First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients

Area of Science:

• Regenerative Medicine
• Cardiovascular Research
• Biomaterials Science

Background:

• Myocardial infarction (MI) frequently leads to left ventricular (LV) dysfunction.
• Current treatments for post-MI LV dysfunction have limitations.
• Novel therapeutic strategies are needed to improve cardiac repair and function.

Purpose of the Study:

• To evaluate the safety and feasibility of transendocardial injections of VentriGel, a cardiac extracellular matrix hydrogel.
• To assess VentriGel delivery in patients with moderate LV dysfunction post-MI.

Main Methods:

• A first-in-man study involving 15 patients with moderate LV dysfunction (25% ≤ LVEF ≤ 45%) between 60 days and 3 years post-MI.
• VentriGel was delivered via transendocardial injection in patients revascularized by percutaneous coronary intervention.
• Primary endpoints included monitoring adverse events and abnormal clinical laboratory results.

Main Results:

• The transendocardial injection of VentriGel was successfully delivered in all 15 patients.
• No major adverse events or significant abnormal clinical laboratory results were reported.
• The procedure demonstrated a favorable safety profile in the early stages of evaluation.

Conclusions:

• Transendocardial injection of VentriGel is a safe and feasible therapeutic approach for patients with post-MI LV dysfunction.
• These findings support further investigation of VentriGel in larger, randomized clinical trials for cardiac repair.
• VentriGel represents a promising novel therapy for myocardial regeneration and LV function improvement.