Stem cell therapy in refractory perineal Crohn's disease: long-term follow-up

Aim: To describe the long-term outcomes of adipose-mesenchymal stem cells, platelet-rich plasma and endorectal advancement flaps in patients with perineal Crohn's disease. Method: This was a single-centre, prospective, observational pilot study performed between March 2013 and December 2016. The study included adult patients diagnosed with perianal Crohn's disease (with complex perianal fistulas) refractory to previous surgical and/or biological treatment. Patients underwent surgical treatment in two stages. Stage 1 consisted of fistula mapping, drainage, seton placement and lipoaspiration to obtain adipose-mesenchymal stem cells. In stage 2 the setons were removed and the fistula tract was debrided. A small endorectal advancement flap was created, with closure of the previous internal fistula opening. Then, 100–120 million adipose-mesenchymal stem cells mixed with platelet-rich plasma were injected into the internal fistula opening and fistula tract. Results: The study included nine patients (seven women), with a median age of 36 years (range 23–57 years). Eleven fistula tracks were treated, of which two were pouch–vaginal fistulas. The median follow-up period was 31 months (range 21–37 months). At the end of the follow-up period, 10/11 (91%) fistulas were completely healed and 1/11 (9%) was partially healed. At the end of this period, there was no evidence of fistula relapse or adverse reactions in any patients. The Perianal Disease Activity Index and Inflammatory Bowel Disease Questionnaire scores significantly improved after the procedure. Conclusion: Combined therapy with adipose-mesenchymal stem cells, platelet-rich plasma and endorectal advancement flaps yielded good results in patients with refractory perineal Crohn's disease.