Islet Transplantation for Patients With Type 1 Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

November 18, 2003

Last Updated Date

May 10, 2006

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00073281 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Islet Transplantation for Patients With Type 1 Diabetes

Official Title ^ICMJE

Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression

Brief Summary

This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Detailed Description

We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Procedure: Islet transplantation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

- Patients with type 1 diabetes with stable renal allografts

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00073281

Responsible Party

Study ID Numbers ^ICMJE

9903

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Mark Hardy, MD

Columbia Presbyterian Hospital

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP