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Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease.
Gastroenterology 2019; 156(8):2208-2216.e1G

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.

Authors+Show Affiliations

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: andedige@rm.dk.Department of Surgery, Pelvic Floor Unit, Aarhus University Hospital, Aarhus, Denmark.Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.Department of Radiology, Aarhus University Hospital, Aarhus, Denmark.Molecular Endocrinology and Stem Cell Research Unit, Department of Endocrinology and Metabolism, Odense University Hospital and Institute of Clinical Research, University of Southern Denmark, Denmark.Molecular Endocrinology and Stem Cell Research Unit, Department of Endocrinology and Metabolism, Odense University Hospital and Institute of Clinical Research, University of Southern Denmark, Denmark.Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.Department of Surgery, Pelvic Floor Unit, Aarhus University Hospital, Aarhus, Denmark.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30772343

Citation

Dige, Anders, et al. "Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease." Gastroenterology, vol. 156, no. 8, 2019, pp. 2208-2216.e1.
Dige A, Hougaard HT, Agnholt J, et al. Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2019;156(8):2208-2216.e1.
Dige, A., Hougaard, H. T., Agnholt, J., Pedersen, B. G., Tencerova, M., Kassem, M., ... Lundby, L. (2019). Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology, 156(8), pp. 2208-2216.e1. doi:10.1053/j.gastro.2019.02.005.
Dige A, et al. Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2019;156(8):2208-2216.e1. PubMed PMID: 30772343.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2019/02/14/ PY - 2018/09/18/received PY - 2019/02/06/revised PY - 2019/02/08/accepted PY - 2019/2/18/pubmed PY - 2019/6/30/medline PY - 2019/2/18/entrez KW - Cell- and Tissue-Based Therapy KW - Crohn’s Disease KW - Perianal Fistulas KW - Treatment SP - 2208 EP - 2216.e1 JF - Gastroenterology JO - Gastroenterology VL - 156 IS - 8 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. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/30772343/Efficacy_of_Injection_of_Freshly_Collected_Autologous_Adipose_Tissue_Into_Perianal_Fistulas_in_Patients_With_Crohn's_Disease L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(19)30375-0 DB - PRIME DP - Unbound Medicine ER -