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Cell Therapy

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

N/A

Recruiting

Led By Amish Raval, MD

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 at 6 months follow-up

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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