Congestive Heart Failure (CHF)
Congestive heart failure (CHF) is a progressive disease that affects around 5.8 million Americans, according to the American Heart Association (AHA), and an estimated 21 million people worldwide. Current treatment options for advanced heart failure are limited to left ventricular assist devices (LVAD) or cardiac transplant, with only a limited number of patients with severe heart failure considered for cardiac transplantation. There is a significant unmet need for new treatment options beyond the standard of care for patients with late stage heart failure.
The development of therapies to improve the survival rates of patients with heart failure is limited by the heart’s inability to substantially regenerate itself. Cell-based therapies for the repair of damaged cardiac tissue provide a promising treatment option.
Myoblast Program
ACT’s myoblast treatment may prove particularly beneficial for patients who have experienced a serious heart attack and are at risk for heart failure. The myoblast program for the treatment of heart failure uses autologous myoblasts – adult stem cells derived from the patients’ skeletal muscles – to attenuate cardiac remodeling and improve cardiac regeneration.
Clinical Development
ACT has successfully completed four Phase 1 safety trials with 40 patients. The controlled, randomized clinical trials investigated the treatment with catheter-delivered muscle stem cells in stage III-V heart failure patients. The data confirmed safety and showed improvements in:
ACT is now cleared by the FDA to commence with a Phase 2 clinical trial, which will be designed as a double blind, placebo controlled trial for 80 CHF late-stage patients who have no access to heart transplant treatment.
Pipeline