Thymic Tolerance in Pediatric Heart Transplantation
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ClinicalTrials.gov Identifier: NCT00151164
(Due to failure to control sufficient patients in the active arm, this study has now been closed.)
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.
Condition or disease
Procedure: donor bone marrow cell injection into thymus gland
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 Outcome Measures
Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
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Ages Eligible for Study:
up to 20 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
History of prior transplant
Listed for multi-organ transplant
Sensitized against human HLA tissue types
Documentation of total thymomectomy during a prior surgery