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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT02293603
Eligibility Criteria:
Major Inclusion Criteria:
1. DCM with left ventricular ejection fraction (LVEF) ≤ 35% as determined by a historical TTE within the previous 6 months
2. New York Heart Association (NYHA) Class III or ambulatory Class IV heart failure
3. Use of evidence based medical-therapy (beta-blockers, ACE-inhibitors/angiotensin receptor blockers, aldosterone antagonist) and with or without device-therapy (Implantable cardioverter-defibrillator or cardiac resynchronizing therapy), in accordance with the ACC/AHA guidelines for the management of heart failure, for at least three months prior to enrollment or documented contraindication or intolerance or patient preference
4. Coronary anatomy suitable for Investigational Product (IP) infusion, as determined by the Eligibility Committee (a team of cardiology experts)
5. Ability to provide informed consent and follow-up with protocol procedures
6. Screening cardiac CT left ventriculogram ejection fraction \<40% with left ventricular dilatation
7. Age ≥ 18 years
Major Exclusion Criteria:
1. Diagnosis of active myocarditis
2. Immunologic incompatibility with all available Master Cell Banks (MCBs) by single-antigen bead (SAB) serum antibody profiling
3. Left Ventricular Assist Devices (LVAD) or those actively in the process of acquiring one
4. Recent placement of a cardiac pacemaker and/or resynchronization pacing therapy within the past three months or those actively in the process of acquiring one
5. History of sustained ventricular tachycardia (VT) requiring cardiopulmonary resuscitation (with the exception of subjects who subsequently received an ICD)
6. Non-cardiovascular disease with life expectancy of \< 3 years
7. Known hypersensitivity to contrast agents
8. Estimated glomerular filtration rate (GFR) \< 50 mL/min
9. Active infection not responsive to treatment
10. Active allergic reactions, connective tissue disease or autoimmune disorders
11. History of cardiac tumor, or cardiac tumor demonstrated on screening
12. History of previous stem cell therapy
13. History of treatment with immunosuppressive agents, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs or anti-vascular endothelial growth factor (VEGF) within 6 months prior to enrollment (not including drug eluting coronary stents)
14. History of receipt of chemotherapeutic agents known to be implicated in cardiac dysfunction \[Adriamycin, trastuzumab (Herceptin)\]
15. Known moderate-severe aortic stenosis/insufficiency or severe mitral stenosis/regurgitation
16. Participation in an on-going protocol studying an experimental drug or device
17. Current active alcohol or drug abuse or inability to comply with protocol-related procedures
18. Pregnant/nursing women and women of child-bearing potential without use of active and highly reliable contraception
19. Known history of Human Immunodeficiency Virus (HIV) infection
20. Known history of chronic viral hepatitis
21. Abnormal liver function (serum glutamic pyruvic transaminase (SGPT) \> 10 times the upper reference range) and/or abnormal hematology (hematocrit \< 25%, white blood cells (WBC) \< 3000 µl, platelets \< 100,000 µl) studies without a reversible, identifiable cause
22. Evidence of tumor on screening of chest/abdominal/pelvic (body) CT scan
23. Any prior organ transplant
24. Being actively listed for, or under active consideration (i.e., work-up) for, a solid organ transplant of any kind
25. Known hypersensitivity to bovine products
26. Known hypersensitivity to dimethyl sulfoxide (DMSO)
27. Any malignancy within past 2 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer)
28. Any prior radiation therapy/treatment to the chest
29. Uncontrolled diabetes (HbA1 \>9.0)
30. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02293603
Study Brief:
Protocol Section:
NCT02293603