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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

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

Popis výsledku anglicky

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

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

Alimentary Pharmacology &amp; Therapeutics

ISSN

0269-2813

e-ISSN

1365-2036

Svazek periodika

61

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

335-345

Kód UT WoS článku

001347104600001

EID výsledku v databázi Scopus

2-s2.0-85207940994