Thymic Tolerance in Pediatric Heart Transplantation

Phase 2TerminatedNCT00151164

National Heart, Lung, and Blood Institute (NHLBI)48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Heart Transplantation

Interventions

donor bone marrow cell injection into thymus glandPROCEDURE

Eligibility

Sex: ALLMin age: 1 DayMax age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients

Secondary Outcomes

Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls

Data from ClinicalTrials.gov

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