Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn’s disease: a pilot study

医学 脐带 克罗恩病 间充质干细胞 外科 不利影响 干细胞 瘘管 耐火材料(行星科学) 移植 移植物抗宿主病 胃肠病学 内科学 疾病 病理 免疫学 物理 生物 天体生物学 遗传学
作者
Juan Wei,Yufei Zhang,Chunyan Chen,Xiaoyue Feng,Zhao Yang,Jinping Feng,Qiong Jiang,Jinjin Fu,Jianhua Xuan,Hong Gao,Lianming Liao,Fangyu Wang
出处
期刊:Stem Cell Research & Therapy [Springer Nature]
卷期号:14 (1)
标识
DOI:10.1186/s13287-023-03531-0
摘要

The aim of the study was to evaluate the efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells (TH-SC01) for complex perianal fistula in patients with Crohn's disease (CD).This was an open-label, single-arm clinical trial conducted at Jinling Hospital. Adult patients with complex treatment-refractory CD perianal fistulas (pfCD) were enrolled and received a single intralesional injection of 120 million TH-SC01 cells. Combined remission was defined as an absence of suppuration through an external orifice, complete re-epithelization, and absence of collections larger than 2 cm measured by magnetic resonance imaging (MRI) at 24 weeks after cell administration.A total of 10 patients were enrolled. Six patients (60.0%) achieved combined remission at 24 weeks. The number of draining fistulas decreased in 9 (90.0%) and 7 (70.0%) patients at weeks 12 and 24, respectively. Significant improvement in Perianal Crohn Disease Activity Index, Pelvic MRI-Based Score, Crohn Disease Activity Index, and quality of life score were observed at 24 weeks. No serious adverse events occurred. The probability of remaining recurrence-free was 70% at week 52.The study demonstrated that local injection of TH-SC01 cells might be an effective and safe treatment for complex treatment-refractory pfCD after conventional and/or biological treatments fail (ClinicalTrials.gov ID, NCT04939337).The study was retrospectively registered on www.gov (NCT04939337) on June 25, 2021.
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