An independent Data Safety Monitoring Board (DSMB) has recommended the continuation of BioCardia’s Phase I/II CardiALLO-HF trial as designed.
The decision comes after an assessment of 30-day safety data from subjects who were treated in the trial’s low-dose 20 million cell cohort.
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This data did not show any treatment-emergent adverse cardiac events or immune reactions to the implanted allogeneic cells.
Following the DSMB’s approval, BioCardia aims to advance the study by enrolling 39 subjects across the US.
The trial aims to explore the efficacy and safety of mesenchymal stromal/stem cells (MSCs) in treating heart failure.
It involves a nine-patient, open-label Phase I dose escalation cohort, followed by a randomised placebo procedure-controlled double-blinded 30-patient cohort.
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By GlobalDataIn Phase I of the trial, three subjects will receive treatments at dosages of either 20 million, 100 million and 200 million cells.
These treatments will be administered using the Helix delivery system, which is designed to be minimally invasive.
BioCardia said that at high dosage levels, the CardiALLO-HF trial will provide at least twice the effective dosage of previous trials of MSCs for treating heart failure.
The trial is reportedly the first clinical study targeted at individuals with active inflammation.
BioCardia CEO Peter Altman said: “Today’s result has the potential to be helpful with ongoing discussions around nondilutive funding and partnering opportunities for our MSC platform.
“Success in this trial can enable future pivotal trial design and funding in the US, conditional time-limited approval with reimbursement in Japan, as well as the advancement of CardiALLO MSC therapy for the likely orphan indications of paediatric and adult congenital heart disease.”
BioCardia recently began enrolling subjects in its Phase III CardiAMP HF II trial of the CardiAMP cell therapy in partnership with Emory University School of Medicine.
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