Diabetes Mellitus, Insulin-Dependent Clinical Trial
Official title:
hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.
Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01322789 -
Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT00035750 -
Risk Factors for Atherogenesis in Type 1 Diabetes
|
N/A | |
| Completed |
NCT00005754 -
Coronary Artery Calcification in Type 1 Diabetes
|
N/A | |
| Completed |
NCT00005474 -
Markers and Mechanisms of Macrovascular Disease in IDDM
|
N/A | |
| Completed |
NCT01216618 -
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
|
Phase 3 | |
| Completed |
NCT01236365 -
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT00071409 -
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
|
Phase 2 | |
| Completed |
NCT00069537 -
Continuous Glucose Monitors for Children With Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT05168657 -
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
|
N/A | |
| Withdrawn |
NCT00297635 -
Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy
|
Phase 2 | |
| Completed |
NCT00184821 -
Ischemic Injury and Ischemic Preconditioning in Diabetes
|
N/A | |
| Completed |
NCT00073255 -
Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
|
Phase 1 | |
| Completed |
NCT00690066 -
PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
|
Phase 2 | |
| Active, not recruiting |
NCT04078308 -
Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT00069628 -
Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer
|
Phase 4 | |
| Completed |
NCT00044408 -
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
|
Phase 3 | |
| Completed |
NCT00044395 -
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
|
Phase 3 | |
| Completed |
NCT00069615 -
Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
|
Phase 4 | |
| Completed |
NCT00005539 -
Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04689685 -
The RADAR Study - Wearable-Based Dysglycemia Detection and Warning in Diabetes
|