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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00128258
Eligibility Criteria:
Inclusion Criteria:
* Age \>=18 years.
* Congestive heart failure with ejection fraction \<= 35.
* Candidates for ventricular device placement as a bridge to transplant.
* Serum bilirubin, SGOT and SGPT \<= 2.5 times the upper level of normal.
* Serum creatinine \< 2.0 times normal or no dialysis.
* New York Heart Association (NYHA) performance status \> 3.
* Negative pregnancy test (in women with childbearing potential).
Exclusion Criteria:
* Pregnant or breastfeeding women.
* History of prior radiation exposure.
* History of bone marrow disorder.
* History of abnormal bleeding or clotting.
* History of liver cirrhosis.
* Inability to obtain 1 x 10\^6 CD 34+ cells after bone marrow processing.
* Acute myocardial infarction \< 6 days from acute event.
* Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer).
* Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
* Eligible for destination ventricular assist device placement.
* Unable to have 250cc bone marrow harvested.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00128258
Study Brief:
Protocol Section:
NCT00128258