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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.)
Sponsor:
Collaborators:
Children's Hospital of Pittsburgh
University of Pittsburgh
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00151164
First received: September 6, 2005
Last updated: July 11, 2016
Last verified: January 2008
September 6, 2005
July 11, 2016
April 2004
October 2007   (Final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT00151164 on ClinicalTrials.gov Archive Site
Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone-marrow and controls.
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Thymic Tolerance in Pediatric Heart Transplantation
Thymic Tolerance in Pediatric Heart Transplantation
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.
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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Heart Transplantation
Procedure: donor bone marrow cell injection into thymus gland
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
October 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00151164
551
P50HL074732-04 ( US NIH Grant/Contract Award Number )
0404019
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National Heart, Lung, and Blood Institute (NHLBI)
  • Children's Hospital of Pittsburgh
  • University of Pittsburgh
Principal Investigator: Steven A. Webber, MBChB University of Pittsburgh Medical School
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP