Alofisel-5003: An Observational Post-Marketing Study on the Effectiveness and Safety of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistulas (INSPIRE)

First published 17/09/2018

Last updated 19/11/2025

EU PAS number:

EUPAS24267

Study

Finalised

Documents

Study protocol

Initial protocol

Alofisel-5003-clinical-study-protocol-redact1.pdf

English (8.75 MB - PDF) View document

Updated protocol

Alofisel-5003-clinical-study-protocol-redact.pdf

First published: 04/11/2025

English (4.18 MB - PDF) View document

Study results

Alofisel-5003-clinical-study-report-redact.pdf

English (731.59 KB - PDF) View document

Study report

Other information

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