The US Food and Drug Administration (FDA) has granted clearance to BioCardia’s Investigational New Drug (IND) application to commence a Phase I/II clinical trial of BCDA-04 in adults recovering from Covid-19-linked acute respiratory distress syndrome (ARDS).

An investigational cell therapy, BCDA-04 is a Neurokinin-1 receptor-positive (NK1R+) allogeneic mesenchymal cell (MSC) population.

With the latest approval, the company intends to commence the first-in-human trial in the third quarter of this year.

The initial portion of the trial will assess increasing doses of the NK1R+ MSCs and the optimal dose will be chosen for the randomised Phase II trial in adult subjects recovering from Covid-19-linked ARDS.

BioCardia chief scientific officer Ian McNiece said: “This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies. 

“After IV delivery, the cells migrate to the lungs for local therapeutic benefit. 

“We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs.”

BioCardia focuses on the development of cellular and cell-derived therapies to treat cardiovascular and pulmonary diseases. 

Fluid accumulation in the tiny, elastic air sacs called alveoli in the lungs causes ARDS. The fluid keeps the lungs from filling with air, which results in less oxygen reaching the bloodstream. 

This deprives organs of the oxygen required for them to work properly.

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