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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT04811261
Eligibility Criteria:
Inclusion Criteria:
1. Be ≥ 18 years of age
2. Have heart failure with reduced ejection fraction and a durable centrifugal flow LVAD
3. Be on a stable regimen of heart failure medications for at least two weeks, including ACE/ARB/ARNi unless there is a documented contraindication to their use. These medications will be provided at an optimized, guideline-directed maximally tolerated dose.
Exclusion Criteria:
1. Durable Biventricular support
2. An axial flow LVAD
3. History of Crohn's Disease, Ulcerative Colitis, or other Inflammatory Bowel Disease on active treatment
4. LVAD implantation within the last 30 days
5. Anticipated need for non-cardiac surgery within the next 12 months
6. Evidence of active systemic infection at time of study product delivery
7. Evidence of infectious diseases such as hepatitis B, hepatitis C and HIV
8. Prior heart transplant recipients
9. Active cancer (or prior diagnosis of cancer within the past 2 years)
10. Recent (\<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids \[\>1 mg/kg of prednisone equivalent\], TNF-α blockers, cyclosporine) not including NSAIDs or corticosteroids used for IV dye allergy only)
11. Chronic auto-immune or auto-inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
12. Recent or planned use of vaccination with live attenuated viruses within the next 30 days
13. Allergy to rubber or latex, or to DMSO.
14. Pregnancy or breastfeeding; fertile women must use contraception to avoid pregnancy.
15. Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
16. Platelet count \< 100K
17. Inability to maintain an INR of 2-3
18. Inability to give informed consent
19. Cognitive or language barriers that prohibit obtaining informed consent or any study elements (interpreter permitted)
20. Any other condition that, in the judgment of the Investigator, would be a contraindication to enrollment, study product administration, or follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04811261
Study Brief:
Protocol Section:
NCT04811261