Biocardia ((BCDA)) announced an update on their ongoing clinical study.
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BioCardia, Inc. is conducting a Phase I/II clinical trial titled ‘Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF).’ The study aims to evaluate the safety and efficacy of using allogenic bone marrow-derived mesenchymal stem cells to treat ischemic heart failure with reduced ejection fraction, a condition characterized by the heart’s inability to pump blood efficiently. This research is significant as it explores a novel therapeutic approach for a condition with limited treatment options.
The intervention being tested is the CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs), delivered using the Helix transendocardial delivery catheter. This combination product is intended to improve heart function in patients with ischemic HFrEF.
The study is interventional, with a randomized allocation and a parallel intervention model. Phase I involves a dose escalation study to identify the optimal dose, while Phase II is a randomized, controlled trial with double masking to assess treatment efficacy. The primary purpose is treatment-focused, aiming to improve patient outcomes.
The study began on June 22, 2023, with an estimated primary completion date in December 2024. These dates are crucial as they guide investors on the timeline for potential results and subsequent market actions.
The clinical study update from BioCardia could positively influence the company’s stock performance and investor sentiment, particularly if the trial results are favorable. This development is noteworthy in the competitive landscape of heart failure treatments, where innovative solutions are highly sought after.
The study is ongoing, and further details are available on the ClinicalTrials portal.