Stem Cells Treatment of Complex Crohn's Anal Fistula (fistula)
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|ClinicalTrials.gov Identifier: NCT03466515|
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anal Fistula Crohn Disease||Procedure: stem cells injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||pilot study with a maximum of 20 patients|
|Masking:||None (Open Label)|
|Official Title:||Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||December 31, 2020|
Patients enrolled in the study will be treated for their anal fistula by surgical closure of the internal opening, debridement of the fistula and injection of patients own stem cells enriched fatty tissue around the fistula.
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.
- healing [ Time Frame: 6 months ]closure of the fistula with no secretions
- recurrence [ Time Frame: 6 months ]recurrence of the fistula
- time to healing [ Time Frame: 6 months ]time required to healing of the fistula
- major adverse effects [ Time Frame: 6 months ]occurrence of infections, sepsis bleeding and allergy.
- radiological healing [ Time Frame: at 6 months ]Changes on MRI scanning
- functional outcome [ Time Frame: 6 months ]changes in Wexner incontinence score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466515
|Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Karam Matlub, MD||University of Southern Denmark|