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Stem Cell Therapy

Stem Cell Therapy for Heart Failure

Phase 1

Waitlist Available

Led By Carl Pepine, MD

Research Sponsored by BioCardia, Inc.

Eligibility Criteria Checklist

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

Must have

New York Heart Association (NYHA) Class II or III

Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through month 12

Awards & highlights

Study Summary

This trial explores using stem cells to treat heart failure caused by lack of blood flow.

Who is the study for?

This trial is for people with chronic heart failure due to past heart attacks, who are on stable medications and have a left ventricular ejection fraction between 20% and 40%. They should be experiencing mild to moderate symptoms (NYHA Class II or III). Those with other serious medical conditions that could make the treatment unsafe cannot participate.Check my eligibility

What is being tested?

The study is testing CardiALLO™, which are special stem cells derived from bone marrow, as a potential treatment for chronic ischemic left ventricular dysfunction. These cells will be delivered directly into the heart muscle using a special catheter.See study design

What are the potential side effects?

Potential side effects may include reactions at the site of cell delivery, immune system responses to the foreign cells, or complications related to catheter use. The full range of side effects is not listed here but can vary based on individual patient response.

Eligibility Criteria

Inclusion Criteria

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

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My heart condition moderately affects my daily activities.

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I have heart issues due to a past heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through month 12

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

Treatment Details

Study Objectives

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

Primary outcome measures

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

Treatment-emergent serious adverse events

Secondary outcome measures

Major Adverse Cardiac Events (MACE)

Minnesota Living with Heart Failure Questionnaire

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation CohortExperimental Treatment1 Intervention

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. Prespecified DSMB review after each dose cohort of the Phase I, before moving to higher dose.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

BioCardia, Inc.Lead Sponsor

5 Previous Clinical Trials

747 Total Patients Enrolled

2 Trials studying Heart Failure

375 Patients Enrolled for Heart Failure

Carl Pepine, MDPrincipal InvestigatorUniversity of Florida

6 Previous Clinical Trials

216 Total Patients Enrolled

1 Trials studying Heart Failure

125 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

Are individuals over 85 being incorporated into the cohort of this trial?

"Complying with the criteria for this trial, individuals who wish to participate must be at least 21 years old and no older than 80."

Answered by AI

Is the Dose Escalation Cohort process a safe one for participants?

"Our team at Power has given Dose Escalation Cohort a safety rating of 1, as this is still in the initial testing phase and there are only preliminary findings regarding its efficacy."

Answered by AI

Are researchers currently seeking volunteers for this research endeavor?

"According to clinicaltrials.gov, this trial is not actively recruiting participants at the moment. The initial post was made on September 1st 2023 and edited for the last time on September 6th of that same year. Although no longer enrolling patients itself, there are currently 728 other trials searching for candidates."

Answered by AI

Who meets the criteria to join this clinical exploration?

"From a cohort of 21 to 80 year olds, this trial is recruiting 9 people suffering from heart failure. To be admitted into the study, patients must meet further requirements such as being diagnosed with chronic left ventricular dysfunction caused by myocardial infarction and having Left Ventricle Ejection Fraction between 20% and 40%. Furthermore they should already have commited themselves to relevant medical therapies or equipment used in their treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (CardiALLO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05925608.