ArticleStem cells translational medicine2016
Treatment of Crohn's-Related Rectovaginal Fistula With Allogeneic Expanded-Adipose Derived Stem Cells: A Phase I-IIa Clinical Trial.
Article in Stem cells translational medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 48 papers, 7 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.
Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease
A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.
Examining the Effect of Additional Injection of Freshly Collected Autologous Adipose Tissue to Bascom's Cleft Lift Surgery in the Treatment of Pilonidal Disease- a Randomized Controlled Trial
Who cites it
48 citing papers in PubMed, 7 syntheses or guidelines pooled it, 119 citations in OpenAlex.
- Stem cell transplantation for induction of remission in medically refractory Crohn's disease.The Cochrane database of systematic reviews · 2022Pooled it
- Efficacy and Safety of Mesenchymal Stem/Stromal Cell Therapy for Inflammatory Bowel Diseases: An Up-to-Date Systematic Review.Biomolecules · 2021Pooled it
- Efficacy of stem cells therapy for Crohn's fistula: a meta-analysis and systematic review.Stem cell research & therapy · 2021Pooled it
- The clinical efficacy of stem cell therapy for complex perianal fistulas: a meta-analysis.Techniques in coloproctology · 2019Pooled it
- TRANSPLANTATION OF ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN REFRACTORY CROHN'S DISEASE: SYSTEMATIC REVIEW.Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery · 2019Pooled it
- Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events.Stem cells translational medicine · 2017Pooled it
- Efficacy of Mesenchymal Stromal Cells for Fistula Treatment of Crohn's Disease: A Systematic Review and Meta-Analysis.Digestive diseases and sciences · 2017Pooled it
- Stem Cell Therapy for Inflammatory Diseases: Progress, Challenges, and Future Directions.MedComm · 2026Review
- Long-term effectiveness of allogeneic bone marrow-derived mesenchymal stromal cell therapy for complex perianal and rectovaginal fistulas in Crohn's disease: a retrospective case series.BMJ open gastroenterology · 2025Article
- [Rectovaginal fistulas : Differentiated diagnostics and treatment].Chirurgie (Heidelberg, Germany) · 2024Review
- Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024Review
- Article
- Colitis-associated carcinogenesis: crosstalk between tumors, immune cells and gut microbiota.Cell & bioscience · 2023Review
- Unlocking the Potential of Mesenchymal Stem Cells in Gynecology: Where Are We Now?Journal of personalized medicine · 2023Review
- Stem Cell Therapy in Inflammatory Bowel Disease: A Review of Achievements and Challenges.Journal of inflammation research · 2023Review
- Treatment of Rectovaginal Fistula.Journal of the anus, rectum and colon · 2023Review
- Stem cell therapy: light in the tunnel for penetrating Crohn's disease.Gastroenterology report · 2023Review
- Use of Mesenchymal Stem Cells in Crohn's Disease and Perianal Fistulas: A Narrative Review.Current stem cell research & therapy · 2023Review
- Engineering stem cells to produce exosomes with enhanced bone regeneration effects: an alternative strategy for gene therapy.Journal of nanobiotechnology · 2022Article
- Stem cell therapy applied for digestive anastomosis: Current state and future perspectives.World journal of stem cells · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
: The aim of this clinical trial was to determine the safety and feasibility of expanded allogeneic adipose-derived stem cells to treat Crohn's-related rectovaginal fistula (CRRVF). We designed a phase I-II clinical trial (https://ClinicalTrials.gov, NCT00999115) to treat 10 patients with CRRVF. Patients receiving biological therapy during follow-up were excluded. Curettage was performed, and a vaginal or rectal flap was added if the surgeon considered it necessary. The therapeutic protocol included intralesional injection of 20 million stem cells in the vaginal walls (submucosal area) and fistula tract. Healing was evaluated 12 weeks later. If the fistula had not healed, a second dose of 40 million stem cells was administered. Patient follow-up was 52 weeks from last cell injection. Healing was defined as re-epithelialization of both vaginal and rectal sides and absence of vaginal drainage. Cytokines and immunological blood tests were monitored. Serious adverse events or rejection issues were not observed. Five patients were excluded because biologic drugs were required to treat a Crohn's disease flare-up during follow-up. Cytokine profiles and immunotoxicity assays showed no statistically significant alterations. Sixty percent of the nonexcluded patients achieved a complete healing. Expanded allogeneic adipose-derived stem-cell injection is a safe and feasible therapy for treating CRRVF, and the healing success rate seems promising (60%). The results of this trial encourage further exploration into this therapy. SIGNIFICANCE: This may be the first publication in which allogeneic stem cells to treat rectovaginal fistula in Crohn´s disease seem to be a feasible and safe treatment. Additional studies are necessary to confirm the efficacy profile of the allogeneic stem cells strategy in a controlled design.
Indexed as
Identifiers
What OpenQuestion holds
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.