ArticleStem cell research & therapy2024
Manufacturing, quality control, and GLP-grade preclinical study of nebulized allogenic adipose mesenchymal stromal cells-derived extracellular vesicles.
Article in Stem cell research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Extracellular vesicles from mesenchymal stromal cells as a promising therapy for ARDS: a systematic review of preclinical studies.Frontiers in medicine · 2025Pooled it
- Regulatory Challenges and Opportunities for Cell-Derived Extracellular Vesicles in Pharmaceutical Development: A European and Global Perspective.Journal of extracellular vesicles · 2026Review
- Review
- Targeting mitochondrial quality control in osteoarthritis with GrpE-like 1-loaded synovial mesenchymal stromal/stem cell small extracellular vesicles.World journal of stem cells · 2026Article
- The immunomodulatory power of mesenchymal stem/stromal cell-derived extracellular vesicles in bone disorders: A comprehensive review.Clinical and experimental medicine · 2026Review
- Human amniotic mesenchymal stem cell-derived extracellular vesicles improve oocyte quality and embryonic development by increasing antioxidant capacity in aged mice.Journal of ovarian research · 2026Article
- Exosome-nanomaterial hybrid nanomedicine for ischemic stroke: microenvironment-informed design, therapeutic applications, and translational challenges.Frontiers in cellular neuroscience · 2026Review
- Precision Engineering of Extracellular Vesicles as Programmable Carriers for mRNA Therapeutics.International journal of nanomedicine · 2026Review
- Engineering exosomes in the treatment of sensorineural hearing loss: from basic research to clinical applications.Frontiers in molecular neuroscience · 2026Review
- iPSC-derived CAR-NK extracellular vesicles for non-small cell lung cancer: evidence, engineering, and translational barriers.Frontiers in immunology · 2026Review
- Dual role and clinical application of extracellular vesicles in acute respiratory distress syndrome: Mechanism analysis and translational challenges.World journal of stem cells · 2025Review
- Mesenchymal stem cell therapies for ARDS: translational promise and challenges.Stem cell research & therapy · 2025Review
- Therapeutic efficacy of intra-articular injection of human adipose-derived mesenchymal stem cells in a sheep model of knee osteoarthritis.Stem cell research & therapy · 2025Article
- Delivery of miR-26a-5p by Subcutaneous Adipose Tissue-Derived Extracellular Vesicles Alleviates Acute Lung Injury in Mice Through CHUK/NF-κB Pathway.International journal of nanomedicine · 2025Article
Corrections and comments
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Authors and funding
17 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHuman adipose stromal cells-derived extracellular vesicles (haMSC-EVs) have been shown to alleviate inflammation in acute lung injury (ALI) animal models. However, there are few systemic studies on clinical-grade haMSC-EVs. Our study aimed to investigate the manufacturing, quality control (QC) and preclinical safety of clinical-grade haMSC-EVs.
methodshaMSC-EVs were isolated from the conditioned medium of human adipose MSCs incubated in 2D containers. Purification was performed by PEG precipitation and differential centrifugation. Characterizations were conducted by nanoparticle tracking analysis, transmission electron microscopy (TEM), Western blotting, nanoflow cytometry analysis, and the TNF-α inhibition ratio of macrophage [after stimulated by lipopolysaccharide (LPS)]. RNA-seq and proteomic analysis with liquid chromatography tandem mass spectrometry (LC-MS/MS) were used to inspect the lot-to-lot consistency of the EV products. Repeated toxicity was evaluated in rats after administration using trace liquid endotracheal nebulizers for 28 days, and respiratory toxicity was evaluated 24 h after the first administration. In vivo therapeutic effects were assessed in an LPS-induced ALI/ acute respiratory distress syndrome (ARDS) rat model.
resultsThe quality criteria have been standardized. In a stability study, haMSC-EVs were found to remain stable after 6 months of storage at - 80°C, 3 months at - 20 °C, and 6 h at room temperature. The microRNA profile and proteome of haMSC-EVs demonstrated suitable lot-to-lot consistency, further suggesting the stability of the production processes. Intratracheally administered 1.5 × 10
conclusionhaMSC-EVs, as an off-shelf drug, have suitable stability and lot-to-lot consistency. Intratracheally administered haMSC-EVs demonstrated excellent safety at the tested dosages in systematic preclinical toxicity studies. Intratracheally administered haMSC-EVs improved the lung function and exerted anti-inflammatory effects on LPS-induced ALI/ARDS model rats.
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