Academic Journal
Clinical safety and efficacy of allogenic human adipose mesenchymal stromal cells-derived exosomes in patients with mild to moderate Alzheimer’s disease: a phase I/II clinical trial
| العنوان: | Clinical safety and efficacy of allogenic human adipose mesenchymal stromal cells-derived exosomes in patients with mild to moderate Alzheimer’s disease: a phase I/II clinical trial |
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| المؤلفون: | Xie, Xinyi, Song, Qingxiang, Dai, Chengxiang, Cui, Shishuang, Tang, Ran, Li, Suke, Chang, Jing, Li, Ping, Wang, Jintao, Li, Jianping, Gao, Chao, Chen, Hongzhuan, Chen, Shengdi, Ren, Rujing, Gao, Xiaoling, Wang, Gang |
| المساهمون: | Grant from Shanghai Science and Technology Committee, National Natural Science Foundation of China, Cellular Biomedicine Group, Inc., Ministry of Science and Technology of the People's Republic of China, Natural Science Foundation of Shanghai Municipality |
| المصدر: | General Psychiatry ; volume 36, issue 5, page e101143 ; ISSN 2517-729X |
| بيانات النشر: | BMJ |
| سنة النشر: | 2023 |
| الوصف: | Background There have been no effective treatments for slowing or reversing Alzheimer’s disease (AD) until now. Growing preclinical evidence, including this study, suggests that mesenchymal stem cells-secreted exosomes (MSCs-Exos) have the potential to cure AD. Aims The first three-arm, drug-intervention, phase I/II clinical trial was conducted to explore the safety and efficacy of allogenic human adipose MSCs-Exos (ahaMSCs-Exos) in patients with mild to moderate AD. Methods The eligible subjects were assigned to one of three dosage groups, intranasally administrated with ahaMSCs-Exos two times per week for 12 weeks, and underwent follow-up visits at weeks 16, 24, 36 and 48. Results No adverse events were reported. In the medium-dose arm, Alzheimer’s Disease Assessment Scale–Cognitive section (ADAS-cog) scores decreased by 2.33 (1.19) and the basic version of Montreal Cognitive Assessment scores increased by 2.38 (0.58) at week 12 compared with baseline levels, indicating improved cognitive function. Moreover, the ADAS-cog scores in the medium-dose arm decreased continuously by 3.98 points until week 36. There were no significant differences in altered amyloid or tau deposition among the three arms, but hippocampal volume shrank less in the medium-dose arm to some extent. Conclusions Intranasal administration of ahaMSCs-Exos was safe and well tolerated, and a dose of at least 4×10 8 particles could be selected for further clinical trials. Trial registration number NCT04388982 . |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1136/gpsych-2023-101143 |
| الاتاحة: | http://dx.doi.org/10.1136/gpsych-2023-101143 https://syndication.highwire.org/content/doi/10.1136/gpsych-2023-101143 |
| Rights: | http://creativecommons.org/licenses/by-nc/4.0/ |
| رقم الانضمام: | edsbas.46B1CC00 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/gpsych-2023-101143 |
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