Biocardia ((BCDA)) announced an update on their ongoing clinical study.
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BioCardia’s CardiAMP Heart Failure II Trial is a pivotal study aimed at assessing the safety and efficacy of the CardiAMP cell therapy system in patients with ischemic heart failure. Officially titled ‘Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial,’ the study seeks to provide therapeutic benefits for those suffering from reduced ejection fraction due to ischemic heart failure.
The intervention being tested is the CardiAMP cell therapy system, which involves the use of autologous bone marrow mononuclear cells (ABM MNC). These cells are harvested from the patient’s bone marrow, processed, and delivered directly to the heart to potentially improve cardiac function.
This interventional study is designed as a randomized, controlled trial with a parallel intervention model. It employs a quadruple masking approach, ensuring that participants, care providers, investigators, and outcomes assessors are blinded. The primary purpose of the study is treatment-focused, comparing the CardiAMP cell therapy system to a sham control procedure.
The study began on February 6, 2024, with the latest update submitted on August 7, 2025. These dates are crucial as they mark the progression and current status of the trial, which is still recruiting participants.
This clinical update could positively influence BioCardia’s stock performance and investor sentiment, as successful outcomes may enhance the company’s market position in the treatment of ischemic heart failure. Competitors in the regenerative medicine space will be closely monitoring these developments.
The CardiAMP Heart Failure II Trial is ongoing, with further details accessible on the ClinicalTrials portal.