Level B· Emerging clinical evidence with positive signalsRandomized Controlled TrialEurope PMCOpen access

Injection of human umbilical cord mesenchymal stem cells exosomes for the treatment of knee osteoarthritis: from preclinical to clinical research

Wang Y., Kong Y., Du J., Qi L., Liu M., Xie S.

Randomized Controlled Trial on Knee Osteoarthritis, Osteoarthritis, Cartilage Damage, Chronic Inflammation, published in J Transl Med (2025) — summary generated from the PubMed abstract.

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Level B· Emerging clinical evidence with positive signalsEvidence level of this study

Several human studies show positive signals, while research methods and sample sizes continue to develop.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

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
Randomized Controlled Trial
Journal
J Transl Med (2025)
Reported sample size
—
Source database
Europe PMC
PMID
40500748
PMCID
PMC12153132
DOI
10.1186/s12967-025-06623-y
Citations
23

Abstract (original English)

Background Background: Exosomes (Exos) derived from mesenchymal stem cells (MSCs) share similar biological functions with MSCs but are more stable under various pathophysiological conditions, with a lower risk of immune rejection. Human umbilical cord mesenchymal stem cells (hUC-MSCs) are a promising source of MSC-derived exosomes (MSC-Exos), particularly for the treatment of osteoarthritis (OA), a degenerative joint disease characterized by inflammation and cartilage damage. Methods In this study, we conducted in vitro experiments on mouse articular chondrocytes and treated mouse OA models with hUC-MSCs-Exos. To validate the results of hUC-MSCs-Exos in humans, a randomized, double-blind, ascending dose study was conducted to investigate the safety and efficacy of hUC-MSCs-Exos in the treatment of OA, and human chondrocyte toxicity experiments were conducted prior to the clinical trial. Results In this study, we successfully extracted hUC-MSCs and verified their multilineage differentiation ability in different culture media. We then verified the Exos morphology and the expression of CD9, CD63, TSG1, and CALN. In preclinical experiments in vitro and in vivo, we verified that hUC-MSC- Exos can reduce the inflammatory response of articular cartilage and promote its regeneration. Finally, clinical experiments confirmed that hUC-MSC- Exos injection treatment of OA patients did not

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 show positive signals, while research methods and sample sizes continue to develop.

How we grade evidence
Cartilage, ArticularChondrocytesMesenchymal Stem CellsUmbilical CordAnimalsHumansMiceOsteoarthritis, KneeDisease Models, AnimalInflammation

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