Systemic Sclerosis Treatment with Autologous Transplant of CD34-Selected Peripheral Blood Stem Cells

Autologous Stem Cell Transplantation with CD34-Selected Peripheral Blood Stem Cells in Patients with Treatment-Resistant Systemic Sclerosis

Protocol Description

The primary objectives of this study by the UPMC Immune Transplant and Therapy Center (ITTC) are to determine the safety and effectiveness of high-dose immunoablative therapy followed by autologous transplantation of CD34-selected peripheral blood stem cells for systemic sclerosis (SSc) patients, using a regimen designed to maximize patient safety while also aiming to eradicate autoreactive clones responsible for the disease. The procedure used has been approved for treatment of patients with certain blood cancers, but not yet for SSc patients.

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants, ages 16 and older, who have been diagnosed with SSc.
Males and Females: Ages 16 to 70

Requirements

Initially, patients in this study will be hospitalized for procedures that prepare the blood and move stem cells from bone marrow into the bloodstream. Their blood will then be collected and put through a process called CD34 selection to remove elements that can cause rejection and help improve success of transplant. Within 3 weeks to 90 days after that, patients will begin a 21-day conditioning regimen, which involves chemotherapy and radiation. During transplant, the CD34-selected stem cells will then be put back into the bloodstream via intravenous infusion. Patients will be followed for 3 years after transplant.
Visits: Hospitalization for procedures and 10 follow-up visits after the transplant
Duration: At least 36 months

Status: Open to Enrollment

Source(s) of Support

University of Pittsburgh Medical Center

Primary Investigator

Paul Szabolcs, MD

Contact Information

For more information about the study or enrollment, please contact:
Shawna McIntyre, Clinical Research Supervisor
412-692-5552