Trial reportStem cells translational medicine2020
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up.
Trial report in Stem cells translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01803347 (Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue), which is not on this map. Cited by 38 papers, 6 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.
Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.
Who cites it
38 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Systematic review and network meta-analysis of cryptoglandular complex anal fistula treatment: evaluation of surgical strategies.Updates in surgery · 2025Pooled it
- Systematic review and meta-analysis of the efficacy and safety of stem cell treatment of anal fistulas.Techniques in coloproctology · 2025Pooled it
- Adipose-derived stem cell therapies for complex anal fistula: a systematic review and meta-analysis of randomized controlled trials.Frontiers in medicine · 2025Pooled it
- Mesenchymal stem cells transplantation for perianal fistulas: a systematic review and meta-analysis of clinical trials.Stem cell research & therapy · 2023Pooled it
- Efficacy and Safety of Sphincter-Preserving Surgery in the Treatment of Complex Anal Fistula: A Network Meta-Analysis.Frontiers in surgery · 2022Pooled it
- Efficacy of stem cells therapy for Crohn's fistula: a meta-analysis and systematic review.Stem cell research & therapy · 2021Pooled it
- Efficacy of injection of autologous adipose tissue in the treatment of patients with complex and recurrent fistula-in-ano of cryptoglandular origin.Techniques in coloproctology · 2024Trial
- Molecular differences of adipose-derived mesenchymal stem cells between non-responders and responders in treatment of transphincteric perianal fistulas.Stem cell research & therapy · 2021Trial
- Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up.Stem cells translational medicine · 2020Trial
- "Local injection of freshly collected autologous adipose tissue as a novel adjunctive treatment in hidradenitis suppurativa".JAAD case reports · 2026Article
- Use of microfragmented autologous adipose tissue (LIPOGEMS®) as a sphincter-saving therapy for complex anal fistulas: a single-center retrospective study.BMC surgery · 2026Observational
- Engineering Approaches to Modify Immunomodulatory Functions of Mesenchymal Stromal Cells (MSCs): Tissue Regeneration and Clinical Application.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Therapeutic Potential of Stem Cell-Derived Exosomes in Skin Wound Healing.Biomimetics (Basel, Switzerland) · 2025Review
- Clinical evaluation of day surgery for anal fistula excision with MRI-assisted diagnosis: a retrospective analysis of 121 cases.Frontiers in medicine · 2025Article
- Metabolic pathways in anal fistula: paving the way for innovative treatments.American journal of translational research · 2025Article
- Therapeutic potential of mesenchymal stem cell-derived extracellular vesicles: A focus on inflammatory bowel disease.Clinical and translational medicine · 2024Review
- Recent advances in the diagnosis and treatment of complex anal fistula.Annals of coloproctology · 2024Review
- Optimum management for complex anal fistula: A network meta-analysis of randomized controlled trials.Surgery open science · 2024Article
- Efficacy of different surgical treatments for management of anal fistula: a network meta-analysis.Techniques in coloproctology · 2023Review
- Up-to-date meta-analysis of long-term evaluations of mesenchymal stem cell therapy for complex perianal fistula.World journal of stem cells · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of this clinical trial (ID Number NCT01803347) was to determine the safety and efficacy of autologous adipose-derived stem cells (ASCs) for treatment of cryptoglandular fistula. This research was conducted following an analysis of the mistakes of a same previous phase III clinical trial. We designed a multicenter, randomized, single-blind clinical trial, recruiting 57 patients. Forty-four patients were categorized as belonging to the intent-to-treat group. Of these, 23 patients received 100 million ASCs plus intralesional fibrin glue (group A) and 21 received intralesional fibrin glue (group B), both after a deeper curettage of tracks and closure of internal openings. Fistula healing was defined as complete re-epithelialization of external openings. Those patients in whom the fistula had not healed after 16 weeks were eligible for retreatment. Patients were evaluated at 1, 4, 16, 36, and 52 weeks and 2 years after treatment. Results were assessed by an evaluator blinded to the type of treatment. After 16 weeks, the healing rate was 30.4% in group A and 42.8% in group B, rising to 55.0% and 63.1%, respectively, at 52 weeks. At the end of the study (2 years after treatment), the healing rate remained at 50.0% in group A and had reduced to 26.3% in group B. The safety of the cellular treatment was confirmed and no impact on fecal continence was detected. The main conclusion was that autologous ASCs for the treatment of cryptoglandular perianal fistula is safe and can favor long-term and sustained fistula healing.
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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.