1 research outputs found
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up
The aim of this clinical trial (ID Number NCT01803347) was to determine the safety
and efficacy of autologous adipose-derived stem cells (ASCs) for treatment of
cryptoglandular fistula. This research was conducted following an analysis of the mistakes
of a same previous phase III clinical trial. We designed a multicenter, randomized,
single-blind clinical trial, recruiting 57 patients. Forty-four patients were
categorized as belonging to the intent-to-treat group. Of these, 23 patients received
100 million ASCs plus intralesional fibrin glue (group A) and 21 received intralesional
fibrin glue (group B), both after a deeper curettage of tracks and closure of internal
openings. Fistula healing was defined as complete re-epithelialization of external
openings. Those patients in whom the fistula had not healed after 16 weeks were eligible
for retreatment. Patients were evaluated at 1, 4, 16, 36, and 52 weeks and
2 years after treatment. Results were assessed by an evaluator blinded to the type of
treatment. After 16 weeks, the healing rate was 30.4% in group A and 42.8% in
group B, rising to 55.0% and 63.1%, respectively, at 52 weeks. At the end of the
study (2 years after treatment), the healing rate remained at 50.0% in group A and
had reduced to 26.3% in group B. The safety of the cellular treatment was confirmed
and no impact on fecal continence was detected. The main conclusion was that autologous
ASCs for the treatment of cryptoglandular perianal fistula is safe and can favor
long-term and sustained fistula healing.RETIC Program of ISCIII-FEDER, Grant/Award
Numbers: RD16/0011/0005, RD16/0011/0013,
RD16/0011/0015; Spanish Ministry of Health
and Consumer Affairs, Grant/Award Numbers:
EC11/074, EC11/394, EC11/26