CellProthera Begins PERFECT Observational Study of ProtheraCytes Cell Therapy for AMI Patients

August 15, 2024—CellProthera, a France-based regenerative cell therapy company developing treatments for ischemic diseases, recently announced the commencement of the PERFECT study that will be conducted at 10 clinical centers across France and the United Kingdom.

According to CellProthera, PERFECT is a long-term follow-up observational study that is expected to demonstrate the long-term safety and efficacy of ProtheraCytes cell therapy for the regeneration and repair of cardiac tissue acute myocardial infarction (AMI) on top of optimal standard of care. PERFECT will be composed of the patients enrolled in the phase 1/2b EXCELLENT trial who received ProtheraCytes after acute AMI.

The investigators will monitor the progression of biological markers, such as NT-proBNP, and evaluate the patient’s clinical status over 10 years. These findings will then be compared with data from patients having received standard of care.

The next steps for the company will be to continue the clinical trial development of ProtheraCytes cell therapy in acute myocardial infarction by conducting a phase 3 study with a larger cohort, advised CellProthera in the press release.

“The patients we enrolled in the EXCELLENT trial had prognostic risk factors for developing severe heart failure symptoms in the years following AMI,” commented Professor Jerome Roncalli, MD, in CellProthera’s press release. “Therefore, we are naturally interested in the long-term follow-up of these patients 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 6 months.” Prof. Roncalli, who serves as Vice President of the Fédération Française de Cardiologie, is Professor of Cardiology at CHU de Toulouse, France.

In July 2024, CellProthera and its investigational partner BioCardia, Inc. announced the findings from EXCELLENT, the companies’ collaborative trial. Previously, CellProthera announced the presentation of the EXCELLENT results by Faiez Zannad, MD, chairman of the study’s steering committee, at the European Society of Cardiology’s Heart Failure 2024 conference held May 11-14 in Lisbon, Portugal.

In the EXCELLENT trial, the ability of ProtheraCytes to repair and regenerate heart tissue was observed with positive changes in prognostic markers including infarct size, left ventricular dimensions, and NT-proBNP level, supporting the cell therapy’s antiremodeling effect, stated the company.

CellProthera developed a GMP-compliant cell expansion process and an automation technology for in vitro production of large quantities of purified, CD34+ stem cells. The company’s lead product, ProtheraCytes, is an autologous cell therapy developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicines Agency. CellProthera’s technology platform includes the StemXpand automated expansion device and the StemPack disposable kit.