FDA Approves IDE for Pivotal Trial of Cesca Therapeutics' System to Treat Critical Limb Ischemia

June 16, 2015—Cesca Therapeutics Inc., a company focused on autologous cell-based regenerative medicine, announced that the US Food and Drug Administration (FDA) has granted full approval for an investigational device exemption (IDE) for the company’s pivotal clinical trial, named the CLIRST III trial, to evaluate Cesca’s SurgWerks-CLI and VXP system for the treatment of patients with late-stage, no-option critical limb ischemia.

According to the company, the CLIRST III pivotal trial will enroll 204 patients at up to 60 hospital sites in the United States, and additional enrollment will be conducted outside the United States up to the anticipated total enrollment of 224 patients. CLIRST III will be a 3:1 randomized, double-blinded, placebo-controlled trial having an adaptive interim analysis for repowering (if necessary) and with a primary endpoint of major amputation-free survival. Additional trial characteristics include the use of an independent, centralized panel of physicians for adjudicating/determining the inclusion of prospective patients, as well as determining the final outcome of an enrolled patient at the 12-month follow-up period.

The SurgWerks-CLI and VXP system, Cesca’s cell-therapy technology for the indication of facilitating limb salvage, is regulated as a class III medical device and has been determined by the FDA to be Centers for Medicare & Medicaid Services category B. Data from the pivotal trial will be used in support of a future premarket approval application. The CLIRST III trial comes after a successful feasibility study conducted in India. 

Before enrollment begins, the company will request Medicare coverage for routine patient treatment costs, as allowed under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which allows reimbursement for routine care and service items that are incurred as part of an IDE study involving a category B device.