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

NCT ID: NCT05925608

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure, Systolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase I: Dose escalation, safety study consisting of 3 cell doses of 20million, 100 million and 200 million allogeneic hMSC. Each dose cohort will consist of 3 patients. Phase II: Randomized, controlled trial to evaluate the treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Phase I requires no masking as all participants will receive one of the three cell doses. Phase II requires masking in order to evaluate treatment effect. Patients will randomized 2:1 to either the treatment or control groups.

Study Groups

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Study Treatment

Phase I of 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. The study treatment (active comparator) is comprised of left ventricular catheterization and treatment with allogeneic hMSC using the Helix transendocardial delivery catheter.

Group Type ACTIVE_COMPARATOR

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

Intervention Type COMBINATION_PRODUCT

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

Control

In Phase II of the study, the control group will undergo left ventricular catheterization with introduction of an iliofemoral sheath but no introduction of the Helix transendocardial delivery catheter but no administration of allogeneic hMSC with the Helix transendocardial delivery catheter.

Group Type SHAM_COMPARATOR

Diagnostic Catheterization

Intervention Type DIAGNOSTIC_TEST

Left ventricular catheterization with no active therapy

Interventions

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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 (treatment)

Intervention Type COMBINATION_PRODUCT

Diagnostic Catheterization

Left ventricular catheterization with no active therapy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioCardia, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Pepine, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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05694

Identifier Type: -

Identifier Source: org_study_id