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Updated: Mar 12, 2026
Intramyocardial Cell Delivery: Observations in Murine Hearts
Published on: January 24, 2014
PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of
Arshed A Quyyumi1, Alejandro Vasquez2, Dean J Kereiakes2
1From the Emory Clinical Cardiovascular Research Institute, Cardiology Division, Emory University School of Medicine, Atlanta, GA (A.A.Q., J.P.); Athens Regional Cardiology, GA (J.P.); Division of Cardiology, Huntsville Hospital, Huntsville, AL (A.V.); The Christ Hospital Heart and Vascular Center, Cincinnati, OH (D.J.K.); Rutgers University, New Jersey Medical School, Newark (M.K.); Division of Cardiology, Rush University Medical Center, Chicago, IL (G.L.S.); Department of Medicine, Division of Cardiology, University of Kentucky, Lexington (A.A.-L.); Emory St. Joseph's Hospital, Atlanta, GA (S.F.); Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.); Scripps Health, La Jolla, CA (R.A.S.); Heart Sciences Center, Gilbert, AZ (N.D.); University of Pittsburgh Medical Center, PA (C.T.); Bluhm Cardiovascular Institute Northwestern Memorial Hospital, Chicago, IL (C.J.D.); Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (G.W.B.); Cardiovascular Medicine, University of Southern California, Los Angeles, CA (D.M.S.); Westchester Heart and Vascular, Westchester Medical Center, Valhalla, NY (M.C.); Caladrius Biosciences Inc, Basking Ridge, NJ (T.M., P.H., A.M.K., V.D., A.C., C.J., R.A.P., R.L.S., D.J.M., A.P., D.W.L.); and PCT, LLC, A Caladrius Company, Allendale, NJ (R.A.P.). aquyyumi@emory.edu.
Insights
Autologous CD34+ cell therapy shows potential safety and efficacy for heart attack patients with left ventricular dysfunction. This largest US study suggests benefits in ejection fraction and survival, warranting further investigation.
Area of Science:
- Cardiovascular Medicine
- Regenerative Medicine
- Cell Therapy
Background:
- ST-segment-elevation myocardial infarction (STEMI) survivors face risks of infarct expansion, heart failure, and mortality despite immediate treatment.
- Left ventricular dysfunction post-STEMI necessitates innovative therapeutic strategies to improve patient outcomes.
Purpose of the Study:
- To evaluate the safety and bioactivity of autologous CD34+ cell intracoronary infusion in patients with left ventricular dysfunction following STEMI.
- To assess the impact of cell therapy on myocardial perfusion and cardiac function in STEMI patients.
Main Methods:
- A Phase 2, randomized, double-blind, placebo-controlled trial (PreSERVE-AMI) enrolled 161 patients with STEMI and ejection fraction ≤48%.
- Participants received either autologous CD34+ cells or a placebo via intracoronary infusion.
- Primary endpoints included safety (adverse events) and efficacy (myocardial perfusion); secondary analyses examined left ventricular ejection fraction, infarct size, and survival.
Main Results:
- No significant differences in myocardial perfusion or adverse events were observed between the CD34+ cell and placebo groups at 6 months.
- Both groups showed increased myocardial perfusion from baseline to 6 months.
- Secondary analyses revealed a dose-dependent favorable effect of CD34+ cells on left ventricular ejection fraction, infarct size, and survival, particularly when adjusted for ischemia time. No deaths occurred in the treatment group at 1 year compared to 3.6% in the control group.
Conclusions:
- The study provides evidence supporting the safety of autologous CD34+ cell therapy in STEMI patients with left ventricular dysfunction.
- Potential efficacy was suggested by secondary analyses, indicating benefits in cardiac function and survival.
- This trial represents the largest US study of cell-based therapy for STEMI, supporting its potential role in managing high-risk patients.
Rationale:
Despite direct immediate intervention and therapy, ST-segment-elevation myocardial infarction (STEMI) victims remain at risk for infarct expansion, heart failure, reinfarction, repeat revascularization, and death.
Objective:
To evaluate the safety and bioactivity of autologous CD34+ cell (CLBS10) intracoronary infusion in patients with left ventricular dysfunction post STEMI.
Methods And Results:
Patients who underwent successful stenting for STEMI and had left ventricular dysfunction (ejection fraction≤48%) ≥4 days poststent were eligible for enrollment. Subjects (N=161) underwent mini bone marrow harvest and were randomized 1:1 to receive (1) autologous CD34+ cells (minimum 10 mol/L±20% cells; N=78) or (2) diluent alone (N=83), via intracoronary infusion. The primary safety end point was adverse events, serious adverse events, and major adverse cardiac event. The primary efficacy end point was change in resting myocardial perfusion over 6 months. No differences in myocardial perfusion or adverse events were observed between the control and treatment groups, although increased perfusion was observed within each group from baseline to 6 months (P<0.001). In secondary analyses, when adjusted for time of ischemia, a consistently favorable cell dose-dependent effect was observed in the change in left ventricular ejection fraction and infarct size, and the duration of time subjects was alive and out of hospital (P=0.05). At 1 year, 3.6% (N=3) and 0% deaths were observed in the control and treatment group, respectively.
Conclusions:
This PreSERVE-AMI (Phase 2, randomized, double-blind, placebo-controlled trial) represents the largest study of cell-based therapy for STEMI completed in the United States and provides evidence supporting safety and potential efficacy in patients with left ventricular dysfunction post STEMI who are at risk for death and major morbidity.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01495364.
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