News | Cardiovascular Clinical Studies | July 10, 2024

CellProthera and BioCardia Collaborate on Successful Phase II Trial of ProtheraCytes for the Treatment of Acute Myocardial Infarction

ProtheraCytes

July 10, 2024 — CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial infarction (AMI) led by CellProthera, as well as plans to continue the relationship into Phase III.

CellProthera’s clinical results from the Phase I/IIb EXCELLENT Trial, which studied the feasibility of transendocardial injection of ProtheraCytes for acute myocardial infarction when delivered in combination with the standard of care, suggested an effective solution for preventing heart failure progression in the patients at high risk following a heart attack.

The ProtheraCytes, which are autologous, expanded CD34+ stem cells, were well tolerated with no unexpected serious adverse events reported. Transendocardial administration of ProtheraCytes, performed utilizing the percutaneous catheter delivery system from BioCardia, was associated with improvements in multiple efficacy endpoints including a significant improvement of the viability of segments from baseline to six months, a consistent positive trend of improvement of LV volumes at six months, and a faster decrease in an important biomarker of heart failure, NTproBNP.

“The promising results of the study confirm the potential of our therapy to provide an effective one-off solution to prevent heart failure progression in AMI patients,” said Matthieu de Kalbermatten, CEO, CellProthera. “We are actively planning for what comes next and we have valued the responsiveness of the BioCardia team throughout the EXCELLENT trial in supporting training, attending clinical cases, and providing delivery systems. We have great learnings today that will enhance our efforts in what comes next, together.”

“The EXCELLENT trial has meaningful results for patient benefit using an approach that we feel makes enormous sense for locally administered high effective dosage of autologous CD34+ cells for these patients,” said Peter Altman, PhD, President and CEO of BioCardia. “I am personally impressed by their approach. It has been an honor to support CellProthera and we look forward to collaborating in the study to follow. We are ready for what comes next with enhancements to our delivery capabilities.”

For more information: www.cellprothera.com


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