Heart Transplantation
Conditions
Keywords
transplantation tolerance, thymus, bone marrow, pediatric heart transplantation
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.
Interventions
PROCEDUREdonor bone marrow cell injection into thymus gland
Sponsors
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Days to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls | — |
Countries
United States
Outcome results
None listed