Evidence map›Paper›PMID 40759457›Full record

ArticleBMJ open gastroenterology2025

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.

Julia Husman, Margarete Wardenga, Sophie Kirk, Katja Matthes, Bernd Naumann, Jakob Dobroschke, Heiner Nebelung, Verena Plodeck, Mathias Krech, Martin Bornhäuser and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Julia HusmanDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.ORCID http://orcid.org/0000-0002-4773-2730
Margarete WardengaDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Sophie KirkDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Katja MatthesDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Bernd NaumannDepartment of Visceral Surgery and Proctology, Diakonissenkrankenhaus Dresden, Dresden, Germany.
Jakob DobroschkeDepartment of General, Visceral and Thoracic Surgery, Proctology, HELIOS Klinikum Pirna, Pirna, Germany.
Heiner NebelungInstitute and Polyclinic for Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Verena PlodeckInstitute and Polyclinic for Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Mathias KrechDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Martin BornhäuserDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Manuel PfeiferInstitute of Legal Medicine, TUD Dresden University of Technology, Dresden, Germany.
Sebastian ZeißigDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Jochen HampeDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
Renate SchmelzDepartment of Medicine 1, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany renate.schmelz@ukdd.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePerianal fistulas in Crohn's disease (CD) are associated with a high burden of illness and their treatment is challenging. Recent data indicate promising short-term efficacy of bone marrow-derived mesenchymal stromal cell (bmMSC) therapy. The aim of this case series is to gather more information on the long-term effectiveness and safety.

methodsBetween 2013 and 2017, bmMSCs were administered under compassionate use to patients at a university hospital in Germany, as no stem cell therapy was approved at the time. Inclusion criteria were inactive CD (Harvey-Bradshaw Index <5) without proctitis, at least one treatment-refractory perianal fistula (with or without rectovaginal additional fistulas) and prior tumour necrosis factor-alpha inhibitor and/or surgical exposure. After curettage of the fistula tract, patients received repeated intrafistular injections with up to 300 million bmMSCs. We retrospectively analysed patient records to assess disease course, clinical fistula remission and radiological activity using the modified van Assche index.

resultsSix female patients with a total of 13 fistulas (9 trans-sphincteric, 2 extrasphincteric and 2 rectovaginal) underwent bmMSC application. Median radiological and clinical long-term follow-up was 80 months (range 44-98 months) after first local bmMSC injection. 8 of 13 fistulas (62%) exhibited complete closure. For rectovaginal fistulas, long-term remission (98 months) was 50% (1 of 2). Pelvic MRI showed a decrease in modified Van Assche index from baseline to long-term follow-up. No immediate adverse events related to bmMSC injections were observed. One patient was diagnosed with a local adenocarcinoma of the rectum 106 months after first bmMSC injection. MRI control 11 months prior showed complete fistula remission. The tumour exhibited a female karyotype, while bmMSC had been derived from a male volunteer.

conclusionIn this analysis, 62% of complex perianal and 50% of rectovaginal fistulas showed long-term remission up to 8 years post-bmMSC therapy. Further real-world data are needed.

Indexed as

Crohn DiseaseMesenchymal Stem Cell TransplantationRectal FistulaRectovaginal FistulaAdultFemaleGermanyHumansMiddle AgedRemission InductionRetrospective StudiesTransplantation, HomologousTreatment OutcomeCROHN'S DISEASEGASTROINTESTINAL FISTULAEIBDSTEM CELLS

Identifiers

PMID40759457
PMCPMC12323515

What OpenQuestion holds

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Registered trials

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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.