Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
Anal Fistula
Interventions
DRUG

ASCs (Cx401, company code)

"Experimental: ASCs: Subjects will be treated with a dose of 20 million ASCs and evaluated after 12 weeks. If needed a second dose of 40 million ASCs will be applied then.~Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 20 million ASCs plus fibrin glue and evaluated after 12 weeks. If needed a second dose of 40 million ASCs plus fibrin glue will be applied then."

DRUG

Fibrin adhesive

Experimental: Fibrin glue: Subjects will be treated with a dose fibrin glue and evaluated after 12 weeks. If needed a second dose of fibrin glue will be applied then.

Trial Locations (10)

28007

Gregorio Marañon University Hospital, Madrid

28040

San Carlos Clinical Hospital, Madrid

28041

12 De Octubre University Hospital, Madrid

28046

La Paz University Hospital, Madrid

31008

Virgen Del Camino Hospital, Pamplona

46014

Universitary General Hospital, Valencia

59009

Lozano Blesa Clinical Hospital, Zaragoza

D-68135

Universitary Clinical Surgery, Mannheim

08221

Mutua de Terrasa Hospital, Tarrasa

Unknown

John Radcliff Hospital, Oxford

All Listed Sponsors
lead

Tigenix S.A.U.

INDUSTRY

NCT00475410 - Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease | Biotech Hunter | Biotech Hunter