Thymic Tolerance in Pediatric Heart Transplantation

Heart Transplantation Clinical Trial

Official title:

Thymic Tolerance in Pediatric Heart Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151164
• Other study ID #: 551
• Secondary ID: P50HL074732-0404
• Status: Terminated
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: July 11, 2016
• Start date: April 2004
• Est. completion date: October 2007

Study information

• Verified date: January 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Procedure:
• donor bone marrow cell injection into thymus gland

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	Children's Hospital of Pittsburgh, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls