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Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

NCT04075825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-23

Study results available
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Summary

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

Conditions

Interventions

OTHER

Placebo

Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study.

BIOLOGICAL

Darvadstrocel

Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2024-04-02
Completion
2024-04-02
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT04075825 on ClinicalTrials.gov