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

Anders Dige, Helene Tarri Hougaard, Jørgen Agnholt, Bodil Ginnerup Pedersen, Michaela Tencerova, Moustapha Kassem, Klaus Krogh, Lilli Lundby

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Background & 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 to confirm fistula resolution in patients with intersphincter and transsphincter fistulas who showed complete healing at clinical examination. Patients without complete fistula healing after 6 weeks and those with later relapse were offered additional injections. No control individuals 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, magnetic resonance imaging showed 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%)required 1 injection, 2 (10%)required 2 injections, and 1 (5%)required 3 injections. The predominant adverse effect was postprocedure 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 to result in complete fistula healing in 57% of patients. ClinicalTrials.gov, Number: NCT03803917.

OriginalsprogEngelsk
TidsskriftGastroenterology
Vol/bind156
Udgave nummer8
Sider (fra-til)2208-2216.e1
ISSN0016-5085
DOI
StatusUdgivet - 1. jun. 2019

Fingeraftryk

Crohn Disease
Adipose Tissue
Cutaneous Fistula
Lipectomy
Perineum
Urinary Retention

Bibliografisk note

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

Citer dette

Dige, Anders ; Hougaard, Helene Tarri ; Agnholt, Jørgen ; Pedersen, Bodil Ginnerup ; Tencerova, Michaela ; Kassem, Moustapha ; Krogh, Klaus ; Lundby, Lilli. / Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. I: Gastroenterology. 2019 ; Bind 156, Nr. 8. s. 2208-2216.e1.
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title = "Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease",
abstract = "Background & 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 to confirm fistula resolution in patients with intersphincter and transsphincter fistulas who showed complete healing at clinical examination. Patients without complete fistula healing after 6 weeks and those with later relapse were offered additional injections. No control individuals 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, magnetic resonance imaging showed 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{\%})required 1 injection, 2 (10{\%})required 2 injections, and 1 (5{\%})required 3 injections. The predominant adverse effect was postprocedure 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 to result in complete fistula healing in 57{\%} of patients. ClinicalTrials.gov, Number: NCT03803917.",
keywords = "Cell- and Tissue-Based Therapy, Crohn's Disease, Perianal Fistulas, Treatment",
author = "Anders Dige and Hougaard, {Helene Tarri} and J{\o}rgen Agnholt and Pedersen, {Bodil Ginnerup} and Michaela Tencerova and Moustapha Kassem and Klaus Krogh and Lilli Lundby",
note = "Copyright {\circledC} 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.",
year = "2019",
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day = "1",
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language = "English",
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Dige, A, Hougaard, HT, Agnholt, J, Pedersen, BG, Tencerova, M, Kassem, M, Krogh, K & Lundby, L 2019, 'Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease', Gastroenterology, bind 156, nr. 8, s. 2208-2216.e1. https://doi.org/10.1053/j.gastro.2019.02.005

Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. / Dige, Anders; Hougaard, Helene Tarri; Agnholt, Jørgen; Pedersen, Bodil Ginnerup; Tencerova, Michaela; Kassem, Moustapha; Krogh, Klaus; Lundby, Lilli.

I: Gastroenterology, Bind 156, Nr. 8, 01.06.2019, s. 2208-2216.e1.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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 - 2019/6/1

Y1 - 2019/6/1

N2 - Background & 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 to confirm fistula resolution in patients with intersphincter and transsphincter fistulas who showed complete healing at clinical examination. Patients without complete fistula healing after 6 weeks and those with later relapse were offered additional injections. No control individuals 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, magnetic resonance imaging showed 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%)required 1 injection, 2 (10%)required 2 injections, and 1 (5%)required 3 injections. The predominant adverse effect was postprocedure 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 to result in complete fistula healing in 57% of patients. ClinicalTrials.gov, Number: NCT03803917.

AB - Background & 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 to confirm fistula resolution in patients with intersphincter and transsphincter fistulas who showed complete healing at clinical examination. Patients without complete fistula healing after 6 weeks and those with later relapse were offered additional injections. No control individuals 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, magnetic resonance imaging showed 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%)required 1 injection, 2 (10%)required 2 injections, and 1 (5%)required 3 injections. The predominant adverse effect was postprocedure 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 to result in complete fistula healing in 57% of patients. ClinicalTrials.gov, Number: NCT03803917.

KW - Cell- and Tissue-Based Therapy

KW - Crohn's Disease

KW - Perianal Fistulas

KW - Treatment

U2 - 10.1053/j.gastro.2019.02.005

DO - 10.1053/j.gastro.2019.02.005

M3 - Journal article

C2 - 30772343

VL - 156

SP - 2208-2216.e1

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 8

ER -