Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence

Trial Profile

Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2017

At a glance

  • Drugs ECCS 50 (Primary)
  • Indications Urinary incontinence
  • Focus Registrational; Therapeutic Use
  • Acronyms ADRESU
  • Most Recent Events

    • 13 Nov 2017 Based on the successful data of this trial, Cytori along with the team at Nagoya University intends to submit for approval to market this form of Cytori Cell Therapy for SUI to Japans Pharmaceuticals and Medical Devices Agency, as reported ina media release.
    • 13 Nov 2017 This trial is approved by Japans Ministry of Health, Labour and Welfare and is primarily sponsored and funded by the Japanese government, including by a grant provided by Japans Agency for Medical Research and Development. The investigators have treated 35 patients. The investigators anticipate complete enrollment by the end of 2017 or early 2018.
    • 13 Nov 2017 According to a Cytori Therapeutics media release, investigators from the Department of Urology at Nagoya University in Japan published the protocol of this trial in September 2017.
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