Evidence map›Paper›PMID 31276044›Full record

ReviewJGH open : an open access journal of gastroenterology and hepatology2019

Systematic review with meta-analysis: Safety and efficacy of local injections of mesenchymal stem cells in perianal fistulas.

Rachele Ciccocioppo, Catherine Klersy, Daniel A Leffler, Raquel Rogers, Dimitri Bennett, Gino Roberto Corazza

Registry-linked trialOpen access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in JGH open : an open access journal of gastroenterology and hepatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05177003 (Study of the 12-month Efficacy of Stem Cell Injection in Crohn's Disease With Complex Ano-perineal Fistula), which is not on this map. Cited by 25 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 7 pooled it
6.4field-weighted citation impact, top 3% of its field
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.

NCT05177003 unknown statusnot on this mapstarted 2021, after this paper: background citation

Study of the 12-month Efficacy of Stem Cell Injection in Crohn's Disease With Complex Ano-perineal Fistula

TypeobservationalSponsorFondation Hôpital Saint-JosephRan2021 to 2024Enrolled27ConditionsCrohn Disease, Ano Fistula
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 7 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
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  8. Observational
  9. Evidence outside the box: Minimally invasive treatment for anal fistula.World journal of gastrointestinal surgery · 2025
    Review
  10. Article
  11. Review
  12. Surgical Management of Perianal Crohn's Disease: Current Evidence and Future Directions.Acta informatica medica : AIM : journal of the Society for Medical Informatics of Bosnia & Herzegovina : casopis Drustva za medicinsku informatiku BiH · 2024
    Article
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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

6 authors at 4 institutions in 3 countries.

Rachele CiccocioppoGastroenterology Unit, Department of Medicine AOUI Policlinico GB Rossi and University of Verona Verona Italy.
Catherine KlersyService of Clinical Epidemiology & Biostatistics, Fondazione IRCCS Policlinico San Matteo and University of Pavia Pavia Italy.
Daniel A LefflerDepartment of Clinical Science Takeda Pharmaceutical Company Limited Cambridge Massachusetts USA.
Raquel RogersDepartment of Pharmacovigilance Takeda Pharmaceutical Company Limited Cambridge Massachusetts USA.
Dimitri BennettDepartment of Epidemiology Takeda Pharmaceutical Company Limited Cambridge Massachusetts USA.ORCID https://orcid.org/0000-0002-8387-9342
Gino Roberto CorazzaDepartment of Internal Medicine Fondazione IRCCS Policlinico San Matteo and University of Pavia Pavia Italy.
Takeda (United States) · USUniversity of Pavia · ITBeth Israel Deaconess Medical Center · USUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Perianal fistulas in Crohn's disease (CD) represent a highly debilitating and difficult-to-treat condition. Given emerging supportive evidence, we conducted a systematic review and meta-analysis of all trials/observational studies to establish the safety and efficacy of local injections of mesenchymal stem cells (MSCs). The PRISMA-P statement was applied for planning and reporting, and MEDLINE, EMBASE, Web of Science, Cochrane, CINAHL, ClinicalTrials.gov database, and ECCO 2017 proceedings were searched for published observational studies and one-arm and randomized clinical trials (RCTs). Safety was assessed in terms of acute local/systemic events, long-term events, and relatedness with MSC treatment. Efficacy was evaluated in terms of external and/or radiological closure of fistula tracks. After a review of 211 citations, 23 studies, including 696 participants, were evaluated. Four were RCTs with a total of 483 patients. Overall, fistula closure occurred in 80% of MSC-treated patients. In RCTs, this rate was 64% in the MSC arm and 37% in the control arm (relative risk (RR) = 1.54). Radiological response occurred in 83% of MSC-treated patients. Treatment-related adverse events occurred in 1% of MSC-treated patients, with severe treatment-related adverse events reaching 0% over a median follow-up of 6 months. In RCTs, treatment-related adverse events occurred in 13% in the MSC arm and 24% in the control arm (RR = 0.65). The relapse rate was 0. These results suggest that a local MSC injection is safe and efficacious. Further clinical trials with standardized end-points are required to ensure the timely implementation of this new therapy in the management of perianal CD.

Indexed as

Crohn's disease fistulascryptoglandular fistulasefficacymesenchymal stem cellssafety

Identifiers

PMID31276044
PMCPMC6586577
OpenAlexW2913914976

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.