Level B· Emerging Clinical EvidenceClinical 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.

Nguyen NT., Phan HT., Le PM., Nguyen LT., Do TT., Phan TT.

Clinical Trial on Type 2 Diabetes, Neuroinflammation, Immune Modulation, published in Trials (2024) — summary generated from the PubMed abstract.

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type: Clinical Trial
Journal: Trials (2024)
Country: England
Reported sample size: —
PMID: 38715140
DOI: 10.1186/s13063-024-08128-3
NCT: NCT05827757

Abstract (original English)

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. 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. 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. AD-MSCs represent a potential intervention to prevent age-related inflammation in patients. ClinicalTrials.gov number is NCT05827757, first registered

What this study does not prove

• This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies exist, but sample sizes, methodology, or follow-up remain limited, so conclusions are not firm.

How we grade evidence

HumansFemaleTransplantation, AutologousMaleMesenchymal Stem Cell TransplantationMiddle AgedAdipose TissueCytokinesInflammationTreatment Outcome

Systemic / IV Type 2 Diabetes Neuroinflammation Immune Modulation

View on PubMed DOI

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.

Abstract (original English)

What this study does not prove

Evidence level

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