印度针对非恶性疾病和非血液学疾病的干细胞治疗方法:一项系统综述。

Stem cell therapy approaches for non-malignant diseases & non-haematological diseases in India: A systematic review.

作者信息

Chavan Chandrashekhar, Ray Suman, Kumar Chandra Mohan

机构信息

Department of Inclusive Health, CSIR-National Institute of Science Communication and Policy Research, New Delhi, India.

Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, India.

出版信息

Indian J Med Res. 2024 Nov;160(5):411-427. doi: 10.25259/ijmr_2141_23.

Abstract

Background & objectives Our study aims to provide the diversity of stem cell use for non-malignant, non-haematological diseases in India through the lens of clinical trials. Methods A PRISMA approach was used to evaluate the safety and efficacy of stem cell use for the period 2001-2021 in India. The outcomes were measured using each disease category, types of stem cells, the origin of stem cells, safety, and efficacy. Results Of the 9206 studies screened, 61 studies that were relevant to stem cell use for non-malignant diseases were included for analysis. Autologous stem cells (75%) were used predominantly compared to allogenic stem cells (18.33%), followed by mixed type (6.67%). Use of bone marrow-derived stem cells (51%) was dominant, followed by melanocytes (19%), adipose (7%), haematopoietic (12%), and (11%) other types of stem cells. The study revealed 37 randomized clinical trial studies conducted in the government research hospital compared to the non-government. Interpretation & conclusions Maintaining the gold standard for stem cell therapy requires randomized clinical trials with large sample sizes, control groups, failures, adverse effects, etc. It is important to have a monitoring and regulation system in stem cell clinical research activities with enough preclinical data and repeated exchanges between the bench and the bedside.

摘要

背景与目的 我们的研究旨在通过临床试验的视角,呈现印度将干细胞用于非恶性、非血液学疾病的多样性。方法 采用PRISMA方法评估2001年至2021年期间印度使用干细胞的安全性和有效性。结果通过每种疾病类别、干细胞类型、干细胞来源、安全性和有效性来衡量。结果 在筛选的9206项研究中,纳入61项与将干细胞用于非恶性疾病相关的研究进行分析。与同种异体干细胞(18.33%)相比,自体干细胞的使用占主导(75%),其次是混合型(6.67%)。骨髓来源干细胞的使用占主导(51%),其次是黑素细胞(19%)、脂肪(7%)、造血干细胞(12%)以及其他类型干细胞(11%)。研究显示,与非政府研究机构相比,政府研究医院开展了37项随机临床试验研究。解读与结论 维持干细胞治疗的金标准需要大样本量、有对照组、有失败案例、有不良反应等的随机临床试验。在干细胞临床研究活动中,拥有一个监测和监管系统很重要,同时要有足够的临床前数据以及实验室与临床之间的反复交流。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18c7/11683502/060d0c3c3f5e/IJMR-160-5-411-g1.jpg

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