18 November 2021 | Thursday | News
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Pivotal trial to support marketing approval of regenerative cells processed with the Celution® System to commence in Q1 2022
Paracrine, Inc. announced today that the FDA has granted full approval of its Investigational Device Exemption (IDE) to conduct a new pivotal trial titled Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers (DFUs): A Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study – The “ASCEND Trial.”
The ASCEND Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of ADRCs in the treatment of patients with DFUs. The trial will include up to 291 patients at 25 clinical sites in the U.S. Trial results will be submitted in a Premarket Approval (PMA) application to the FDA to support regulatory approval.
Dr. Robert G. Frykberg, Co-Principal Investigator for The ASCEND Trial and past Foot Care Council Chair of the American Diabetes Association, stated: “Despite recent advancements in wound care and pharmacotherapy techniques, up to one quarter of patients with diabetes will develop diabetic foot ulcers – a leading cause of disability worldwide. The goal of this pivotal study is to compare the use of ADRCs against the current standard of care and determine if ADRCs can improve clinical outcomes in this challenging patient population.”