Stem cell therapy for female stress urinary incontinence: Results, limitations and lessons learned from a pilot clinical study
Souza RC., Bortolini MAT., Melino Y., de Godoy JAP., Alvarez K., Oliveira D.
Clinical Trial, published in PLoS One (2026) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Clinical Trial
- Journal
- PLoS One (2026)
- Reported sample size
- —
- Source database
- Europe PMC
- PMID
- 41758757
- PMCID
- PMC12948050
- DOI
- 10.1371/journal.pone.0342452
- Citations
- 1
Abstract (original English)
Objective This 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). Methods Twenty-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. Results Eleven 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, improveme
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
How we grade evidenceBrowse all related research
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