Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Adult patients (\>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:
• able to communicate with Danish language
• able to provide informed consent
• having address in the region of southern Denmark during the study
Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Karam M Sørensen, Ph.D
ouh.a.forskningsenheden@rsyd.dk
+4565415190
Backup
Tina D Hansen
ouh.a.forskningsenheden@rsyd.dk
+4565415190
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2028-10-08
Participants
Target number of participants: 75
Treatments
Experimental: Autologous ADRC
Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
Experimental: allogenic ADRC001
Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
Related Therapeutic Areas
Sponsors
Leads: University of Southern Denmark