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

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

April 2, 2024

Study Completion Date

April 2, 2024

Conditions
Crohn's DiseaseComplex Perianal Fistula
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.

Trial Locations (58)

1062

MH Egeszsegugyi Kozpont, Budapest

1088

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Budapest

2018

GZA Sint-Vincentius, Antwerp

3000

UZ Leuven, Leuven

6720

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Szeged

9000

Universitair Ziekenhuis Gent, Ghent

10029

Icahn School of Medicine at Mount Sinai, New York

10075

Lenox Hill Hospital, New York

11030

Northwell Health, Manhasset

17033

Penn State Hershey Medical Center - Surgery, Hershey

21005

H.U.V. del Rocio, Seville

21205

Johns Hopkins School of Medicine, Baltimore

22908

University of Virginia, Charlottesville

28040

Fundacion Jimenez Diaz, Madrid

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

31096

Rambam Medical Centre, Haifa

33136

University of Miami Hospital, Miami

33331

Cleveland Clinic Florida, Fort Lauderdale

33606

USF Health South Tampa Center for Advanced Healthcare, Tampa

33613

AdventHealth Tampa, Tampa

35033

CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti, Rennes

36071

C.H.U. de Pontevedra, Pontevedra

37212

Vanderbilt University Medical Center, Nashville

41124

AOU Policlinico di Modena - Gastroenterologia, Modena

46237

Indiana University - Colon and Rectal, Indianapolis

52621

The Chaim Sheba Medical Center, Tel Litwinsky

54511

CHRU de Brabois Hopitaux de Brabois, Vandœuvre-lès-Nancy

55905

Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery, Rochester

59037

CHRU de Lille - Hopital Claude Huriez - Gastroenterologie, Lille

63003

CHU de Clermont-Ferrand - Estaing, Clermont-Ferrand

66160

University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic, Kansas City

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75010

Hopital Saint Louis, Paris

75014

Paris St. Joseph Hospital, Paris

90048

Cedar-Sinai Medical Center, West Hollywood

94115

University of California San Francisco, San Francisco

98101

Virginia Mason Medical Center - Gastroenterology, Seattle

4941492

Rabin Medical Center, Beilinson Hospital -Gastroenterology, Petah Tikva

9112001

Hadassah Medical Organization, Hadassah Medical Center, Ein-, Jerusalem

06510

Yale University School of Medicine, New Haven

02114

Massachussetts General Hospital - Gastroenterology, Boston

03576

Dartmouth Hitchcock Medical Center - Cancer Center, Lebanon

07960

Morristown Medical Center - Gastroenterology, Morristown

02904

Brown Surgical Associates,Inc., Providence

268 31

NH Hospital a.s., Hořovice

500 05

FN Hradec Kralove, Hradec Králové

H-4032

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika, Debrecen

00168

Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore, Roma

PU A. Gemelli, Universita Cattolica del Sacro Cuore, Roma

50-449

Centrum Medyczne Melita Medical, Wroclaw

02-972

Wielospecjalistyczny Szpital Medicover, Warsaw

07120

Hospital Universitario Son Espases, Palma de Mallorca

08916

H.U. G.Trias i Pujol, Badalona

08208

Parc Tauli Hospital Universitari, Sabadell

08003

Hospital Del Mar, Barcelona

08036

Hospital Clinic De Barcelona, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY