Autologous Stem Cell Transplantation for Crohn's Disease

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Paul Szabolcs
Study ID
NCT00692939
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • autologous CD34-selected peripheral blood stem cells transplant — BIOLOGICAL
    high-dose immunotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC)
  • Alemtuzumab — DRUG
    Transplant conditioning
  • ATG — DRUG
    Transplant conditioning
  • Melphalan — DRUG
    Transplant conditioning
  • Thiotepa — DRUG
    Transplant conditioning
  • Rituximab — DRUG
    Transplant conditioning
  • Cyclophosphamide — DRUG
    Mobilization
  • G-CSF — DRUG
    Mobilization
  • Mesna — DRUG
    Mobilization

Study Details

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.

Key Dates

Start date
Jun 26, 2012
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    High-dose immunotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC)

Primary Outcome Measure

Number of participants with regimen-related toxicities. [ Time Frame: From baseline to 24 months post bone marrow transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of Pittsburgh of UPMC-Bone Marrow TeamPittsburghPennsylvania15224
Shawna H McIntyre, RN
[email protected]
412-692-5552
Paul Szabolcs, MD (PRINCIPAL_INVESTIGATOR)
UPMC Prebyterian- Adult GastroenterologyPittsburghPennsylvania15213
David Binion, MD
[email protected]
412-383-6968
Beata Pasek, RN
[email protected]
412-648-6995

Find similar trials in Pittsburgh, PA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Children's Hospital of Pittsburgh of UPMC-Bone Marrow Team· Pittsburgh, PAUPMC Prebyterian- Adult Gastroenterology· Pittsburgh, PA

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