Trial reportPloS one2026
Stem cell therapy for female stress urinary incontinence: Results, limitations and lessons learned from a pilot clinical study.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Autologous regenerative cell therapy for female stress urinary incontinence: a systematic review and meta-analysis of clinical outcomes.Frontiers in medicine · 2026Pooled it
- Regenerative Medicine Approaches to Stress Urinary Incontinence.Biomimetics (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis pilot clinical study aimed to develop and validate standardized manufacturing and quality control procedures for autologous skeletal muscle-derived (SkM-MSCs) and bone marrow-derived mesenchymal stem cells (BM-MSCs), and to explore the feasibility, safety and preliminary efficacy of periurethral injection of these products in women with stress urinary incontinence (SUI).
methodsTwenty-six diagnosed with SUI were enrolled and allocated to receive either SkM-MSCs or BM-MSCs. Autologous MSCs were isolated from skeletal muscle or bone marrow biopsies, expanded under Good Manufacturing Practices (GMP), and subjected to rigorous quality control assessments, including identity, genetic stability, viability, potency, and sterility. In this pilot study, ten million MSCs were injected periurethrally under local anesthesia, and participants were followed for 12 months post-treatment.
resultsEleven SkM-MSCs and nine BM-MSCs final products met all quality criteria and were administered. One participant from the SkM-MSCs lost the follow-up. MSC therapies were well tolerated, with no long-term adverse effects or tumor formation observed. In the SkM-MSCs group, the proportion of women with a positive cough test decreased significantly from 100% to 40% (p = 0.010). In the BM-MSCs group, modest improvements were seen but did not reach statistical significance. Overall, improvements in both pad test outcomes and quality of life measures among participants were observed, though not uniformly significant. The study was discontinued before reaching its intended sample size due to limited efficacy, logistical challenges, and financial constraints.
conclusionAutologous MSC‑based therapy for SUI was feasible and showed an acceptable short‑term safety profile in this pilot research setting; however, clinical efficacy remained modest. The manufacturing and quality control methodology is reproducible in specialized cell processing centers, but its application should remain confined to clinical research conducted in compliance with current regulations governing human cell therapy. Future studies with optimized cell products, refined delivery strategies and adequately powered, randomized designs are required before any potential translation to routine clinical practice can be considered.
Indexed as
Identifiers
What Socratic 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 Socratic graph.