Induction of Donor Specific Tolerance in Recipients of Cardiac Allografts by Donor Stem Cell Infusion

NCT00497757 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ICT-7494-041698
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients who need a heart transplant.

Conditions

Heart Transplantation

Keywords

Marrow/hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Enriched Hematopoetic Stem Cell Engraftment

  One month to three years

Study Arms (1)

Cardiac Failure Patients

EXPERIMENTAL

Recipients treated with an enriched hematopoetic stem cell infusion from the heart donor's bone marrow

Biological: enriched hematopoetic stem cell infusion

Interventions

enriched hematopoetic stem cell infusion BIOLOGICAL

Enriched Hematopoetic Stem Cell Infusion

Cardiac Failure Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between the ages of 18 and 70 years and meet the institution's criteria for cardiac transplantation.
• Subjects must have acceptable negative results for infectious disease markers done within two weeks of the bone marrow infusion.
• Subject is receiving a first cardiac transplant.
• Subjects receiving a multi-organ transplant (i.e., heart/kidney) may be included at the discretion of the PI and investigators.
• Note: These multi-organ subjects will have identical criteria with the exception of adequate function of the affected organ to be transplanted (i.e., kidney). They are included in the total of thirty subjects to be transplanted.
• Subject must have a negative crossmatch with the donor.
• Women who are of child bearing potential must have a negative pregnancy test (urine test within 48 hours) before TBI and agree to use reliable contraception for one year following transplant.
• Subject is able to give informed consent.

You may not qualify if:

• Clinically active bacterial, fungal, viral or parasitic infection
• Pregnancy
• Previous radiation therapy at a dose that would preclude TBI
• Subject is unable to give informed consent
• If the procedures associated with the study (i.e., delivering TBI) would significantly extend the cold ischemia time of the heart, the protocol will be abandoned and the patient will receive a conventional heart transplant.

Sponsors & Collaborators

• Suzanne T. Ildstad: lead

Study Officials

• Suzanne T Ildstad, MD

  University of Louisville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Open label

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: July 1, 2003
• Primary Completion: November 7, 2011
• Study Completion: December 1, 2016
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share