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Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018785
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Kidney Disease Procedure: donor bone marrow infusion

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Study Start Date: October 1998
Estimated Study Completion Date: September 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Living related donor kidney transplant recipients and the living related donors.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018785


Locations
United States, Florida
VAMC Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
VA Office of Research and Development
Investigators
OverallOfficial: Camillo Ricordi, M.D.
OverallOfficial: Andreas Tzakis, M.D.
OverallOfficial: Violet Esquenazi, Ph.D.
OverallOfficial: Keith Zucker, Ph.D.
  More Information

ClinicalTrials.gov Identifier: NCT00018785     History of Changes
Other Study ID Numbers: IMMU-035-98S
First Submitted: July 3, 2001
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
kidney transplantation
immunosuppression
bone marrow

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases