Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (CardiALLO)
Study Details
Study Description
Brief Summary
This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from the NK1R+ Mesenchymal stem cells as a therapy for chronic ischemic left ventricular dysfunction delivered using the investigational Helix transendocardial delivery catheter.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow-derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure. At present, several types of adult bone marrow derived stem cells hold great promise to treat heart failure. Allogenic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as having potential to provide a safe and effective treatment for patients with ischemic heart failure. Mesenchymal stem cells are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells which give rise to marrow adipose tissue). The CardiALLO cell therapy is an allogenic bone marrow-derived NK1R+ selected and culture-expanded mesenchymal stem cells that will be delivered intramyocardially using the investigational Helix delivery catheter. The purpose of this study is to determine the safety, optimal dose and efficacy of CardiALLO cell therapy system in patients with post-myocardial infarction heart failure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 1 The study will utilize a dose escalation study design with three patients at 20 million MSCs, three patients at 100 million MSC, and three patients at 200 million MSC to identify dose for Phase II. Prespecified DSMB review after each dose cohort of the Phase I, before moving to higher dose. |
Combination Product: CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs)
CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) delivered with the Helix transendocardial delivery catheter
|
Outcome Measures
Primary Outcome Measures
- Treatment-emergent serious adverse events [Through 30 days post-procedure.]
Incidence of TE-SAE defined as a composite of death, non-fatal MI, stroke, worsening HF (requiring admission, iv diuretics and/or inotropics), myocardial perforation (with tamponade), ventricular arrythmias >15 seconds
- Composite endpoint consisting of all cause or cardiac death, non-fatal cardiac-related hospitalizations and functional capacity measured using the 6 minute walk distance. [Through Month 12]
The primary efficacy endpoint is a composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events excluding those deemed procedure related occurring within the first 7 days (heart failure hospitalization, stroke or MI) ordered by time to event, and (3) change for 6MWD.
Secondary Outcome Measures
- Overall survival [Through 12 months]
Overall survival time
- Major Adverse Cardiac Events (MACE) [Through 12 months]
A composite of all-cause death, hospitalization for worsening heart failure, nonfatal recurrent myocardial infarction, placement of a left ventricular assist device [LVAD], or heart transplantation)
- Minnesota Living with Heart Failure Questionnaire [Through 12 months]
Self-reported questionnaire asking about heart failure symptoms
Eligibility Criteria
Criteria
Inclusion Criteria:
-
New York Heart Association (NYHA) Class II or III
-
Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction
-
Left ventricular ejection fraction between 20% and 40%
-
On stable, guideline-directed medical and device therapy, as appropriate
Exclusion Criteria:
- Other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- BioCardia, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05063