Phase 3 Recruiting NCT06112233

VeriCel CardioCell therapy for refractory coronary artery disease

VeriCel Therapeutics · Interventional, Randomized 2:1 · n=240

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Medicine Coronary Artery Disease

Overview

CardioCell is an autologous cell-therapy product designed to promote myocardial regeneration in patients with refractory angina due to severe coronary artery disease who have exhausted standard treatment options. This study evaluates safety and angina relief at six and twelve months post-injection.

Full record on ClinicalTrials.gov (NCT ID NCT06112233).

Eligibility

Inclusion criteria

- Age 45–80 years at screening - Diagnosis of CCS class III or IV angina despite maximally tolerated medical therapy - Documented coronary artery disease unsuitable for revascularization - Left ventricular ejection fraction ≥ 30%

Exclusion criteria

- Acute coronary syndrome within 90 days - Severe valvular heart disease requiring surgical intervention - Current malignancy under active treatment - Inability to undergo MRI imaging

Age range: 45–80 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase: Phase 3
Study type: Interventional
Allocation: Randomized 2:1
Masking: Triple-blind (participant, investigator, outcomes assessor)
Intervention model: Parallel assignment
Primary purpose: Treatment
Enrollment target: 240 participants
Started: February 2025
Estimated completion: December 2028

Outcome measures

Primary endpoint

Change in weekly angina frequency at month 6

Secondary endpoints

- Change in Seattle Angina Questionnaire score - Exercise tolerance via 6-minute walk test - Major adverse cardiac events at month 12

Locations & contacts

Showing 4 of 4 sites

4 sites currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

Cleveland Clinic — Cleveland, OH

Principal Investigator: A. Marc Gillinov, MD · Status: Recruiting

Mount Sinai Heart — New York, NY

Principal Investigator: Valentin Fuster, MD · Status: Recruiting

Texas Heart Institute — Houston, TX

Principal Investigator: James T. Willerson, MD · Status: Recruiting

Cedars-Sinai Heart Institute — Los Angeles, CA

Principal Investigator: Eduardo Marbán, MD · Status: Recruiting

Sources

REG

ClinicalTrials.gov — NCT06112233

Trial registry · primary record