Safety and efficacy of autologous adipose tissue-derived stem cell transplantation in aging-related low-grade inflammation patients: a single-group, open-label, phase I clinical trial

自体脂肪组织来源的干细胞移植在衰老相关低度炎症患者中的安全性和有效性:一项单组、开放标签、I 期临床试验

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作者:Ngoc-Huynh Ton Nguyen, Hao Thanh Phan, Phong Minh Le, Lan-Huong Thi Nguyen, Thuy Thi Do, Thien-Phuc Thanh Phan, Trinh Van Le, Thanh Minh Dang, Chinh-Nhan Lu Phan, Tung-Loan Thi Dang, Nhung Hai Truong

Background

Inflamm-aging is associated with the rate of aging and is significantly related to diseases such as Alzheimer's disease, Parkinson's disease, atherosclerosis, heart disease, and age-related degenerative diseases such as type II diabetes and osteoporosis. This study aims to evaluate the safety and efficiency of autologous adipose tissue-derived mesenchymal stem cell (AD-MSC) transplantation in aging-related low-grade inflammation patients.

Conclusion

AD-MSCs represent a potential intervention to prevent age-related inflammation in patients.

Methods

This study is a single-group, open-label, phase I clinical trial in which patients treated with 2 infusions (100 million cells i.v) of autologous AD-MSCs were initially evaluated in 12 inflamm-aging patients who concurrently had highly proinflammatory cytokines and 2 of the following 3 diseases: diabetes, dyslipidemia, and obesity. The treatment effects were evaluated based on plasma cytokines.

Results

During the study's follow-up period, no adverse effects were observed in AD-MSC injection patients. Compared to baseline (D-44), the inflammatory cytokines IL-1α, IL-1β, IL-8, IL-6, and TNF-α were significantly reduced after 180 days (D180) of MSC infusion. IL-4/IL-10 at 90 days (D90) and IL-2/IL-10 at D180 increased, reversing the imbalance between proinflammatory and inflammatory ratios in the patients.

Trial registration

ClinicalTrials.gov number is NCT05827757, first registered on 13th Oct 2020.

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