Stem Cells Treatment of Complex Crohn's Anal Fistula

NACompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Anal FistulaCrohn Disease
Interventions
PROCEDURE

stem cells injection

two surgical interventions as day-surgery, starting with liposuction from the abdomen (about 200-300 ml), and fistula tract debridement and closure of internal opening. The external opening is excised. About 30-40 ml fresh harvested patients own fatty tissue are then injected with large needle around the fistula from internal til external opening.The resting harvested fatty tissue will be sent to stem cells (Adipose Derived Regenrative Cells ADRCs) isolation, using Cytori Celusion system®. When the stem cells isolation is completed, 4ml concentrated stem cells ( contains around 20-40 millions cells ) will be injected around the prepared fistula tract, the same site where the fresh harvested fatty tissue injected before.

Trial Locations (1)

5000

Odense University Hospital, Odense

All Listed Sponsors
collaborator

Odense University Hospital

OTHER

lead

University of Southern Denmark

OTHER

NCT03466515 - Stem Cells Treatment of Complex Crohn's Anal Fistula | Biotech Hunter | Biotech Hunter