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NCT01241864 · ClinicalTrials.gov registry record · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
A Phase 2 study of Diabetes Mellitus, Type 1, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01241864: Recruiting Phase 2 study of Diabetes Mellitus, Type 1, sponsored by University of Chicago.
NCT01241864 is a Phase 2 study of Diabetes Mellitus, Type 1 that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 10 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01241864, a Phase 2 study of Diabetes Mellitus, Type 1, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
Primary Outcome
The proportion of subjects with both an HbAlc \<6.5% and an absence of severe hypoglycemic events at 1 year after the first islet transplant or a reduction in HbAlc of at least 1 point and an absence of severe hypoglycemic events at 1 year after the first islet transplant.
Conditions Studied
Interventions
- BIOLOGICAL Allogenic islet cells (human, U. Chicago)
- PROCEDURE Intraportal infusion of islet cells
Study Locations (1)
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT01241864 shows while recruiting
NCT01241864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Allogenic islet cells (human, U. Chicago) is the first listed.
NCT01241864 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01241864 about?
NCT01241864 is a clinical study titled "Islet Transplantation in Type 1 Diabetic Kidney Allograft". The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These c...
What is the current status of trial NCT01241864?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2010-12. Estimated completion is 2026-12.
What conditions does trial NCT01241864 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT01241864?
The interventions under investigation include: Allogenic islet cells (human, U. Chicago) (BIOLOGICAL), Intraportal infusion of islet cells (PROCEDURE).
Who is sponsoring clinical trial NCT01241864?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01241864 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01241864's enrollment target sits among peer trials
10 111th of 118 higher than 5 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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