Back to resultsLiving-Related Donor Bone Marrow Immunoregulation in Kidney Transplants
Primary Purpose
Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
donor bone marrow infusion
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Disease focused on measuring kidney transplantation, immunosuppression, bone marrow
Eligibility Criteria
Living related donor kidney transplant recipients and the living related donors.
Sites / Locations
- VAMC Miami
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00018785
First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00018785
Brief Title
Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants
Official Title
Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
Diabetes and end-stage kidney, liver and heart disease are prominent health issues among veteran patients. Successful solid organ transplantation in the absence of chronic immunosuppressive therapy (specific acquired immunological tolerance) is a desirable therapeutic option. This project extends recent observations supporting the use of concommitant donor bone marrow cell infusion as a means of modulating the immune response in kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially toxic immunosuppressive drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease
Keywords
kidney transplantation, immunosuppression, bone marrow
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
donor bone marrow infusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Living related donor kidney transplant recipients and the living related donors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camillo Ricordi, M.D.
First Name & Middle Initial & Last Name & Degree
Andreas Tzakis, M.D.
First Name & Middle Initial & Last Name & Degree
Violet Esquenazi, Ph.D.
First Name & Middle Initial & Last Name & Degree
Keith Zucker, Ph.D.
Facility Information:
Facility Name
VAMC Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants
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