hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2003 by National Center for Research Resources (NCRR). Recruitment status was Active, not recruiting

First Received on January 16, 2001. Last Updated on October 31, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Juvenile Diabetes Research Foundation
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00008801

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Experimental Transplantation, Homologous Islets of Langerhans Transplantation	Drug: hOKT3gamma1 (Ala-ala)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1 Islet Cell Transplantation

Drug Information available for: Gamma Rays

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008801

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Juvenile Diabetes Research Foundation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00008801 History of Changes
Other Study ID Numbers:	NCRR-M01RR00400-0672
Study First Received:	January 16, 2001
Last Updated:	October 31, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Experimental
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012