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Autologous Stem Cell Transplantation with CD34-Selected Peripheral Blood Stem Cells PBSC in Patients with Treatment Resistant Systemic Sclerosis (SSc) (NCT03630211)

The trial, Autologous Stem Cell Transplantation with CD34-Selected Peripheral Blood Stem Cells PBSC in Patients with Treatment Resistant Systemic Sclerosis (SSc), will utilize intermediate doses of radiation and chemotherapy, paired with intense immunoablative serotherapy to eradicate most, if not all disease causing autoreactive lymphocytes and other immune cells. Patients are expected to recover and return to physical activity soon after autologous stem cell infusion regenerates white and red cells. Importantly, laboratory based CD34 selection will remove potentially autoreactive lymphocytes from the collected stem cells.

The hypothesis is that after autologous purified stem cell infusion that was depleted of potentially disease-causing T and B lymphocytes, a normal immune system will reconstitute either without recurrence of active disease or with significantly delayed disease progression and overall reduced disease burden.

In addition, we propose this innovative conditioning regimen is a safer strategy from a cardiopulmonary, urinary, and bone marrow toxicity perspective compared to the published work of other centers, nevertheless, leads to improved SSc symptoms with prevention or delay of disease recurrence and/or progression.

  Eligibility

This study is open to teens and adults, with advanced SSc, between the ages of 8-60 years. For additional requirements and criteria please visit the NIH Clinical Trials website.

Actual Study Start Date: July 31, 2018

Learn more about this trial on its clinicaltrials.gov page or contact Shawna McIntyre, BSN, RN at mcintyresm@upmc.edu.

  Project Team

Principal Investigator:
Paul Szabolcs, MD

Team Members:
Robyn T. Domsic, MD, MPH
William Follansbee, MD
Dwight Heron, MD
Annie Im, MD
Daniel Kass, MD
Geoffrey Kurland, MD
Robert Lafyatis, MD
Adam Olson, MD
Kathryn Torok, MD

Contact Information

For more information, call the UPMC Immune Transplant and Therapy Center at 1-888-4UPMC-ITTC (1-888-487-6248).

UPMC
200 Lothrop St.
Pittsburgh, PA 15213-2582

Additional Resources

For patients:
UPMC Transplant Services
Immunotherapy at UPMC Hillman Cancer Center
The Aging Institute

For researchers:
Thomas E. Starzl Transplantation Institute
Cancer Immunotherapy Research at UPMC Hillman Cancer Center
University of Pittsburgh Department of Immunology

© 2023 UPMC – The UPMC Immune Transplant and Therapy Center is a partnership between UPMC and the University of Pittsburgh.

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