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Thymic Tolerance in Pediatric Heart Transplantation

NCT00151164 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-07-12

No results posted yet for this study

Summary

The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. They further hypothesize that recipients receiving donor bone marrow will experience less acute rejection events with reduced long-term requirements for immunosuppressive medications when compared to controls who do not receive marrow but who are managed under an identical immunosuppressive protocol.

Conditions

  • Heart Transplantation

Interventions

PROCEDURE

donor bone marrow cell injection into thymus gland

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Steven A. Webber, MBChB · University of Pittsburgh Medical School

Study Design

Allocation
NON_RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00151164 on ClinicalTrials.gov