Mesenchymal stromal/stem cell (MSC)-Derived exosomes in clinical trials
Open accessAbstract
Mesenchymal stromal/stem cells (MSCs) are widely utilized in cell therapy because of their robust immunomodulatory and regenerative properties. Their paracrine activity is one of the most important features that contribute to their efficacy. Recently, it has been demonstrated that the production of various factors via extracellular vesicles, especially exosomes, governs the principal efficacy of MSCs after infusion in experimental models. Compared to MSCs themselves, MSC-derived exosomes (MSC-Exos) have provided significant advantages by efficiently decreasing unfavorable adverse effects, such as infusion-related toxicities. MSC-Exos is becoming a promising cell-free therapeutic tool and an increasing number of clinical studies started to assess the therapeutic effect of MSC-Exos in different diseases. In this review, we summarized the ongoing and completed clinical studies using MSC-Exos for immunomodulation, regenerative medicine, gene delivery, and beyond. Additionally, we summarized MSC-Exos production methods utilized in these studies with an emphasis on MSCs source, MSC-Exos isolation methods, characterization, dosage, and route of administration. Lastly, we discussed the current challenges and future directions of exosome utilization in different clinical studies as a novel therapeutic strategy.
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The immunomodulatory function of MSC-Exos significantly declines when BMSCs undergo differentiation into osteoblasts.
“However, the immunomodulatory function of MSC-Exos significantly declines when BMSCs undergo differentiation into osteoblasts.”
From Hydrogel scaffold encapsulating MSC-Exos and ZIF-8 promotes bone regeneration via coordinating osteogenesis and immunomodulation (2025) · cites this paper as [31]
The ‘Therapeutic potential of MSC-Exos in preclinical studies’ section says bone-marrow MSC exosomes can have immunomodulatory effects. The Introduction mentions exosome differences that may relate to MSC differentiation status, but neither passage reports a significant decline in immunomodulatory function when BMSCs differentiate into osteoblasts. Page numbers are unavailable in our copy. (LLM, conf=0.82)
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Self-citation
Flagged first, then by citations
Research works printed but not linked: 3
- [41]Hassanzadeh A Rahman HS Markov A Endjun JJ Zekiy AO Chartrand MS Mesenchymal stem/stromal cell-derived exosomes in regenerative medicine and cancer; Overview of development, challenges, and opportunities Stem Cell Res Therapy. 2021 12 1 297 10.1186/s13287-021-02378-7 PMC8138094 34020704 · DOI
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- [91]Rongjie Guo JJ, chenchen wang, Qi Liang, Kai Hu. MSC-EVs treat dry eye disease by regulating dendritic cells and promoting tissue repair. Invest Ophthalmol Vis Sci 2022;63(7):1978–A0308.
Cited by
Sorted by citations
Kalluri, V. S., Smaglo, B. G., Mahadevan, K. K., Kirtley, M. L., McAndrews, K. M., Mendt, M., Yang, S., Maldonado, A. S., Sugimoto, H., Salvatierra, M. E., et al. (2025) · Nature Communications · doi:10.1038/s41467-025-63718-2 · Cited by 70 · see citing works
Exosomes to exosome-functionalized scaffolds: a novel approach to stimulate bone regeneration
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Si, Y., Li, X., Dong, S., Gao, X., Zhu, Y., Mo, L., Wang, Z., Wang, S., & Zhang, C. (2025) · Bioactive Materials · doi:10.1016/j.bioactmat.2025.08.026 · Cited by 17 · see citing works
“The instability of the immunomodulatory capacity of MSC-Exos makes it challenging to fully satisfy the therapeutic requirements of bone repair in clinical settings [31].”
- Authors
- Lotfy, A., AboQuella, N. M., & Wang, H.
- Affiliations
- Medical University of South Carolina (US)
- Charité – Universitätsmedizin Berlin (DE)
- Corresponding author
- Lotfy, Ahmed
- Venue
- Stem Cell Research & Therapy
- Published
- 2023-04-07
- Volume
- 14
- Issue
- 1
- Pages
- 66-66
- ISSN
- 1757-6512 (ISSN-L)
- PMC
- PMC10079493
- OpenAlex
- W4362659077
- Cited by
- 482
- References
- 98
- Citations by year
- 2026: 141 · 2025: 211 · 2024: 113 · 2023: 17
- FWCI
- 12.69
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Stem Cell Research & Therapy (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK105183, DK120394, DK118529)
- U.S. Department of Veterans Affairs (I01BX004536)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Extracellular vesicles in disease
- Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
- Health Sciences › Medicine › Urology › Periodontal Regeneration and Treatments
- Keywords
- mesenchymal stem cells, exosomes, cell-free therapy, clinical trials, immunomodulation, regenerative medicine, gene delivery, extracellular vesicles, exosome isolation, route of administration, dosage, infusion-related toxicity, paracrine signaling
- MeSH terms
- Extracellular Vesicles, Exosomes, Immunomodulation, Mesenchymal Stem Cells, Cell- and Tissue-Based Therapy
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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