a matched sibling or unrelated stem cell donor

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• Age over 70

• Lack of suitable donor

• Eligible for autologous transplant study (SCOT trial)

• Severe organ dysfunction (such as heart, lung, liver, etc.)

• Untreated psychiatric conditions

• Other cancers

• HIV positivity

• Severe infections

• Pregnancy

• Lack of willingness to use contraceptive techniques

Other exclusion criteria may apply.



Research Study Number       2067.00
    
Contact       Bernadette McLaughlin
    
Telephone       206/667-4916
    
E-mail      
    
   

Keywords
Autoimmune Diseases; Scleroderma; Systemic Sclerosis; Non-malignant Condition

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