ArticleEBioMedicine2023
Local fistula injection of allogeneic human amnion epithelial cells is safe and well tolerated in patients with refractory complex perianal Crohn's disease: a phase I open label study with long-term follow up.
Article in EBioMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
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Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Fistula Outcomes After Seton Removal in Patients with Perianal Fistulizing Crohn's Disease: A Systematic Review and Meta-Analysis.Digestive diseases and sciences · 2026Pooled it
- Evaluating Quality of Life in Surgically Treated IBD Patients: A Systematic Review of Physical, Emotional and Social Impacts.Medicina (Kaunas, Lithuania) · 2025Pooled it
- Systematic review and meta-analysis of the efficacy and safety of stem cell treatment of anal fistulas.Techniques in coloproctology · 2025Pooled it
- Are All Cells Created Equal? Novel Cell-Based Regenerative Therapies in Inflammatory Bowel Disease.International journal of molecular sciences · 2026Review
- Stem cell- and extracellular vesicle-based therapies for perianal fistulizing Crohn's disease: An updated review.World journal of gastroenterology · 2025Review
- Mesenchymal Stem Cell Therapy for Perianal Crohn's Disease: Surgical Appraisal of Evidence and Translational Potential.ANZ journal of surgery · 2025Article
- Advances of exosome regulating‑FXR to repair inflammatory bowel disease (Review).International journal of molecular medicine · 2025Review
- Efficacy of exosomes in acute kidney injury treatment and the associated mechanism (Review).Molecular medicine reports · 2025Review
- Scale-Up of Human Amniotic Epithelial Cells Through Regulation of Epithelial-Mesenchymal Plasticity Under Defined Conditions.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Clinical evaluation of day surgery for anal fistula excision with MRI-assisted diagnosis: a retrospective analysis of 121 cases.Frontiers in medicine · 2025Article
- Human Amniotic Epithelial Stem Cells Alleviate Autoimmune Premature Ovarian Insufficiency in Mice by Targeting Granulosa Cells via AKT/ERK Pathways.Stem cell reviews and reports · 2024Article
- Comparison of the Efficacy of Two Routes of Administration of Human Amniotic Epithelial Cells in Cell Therapy of Acute Hepatic Insufficiency.Pharmaceuticals (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLocal fistula injection of mesenchymal stromal/stem cells (MSC) is effective for complex perianal Crohn's fistulas but is also expensive and requires specialised facilities for cell revival before administration. Human amnion epithelial cells (hAEC) are non-MSC cells with therapeutic properties. The primary aim of this study was safety of hAEC therapy. Secondary aims included hAEC efficacy, feasibility of the protocol and impact on quality of life.
methodsA phase I open label study of ten adults with active complex Crohn's perianal fistulas refractory to conventional treatment, including anti-tumour necrosis factor alpha therapy, was undertaken. A single dose of hAEC was injected into the fistula tract(s) after surgical closure of the internal opening(s). Study outcomes were assessed at week 24 with follow up for at least 52 weeks.
findingsLocal injection of hAEC was safe, well tolerated and the injection procedure was feasible. Complete response occurred in 4 patients, and a partial response in an additional 4 patients. There was a mean reduction in the Perianal Disease Activity Index of 6.5 points (95% CI -9.0 to -4.0, p = 0.0002, paired t-test), modified Van Assche MRI Index of 2.3 points (95% CI -3.9 to -0.6, p = 0.012, paired t-test) and a mean improvement of 15.8 points (95% CI 4.9 to 26.8, p = 0.010, paired t-test) in quality of life using the Short IBD-Questionnaire in complete responders.
interpretationLocal injection of hAEC therapy for refractory complex perianal fistulising Crohn's disease appears safe, well-tolerated, feasible and demonstrated improvement. Quality of life is improved in those who achieve complete fistula healing.
fundingThis study was funded by competitive research grant funding from the Gastroenterological Society of Australia Seed Grant 2018.
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