Evidence map›Paper›PMID 36811811›Full record

ArticleTechniques in coloproctology2023

Deep remission improves the quality of life of patients with Crohn's disease and anoperineal fistula treated with darvadstrocel: results of a French pilot study.

N Fathallah, M Akaffou, M A Haouari, L Spindler, A Alam, A Barré, E Pommaret, A Fels, V de Parades

Erratum issuedAbstract read
PubMed Publisher
In one paragraph

Article in Techniques in coloproctology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
6.0field-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.

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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024
    Review
  11. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

N FathallahDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France. drnadia.fathallah@gmail.com.ORCID http://orcid.org/0000-0002-5219-827X
M AkaffouDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
M A HaouariRadiology Department, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
L SpindlerDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
A AlamDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
A BarréDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
E PommaretDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
A FelsClinical Research Centre, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
V de ParadesDepartment of MedicoSurgical Proctology, Institut Léopold Bellan, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
Hôpital Paris Saint-Joseph · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe injection of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) into anal fistulas in patients with Crohn's disease has never been evaluated in "real-life" conditions in France.

methodsWe prospectively studied the first patients receiving MSC injections at our center and undergoing 12 months of follow-up. The primary endpoint was the clinical and radiological response rate. The secondary endpoints were symptomatic efficacy, safety, anal continence, quality of life (Crohn's anal fistula-quality of life scale, CAF-QoL), and predictive factors of success.

resultsWe included 27 consecutive patients. The complete clinical and radiological response rates at M12 were 51.9% and 50%, respectively. The combined complete clinical-radiological response (deep remission) rate was 34.6%. No major adverse effects or changes in anal continence were reported. The perianal disease activity index decreased from 6.4 to 1.6 (p < 0.001) for all patients. The CAF-QoL score also decreased from 54.0 to 25.5 (p < 0.001). At the end of the study, M12, the CAF-QoL score was significantly lower only in patients with a complete combined clinical-radiological response relative to those without a complete clinical-radiological response (15.0 versus 32.8, p = 0.01). Having a multibranching fistula and infliximab treatment were associated with a combined complete clinical-radiological response.

conclusionsThis study confirms reported efficacy data for the injection of MSC for complex anal fistulas in Crohn's disease. It also shows a positive impact on the quality of life of patients, particularly those for whom a combined clinical-radiological response was achieved.

Indexed as

Crohn DiseaseRectal FistulaHumansPilot ProjectsQuality of LifeTreatment OutcomeAnal fistulasCrohn’s diseaseDeep remissionQuality of lifeStem cells

Identifiers

PMID36811811
OpenAlexW4321479894

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.