Autologous Stem Cell Transplantation for Crohn's Disease

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age10-60
SponsorPaul Szabolcs

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 250), (PCDAI 30-45), but who are dependent on daily doses of corticosteroids, that are unable to be withdrawn, and aggressive medical treatment to maintain moderate disease status.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

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Paul Szabolcs

Lead sponsor

University of Pittsburgh

Sponsor institution