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Allogenic Islet Cell Transplantation

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Oct 2025 to Oct 2030v29
  2. 3 versions Re-verified since Nov 7, 2022, no change to tracked fieldsv26-v28
  3. Primary completion date: Oct 2022 to Oct 2025v25
  4. 2 versions Re-verified since Sep 25, 2019, no change to tracked fieldsv23-v24
  5. Primary completion date: Oct 2018 to Oct 2022 Completion date: Oct 2018 to Oct 2025v22 Show 1 more changeShow less
    • Completion date: Oct 2018 to Oct 2025
Show 20 earlier versionsHide 20 earlier versions
  1. Re-verified, no change to tracked fieldsv21
  2. Primary completion date: Oct 2017 to Oct 2018 Completion date: Oct 2018v20 Show 1 more changeShow less
    • Completion date: Oct 2018
  3. Primary completion date: Oct 2016 to Oct 2017v19
  4. Primary completion date: Oct 2013 to Oct 2016 Study arms: 0 to 1v18 Show 1 more changeShow less
    • Study arms: 0 to 1
  5. Re-verified, no change to tracked fieldsv17
  6. Trial status: Recruiting to Active, Not Recruiting Site details revisedv16 Show 1 more changeShow less
    • Site details revised
  7. Primary completion date: Oct 2010 to Oct 2013 Site contact updatedv15 Show 1 more changeShow less
    • Site contact updated
  8. Eligibility criteria expanded, about 1 wordv14 See this version in full on ClinicalTrials.gov ↗
  9. Primary completion date: Oct 2009 to Oct 2010v13
  10. Site contact updatedv12
  11. Eligibility criteria shortened, about 8 wordsv11 See this version in full on ClinicalTrials.gov ↗
  12. Primary completion date: Oct 2008 to Oct 2009v10
  13. Site contact updatedv9
  14. Site contact updatedv8
  15. Primary endpoints revised (2) Primary completion date: Oct 2008 · Secondary endpoints: details revised at 1 of 1 entry · Site contact updatedv7 Show 3 more changesShow less
    • Primary completion date: Oct 2008
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  16. 2 versions Re-verified since Nov 30, 2006, no change to tracked fieldsv5-v6
  17. Eligibility criteria shortened, about 6 wordsv4 See this version in full on ClinicalTrials.gov ↗
  18. Re-verified, no change to tracked fieldsv3
  19. Primary endpoints revised (2) Interventions: Allogenic Islet Cells (human, U. Chicago) (Drug), Intraportal infusion of islet cells (Procedure) to Allogenic islet cells (human, U. Chicago) (Drug), Intraportal infusion of islet cells (Procedure) · Secondary endpoint revised · Eligibility criteria expanded, about 3 words · 1 morev2 Show 4 more changesShow less
    • Interventions: Allogenic Islet Cells (human, U. Chicago) (Drug), Intraportal infusion of islet cells (Procedure) to Allogenic islet cells (human, U. Chicago) (Drug), Intraportal infusion of islet cells (Procedure)
    • Secondary endpoint revised
    • Eligibility criteria expanded, about 3 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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.
University of Chicago
304 trials monitored
See 9 trials at risk
Diabetes
4,286 trials monitored
See 185 trials at risk
Type 1 Diabetes
853 trials monitored
See 38 trials at risk
The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.
Trial Details
NCT Number NCT00160732
Lead Sponsor University of Chicago
Conditions Diabetes Mellitus, Type 1
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov