Phase I Study of Safety and Early Effectiveness of Stem Cell Treatment for Urinary Incontinence in Women Over 50

What this Trial Is About

Researchers are evaluating the safety, feasibility, and initial effectiveness of expanded allogeneic mesenchymal stem cells derived from adipose tissue HC106 for treating urinary incontinence in women over 50 years old. This is a phase I, controlled trial aiming to gather proof of concept and preliminary data on this treatment for female urinary incontinence, specifically stress or mixed urinary incontinence with a predominance of effort-related leakage. The trial includes two groups one receiving a single dose of 40 million HC016 stem cells injected near the urinary sphincter, and a control group receiving a placebo saline solution injection. The cell or placebo injection is done under anesthesia and guided by cystoscopy to target specific points in the sphincter. The treatment involves one injection session, and the study follows participants to evaluate safety and effects. Participants will undergo assessments including a PAD-test, flowmetry, and quality of life questionnaires SF-12 and ICQ-SF at 3 and 6 months after treatment. Safety is monitored closely, especially for any complications within 7 days post-treatment. The total participation includes initial treatment and follow-up visits over at least 6 months to assess treatment impact and patient well-being.

Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old