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

NCT05925608 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 05694
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent serious adverse events

  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.

• Composite endpoint consisting of all cause or cardiac death, non-fatal cardiac-related hospitalizations and functional capacity measured using the 6 minute walk distance.

  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.

  Through Month 12

Secondary Outcomes (3)

• Overall survival

  Through 12 months

• Major Adverse Cardiac Events (MACE)

  Through 12 months

• Minnesota Living with Heart Failure Questionnaire

  Through 12 months

Study Arms (2)

Study Treatment

ACTIVE COMPARATOR

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.

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

Control

SHAM COMPARATOR

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.

Diagnostic Test: Diagnostic Catheterization

Interventions

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)

Study Treatment

Diagnostic Catheterization DIAGNOSTIC_TEST

Left ventricular catheterization with no active therapy

Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• BioCardia, Inc.: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 36210, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carl Pepine, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 29, 2023
• Study Start: August 23, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)