About this trial
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.
Eligibility criteria
Qualifiers
Male or female, 10 through 60 years old, inclusive at time of informed consent.
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 aggressive medical treatment, and not eligible for treatment using a surgical approach without the risk of precipitating short bowel syndrome and dependence of parenteral nutrition or who have other conditions that preclude surgery
Patients with a persistently high Harvey Bradshaw Index (HBI) (>6), CDAI (>250) or Pediatric CD Activity Index (PCDAI>45) (44) score or those in the lower, moderate range (HBI ≤ 6), (CDAI < 250), (PCDAI 30-45), but who are dependent on daily doses of corticosteroids, that are unable to be withdrawn, and aggressive medical treatment to maintain moderate disease status.
Disqualifiers
Patients who have not been treated with adequate dosing of 6-MP, 5-ASA products and metronidazole.
Patients who achieved a sustained, corticosteroid free response to anti-TNF alpha therapy, anti-integrin therapy or anti-IL12/23 therapy after a 4 month course of treatment.
Toxic megacolon, intestinal perforation
Conjugated bilirubin > 2.0 mg/dL.
Trial design
Treatments tested in this trial
- autologous CD34-selected peripheral blood stem cells transplant
- Alemtuzumab
- ATG
- Melphalan
- Thiotepa
- Rituximab
- Cyclophosphamide
- G-CSF
- Mesna
Treatment groups
Sponsors and collaborators
Paul Szabolcs
Lead sponsor
University of Pittsburgh
Sponsor institution