CellProthera is set to begin a Phase III study exploring the potential of its stem cell therapy in patients with heart failure post-myocardial infarction in Q1 2027, the biotech’s CEO, Matthieu de Kalbermatten, tells Clinical Trials Arena.
For this study, CellProthera hopes to enrol between 300 and 400 patients at around 50 sites across the US and Europe – though the company is also looking into running a part of the study in an Asian country too. According to Kalbermatten, the trial will follow a protocol design prepared with key opinion leaders (KOLs) in the heart failure and post-myocardial infarction space, which has already got “positive feedback” from US regulators.
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The trial will assess the efficacy and safety of CellProthera’s ProtheraCytes, which are designed to repair, protect and promote the regeneration and revascularisation of damaged cardiac tissue without the need for immunosuppressants. The therapy was also created to reduce the level of scar tissue formation on the heart, Kalbermatten says. This can help stop the organ’s expansion, while allowing the previously damaged tissue to become contractile again.
According to Kalbermatten, a treatment option like this could be particularly beneficial for the 5-10% of patients who experience extensive cardiac tissue damage post-heart attack due to a delay in receiving treatment. “These cells should be able to protect the tissue that’s about to die by promoting its regeneration, as well as its revascularisation,” Kalbermatten comments.
Catheter to allow precision stem cell delivery
For the ProtheraCytes to exhibit their therapeutic effect, they must be administered to the right location. To achieve this, CellProthera recently bought the rights to a transendocardial catheter from Celyad Oncology, which will facilitate the direct delivery of the CD34+ stem cells to the damaged cardiac tissue in the Phase III study.
While this will add a layer of complexity to CellProthera’s regulatory proceedings, Kalbermatten noted that the catheter constitutes a “highly important” part of the trial. “The transendocardial catheter will allow us to precisely and accurately inject the stem cells around the scar of the heart,” he said.
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By GlobalDataIf CellProthera were to secure regulatory approval for its ProtheraCytes, Kalbermatten noted that the catheter would be part of the therapy’s final approval – though the company will need to obtain a CE mark for the catheter first.
As this novel catheter is not routinely used when treating heart failure, CellProthera is planning to fully train operators on how to use the medical device before it is applied in the clinical or commercial setting.
Internalised automation to drive stem cell manufacturing scale-out
While stem cell therapies are increasingly garnering attention across the pharmaceutical landscape, Kalbermatten acknowledges that this type of medicine can be operationally challenging and expensive to produce at scale.
To overcome this hurdle, CellProthera is incorporating automation, which Kalbermatten says will allow the company to produce several batches in parallel.
If its stem cells were to secure regulatory approval, Kalbermatten says CellProthera plans to follow a scale-out model, in which the company would develop a “completely closed” system incorporating robotics to bring down production costs and streamline the manufacturing process.
While several cell therapy companies rely on contract development and manufacturing organisations (CDMOs) to craft their cell therapies, Kalbermatten notes that he wants CellProthera to take a self-sufficient approach by internalising all manufacturing efforts.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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