Allogeneic expanded adipose‐derived mesenchymal stem cell therapy for perianal fistulas in Crohn’s disease: A case series

Cabalzar-Wondberg, Daniela; Turina, Matthias; Biedermann, Luc; Rogler, Gerhard; Schreiner, Philipp

doi:10.1111/codi.15587

Cited by 22 publications

(23 citation statements)

References 23 publications

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“…Although in ammatory tracts improved in two thirds of the cases by MRI, deep response was observed in only one third of patients. Our results are similar to those of certain previous studies [12,13] but less favorable than those for others [14]. These differences could be explained by a more severe stula pro le (multi-operated, "old", multibranched, associated with anal stricture, in failure of a previous obturation technique in 1/3 of cases) and stronger criteria to analyze the response.…”

Section: Discussionsupporting

confidence: 86%

“…These results led to marketing authorization in Europe and their commercialization (darvadstrocel, Takeda company) in France since 2020. To date, evaluations of this treatment in real-life situations are still limited [12][13][14]. Our objective was to collect data from the initial experience in France in 2 tertiary centers with at least one year of clinical and radiological follow-up.…”

Section: Introductionmentioning

confidence: 99%

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Allogenic stem cells for anal Crohn’s fistula: treating early improves the deep response rate

Fathallah

Siproudhis²,

Akaffou

et al. 2023

Preprint

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Purpose: The aim of this study was to evaluate the real-life clinical and radiological efficacy of darvadstrocel injection into complex perianal fistulas in Crohn’s disease. Secondary endpoints were to assess symptomatic efficacy, outcomes and factors associated with complete combined clinical-radiological response (deep response). Methods: After marketing the product in France, all patients treated consecutively were included. A complete clinical response was defined by a complete closure of all external openings with no discharge on pressure. A partial response was defined by closure of ≥ 50% of external openings with no discharge on pressure. A complete radiological response (MRI), evaluated at least after six months of follow-up, was defined by a completely fibrotic sequela without abscess. Results: Forty-three patients were included (M/F: 22/21, median age 37 [26-45] years). The fistulas of all patients were already drained with seton(s) and were on biologic treatment. After a median follow-up of 383 [359-505] days, 28 (65%) patients showed a clinical response (22 complete and 6 partial). Only 16 (37%) achieved a deep response. The PDAI decreased significantly after treatment: 39 (91%) patients reported symptomatic improvement in terms of discharge, pain, and induration, and 28 (65%) no longer had any perineal symptoms. Only a short history of Crohn’s disease < 3 years was significantly associated with deep response (OD 4.5 [1.0-19.1], p = 0.04). Conclusion: Darvadstrocel injection resulted in a clinical response for two thirds of patients and deep response for one third. A shorter duration of Crohn’s disease was associated with deep response.

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Section: Discussionsupporting

confidence: 86%

Section: Introductionmentioning

confidence: 99%

Allogenic stem cells for anal Crohn’s fistula: treating early improves the deep response rate

Fathallah

Siproudhis²,

Akaffou

et al. 2023

Preprint

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“…But there only one trail in BSCs group decreased the credibility of BSCs’ efficacy. Some studies supported that ASCs are equal even superior to BSCs in terms of immunosuppressive capacity [ 8 , 59 , 60 ]. Subcutaneous adipose tissue is a cradle of ACSs, and liposuction could help obtaining cells easily.…”

Section: Discussionmentioning

confidence: 99%

Mesenchymal stem cells transplantation for perianal fistulas: a systematic review and meta-analysis of clinical trials

