Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn’s Disease

Abstract Background and aims Perianal fistulas are common in patients with Crohn´s disease (CD). Injections of cultured autologous and allogeneic adipose tissue-derived stem cells have been shown to heal CD-associated fistulas. Unfortunately, this treatment is time-consuming and expensive. We investigated the effects of injecting freshly collected autologous adipose tissue into perianal fistulas in patients with CD. Methods In a prospective interventional study freshly collected autologous adipose tissues were injected into complex perianal fistulas of 21 patients with CD, from March 2015 through June 2018. The primary endpoint was complete fistula healing (no symptoms of discharge, no visible external fistula opening in the perineum, and no internal opening detected by rectal digital examination) 6 months after the last injection. We performed pelvic magnetic resonance imaging (MRI) to confirm fistula resolution in patients with inter-sphincter and trans-sphincter fistulas who demonstrated complete healing at clinical examination. Patients without complete fistula healing after 6 weeks and those with later relapse were offered additional injections. No controls were included. Results Six months after the last adipose tissue injection, 12 patients (57%) had complete fistula healing. Three patients (14%) had ceased fistula secretion and 1 patient (5%) reported reduced secretion. Among 10 patients with trans-sphincter or inter-sphincter fistulas, MRI revealed complete fistula resolution in 9 patients and a markedly reduced gracile fistula in the remaining patient. Of the 12 patients with complete fistula healing, 9 (43% of total) required 1 injection, 2 patients (10% of total) required 2 injections, and 1 patient (5% of total) required 3 injections. The predominant adverse effect of was post-procedure proctalgia lasting a few days. Two patients developed small abscesses, 1 had urinary retention, and 1 had minor bleeding during liposuction. Conclusion In a study of 21 patients with CD and perianal fistulas, we found injection of recently collected autologous adipose tissue to be safe and result in complete fistula healing in 57% of the patients. ClinicalTrials.gov no: NCT03803917