Trial reportAnnals of surgery2018
Autologous Myoblasts for the Treatment of Fecal Incontinence: Results of a Phase 2 Randomized Placebo-controlled Study (MIAS).
Trial report in Annals of surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses 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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration.United European gastroenterology journal · 2022Guideline
- Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review.United European gastroenterology journal · 2020Pooled it
- Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence.Stem cell research & therapy · 2018Trial
- Progress on cell therapy for skeletal muscle disorders.Advanced drug delivery reviews · 2026Review
- Clinical translational research on stem cell products: prospects and challenges.Signal transduction and targeted therapy · 2026Review
- The Japan Society of Coloproctology Practice Guidelines for Fecal Incontinence 2024 (Revised Second Edition).Journal of the anus, rectum and colon · 2026Review
- Organoid culture promotes dedifferentiation of mouse myoblasts into stem cells capable of complete muscle regeneration.Nature biotechnology · 2025Article
- Controversies in fecal incontinence.World journal of gastroenterology · 2025Article
- 3D spheroids versus 2D-cultured human adipose stem cells to generate smooth muscle cells in an internal anal sphincter-targeting cryoinjured mouse model.Stem cell research & therapy · 2024Article
- Stem cell therapy combined with controlled release of growth factors for the treatment of sphincter dysfunction.Cell & bioscience · 2023Review
- Differentiation of Adipose-Derived Stem Cells into Smooth Muscle Cells in an Internal Anal Sphincter-Targeting Anal Incontinence Rat Model.Journal of clinical medicine · 2023Article
- Faecal incontinence in adults.Nature reviews. Disease primers · 2022Review
- The Effect of Mesenchymal Stem Cells, Adipose Tissue Derived Stem Cells, and Cellular Stromal Vascular Fraction on the Repair of Acute Anal Sphincter Injury in Rats.Bioengineering (Basel, Switzerland) · 2022Article
- Stromal cell derived factor 1 plasmid to regenerate the anal sphincters.Journal of tissue engineering and regenerative medicine · 2022Article
- Review
- What Is Fecal Incontinence That Urologists Need to Know?International neurourology journal · 2021Article
- Fecal Incontinence in the Elderly.Clinics in geriatric medicine · 2021Review
- Myogenic Cell Transplantation in Genetic and Acquired Diseases of Skeletal Muscle.Frontiers in genetics · 2021Review
- Manufacturing autologous myoblast for regenerative medicine applications.Cytotechnology · 2020Article
- Generation of myogenic progenitor cell-derived smooth muscle cells for sphincter regeneration.Stem cell research & therapy · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of this study was to evaluate the efficacy of intrasphincteric injections of autologous myoblasts (AMs) in fecal incontinence (FI) in a controlled study. SUMMARY OF BACKGROUND DATA: Adult stem cell therapy is expected to definitively cure FI by regenerating damaged sphincter. Preclinical data and results of open-label trials suggest that myoblast therapy may represent a noninvasive treatment option.
methodsWe conducted a phase 2 randomized, double-blind, placebo-controlled study of intrasphincteric injections of AM in 24 patients. The study compared outcome after AM (n = 12) or placebo (n = 12) injection using Cleveland Clinic Incontinence (CCI), score at 6 and 12 months. Patients in the placebo group were eligible to receive frozen AM after 1 year.
resultsAt 6 months, the median CCI score significantly decreased from baseline in both the AM (9 vs 15, P = 0.02) and placebo (10 vs 15, P = 0.01) groups. Hence, no significant difference was found between the 2 groups (primary endpoint) at 6 months. At 12 months, the median CCI score continued to ameliorate in the AM group (6.5 vs 15, P = 0.006), while effect was lost in the placebo group (14 vs 15, P = 0.35). Consequently, there was a higher response rate at 12 months in the treated than the placebo arm (58% vs 8%, P = 0.03). After delayed frozen AM injection in the placebo group, the response rate was 60% (6/10) at 12 months.
conclusionsIntrasphincteric AM injections in FI patients have shown tolerance, safety, and clinical benefit at 12 months despite a transient placebo effect at 6 months.
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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.