Safety and efficacy of stem cell therapy for Crohn's disease: An umbrella review of systematic reviews.

IF 12.5 2区 医学 Q1 SURGERY International journal of surgery Pub Date : 2024-10-01 DOI:10.1097/JS9.0000000000002104
Lakshmi Thangavelu, Syam Mohan, Hassan Ahmad Alfaifi, Abdullah Farasani, Soumya V Menon, Pooja Bansal, Chhavi Choudhary, M Ravi Kumar, Raghav Vashishth, Afrah Majeed Ahmed Al-Rihaymee, Sarvesh Rustagi, Anil K Malhotra, Muhammed Shabil, Mahalaqua Nazli Khatib, Quazi Syed Zahiruddin, Siddig Ibrahim Abdelwahab, Ganesh Bushi, Saleh Hussain A Almasabi, Hayam A Alrasheed, Ali A Rabaan
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Abstract

Background: Crohn's disease is a chronic, relapsing form of inflammatory bowel disease marked by severe gastrointestinal inflammation and a broad range of debilitating symptoms. Despite advances in medical treatments, achieving sustained remission remains challenging for many patients. This umbrella review aims to consolidate evidence from various systematic reviews to evaluate the efficacy and safety of stem cell therapies in treating Crohn's disease.

Methods: This review followed the Joanna Briggs Institute methodology and adhered to PRISMA guidelines. A literature search of PubMed, Web of Science, Embase, and the Cochrane Library covered records up to April 20, 2024. Only systematic reviews and meta-analyses on stem cell therapy for Crohn's disease were considered. Data were extracted and analyzed for clinical efficacy indicators like remission induction and safety metrics, including adverse events and mortality rates.

Results: Sixteen systematic reviews were included, spanning studies conducted between 2009 and 2023. Stem cell therapy showed a pooled risk ratio (RR) of 1.299 (95% CI: 1.192 to 1.420) for clinical remission, indicating a 29.9% increased likelihood of remission compared to controls. The pooled RR for healing perianal Crohn's disease was 1.358 (95% CI: 1.13 to 1.631), suggesting a 35.8% increased likelihood of healing. A pooled RR of 1.481 (95% CI: 1.036 to 2.116) shows a 48.1% higher immediate fistula closure rate with stem cell therapy. For long-term outcomes, a RR of 1.422 (95% CI: 1.091 to 1.854) indicates a 42.2% increased likelihood of maintaining closure. However, stem cell therapy did not significantly impact Crohn's Disease Activity Index (CDAI) (RR: 1.154, 95% CI: 0.193 to 6.883) and Perianal Disease Activity Index (PDAI) scores (mean difference at 12 weeks: -0.505, 95% CI: -2.481 to 1.471; mean difference at 24 weeks: -0.338, 95% CI: -1.638 to 0.963). The safety profile was comparable to conventional therapies, with a pooled RR of 0.972 (95% CI: 0.739 to 1.278) for adverse events and 1.136 (95% CI: 0.821 to 1.572) for serious adverse events.

Conclusion: Stem cell therapy offers significant progress in treating Crohn's disease, particularly in complex cases, by improving fistula closure rates and suggesting potential as a supplementary therapy. Its safety profile aligns with conventional treatments, yet ongoing clinical trials are crucial to optimize its use. Continual research will enable healthcare providers to tailor more effective treatment strategies for this challenging condition.

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干细胞疗法治疗克罗恩病的安全性和有效性:系统综述总览。
背景:克罗恩病是一种慢性、复发性炎症性肠病,以严重的胃肠道炎症和一系列使人衰弱的症状为特征。尽管医学治疗取得了进步,但对于许多患者来说,实现持续缓解仍是一项挑战。本综述旨在整合各种系统综述的证据,评估干细胞疗法治疗克罗恩病的疗效和安全性:本综述采用乔安娜-布里格斯研究所(Joanna Briggs Institute)的方法,并遵守PRISMA指南。PubMed、Web of Science、Embase和Cochrane图书馆的文献检索涵盖了截至2024年4月20日的记录。只考虑了有关干细胞治疗克罗恩病的系统综述和荟萃分析。提取数据并分析临床疗效指标(如缓解诱导)和安全性指标(包括不良事件和死亡率):结果:共纳入16篇系统综述,研究时间跨度为2009年至2023年。干细胞疗法的临床缓解风险比(RR)为 1.299(95% CI:1.192 至 1.420),与对照组相比,缓解的可能性增加了 29.9%。肛周克罗恩病痊愈的总RR为1.358(95% CI:1.13至1.631),表明痊愈的可能性增加了35.8%。综合RR为1.481(95% CI:1.036至2.116),显示干细胞疗法的即时瘘管闭合率提高了48.1%。长期结果的RR为1.422(95% CI:1.091至1.854),显示维持闭合的可能性增加42.2%。不过,干细胞疗法对克罗恩病活动指数(CDAI)(RR:1.154,95% CI:0.193 至 6.883)和肛周疾病活动指数(PDAI)评分(12 周时的平均差异:-0.505,95% CI:0.193 至 6.883)没有明显影响:12周时的平均差异为-0.505,95% CI:-2.481 至 1.471;24周时的平均差异为-0.338,95% CI:-2.481 至 1.471:-0.338,95% CI:-1.638 至 0.963)。安全性与传统疗法相当,不良事件的汇总RR为0.972(95% CI:0.739至1.278),严重不良事件的汇总RR为1.136(95% CI:0.821至1.572):干细胞疗法在治疗克罗恩病(尤其是复杂病例)方面取得了重大进展,提高了瘘管闭合率,并显示出作为辅助疗法的潜力。干细胞疗法的安全性与传统疗法一致,但持续的临床试验对于优化干细胞疗法的使用至关重要。持续的研究将使医疗服务提供者能够为这种具有挑战性的疾病量身定制更有效的治疗策略。
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来源期刊
CiteScore
17.70
自引率
3.30%
发文量
0
审稿时长
6-12 weeks
期刊介绍: The International Journal of Surgery (IJS) has a broad scope, encompassing all surgical specialties. Its primary objective is to facilitate the exchange of crucial ideas and lines of thought between and across these specialties.By doing so, the journal aims to counter the growing trend of increasing sub-specialization, which can result in "tunnel-vision" and the isolation of significant surgical advancements within specific specialties.
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