Allogenic Islet Cell Transplantation

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  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
    • Study completion date: Oct 2018 to Oct 2025
    v22
Show 20 earlier versionsHide 20 earlier versions
  1. Re-verified, no change to tracked fieldsv21
  2. Primary completion date: Oct 2017 to Oct 2018
    • Study completion date: Oct 2018
    v20
  3. Primary completion date: Oct 2016 to Oct 2017v19
  4. Primary completion date: Oct 2013 to Oct 2016
    • Study arms: 0 to 1
    v18
  5. Re-verified, no change to tracked fieldsv17
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  7. Primary completion date: Oct 2010 to Oct 2013
    • Site contact updated
    v15
  8. Eligibility criteria expanded, about 1 wordv14
  9. Primary completion date: Oct 2009 to Oct 2010v13
  10. Site contact updatedv12
  11. Eligibility criteria shortened, about 8 wordsv11
  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 updated
    v7
  16. 2 versions Re-verified since Nov 30, 2006, no change to tracked fieldsv5-v6
  17. Eligibility criteria shortened, about 6 wordsv4
  18. Re-verified, no change to tracked fieldsv3
  19. Primary endpoints revised (2)v2 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
  1. Study First Submitted
  • 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
308 trials monitored
See 14 trials at risk
Diabetes
5,133 trials monitored
See 238 trials at risk
Type 1 Diabetes
893 trials monitored
See 41 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
(from sponsor)		 Diabetes Mellitus, Type 1
Related terms Diabetes Mellitus, Type 1
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov