Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

551


NCT ID:

NCT00151164


Secondary ID:

P50HL074732-04


Study Acronym:


Brief Title:

Thymic Tolerance in Pediatric Heart Transplantation


Official Title:

Thymic Tolerance in Pediatric Heart Transplantation


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

20 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Heart, Lung, and Blood Institute (NHLBI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

Due to failure to control sufficient patient


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

48


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Steven A. Webber, MBChB
Principal Investigator
University of Pittsburgh Medical School

Study Dates

Start Date:April 2004
Completion Date:October 2007
Completion Type:Actual
Primary Completion Date:October 2007
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:July 11, 2016
First Received Date:September 6, 2005

Study Outcomes

Outcome Type: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:donor bone marrow cell injection into thymus gland

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Children's Hospital of Pittsburgh

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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