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A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

NCT04118088 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-01-22

Study results available
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Summary

The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.

Conditions

Interventions

BIOLOGICAL

Darvadstrocel

Darvadstrocel suspension of human expanded adipose stem cells.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2025-02-14
Completion
2025-02-14
FDA Drug
Yes

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Israel
  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118088 on ClinicalTrials.gov