CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

NCT03455725 · tracked via the Priya Life Science USA tracker

Sponsor

BioCardia, Inc.

Phase

Not applicable

Started

2021-06-30

Last updated

2026-01-06

Condition(s) studied

Refractory AnginaChronic Myocardial Ischemia

Investigational drug(s) / intervention(s)

CardiAMP Cell Therapy SystemSham Treatment

CardiAMP Cell Therapy System: The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters.

Sham Treatment: Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed

Study summary

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment

Treatment Group:

Subjects treated with aBMC using the CardiAMP cell therapy system

Sham Control Group:

Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Eligibility

Sex

ALL

Min age

21 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Male or female 21 to 80 years of age 2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina. 3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs. 4. Evidence of inducible myocardial ischemia on baseline stress testing 5. Obstructive coronary disease unsuitable for conventional revascularization 6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period). 7. Able to complete an exercise tolerance test on the treadmill 8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography. 9. Qualification of a pre-procedure screening of bone-marrow aspiration Exclusion Criteria Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Primary outcome measure(s)

Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol — Baseline and 6 months visit
A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).

Trial sites (2)

Facility	City	Region	Status
University of Florida	Gainesville	Florida
University of Wisconsin Madison	Madison	Wisconsin

More BioCardia, Inc. trials in the USA

Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells Active, not recruiting

CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction Recruiting

Other trials for the same condition

Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina. Recruiting

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03455725 on ClinicalTrials.gov ↗ ← All trials in the USA