Trial reportStem cell research & therapy2023
Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn's disease: a pilot study.
Trial report in Stem cell research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04939337 (Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells), which is not on this map. Cited by 15 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.
Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic review and meta-analysis of the efficacy and safety of stem cell treatment of anal fistulas.Techniques in coloproctology · 2025Pooled it
- Efficacy of mesenchymal stem cell-based therapies in the treatment of perianal fistulizing Crohn's disease: a systematic review and meta-analysis.Stem cell research & therapy · 2025Pooled it
- Endoscopic submucosal injection of umbilical cord mesenchymal stem cells for radiation-induced late rectal injury.Endoscopy · 2026Trial
- Application of Human Umbilical Cord Mesenchymal Stem Cells and Their Derived Exosomes in Gastrointestinal Diseases.International journal of nanomedicine · 2026Review
- Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China.Intestinal research · 2026Article
- Therapeutic potential and mechanistic insights into adipose-derived stem cells and mesenchymal stem cell-derived exosomes in patients with Crohn's disease-associated fistulas: challenges and future perspectives.Stem cell research & therapy · 2025Review
- Advancing regenerative therapies with umbilical cord-derived mesenchymal stem cells: A review.Biomolecules & biomedicine · 2025Review
- Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.Signal transduction and targeted therapy · 2025Review
- Global trends in surgically based treatment of anal fistula in Crohn's disease: a bibliometric and visualization analysis.International journal of surgery (London, England) · 2025Article
- Clinical evaluation of day surgery for anal fistula excision with MRI-assisted diagnosis: a retrospective analysis of 121 cases.Frontiers in medicine · 2025Article
- Effects, methods and limits of the cryopreservation on mesenchymal stem cells.Stem cell research & therapy · 2024Review
- Optimization of transplantation methods using isolated mesenchymal stem/stromal cells: clinical trials of inflammatory bowel diseases as an example.Inflammation and regeneration · 2024Article
- Comparison of different sources of mesenchymal stem cells: focus on inflammatory bowel disease.Inflammopharmacology · 2024Review
- Therapeutic Prospects of Mesenchymal Stem Cell and Their Derived Exosomes in the Regulation of the Gut Microbiota in Inflammatory Bowel Disease.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Advancing therapeutic frontiers: a pipeline of novel drugs for luminal and perianal Crohn's disease management.Therapeutic advances in gastroenterology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
objectivesThe aim of the study was to evaluate the efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells (TH-SC01) for complex perianal fistula in patients with Crohn's disease (CD).
methodsThis was an open-label, single-arm clinical trial conducted at Jinling Hospital. Adult patients with complex treatment-refractory CD perianal fistulas (pfCD) were enrolled and received a single intralesional injection of 120 million TH-SC01 cells. Combined remission was defined as an absence of suppuration through an external orifice, complete re-epithelization, and absence of collections larger than 2 cm measured by magnetic resonance imaging (MRI) at 24 weeks after cell administration.
resultsA total of 10 patients were enrolled. Six patients (60.0%) achieved combined remission at 24 weeks. The number of draining fistulas decreased in 9 (90.0%) and 7 (70.0%) patients at weeks 12 and 24, respectively. Significant improvement in Perianal Crohn Disease Activity Index, Pelvic MRI-Based Score, Crohn Disease Activity Index, and quality of life score were observed at 24 weeks. No serious adverse events occurred. The probability of remaining recurrence-free was 70% at week 52.
conclusionThe study demonstrated that local injection of TH-SC01 cells might be an effective and safe treatment for complex treatment-refractory pfCD after conventional and/or biological treatments fail (ClinicalTrials.gov ID, NCT04939337).
trial registrationThe study was retrospectively registered on www. CLINICALTRIALS: gov (NCT04939337) on June 25, 2021.
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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.