NCT00151164

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

July 12, 2016

Status Verified

January 1, 2008

Enrollment Period

3.5 years

First QC Date

September 6, 2005

Last Update Submit

July 11, 2016

Conditions

Heart Transplantation

Keywords

transplantation tolerancethymusbone marrowpediatric heart transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

donor bone marrow cell injection into thymus glandPROCEDURE

Eligibility Criteria

Age1 Day - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of prior transplant
  • Listed for multi-organ transplant
  • Sensitized against human HLA tissue types
  • Documentation of total thymomectomy during a prior surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Steven A. Webber, MBChB

    University of Pittsburgh Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

July 12, 2016

Record last verified: 2008-01

Locations

US(1)