What is the clinical evidence from this study?

Study design: RCT. Population: Heart failure post-myocardial infarction (porcine model) (n=29). Intervention: Cardiospheres or cardiosphere-derived cells (CDCs) vs. Placebo. Primary outcome: Ejection fraction at 8 weeks (p=0.01).

What question did this study set out to answer?

Evaluate the safety and efficacy of direct intramyocardial injection of autologous cardiosphere-derived cells versus cardiospheres in a mini-pig model of heart failure following myocardial infarction.

August 23, 2026Journal of the American College of CardiologyOpen Access

Intramyocardial Injection of Autologous Cardiospheres or Cardiosphere-Derived Cells Preserves Function and Minimizes Adverse Ventricular Remodeling in Pigs With Heart Failure Post-Myocardial Infarction

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Key result

Cardiospheres or CDCs improve ejection fraction over placebo in preclinical ischemic cardiomyopathy.

P=0.01
n=29

Why the study?

Intramyocardial injection of cardiosphere-derived cells or cardiospheres has not been assessed in large animal models of heart failure after myocardial infarction.

Does intramyocardial injection of autologous cardiospheres or CDCs improve ejection fraction and ventricular remodeling in a mini-pig model of heart failure post-myocardial infarction?

Comparison

Intramyocardial injection of autologous cardiospheres or CDCs vs placebo

Design

Randomized controlled trial in mini-pigs

Follow-up

8 weeks

Authors

SLShuo-Tsan LeeCedars-Sinai Smidt Heart Institute AWAnthony J. WhiteGloucestershire Hospitals NHS Foundation Trust SMSatoshi MatsushitaJuntendo University

Discussion

Member takes

Implication

Intramyocardial injection of autologous cardiospheres or CDCs is safe and preserves ventricular function in a porcine model of ischemic cardiomyopathy, with cardiospheres showing superior effects on hemodynamics and remodeling.

Key Points

Evaluate the safety and efficacy of direct intramyocardial injection of autologous cardiosphere-derived cells versus cardiospheres in a mini-pig model of heart failure following myocardial infarction.
Mini-pigs were randomly allocated 4 weeks after anteroseptal myocardial infarction to receive direct intramyocardial injections of placebo (n = 11), autologous cardiospheres (n = 8), or autologous cardiosphere-derived cells (n = 10) across 20 peri-infarct sites (0.5 million cells/site).
Functional echocardiographic, hemodynamic, and electrophysiologic evaluations were conducted at baseline and 8 weeks post-injection, followed by terminal tissue collection for histopathology.
Ejection fraction at 8 weeks post-treatment was significantly higher than placebo in both the cardiosphere-derived cell group (p = 0.01) and the cardiosphere group (p = 0.01).
Cardiospheres induced disproportionate improvements in echocardiographic and hemodynamic indexes and attenuated adverse ventricular remodeling more effectively than cardiosphere-derived cells.
Electrophysiologic testing revealed no significant differences in arrhythmogenicity among groups, and no tumor formation was observed.

Study Design

Type

RCT (n=29)

Randomization

randomly allocated

Structured PICO

Does intramyocardial injection of autologous cardiospheres or CDCs improve ejection fraction and ventricular remodeling in a mini-pig model of heart failure post-myocardial infarction?

Population

29 mini-pigs with heart failure 4 weeks post-myocardial infarction, followed for 8 weeks.

Intervention

Intramyocardial injection of autologous cardiospheres (n=8) or cardiosphere-derived cells (CDCs) (n=10) (0.5 million cells/site across 20 peri-infarct sites) 4 weeks post-myocardial infarction

Comparator

Placebo injection (n=11)

Outcome

Ejection fraction at 8 weeks post-injectionsurrogate

Main Result

p-value: p=0.01

Cite This Study

Lee et al. (2011) conducted an RCT in Heart failure post-myocardial infarction (porcine model) (n=29). Cardiospheres or cardiosphere-derived cells (CDCs) vs. Placebo was evaluated on Ejection fraction at 8 weeks (p=0.01). Intramyocardial injection of cardiospheres or CDCs improved ejection fraction at 8 weeks compared to placebo (p=0.01 for both) in a porcine model of ischemic cardiomyopathy.

synapsesocial.com/papers/6a8a669d5416a23081b2e35e https://doi.org/10.1016/j.jacc.2010.07.049

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Intramyocardial Injection of Autologous Cardiospheres or Cardiosphere-Derived Cells Preserves Function and Minimizes Adverse Ventricular Remodeling in Pigs With Heart Failure Post-Myocardial Infarction

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Intramyocardial Injection of Autologous Cardiospheres or Cardiosphere-Derived Cells Preserves Function and Minimizes Adverse Ventricular Remodeling in Pigs With Heart Failure Post-Myocardial Infarction

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

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