Thymic Tolerance in Pediatric Heart Transplantation | NCT00151164

Studies
Thymic Tolerance in Pediatric Heart Transplantation

NCT00151164

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Terminated

Last Update Posted

Jul 12, 2016Estimated

Enrollment

48Estimated

Phase

Phase 2

Conditions

Heart Transplantation

Interventions

donor bone marrow cell injection into thymus gland

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50HL074732-04	U.S. NIH Grant/Contract		View source
0404019

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to failure to control sufficient patients in the active arm, this study has now been closed.

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Name	Class
University of Pittsburgh	OTHER

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Name	Type	Description	Arm Group Labels	Other Names
donor bone marrow cell injection into thymus gland	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven A. Webber, MBChB	University of Pittsburgh Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Pittsburgh		Pittsburgh	Pennsylvania	15213	United States