hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
This trial is active, not recruiting.
|Conditions||diabetes mellitus, insulin-dependent, diabetes mellitus, experimental, transplantation, homologous, islets of langerhans transplantation|
|Phase||phase 1/phase 2|
|Sponsor||National Center for Research Resources (NCRR)|
|Collaborator||Juvenile Diabetes Research Foundation|
|Trial identifier||NCT00008801, NCRR-M01RR00400-0672|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Male or female participants from 18 years up to 60 years old.
Inclusion: - Primary islet allotransplant - surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team - Age 18 or older - must give written informed consent
|Official title||hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure|
|Description||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.|
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