Wang

Jiang²,

Zhang

et al. 2023

Stem Cell Res Ther

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Background Perianal fistulas, characterised as granulomatous inflammation of fistulas around the anal canal, are associated with significant morbidity resulting in a negative impact on quality of life and a tremendous burden to the healthcare system. Treatment of anal fistulas usually consists of anal surgery; however, results of closure rates are not satisfactory especially with complex perianal fistulas, after which many patients may suffer from anal incontinence. Recently, the administration of mesenchymal stem cells (MSCs) has shown promising efficacy. Herein, we aim to explore whether MSCs are effective for complex perianal fistulas and if they have either short-term, medium-term, long-term or over-long-term efficacy. Additionally, we want to elucidate whether factors such as drug dosage, MSC source, cell type, and disease aetiology influence treatment efficacy. Main body of the abstract We searched four online databases and analysed data based on information within the clinical trials registry. The outcomes of eligible trials were analysed with Review Manager 5.4.1. Relative risk and related 95% confidence interval were calculated to compare the effect between the MSCs and control groups. In addition, the Cochrane risk of bias tool was applied to evaluate the bias risk of eligible studies. Meta-analyses showed that therapy with MSCs was superior to conventional treatment for complex perianal fistulas in short-, long- and over-long-term follow-up phases. However, there was no statistical difference in treatment efficacy in the medium term between the two methods. Subgroup meta-analyses showed factors including cell type, cell source and cell dosage were superior compared to the control, but there was no significant difference between different experimental groups of those factors. Besides, local MSCs therapy has shown more promising results for fistulas as a result of Crohn’s Disease (CD). Although we tend to maintain that MSCs therapy is effective for cryptoglandular fistulas equally, more studies are needed to confirm this conclusion in the future. Short conclusion MSCs Transplantation could be a new therapeutic method for complex perianal fistulas of both cryptoglandular and CD origin showing high efficacy in the short-term to over-long-term phases, as well as high efficacy in sustained healing. The difference in cell types, cell sources and cell dosages did not influence MSCs’ efficacy.

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“…In den Jahren 2021 bzw. 2023 wurden 3 Studien publiziert, die gewissermaßen "Real World Evidence" außerhalb kontrollierter Studien zur lokalen Stammzellinjektion (Darvadstrocel) beinhalten [31,32,33].…”

Section: "Real-world"-datenunclassified

“…Die Daten wurden am Universitätsspital Zürich erhoben und die Heilungsrate betrug nach einem mittleren Follow-up von 41,5 Wochen 72,7 %, d. h. 8 von 11 Fisteln waren komplett verschlossen. Bei 36,5 % (4/11) traten im Follow-up Perianalabszesse auf [31].…”

Section: "Real-world"-datenunclassified

Stammzelltherapie bei komplexen perianalen Fisteln bei Morbus Crohn: Aktuelle Evidenz und Ausblick

Schwandner

2023

Zentralbl Chir

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ZusammenfassungTrotz Weiterentwicklungen in interdisziplinärer Diagnostik und Therapie stellen komplexe Analfisteln bei Morbus Crohn weiterhin eine Herausforderung für medikamentöse und chirurgische Therapiekonzepte dar. Konventionelle chirurgische Techniken (u. a. Flap, LIFT) sind mit relativ hohen Persistenz- und Rezidivraten vergesellschaftet. Vor diesem Hintergrund zeigen Ergebnisse der Stammzelltherapie eine vielversprechende, sphinkterschonende Therapieoption. Insbesondere die allogene mesenchymale Stammzelltherapie (Darvadstrocel) konnte im Rahmen der randomisierten ADMIRE-CD-Studie eine hohe Wirksamkeit bei komplexen Crohn-Fisteln zeigen, die auch in limitierten „Real-World“-Daten reproduziert werden konnte. Die aktuelle Evidenz der allogenen mesenchymalen Stammzellen hat hierbei auch Einzug in internationale Leitlinien erhalten. Inwieweit die allogene mesenchymale Stammzelltherapie in Zukunft eine effektive Therapieoption im interdisziplinären Management der komplexen perianalen Fistel bei Morbus Crohn darstellt, kann derzeit noch nicht definitiv bewertet werden.

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Allogeneic expanded adipose‐derived mesenchymal stem cell therapy for perianal fistulas in Crohn’s disease: A case series

Cited by 22 publications

References 23 publications

Allogenic stem cells for anal Crohn’s fistula: treating early improves the deep response rate

Allogenic stem cells for anal Crohn’s fistula: treating early improves the deep response rate

Mesenchymal stem cells transplantation for perianal fistulas: a systematic review and meta-analysis of clinical trials

Stammzelltherapie bei komplexen perianalen Fisteln bei Morbus Crohn: Aktuelle Evidenz und Ausblick

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