Back to resultsIslet Transplantation for Patients With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Islet transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring diabetes, autoimmunity
Eligibility Criteria
Patients with type 1 diabetes with stable renal allografts
Sites / Locations
- Columbia Presbyterian Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00073281
First Posted
November 18, 2003
Last Updated
January 14, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00073281
Brief Title
Islet Transplantation for Patients With Type 1 Diabetes
Official Title
Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
diabetes, autoimmunity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Islet transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with type 1 diabetes with stable renal allografts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hardy, MD
Organizational Affiliation
Columbia Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Islet Transplantation for Patients With Type 1 Diabetes
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