| Trial ID: | L5766 |
| Source ID: | NCT00160732
|
| Associated Drug: |
Allogenic Islet Cells (Human, U. Chicago)
|
| Title: |
Allogenic Islet Cell Transplantation
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Allogenic islet cells (human, U. Chicago)|PROCEDURE: Intraportal infusion of islet cells
|
| Outcome Measures: |
Primary: decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent., Monthly|decrease in incidence of hypoglycemic events, Monthly | Secondary: absence of complications from the procedure and side effects of the medication, Monthly
|
| Sponsor/Collaborators: |
Sponsor: University of Chicago
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-10
|
| Completion Date: |
2025-10
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-07
|
| Locations: |
The University of Chicago Hospitals, Chicago, Illinois, 60637, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00160732
|
