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Clinical Trial
. 2024 May 8;25(1):309.
doi: 10.1186/s13063-024-08128-3.

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

Ngoc-Huynh Ton Nguyen  1 , Hao Thanh Phan  1 , Phong Minh Le  1 , Lan-Huong Thi Nguyen  1 , Thuy Thi Do  1 , Thien-Phuc Thanh Phan  1 , Trinh Van Le  2   3 , Thanh Minh Dang  2   3 , Chinh-Nhan Lu Phan  4   3 , Tung-Loan Thi Dang  5   3 , Nhung Hai Truong  6   7
Affiliations
Clinical Trial

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

Ngoc-Huynh Ton Nguyen et al. Trials. .

Abstract

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.

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.

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

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

Keywords: Immune modulation; Inflamm-aging; Inflammatory; Mesenchymal stem cell; Proinflammatory.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study time points
Fig. 2
Fig. 2
The effect of adipose stem cell transplantation on inflammatory cytokines in patients. Baseline (D-44), 90 days (D90), and 180 days (D180) after stem cell transplant; the patient’s inflammatory cytokines level were compared to their D-44 at D90 and D180 after transplant. A Interleukin 1α. B Interleukin 1β. C Interleukin 2. D Interleukin 8. E Interleukin 6. F Tumor necrosis factor α. G Interferon γ. H Vascular endothelial growth factor. The Wilcoxon signed-rank test was used to compare D90 and D180 with the D-44, and a p-value < 0.05 was considered statistically significant
Fig. 3
Fig. 3
Anti-inflammatory cytokine effects of adipose stem cell transplantation in patients. The patients’ anti-inflammatory cytokines at D-44, D90, and D180 after stem cell transplant. A Interleukin 4. B Interleukin 10. C Monocyte chemoattractant protein-1. D Epidermal growth factor. The Wilcoxon signed-rank test was used to compare D90 and D180 with the baseline (D-44), and a p-value < 0.05 was considered statistically significant
See this image and copyright information in PMC

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