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Autologous Stem Cell Transplantation for Crohn's Disease

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2027
    • Site contacts updated at 1 of 2 sites
    v32
  2. Site contacts updated at 1 of 2 sitesv31
  3. 5 versions Re-verified since Mar 20, 2020, no change to tracked fieldsv26-v30
  4. Primary completion date: Dec 2019 to Dec 2025
    • Study sites: 3 to 2
    • Study completion date: Dec 2020 to Dec 2026
    v25
  5. Site contacts updated at 1 of 3 sitesv24
Show 22 earlier versionsHide 22 earlier versions
  1. Interventions: ATG (Drug), Alemtuzumab (Drug), G-CSF (Drug), Melphalan (Drug), Mesna (Drug), Rituximab (Drug), Thiotepa (Drug), autologous CD34-selected… to ATG (Drug), Alemtuzumab (Drug), Cyclophosphamide (Drug), G-CSF (Drug), Melphalan (Drug), Mesna (Drug), Rituximab (Drug), Thiotepa (Drug)…
    • Site contacts updated at 1 of 3 sites
    v23
  2. Secondary endpoints revised (7)v22
  3. Enrollment target: 10 to 20
    • Study sites: 1 to 3
    v21
  4. Interventions: autologous CD34-selected peripheral blood stem cells transplant (Biological) to ATG (Drug), Alemtuzumab (Drug), G-CSF (Drug), Melphalan (Drug), Mesna (Drug), Rituximab (Drug), Thiotepa (Drug), autologous CD34-selected…v20
  5. Primary endpoints: 1 to 5
    • Eligibility criteria expanded, about 182 words
    • Secondary endpoints: 5 to 7
    v19
  6. Primary completion date: Dec 2017 to Dec 2019
    • Start date: Oct 2011 to Jun 26, 2012
    • Study completion date: Dec 2017 to Dec 2020
    • Collaborators shortened, about 3 words
    v18
  7. 2 versions Re-verified since Mar 16, 2017, no change to tracked fieldsv16-v17
  8. Primary completion date: Dec 2015 to Dec 2017
    • Study completion date: Dec 2016 to Dec 2017
    v15
  9. Re-verified, no change to tracked fieldsv14
  10. Primary completion date: Dec 2014 to Dec 2015
    • Study completion date: Dec 2014 to Dec 2016
    v13
  11. Re-verified, no change to tracked fieldsv12
  12. Site contact updatedv11
  13. Phase: Phase 1 to Phase 1/2
    • Site contact updated
    v10
  14. Site contact updatedv9
  15. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v8
  16. Lead sponsor: Duke University to Paul Szabolcs
    • Start date: Apr 2005 to Oct 2011
    • Trial status: Recruiting to Not Yet Recruiting
    • Study site revised
    v7
  17. Re-verified, no change to tracked fieldsv6
  18. Primary and study completion dates: Dec 2012 to Dec 2014v5
  19. Primary and study completion dates: Dec 2010 to Dec 2012v4
  20. 2 versions Re-verified since Nov 6, 2008, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00692939
Lead Sponsor Paul Szabolcs
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov