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NCT05925608 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Heart Failure, Systolic, sponsored by BioCardia.

Active
Registry status
Phase 1
Development phase
39
Enrollment target
1
Study location

NCT05925608 is a Phase 1 study of Heart Failure, Systolic that is active but no longer recruiting, run by BioCardia. The registered enrollment target is 39 participants, below the 333-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05925608, a Phase 1 study of Heart Failure, Systolic, is active but no longer recruiting, sponsored by BioCardia.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
39 participants
Enrollment target
1
Study location

Study 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 Studied

Heart Failure, Systolic

Interventions

  • COMBINATION_PRODUCT CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs)
  • DIAGNOSTIC_TEST Diagnostic Catheterization

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2023-08-23
Est. Completion 2027-12
Phase Phase 1

Sponsor

BioCardia

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05925608

The ClinicalTrials.gov registry entry for NCT05925608 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 333-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (88% lower). The listed sponsor is BioCardia, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure, Systolic appearing as the primary indexed condition, and to 2 interventions - of which CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) is the first listed.

NCT05925608 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT05925608 about?

NCT05925608 is a clinical study titled "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.

What is the current status of trial NCT05925608?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2023-08-23. Estimated completion is 2027-12.

What conditions does trial NCT05925608 study?

This clinical trial studies the following conditions: Heart Failure, Systolic.

What interventions are being tested in trial NCT05925608?

The interventions under investigation include: CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) (COMBINATION_PRODUCT), Diagnostic Catheterization (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05925608?

This trial is sponsored by BioCardia, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05925608 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.