Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease
Paul Szabolcs
Summary
The objective of this study is to evaluate the safety and effectiveness of administering high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC) in pediatric and adult patients with severe Crohn's disease.
Description
Crohn's disease is considered to be an immune-mediated disease of the intestinal tract, typically treated using immune modulating or immune suppressive therapies. These treatments include local anti-inflammatory agents such as 5 aminosalicylic acid products, broad immune suppression using corticosteroids, azathioprine, or methotrexate; cytokine suppression such as antibody against TNFα; IL-12 and antibiotics such as ciprofloxacin and metronidazole that work by decreasing the putative antigen exposure to the intestine. There is little in the literature available on mortality data related to Cro…
Eligibility
- Age range
- 10–60 years
- Sex
- All
- Healthy volunteers
- No
5.1 Inclusion Criteria 1. Subject and/or guardian must be able to understand and provide informed consent. 2. Male or female, 10 through 60 years old, inclusive at time of informed consent. 3. Examples of subjects for whom stem cell transplant therapy would be appropriate include, but are not limited to: * Patients who have had prior surgery and subsequent severe recurrent disease in spite of aggressive maintenance therapy, necessitating consideration of further extensive surgical resections. * Patients who have diffuse small bowel and colonic disease and who are refractory to aggressi…
Interventions
- Biologicalautologous CD34-selected peripheral blood stem cells transplant
high-dose immunotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC)
- DrugAlemtuzumab
Transplant conditioning
- DrugATG
Transplant conditioning
- DrugMelphalan
Transplant conditioning
- DrugThiotepa
Transplant conditioning
- DrugRituximab
Transplant conditioning
- DrugCyclophosphamide
Locations (2)
- UPMC Prebyterian- Adult GastroenterologyPittsburgh, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC-Bone Marrow TeamPittsburgh, Pennsylvania