Evaluation of the Effectiveness and Safety of Mesenchymal Stem Cell Treatment in Fistulising Crohn's Disease: An International Real-Life Retrospective Multicentre Cohort Study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43927677" target="_blank" >RIV/00064173:_____/25:43927677 - isvavai.cz</a>

Result on the web

<a href="https://doi.org/10.1111/apt.18359" target="_blank" >https://doi.org/10.1111/apt.18359</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/apt.18359" target="_blank" >10.1111/apt.18359</a>

Result language

angličtina

Original language name

Evaluation of the Effectiveness and Safety of Mesenchymal Stem Cell Treatment in Fistulising Crohn's Disease: An International Real-Life Retrospective Multicentre Cohort Study

Original language description

Background: Perianal fistulas of Crohn&apos;s disease (CD) create a significant burden on patients&apos; lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. Aims: To examine the usability of darvadstrocel therapy in managing perianal CD. Methods: We enrolled patients with CD and perianal fistulas in this retrospective multicenter study. The primary outcome was perianal clinical remission (defined as all treated fistulas closed) at weeks 26 and 52. Secondary outcomes were clinical response rates (GREATER-THAN OR EQUAL TO 1 fistulas closed), perianal activity (PDAI), patient satisfaction, and adverse events. Data were recorded at baseline and weeks 12, 26 and 52. Prediction of primary outcomes was performed by logistic regression. Results: Overall, among 223 patients (male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until weeks 26 and 52. Baseline PDAI score (OR 0.75), number of fistulas (OR 0.28) and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at weeks 26 and 52. Improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of patients, respectively. Adverse events occurred in 13.5% of patients; perianal abscesses and proctalgia were the most frequently reported. Conclusion: Effectiveness data were higher than in clinical trials. The safety profile was reassuring, and patients&apos; satisfaction was high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30219 - Gastroenterology and hepatology

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Alimentary Pharmacology &amp; Therapeutics

ISSN

0269-2813

e-ISSN

1365-2036

Volume of the periodical

61

Issue of the periodical within the volume

2

Country of publishing house

GB - UNITED KINGDOM

Number of pages

11

Pages from-to

335-345

UT code for WoS article

001347104600001

EID of the result in the Scopus database

2-s2.0-85207940994