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CardiAMP™ Cell Therapy for Heart Failure Trial

NCT02438306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.

Conditions

  • Heart Failure, Systolic

Interventions

BIOLOGICAL

Autologous cell therapy

Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.

OTHER

Sham

An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.

Sponsors & Collaborators

  • BioCardia, Inc.

    lead INDUSTRY

Principal Investigators

  • Carl Pepine, MD · University of Florida

  • Amish Raval, MD · University of Wisconsin, Madison

  • Duncan Stewart, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2025-02-28
Completion
2025-06-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438306 on ClinicalTrials.gov