BioCardia pauses enrollment in PhIII trial of heart failure stem cell therapy

Bio­Car­dia has paused en­roll­ment in a piv­otal study of its stem cell ther­a­py for heart fail­ure af­ter an in­de­pen­dent re­view board de­ter­mined the tri­al was not like­ly to suc­ceed.

The Sun­ny­vale, CA-based biotech said Mon­day morn­ing that the da­ta and safe­ty mon­i­tor­ing board (DSMB) re­viewed an in­ter­im read­out of the Phase III tri­al of its stem cell ther­a­py for sys­tolic heart fail­ure. The board de­ter­mined it was “un­like­ly to meet” the pri­ma­ry ef­fi­ca­cy end­point, a com­pos­ite mea­sure of sur­vival, ma­jor car­diac events (such as heart at­tacks) and re­sults from a six-minute walk test at one year.

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