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hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure Clinical research trials and hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure. hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure clinical trial. Test subjects typically receive the most effective healthcare possible for their hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure  hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure
hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure
For Condition: Diabetes Mellitus, Experimental,Diabetes Mellitus, Insulin-Dependent,Islets of Langerhans Transplantation,Transplantation, Homologous
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Juvenile Diabetes Research Foundation,Juvenile Diabetes Foundation International Islet Transplantation Center
Synopsis: 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 surgican and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gammal1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.
Details: 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:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
University of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bernhard Hering 612-626-5735
Additional Information:
Study ID Numbers: NCRR-M01RR00400-0672;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008801
Other Diabetes Mellitus, Experimental Studies:
1. hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure
Related Studies:
Other Diabetes Mellitus, Experimental Clinical Trials
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hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure
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