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

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

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.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adipose Tissue*
  • Adult
  • Age Factors
  • Aged
  • Aging
  • Cytokines* / blood
  • Female
  • Humans
  • Inflammation Mediators / blood
  • Inflammation* / blood
  • Male
  • Mesenchymal Stem Cell Transplantation* / adverse effects
  • Mesenchymal Stem Cell Transplantation* / methods
  • Middle Aged
  • Time Factors
  • Transplantation, Autologous*
  • Treatment Outcome

Substances

  • Cytokines
  • Inflammation Mediators

Associated data

  • ClinicalTrials.gov/NCT05827757