26 Sep CellProthera completes enrollment in Phase I/IIB trial for post-myocardial infarction cell therapy
- Final patient receives ProtheraCytes® cell therapy to regenerate damaged heart tissue following severe heart attack
- Study remains on track for final readout in H1 2024
Mulhouse, France, September 20, 2023 – CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, today announces the last patient has enrolled and been treated in its EXCELLENT phase I/IIb clinical trial for its ProtheraCytes® autologous cell therapy, intended to prevent heart failure in patients following severe acute myocardial infarction (AMI). With this milestone, CellProthera remains on track for a full readout from the EXCELLENT (Expanded Cell Endocardiac Transplantation) trial by the first half of next year.
In total, 49 patients have enrolled in the trial across 13 sites in the UK and France, 33 of whom have been treated with CellProthera’s lead asset, ProtheraCytes. The cellular product is made by expanding each patient’s CD34+ stem cells, known for their ability to promote the formation of new blood vessels, and have previously been shown in a pilot study to prevent the need for a heart transplant in patients with heart failure following severe AMI.
In the EXCELLENT study, patients will be monitored for 6 months, and a final readout is expected in the first half of 2024. CellProthera is already preparing for a Phase III trial, which is expected to begin by the end of next year.
“The treatment of our final patient within the Phase II trial is a landmark moment, which brings us one step closer to improving the quality of many patients suffering the long-term effects after a heart attack. There are currently a third of a million patients with severely damaged heart tissues from AMI in the US, Europe and Japan alone. These patients have limited alternative therapeutic options and CellProthera’s therapy is first one-time curative solution,” said Matthieu de Kalbermatten, CEO, CellProthera. “With the progress of the trial to date, we can be confident in the lead up to the final readout, and look forward to the preparation of our next phase of clinical development.”
CellProthera partnered with BioCardia, Inc. to use the CE Marked Helical Infusion Catheter for transendocardial biotherapeutic delivery administration of ProtheraCytes in the EXCELLENT study. One specific reason for this was that the Helical Injection Catheter allows the safe injection of stem cells directly into the myocardium. BioCardia staff supported every clinical case and has been a solid partner. In February 2023, CellProthera and BioCardia extended the agreement and intend to work together to progress the collaboration past the completion of the EXCELLENT phase I/IIb trial.
About CellProthera: CellProthera is a regenerative cell therapy developer specializing in ischemic diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMPcompliant cell expansion process as well as a proprietary automation technology for in vitro production of a large quantity of purified, CD34+ stem cells. Its lead therapy, ProtheraCytes®, is an autologous cell therapy and has been developed for tissue reperfusion and salvage of various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicine Agency (EMA). CellProthera’s proprietary technology platform comprises an automated expansion device called StemXpand® and its disposable kit StemPack(R). CellProthera is headquartered in France and has 22 employees
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