Thymic Tolerance in Pediatric Heart Transplantation
Phase 2
Terminated
- Conditions
- Heart Transplantation
- Registration Number
- NCT00151164
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
Trial Locations
- Locations (1)
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States