CellProthera expands clinical trial sites for phase IIb myocardial infarction study

CellProthera expands clinical trial sites for phase IIb myocardial infarction study

Expansion will further accelerate recruitment for trial to conclude and prepare sites for phase III study

Mulhouse, France, December 14, 2022 – CellProthera, a regenerative cell therapy developer specializing in cardiology and myocardial infarction, today announces it has added another major investigational center, St Bartholomew’s Hospital, London, UK, for its phase I/IIb ‘EXCELLENT’ clinical trial.

The CellProthera EXCELLENT (Expanded Cell Endocardiac Transplantation) multicentric, randomized, controlled phase I/IIb clinical trial is evaluating CellProthera’s lead advanced therapy medicinal product (ATMP), ProtheraCytes(R), in targeting regeneration of the cardiac tissue after severe Acute Myocardial Infarction (AMI) to prevent heart failure. ProtheraCytes has been developed as a one shot minimal invasive autologous ATMP cell therapy to improve the quality of life of post-AMI patients who have no therapeutic solution to restore the heart’s function, and to reduce ongoing hospitalizations and invasive medical treatments such as heart transplants. CellProthera is currently evaluating the feasibility of applying ProtheraCytes to other cardiovascular diseases, including ischemic strokes and refractory angina.

“The regeneration of damaged heart tissue after severe AMI to prevent heart failure is an unmet medical need suffered by over a million patients per year in just the US, Europe and Japan. Developing a minimally invasive therapy to improve the lives of so many patients as quickly as possible, and avoid heart transplants, is critical,” said Matthieu de Kalbermatten, CEO, CellProthera. “Adding St Bartholomew's Hospital as an internationally renowned center for cardiovascular disease will enable CellProthera to further accelerate the final stage of recruitment, complete the phase I/IIb trial and report results in the second half of 2023.”

A major reason CellProthera selected St Bartholomew’s Hospital is to include one of the leading heart centers in the UK, leveraging on the unique expertise of Professor Anthony Mathur and his research team. Professor Mathur and his team have extensive experience and a significant number of publications on the use of cell therapies for the treatment of cardiovascular diseases.

CellProthera has added St Bartholomew’s Hospital as a clinical investigation center for the recruitment and treatment of patients in addition to four leading heart centers in the UK, located in Edinburgh, Birmingham, Dundee and Leeds, as well as seven additional centers in France. CellProthera appointed the Newcastle Centre for Life’s GMP cell therapy center to produce the ATMP for the phase I/IIb trial.

The EXCELLENT phase I/IIb trial has enrolled over three quarters of patients. The final read-out is expected as early as in the second half of 2023. Upon completion of the phase I/IIb trial, a pivotal phase III trial will take place aiming for potential market authorization in 2025.