Thymic Tolerance in Pediatric Heart Transplantation

Stopped early · Phase 2

Conditions studied: Heart Transplantation

In brief

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.

Key facts

Study ID

NCT00151164

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

48

Starts

2004-04-01

Expected to finish

2007-10-01

Last updated by the study team

2016-07-12

Who can join

Age: 0 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of prior transplant
• Listed for multi-organ transplant
• Sensitized against human HLA tissue types
• Documentation of total thymomectomy during a prior surgery

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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