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Cell Therapy

CardiAMP Cell Therapy for Chronic Myocardial Ischemia (CardiAMP CMI Trial)

N/A

Recruiting

Research Sponsored by BioCardia, Inc.

Eligibility Criteria Checklist

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

Must have

Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs

Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at 12 months follow-up

Awards & highlights

CardiAMP CMI Trial Summary

This trial is studying whether a certain cell therapy system can help improve heart function in people with heart failure. The trial will compare the effects of the cell therapy system to a sham (fake) treatment.

Who is the study for?

This trial is for adults aged 21-80 with chronic refractory angina, who experience frequent angina episodes despite maximum medication. They must have a heart's left ventricular ejection fraction ≥40%, inducible myocardial ischemia, and coronary disease not suitable for standard treatment. Excludes those with other significant health issues.Check my eligibility

What is being tested?

The study compares the CardiAMP cell therapy system (a bone marrow cell therapy) to a sham treatment in managing chronic myocardial ischemia and angina. Participants are randomly assigned in a 2:1 ratio to either receive the real treatment or a sham procedure without actual therapy.See study design

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include reactions at the bone marrow aspiration site, complications from catheter insertion during delivery of cells or placebo, and general risks associated with invasive cardiac procedures.

CardiAMP CMI Trial Eligibility Criteria

Inclusion Criteria

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

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My chest pain is not controlled despite taking the highest safe doses of my medication.

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I have severe chest pain that doesn't improve with regular treatments.

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My heart's arteries are blocked and can't be fixed with usual procedures.

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I experience chest pain episodes at least 7 times a week.

CardiAMP CMI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at 12 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at 12 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 12 months follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol

Secondary outcome measures

Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up

Efficacy: Change of Angina Frequency (per week) at 6 months follow-up

Efficacy: Change of angina frequency (per week) at 12 months follow-up

+4 more

CardiAMP CMI Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CardiAMP cell therapy systemActive Control1 Intervention

Roll-in phase: Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system.

Group II: Sham procedure controlPlacebo Group1 Intervention

Randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioCardia, Inc.Lead Sponsor

5 Previous Clinical Trials

413 Total Patients Enrolled

Media Library

CardiAMP Cell Therapy System (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03455725 — N/A

Frequently Asked Questions

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

What is the participant capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov has published that this clinical trial is currently enrolling participants; it was posted on June 30th 2021 and updated most recently on September 30th, 2021. 343 individuals need to be registered from 1 medical facility."

Answered by AI

Does this experimental treatment accept geriatric participants?

"To be included in this research, patients must range from 21 to 80 years of age. There are 50 studies for minors and 886 trials catering toward seniors."

Answered by AI

Who is eligible to partake in this scientific evaluation?

"This clinical trial is seeking 343 individuals aged 21 to 80 that suffer from myocardial ischaemia. Applicants must evidence a lack of control of angina symptoms even under maximal anti-anginal drug treatment and have at least 7 episodes of chest pain per week throughout the 4-week qualifying period. Additionally, they should possess obstructive coronary disease precluding traditional revascularization procedures."

Answered by AI

Does this experiment currently have any open enrollment opportunities?

"According to clinicaltrials.gov, this medical research is currently accepting participants. Initially posted on June 30th 2021, the study was recently refreshed in September of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

2021. "CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03455725.