Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT00497757
Eligibility Criteria:
Inclusion Criteria:
* 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's panel reactive antibody (PRA) is \<40. If the patient is plasmapheresed prior to the heart transplant, then the pre-transplant PRA will not be a consideration for inclusion/exclusion.
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00497757
Study Brief:
Protocol Section:
NCT00497757