Heart Failure Clinical Trial

Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (CardiALLO)

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.

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Full 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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT05925608

Recruitment Status:

Enrolling by invitation

Sponsor:

BioCardia, Inc.

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There is 1 Location for this study

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University of Florida
Gainesville Florida, 36210, United States

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Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT05925608

Recruitment Status:

Enrolling by invitation

Sponsor:


BioCardia, Inc.

How clear is this clinincal trial information?

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