The randomized, placebo-controlled 60-patient Phase 2 trial compared the safety and efficacy of three doses of Revascor™ on top of maximal approved therapies versus maximal therapies alone in patients with moderate-to-severe congestive heart failure (CHF) defined by New York Heart Association (NYHA) class II or III status and ejection fraction below 40%. The trial enrolled both ischemic and non-ischemic heart failure patients. Heart failure patients with this degree of severity are known to have a high cardiac mortality over a 12-24 month period despite being on maximal approved drug and device therapies.
Treatment with MPCs was well-tolerated, with 13% of patients developing transient or persistent anti-donor antibodies which were without clinical consequence. Over a 22-month mean follow-up period, only 1/45 (2%) patients who received a single injection of Revascor™ died of cardiac causes compared with 3/15 (20%) controls (p=0.02). In addition, MPC treatment significantly delayed the time to a first Major Adverse Cardiac Event, MACE, a composite of cardiac death, heart attack or revascularization procedures (p=0.036), and reduced the overall risk for MACE by 78% (p=0.011).
Over a mean follow-up of 18 months, 0/15 patients who received the highest dose of MPC (150M) had been hospitalized for heart failure or had died. In contrast, 3/15 (20%) controls and 6/30 (20%) patients who received low (25M) or mid (75M) doses of MPC had either been hospitalized with heart failure or had died. This clinical improvement associated with the 150M dose was accompanied by evidence of cardiac remodelling (reduction in left ventricular end systolic volumes compared with controls
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