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

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

MedlinePlus related topics:

Diabetes Diabetes Type 1 Islet Cell Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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

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

Study placed in the following topic categories:

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus, Type 1

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Diabetes Mellitus, Experimental

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008

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