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.