Long-term clinical outcomes of stem cell-based interventions in Crohn's-related perianal fistula: A systematic review and meta-analysis.

چکیده اصلی

BACKGROUND: Perianal fistulas are a debilitating complication of Crohn's disease, frequently refractory to conventional medical and surgical therapy. Stem cell-based interventions, particularly mesenchymal stem cells (MSCs), have emerged as a promising therapeutic alternative, yet long-term outcomes remain uncertain. METHODS: Web of Science, PubMed, Embase, Scopus, and the Cochrane Library were searched through September 1, 2024. Studies evaluating stem cell or stem cell-derived products for Crohn's disease-associated perianal fistulas with ≥12 months' follow-up were included. Efficacy outcomes included clinical and radiological healing and recurrence; safety outcomes encompassed adverse events, infections, malignancies and mortality. Meta-analyses were conducted using random-effects models. The primary analysis was restricted to RCTs, while observational and early-phase studies were analysed separately. An exploratory pooled estimate across all study designs was also performed. RESULTS: Eighteen studies comprising 750 patients were included, with follow-up ranging from 12 months to 4 years. In the primary analysis of RCTs, the pooled long-term healing rate was 59% (95% CI, 51%-67%), with no observed heterogeneity (I2 = 0%). Observational and early-phase studies demonstrated broadly comparable healing rates but with greater heterogeneity and a higher risk of bias. An exploratory pooled analysis across all studies yielded an overall healing rate of 63% (95% CI 55%-70%), although this estimate should be interpreted with caution due to differences in study design. Safety profiles were favourable across studies. No treatment-related deaths and no definitively therapy-associated malignancies were identified. CONCLUSIONS: Stem cell-based therapy is a safe and effective long-term treatment option for Crohn's disease associated perianal fistulas, achieving durable closure in approximately two-thirds of patients.

ترجمه فارسی چکیده

پس‌زنی‌های پیرانال، یک عارضه ناتوان‌کننده در بیماری کرون هستند که اغلب به درمان‌های پزشکی و جراحی معمولی پاسخ نمی‌دهند. مداخلات مبتنی بر سلول‌های بنیادی، به‌ویژه سلول‌های بنیادی مزانشیمی (MSC)، به عنوان یک جایگزین درمانی امیدوارکننده ظهور کرده‌اند، اما نتایج بلندمدت هنوز نامشخص است. در این مرور سیستماتیک و متاآنالیز، مطالعات ارزیابی‌کننده سلول‌های بنیادی یا محصولات مشتق‌شده از آن‌ها برای فیستول‌های پیرانال مرتبط با بیماری کرون با پیگیری حداقل ۱۲ ماهه شامل شدند. شاخص‌های اثربخشی شامل بهبودی بالینی و رادیولوژیک و بازگشت بیماری بودند. پروفایل ایمنی مطالعات در مجموع مطلوب بود و هیچ مرگ‌ومیری مرتبط با درمان و هیچ سرطانی قطعی مرتبط با درمان شناسایی نشد. نتیجه‌گیری کلی این است که درمان مبتنی بر سلول‌های بنیادی یک گزینه درمانی ایمن و مؤثر بلندمدت برای فیستول‌های پیرانال مرتبط با بیماری کرون است که منجر به بسته شدن پایدار در حدود دو سوم بیماران می‌شود.

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