Evidence map›Paper›PMID 23053677›Full record

Trial reportInternational journal of colorectal disease2013

Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease: results from a multicenter phase I/IIa clinical trial.

F de la Portilla, F Alba, D García-Olmo, J M Herrerías, F X González, A Galindo

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2013. 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 155 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 17 pooled it
22.0field-weighted citation impact, top 1% 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.

NCT01803347 phase3completednot on this map

Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.

TypeinterventionalSponsorInstituto de Investigación Sanitaria de la Fundación Jiménez DíazRan2013 to 2017Enrolled80ConditionsAnal FistulaArms◦Drug: ASCs. + fibrin glue, fibrin glue
NCT04073472 phase1withdrawnnot on this mapstarted 2021, after this paper: background citation

A Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch

TypeinterventionalSponsorThe Cleveland ClinicRan2021 to 2023Enrolled0ConditionsCrohn's Disease, Fistula, Anal Fistula, Pouch, IlealArmsmesenchymal stem cells (MSCs)
NCT05578508 phase1withdrawnnot on this mapstarted 2022, after this paper: background citation

A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis

TypeinterventionalSponsorThe Cleveland ClinicRan2022 to 2024Enrolled0ConditionsPouchitis, Crohn's Disease, Ulcerative Colitis Chronic, Inflammatory Bowel DiseasesArmsMesenchymal Stem Cells (MSCs)
3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 17 syntheses or guidelines pooled it, 357 citations in OpenAlex.

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  12. 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 · 2019
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95 more citing papers are in PubMed but not listed here.

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 5 institutions in 1 country.

F de la PortillaColoproctology Unit, Gastrointestinal Surgery Department, Virgen del Rocio University Hospital, Avda. Manuel Siurot s/n, 41013 Seville, Spain. delaportilla@ya.com
F Alba
D García-Olmo
J M Herrerías
F X González
A Galindo
Hospital Universitario de Valme · ESHospital Universitario La Paz · ESHospital Universitario Son Espases · ESHospital Universitario Virgen del Rocío · ESHospital Universitario Virgen Macarena · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe management of perianal fistula in patients with Crohn's disease is an extremely challenging medical problem as many fistulas do not respond to available treatments. The objectives were to assess the safety and efficacy of a suspension of expanded adipose-derived allogeneic mesenchymal stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease

methodsAn open-label, single-arm clinical trial was conducted at six Spanish hospitals. Twenty-four patients were administered intralesionally with 20 million eASCs in one draining fistula tract. A subsequent administration of 40 million eASCs was performed if fistula closure was incomplete at week 12. Subjects were followed until week 24 after the initial administration.

resultsTreatment-related adverse events did not indicate any clinical safety concerns after 6 months follow-up. The full analysis of efficacy data at week 24 showed 69.2 % of the patients with a reduction in the number of draining fistulas, 56.3 % of the patients achieved complete closure of the treated fistula achieved, and 30 % of the cases presenting complete closure of all existing fistula tracts. Of note, closure was strictly defined as: absence of suppuration through the external orifice and complete re-epithelization, plus absence of collections measured by magnetic resonance image scan (MRI). Furthermore, MRI Score of Severity showed statistically significant differences at week 12 with a marked reduction at week 24.

conclusionsLocally injected eASCs appear to be a simple, safe, and beneficial therapy for perianal fistula in Crohn's disease patients. Additional studies are needed to further confirm the efficacy of the eASCs.

Indexed as

Stem Cell TransplantationAdipose TissueAdultCell ProliferationCrohn DiseaseDemographyFemaleHumansMaleRectal FistulaStem CellsTime FactorsTransplantation, HomologousTreatment Outcome

Identifiers

PMID23053677
OpenAlexW2136279247

What OpenQuestion holds

Textmetadata
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.