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Autologous Cell Therapy

Cell Therapy for Heart Failure

Phase 3

Waitlist Available

Led By Duncan Stewart, MD

Research Sponsored by BioCardia, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria.

A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will compare a new cell therapy for heart failure to a sham treatment.

Who is the study for?

This trial is for people with chronic heart failure due to a past heart attack, who have a left ventricular ejection fraction between 20% and 40%, and are in NYHA Class II or III. They must be on stable heart failure medication for at least three months and pass a bone-marrow screening.Check my eligibility

What is being tested?

The study tests CardiAMP cell therapy against a sham (fake) procedure. It's blinded, meaning patients and evaluators don't know who gets the real treatment. The trial includes up to 10 initial subjects before full randomization.See study design

What are the potential side effects?

While specific side effects aren't listed here, autologous cell therapies like CardiAMP may cause immune reactions, infection risk at injection sites, bleeding or clotting issues, and potential impacts on other organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart's left side is weak due to a past heart attack.

Select...

I have heart issues due to a past heart attack.

Select...

My heart condition moderately affects my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis.

Secondary outcome measures

Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Survival

Time to first Major Adverse Cardiac Events (MACE)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CardiAMP cell therapyExperimental Treatment1 Intervention

Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.

Group II: Sham ComparatorPlacebo Group1 Intervention

Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioCardia, Inc.Lead Sponsor

5 Previous Clinical Trials

631 Total Patients Enrolled

2 Trials studying Heart Failure

259 Patients Enrolled for Heart Failure

Duncan Stewart, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation

Carl Pepine, MDPrincipal InvestigatorUniversity of Florida

6 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Heart Failure

9 Patients Enrolled for Heart Failure

Media Library

CardiAMP™ Cell Therapy (Autologous Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02438306 — Phase 3

Heart Failure Research Study Groups: CardiAMP cell therapy, Sham Comparator

Heart Failure Clinical Trial 2023: CardiAMP™ Cell Therapy Highlights & Side Effects. Trial Name: NCT02438306 — Phase 3

CardiAMP™ Cell Therapy (Autologous Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02438306 — Phase 3

Heart Failure Patient Testimony for trial: Trial Name: NCT02438306 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions for this clinical trial?

"Yes, this information is correct. The clinical trial in question was first posted on December 1st, 2016 and updated as recently as August 1st, 2022."

Answered by AI

Does the age limit for this study exclude individuals over 65 years old?

"Eligibility requirements for this specific trial state that patients must be aged 21 to 90. There are 24 other clinical trials available for minors and 723 different trials for seniors."

Answered by AI

Are multiple hospitals in Canada administering this trial?

"The principal clinical trial site is based in the Johns Hopkins University School of Medicine - Dept of Cardiology. Additionally, there are 29 other locations where this study is taking place, such as the Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics in Cleveland, Ohio and Cleveland Clinic in Ottawa, Ontario."

Answered by AI

Has the Autologous cell therapy treatment received FDA approval?

"There is some clinical evidence to support autologous cell therapy's efficacy, as well as numerous rounds of data confirming its safety. These characteristics warrant a score of 3 on our team's 1-to-3 scale."

Answered by AI

Who else is applying?

What state do they live in?

Michigan

Alabama

Texas

Other

How old are they?

18 - 65

What site did they apply to?

California Pacific Medical Center

MedStar Health Research Institute

Texas Heart Institute

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

While I have heart failure I do not have any other health issues. I feel that I would provide a great test subject with no comorbidities. I can travel to and from Baltimore with no problem and I have a flexible work schedule if needed.

PatientReceived 2+ prior treatments