- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925608
Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (CardiALLO)
October 5, 2023 updated by: BioCardia, Inc.
Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells in Patients With Post-Myocardial Infarction Heart Failure
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.
Study Overview
Status
Enrolling by invitation
Conditions
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 Type
Interventional
Enrollment (Estimated)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 36210
- University of Florida
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation Cohort
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.
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CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) delivered with the Helix transendocardial delivery catheter (treatment)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-emergent serious adverse events
Time Frame: 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
|
Through 30 days post-procedure.
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Composite endpoint consisting of all cause or cardiac death, non-fatal cardiac-related hospitalizations and functional capacity measured using the 6 minute walk distance.
Time Frame: 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.
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Through Month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Through 12 months
|
Overall survival time
|
Through 12 months
|
Major Adverse Cardiac Events (MACE)
Time Frame: 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)
|
Through 12 months
|
Minnesota Living with Heart Failure Questionnaire
Time Frame: Through 12 months
|
Self-reported questionnaire asking about heart failure symptoms with lower score being better
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Through 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carl Pepine, MD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2023
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 22, 2023
First Submitted That Met QC Criteria
June 22, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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