Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease
Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease
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DOI：
10.1053/j.gastro.2019.02.005
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发表时间：
2019-06-01
期刊：
影响因子：
29.4
通讯作者：
Lundby, Lilli
中科院分区：
文献类型：
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作者：
Dige, Anders;Hougaard, Helene Tarri;Lundby, Lilli
背景与目的：肛周瘘在克罗恩病（CD）患者中很常见。注射培养的自体和异体脂肪组织来源的干细胞已被证明可以治愈cd相关的瘘管。不幸的是，这种治疗既耗时又昂贵。方法：在一项前瞻性介入研究中，从2015年3月至2018年6月，将新鲜采集的自体脂肪组织注射到21例CD患者的复杂肛周瘘管中。主要终点为末次注射后6个月瘘管完全愈合（无排泄症状，会阴部未见外瘘开口，直肠指检未见内瘘开口）。我们对临床检查显示完全愈合的括约肌间瘘和括约肌间瘘患者进行盆腔磁共振成像以确认瘘的消退。6周后瘘管未完全愈合的患者和后来复发的患者给予额外的注射。不包括对照个体。结果：最后一次脂肪组织注射后6个月，12例患者（57%）瘘完全愈合。3例（14%）患者停止分泌瘘管，1例（5%）患者报告分泌减少。在10例经括约肌或括约肌间瘘管患者中，磁共振成像显示9例患者瘘管完全消退，其余患者细端瘘管明显缩小。在12例瘘管完全愈合的患者中，9例（43%）需要1次注射，2例（10%）需要2次注射，1例（5%）需要3次注射。主要的不良反应是术后持续数天的直痛。2例出现小脓肿，1例出现尿潴留，1例在抽脂过程中出现轻微出血。结论：在对21例CD伴肛周瘘管患者的研究中，我们发现注射近期采集的自体脂肪组织是安全的，57%的患者瘘管完全愈合。ClinicalTrials.gov，编号：NCT03803917。
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 trans-sphincter 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 intersphincter 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.