FDA permits phase II trial for stem cell treatment of CLI

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The FDA has authorized commencement of a phase II clinical trial evaluating the efficacy and safety of Juventas Therapeutics’ JVS-100 for the treatment of critical limb ischemia (CLI).

JVS-100 encodes stromal-cell derived factor 1 (SDF-1), which has been shown in several preclinical studies to promote tissue repair through activation of stem cell repair pathways, promotion of new blood vessel formation and prevention of ongoing cell death, according to the Cleveland-based Juventas.

The new trial builds on the JVS-100 cardiovascular program that includes a U.S. phase I heart failure clinical trial for which the company recently completed enrollment of 17 patients.

The randomized, placebo-controlled study will evaluate the efficacy and safety of JVS-100 in 48 patients (36 JVS-100 treated; 12 placebo) with Rutherford Class IV or V CLI. The clinical trial will measure several efficacy endpoints including time to amputation, transcutaneous oximetry (TcPO2), ankle brachial index and ulcer closure.

"Critical limb ischemia is a devastating disease for which there is currently no FDA-approved drug for treatment," said the trial’s principal investigator Douglas W. Losordo, MD, director of the Feinberg Cardiovascular Research Institute at the Northwestern University Feinberg School of Medicine in Chicago.