Trial reportInternational urology and nephrology2018
A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence.
Trial report in International urology and nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Autologous regenerative cell therapy for female stress urinary incontinence: a systematic review and meta-analysis of clinical outcomes.Frontiers in medicine · 2026Pooled it
- Stem cell therapy for female stress urinary incontinence: Results, limitations and lessons learned from a pilot clinical study.PloS one · 2026Trial
- Implantation of Autologous Skeletal Muscle-Derived Cells Combined with Electrical Stimulation in Patients with Stress Urinary Incontinence.International urogynecology journal · 2025Trial
- Transurethral injection of autologous muscle precursor cells for treatment of female stress urinary incontinence: a prospective phase I clinical trial.International urogynecology journal · 2023Trial
- Improved global response outcome after intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder.International urology and nephrology · 2021Trial
- Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.World journal of urology · 2020Trial
- Progress on cell therapy for skeletal muscle disorders.Advanced drug delivery reviews · 2026Review
- Improved Sphincter Muscle Regeneration by Myoblasts fromMedical sciences (Basel, Switzerland) · 2026Article
- Autologous muscle precursor cell injection into the bladder neck improves the symptoms of stress urinary incontinence in adult females.Stem cells translational medicine · 2025Article
- The Outcome of Cell Therapy Treating Urinary Incontinence Correlates with Precise Cell Localization in the Sphincter Complex.Biomedicines · 2025Article
- Optimizing transport methods to preserve function of self-innervating muscle cells for laryngeal injection.Laryngoscope investigative otolaryngology · 2024Article
- The electronic artificial urinary sphincter: ongoing innovation of a classic device-a narrative review.Translational andrology and urology · 2024Review
- Cell Therapy in the Treatment of Female Stress Urinary Incontinence: Current Status and Future Proposals.Life (Basel, Switzerland) · 2024Review
- Impact of Needle Selection on Survival of Muscle-Derived Cells When Used for Laryngeal Injections.Journal of cell science & therapy · 2023Article
- Update on Urethral Bulking for Stress Urinary Incontinence in Women.Current urology reports · 2022Review
- Adult stem cell sources for skeletal and smooth muscle tissue engineering.Stem cell research & therapy · 2022Review
- Autologous Muscle-Derived Cell Therapy for Swallowing Impairment in Patients Following Treatment for Head and Neck Cancer.The Laryngoscope · 2022Article
- Bringing hydrogel-based craniofacial therapies to the clinic.Acta biomaterialia · 2022Review
- Current status of stem cell treatments and innovative approaches for stress urinary incontinence.Frontiers in medicine · 2022Review
- Treatment of Stress Urinary Incontinence with Muscle Stem Cells and Stem Cell Components: Chances, Challenges and Future Prospects.International journal of molecular sciences · 2021Review
Corrections and comments
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Authors and funding
14 authors at 8 institutions in 4 countries.
Funding
Abstract
purposeThe purpose of the study was to assess safety and efficacy of autologous muscle derived cells for urinary sphincter repair (AMDC-USR) in female subjects with predominant stress urinary incontinence.
methodsA randomized, double-blind, multicenter trial examined intra-sphincteric injection of 150 × 10
resultsAMDC-USR was safe and well-tolerated with no product-related serious adverse events or discontinuations due to adverse events. Interim analysis revealed an unexpectedly high placebo response rate (90%) using the composite primary outcome which prevented assessment of treatment effect as designed and thus enrollment was halted at 61% of planned subjects. Post hoc analyses suggested that more stringent endpoints lowered placebo response rates and revealed a possible treatment effect.
conclusionsAlthough the primary efficacy finding was inconclusive, these results inform future trial design of AMDC-USR to identify clinically meaningful efficacy endpoints based on IEF reduction, understanding of placebo response rate, and refinement of subject selection criteria to more appropriately align with AMDC-USR's proposed mechanism of action.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.