Thymic Tolerance in Pediatric Heart Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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donor bone marrow cell injection into thymus gland

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Less than 21 years of age at listing
* Listed for primary orthotopic heart transplant at Children's Hospital of Pittsburgh, between 04/01/04 and 03/31/08

Exclusion Criteria

* History of prior transplant
* Listed for multi-organ transplant
* Sensitized against human HLA tissue types
* Documentation of total thymomectomy during a prior surgery

Minimum Eligible Age

1 Day

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No