CellProthera, a regenerative cell therapy company, has announced the start of the PERFECT study, a long-term observational follow-up of patients from the Phase I/IIb EXCELLENT trial who received ProtheraCytes after experiencing a severe heart attack. The study aims to demonstrate the sustained safety and efficacy of ProtheraCytes in regenerating and repairing cardiac tissue following acute myocardial infarction (AMI), in conjunction with optimal standard of care.
Evaluating Long-Term Impact of ProtheraCytes
The PERFECT study will monitor the progression of biological markers, including NT-proBNP, and assess the clinical status of patients over a 10-year period. This data will be compared with that of patients who received standard of care. The EXCELLENT trial, which preceded this observational study, indicated that ProtheraCytes had the ability to repair and regenerate heart tissue, showing positive changes in prognostic markers such as infarct size, left ventricular dimensions, and NT-proBNP levels, suggesting an anti-remodeling effect.
Matthieu de Kalbermatten, CEO of CellProthera, stated, "We look forward to the clinical data of this long-term follow-up study. After demonstrating very promising improvements in the efficacy endpoints at six months, suggesting our therapy’s ability to act against adverse left ventricular remodeling, we are eager to analyze its impact on the long-term clinical outcome of the patients. This is precious information that will strengthen the body of evidence in favor of our drug candidate."
Addressing Unmet Needs in AMI Treatment
Despite advancements in standard of care, the mortality rate from ischemic heart failure and other complications within the first year following an AMI remains significant, ranging from 5% to 10%. ProtheraCytes offer a potential solution by enhancing revascularization, controlling inflammation, preventing cell death, and promoting heart cell regeneration, thereby facilitating the repair of damaged heart tissue.
Study Locations and Expert Insights
The PERFECT study is being conducted across 10 clinical centers in France and the UK, including University Hospitals of Toulouse-Rangueil, Montpellier, Bordeaux, and Dijon, as well as general hospitals like Jacques Cartier in Massy and Mulhouse Ghrmsa. Additional participating institutions include the Royal Infirmary of Edinburgh, St Barts Hospital in London, Queen Elizabeth University Hospital of Birmingham, and Dundee Hospital, pending regulatory approval.
Professor Jerome Roncalli, Professor of Cardiology at CHU de Toulouse and Vice President of the Fédération Française de Cardiologie, noted, "The patients we enrolled in the EXCELLENT trial had prognostic risk factors for developing severe heart failure symptoms in the years following acute myocardial infarction. Therefore, we are naturally interested in the long-term follow-up of these patients in order to observe the effect of ProtheraCytes on the progress of their health status. I can’t wait to see the results, which I hope will be positive given the results observed at six months."
Future Directions
CellProthera plans to advance the clinical development of ProtheraCytes cell therapy for acute myocardial infarction by initiating a Phase III study involving a larger patient cohort.
