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

TY - JOUR

T1 - Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease

AU - Dige, Anders

AU - Hougaard, Helene Tarri

AU - Agnholt, Jørgen

AU - Pedersen, Bodil Ginnerup

AU - Tencerova, Michaela

AU - Kassem, Moustapha

AU - Krogh, Klaus

AU - Lundby, Lilli

N1 - Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.

PY - 2019/6

Y1 - 2019/6

N2 - 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.

AB - 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.

KW - Cell- and Tissue-Based Therapy

KW - Crohn's Disease

KW - Perianal Fistulas

KW - Treatment

KW - MANAGEMENT

KW - CLINICAL-TRIAL

KW - STROMAL-VASCULAR FRACTION

KW - MESENCHYMAL STEM-CELLS

U2 - 10.1053/j.gastro.2019.02.005

DO - 10.1053/j.gastro.2019.02.005

M3 - Journal article

C2 - 30772343

SN - 0016-5085

VL - 156

SP - 2208-2216.e1

JO - Gastroenterology

JF - Gastroenterology

IS - 8

ER -