Thymic Tolerance in Pediatric Heart Transplantation

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Terminated
Phase 2

Conditions

Heart Transplantation

Treatments

Procedure: donor bone marrow cell injection into thymus gland

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00151164
551
0404019
P50HL074732-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

1 day to 20 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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