Thymic Tolerance in Pediatric Heart Transplantation

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