Safety evaluation of repeated intra-articular injections of human adipose-derived mesenchymal stem cells in cynomolgus monkeys .
Chen Z., Lei J., Chen X., Xie H., Dai Y., Bu J.
Laboratory Study, published in iScience (2026) — summary generated from the PubMed abstract.
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
- 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
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
- Laboratory Study
- Journal
- iScience (2026)
- Country
- United States
- Reported sample size
- —
- Source database
- PubMed
- PMID
- 42016311
- PMCID
- PMC13092469
- DOI
- 10.1016/j.isci.2026.115476
Abstract (original English)
Mesenchymal stem cells (MSCs) have demonstrated significant potential in tissue regeneration; however, safety concerns remain a primary barrier to their clinical implementation. To further substantiate and expand upon these safety findings, an exhaustive safety evaluation was performed in non-human primates. No mortalities of cynomolgus monkeys were observed throughout the study. Aside from minor individual parameter fluctuations, no significant toxicological effects were observed in terms of general toxicity indicators, hematological profiles, biochemical analyses, urinalysis, immunological parameters, and macroscopic organ assessments. Both low- and high-dose haMSC groups exhibited mild to moderate inflammatory cell infiltration in the synovium. Biodistribution analysis revealed that haMSC gene copies were detectable exclusively at the injection site and were undetectable by 16 weeks post-final administration. This study affirms the safety profile of high-dose haMSCs following multiple intra-articular injections in non-human primates, offering robust safety data to bolster the clinical application of stem cell therapies in regenerative medicine.
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • This is preclinical work; animal or laboratory results cannot be applied to humans.
Evidence level
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
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