Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Thymic Tolerance in Pediatric Heart Transplantation

This study has been terminated.
(Due to failure to control sufficient patients in the active arm, this study has now been closed.)
Children's Hospital of Pittsburgh
University of Pittsburgh
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: September 6, 2005
Last updated: January 31, 2008
Last verified: January 2008

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.

Condition Intervention Phase
Heart Transplantation
Procedure: donor bone marrow cell injection into thymus gland
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Thymic Tolerance in Pediatric Heart Transplantation

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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:
  • Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls

Estimated Enrollment: 48
Study Start Date: April 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00151164

United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Children's Hospital of Pittsburgh
University of Pittsburgh
Principal Investigator: Steven A. Webber, MBChB University of Pittsburgh Medical School
  More Information

No publications provided Identifier: NCT00151164     History of Changes
Other Study ID Numbers: 551, P50 HL074732-04, 0404019
Study First Received: September 6, 2005
Last Updated: January 31, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
transplantation tolerance
bone marrow
pediatric heart transplantation processed this record on March 03, 2015