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A Phase 2a Multi-Center, Prospective, Randomized Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects With Diabetic Foot Ulcers (DFU)

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Trial Profile

A Phase 2a Multi-Center, Prospective, Randomized Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects With Diabetic Foot Ulcers (DFU)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Jan 2025

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At a glance

  • Drugs Purified exosome product RION (Primary) ; Fibrin
  • Indications Diabetic foot ulcer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Rion

    • Most Recent Events

    • 13 Jan 2025 According to a RION media release, patient enrollment has been completed in this trial. Upon successful completion of this trial, RION plans to initiate a pivotal Phase 3 study, with the goal of filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).
    • 13 Jan 2025 Status changed from recruiting to active, no longer recruiting, according to a RION media release.
    • 07 May 2024 According to a RION media release, company announced that the first subject was dosed in the Phase 2 clinical trial with its novel product, known as Purified Exosome Product.

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