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: 08 Mar 2018
At a glance
- Drugs ECCS 50 (Primary)
- Indications Urinary incontinence
- Focus Registrational; Therapeutic Use
- Acronyms ADRESU
- 08 Mar 2018 According to a Cytori Therapeutics media release, company expects data read-outs from this trial later in 2018.
- 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.