| Trial ID: | L6516 |
| Source ID: | NCT00579371
|
| Associated Drug: |
Islets Of Langerhans
|
| Title: |
Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Islets of Langerhans Transplantation|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Islets of Langerhans
|
| Outcome Measures: |
Primary: Incidence of insulin independence with a single islet transplant, Incidence of insulin independence with a single transplantation measured at one year post-transplantation., 1 year post-transplantation | Secondary: Islet mass resulting in insulin independence/reduced exogenous insulin requirement, Insulin independence or reduced exogenous insulin required measured at one year post-transplantation., 1 year post-transplantation|Graft survival, The survival of the Islets of Langerhans graft as measured at three years post-transplantation., 3 years post-transplantation|Metabolic functional assessments of the islet graft, An assessment of the metabolic function of the islet of Langerhans graft as measured three years post-transplantation., 3 years post-transplantation
|
| Sponsor/Collaborators: |
Sponsor: University of Nebraska
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-03-17
|
| Completion Date: |
2011-03
|
| Results First Posted: |
|
| Last Update Posted: |
2023-12-21
|
| Locations: |
The Nebraska Medical Center, Omaha, Nebraska, 68198, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00579371
|
