A Survey of Darvadstrocel in People With Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2029-12-31

Brief Summary

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This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Darvadstrocel

Darvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care.

Darvadstrocel

Intervention Type BIOLOGICAL

Darvadstrocel injection

Interventions

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Darvadstrocel

Darvadstrocel injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Cx601

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.

Exclusion Criteria None

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No