Evidence map›Paper›PMID 36149832›Full record

Trial reportJournal of Crohn's & colitis2023

Darvadstrocel for Complex Perianal Fistulas in Japanese Adults with Crohn's Disease: A Phase 3 Study.

Satomi Furukawa, Tsunekazu Mizushima, Ryo Nakaya, Mari Shibata, Takayoshi Yamaguchi, Kenji Watanabe, Kitaro Futami

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03706456 (A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease), which is not on this map. Cited by 25 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 4 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT03706456 phase3completednot on this map

A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease

TypeinterventionalSponsorTakedaRan2019 to 2023Enrolled22ConditionsComplex Perianal Fistulas in Adult Participants With Crohn's DiseaseArmsDarvadstrocel
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Satomi FurukawaDepartment of Coloproctology, JCHO Tokyo Yamate Medical Center, Shinjuku, Tokyo, Japan.
Tsunekazu MizushimaDepartment of Therapeutics for Inflammatory Bowel Diseases, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Ryo NakayaTakeda Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Mari ShibataTakeda Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Takayoshi YamaguchiTakeda Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Kenji WatanabeCenter for Inflammatory Bowel Disease, Division of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.ORCID 0000-0002-3781-4724
Kitaro FutamiDepartment of Surgery, Center for Clinical Medical Research, Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, Japan.
Takeda (Japan) · JPFukuoka University · JPHyogo Medical University · JPThe University of Osaka · JPTokyo Yamate Medical Center · JP

Funding

Takeda Pharmaceutical Company
6 · The paper itself

Abstract

BACKGROUND AND

aimsPrevious studies conducted in Europe suggested that darvadstrocel, a suspension of expanded, allogeneic, adipose-derived, mesenchymal stem cells, is safe and effective for treatment-refractory complex perianal fistulas in patients with Crohn's disease. The aim of this study was to evaluate the efficacy and safety of darvadstrocel for the treatment of complex perianal fistulas in Japanese adults with Crohn's disease.

methodsThis is a phase 3, open-label, single-arm study conducted at nine sites in Japan. Adult patients with non-active or mildly active Crohn's disease and complex perianal fistulas received a single 24-mL intralesional injection of darvadstrocel [120 × 106 cells]. The primary endpoint was combined remission (clinically confirmed closure of all treated external openings that were draining at screening, and absence of collections >2 cm, [confirmed by magnetic resonance imaging] among treated fistulas) at Week 24.

resultsBetween March 6, 2019 and February 1, 2021, 22 patients received darvadstrocel and completed the 52-week follow-up. The proportion of patients achieving combined remission at Week 24 was 59.1% (95% confidence interval [CI], 38.5-79.6). The effect was maintained at Week 52, with 68.2% [95% CI, 48.7-87.6] of patients achieving combined remission. Treatment-related adverse events included: one [4.5%] patient with worsening of Crohn's disease and diarrhoea, and one [4.5%] patient with blood bilirubin increase. No new safety findings were identified in this study.

conclusionsThe efficacy and tolerability of darvadstrocel in Japanese adult patients with treatment-refractory complex perianal fistulas in Crohn's disease were similar to those observed in the previous European study. ClinicalTrials.gov number, NCT03706456.

Indexed as

Crohn DiseaseMesenchymal Stem Cell TransplantationRectal FistulaAdultEast Asian PeopleHumansTreatment OutcomeCrohn’s diseaseDarvadstrocelperianal fistula

Identifiers

PMID36149832
PMCPMC10069615
OpenAlexW4296793588

What OpenQuestion holds

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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.