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NCT Number: NCT05925608

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

This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida

Gainesville, Florida, 36210, United States

About this study

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 cell treatment which is 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 ischemic heart failure with reduced ejection fraction (HFrEF). Phase I is designed to determine effective dose and Phase II is designed to evaluate effectiveness for improving clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • NTproBNP level of >500 pg/ml.
  • Have inflammation > 2 mg/L as measured by high-sensitivity C-reactive protein (hs-CRP) test.

Exclusion criteria

  • Other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.

Treatment and study plan

CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs)

Combination Product

CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) delivered with the Helix transendocardial delivery catheter (treatment)

Diagnostic Catheterization

Diagnostic Test

Left ventricular catheterization with no active therapy

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Overall survival

    Time frame: Through 12 months

    Overall survival time

  2. 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)

  3. Minnesota Living with Heart Failure Questionnaire

    Time frame: Through 12 months

    Self-reported questionnaire asking about heart failure symptoms with lower score being better

Sponsors and collaborators

Lead sponsor

BioCardia, Inc.

Industry

Registry information

Official study title

Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF)

Acronym: CardiALLO

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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