Clinical Trial: Islet Transplantation for patients with Type 1 diabetes


	Home	\|	Search	\|	Browse	\|	Resources	\|	Help	\|	What's New	\|	About

Islet Transplantation for patients with Type 1 diabetes

This study is currently recruiting patients.

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

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

Condition	Treatment or Intervention	Phase
Diabetes Mellitus, Type 1	Procedure: Islet transplantation	Phase I

MedlinePlus related topics: Juvenile Diabetes

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

Official Title: Islet Transplantation for patients with Type 1 diabetes and stable renal allografts using steroid sparing immunosuppression

Further Study Details:

Expected Total Enrollment: 10

Study start: August 2003; Study completion: December 2004

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.

Eligibility

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both

Criteria

Patients with type 1 diabetes with stable renal allografts

Location and Contact Information

New York
Columbia Presbyterian Medical Center, New York, New York, 10032, United States; Recruiting

Kevan C Herold, M.D. 212-342-3253 kh318@columbia.edu
Kevan C Herold, MD, Sub-Investigator

Study chairs or principal investigators

Mark Hardy, MD, Principal Investigator, Columbia Presbyterian Hospital

More Information

Study ID Numbers: 9903
Record last reviewed: May 2004
Record first received: November 18, 2003
ClinicalTrials.gov Identifier: NCT00073281
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services