First‐in‐human clinical trial of allogeneic, platelet‐derived extracellular vesicles as a potential therapeutic for delayed wound healing
Open accessAbstract
The release of growth factors, cytokines and extracellular matrix modifiers by activated platelets is an important step in the process of healthy wound healing. Extracellular vesicles (EVs) released by activated platelets carry this bioactive cargo in an enriched form, and may therefore represent a potential therapeutic for the treatment of delayed wound healing, such as chronic wounds. While EVs show great promise in regenerative medicine, their production at clinical scale remains a critical challenge and their tolerability in humans is still to be fully established. In this work, we demonstrate that Ligand-based Exosome Affinity Purification (LEAP) chromatography can successfully isolate platelet EVs (pEVs) of clinical grade from activated platelets, which retain the regenerative properties of the parent cell. LEAP-isolated pEVs display the expected biophysical features of EV populations and transport essential proteins in wound healing processes, including insulin growth factor (IGF) and transforming growth factor beta (TGF-ß). In vitro studies show that pEVs induce proliferation and migration of dermal fibroblasts and increase dermal endothelial cells' angiogenic potential, demonstrating their wound healing potential. pEV treatment activates the ERK and Akt signalling pathways within recipient cells. In a first-in-human, double-blind, placebo-controlled, phase I clinical trial of healthy volunteer adults, designed primarily to assess safety in the context of wound healing, we demonstrate that injections of LEAP-purified pEVs in formulation buffer are safe and well tolerated (Plexoval II study, ACTRN12620000944932). As a secondary objective, biological activity in the context of wound healing rate was assessed. In this cohort of healthy participants, in which the wound bed would not be expected to be deficient in the bioactive cargo that pEVs carry, all wounds healed rapidly and completely and no difference in time to wound closure of the treated and untreated wounds was observed at the single dose tested. The outcomes of this study evidence that pEVs manufactured through the LEAP process can be injected safely in humans as a potential wound healing treatment, and warrant further study in clinical trials designed expressly to assess therapeutic efficacy in patients with delayed or disrupted wound healing.
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More recent clinical studies using topical MSC-derived or platelet-derived EVs have reported accelerated wound healing, improved texture, reduced erythema, and increased collagen synthesis.
“More recent clinical studies using topical MSC-derived or platelet-derived EVs have reported accelerated wound healing, improved texture, reduced erythema, and increased collagen synthesis [24,25].”
From A 28-Day Pilot Study of the Effects on Facial Skin Hydration, Elasticity, and Texture of a Centella asiatica Extracellular Vesicle-Based Skin Care Formulation (2025) · cites this paper as [24]
The Results (Safety of clinical pEVs; page unavailable) report the same mean healing time, 22.8 ± 8.7 days, for platelet-EV-treated and placebo wounds—not accelerated healing. The Methods (Clinical trial procedure; page unavailable) say the EVs were injected beside the wounds, not applied topically. The paper does not report improved texture, reduced erythema, or increased collagen synthesis as clinical outcomes. (LLM, conf=0.89)
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- Authors
- Johnson, J., Law, S. Q. K., Shojaee, M., Hall, A. S., Bhuiyan, S., Lim, M. B. L., Silva, A., Kong, K. J. W., Schoppet, M., Blyth, C., Ranasinghe, H. N., Sejic, N., Chuei, M. J., Tatford, O. C., Cifuentes‐Rius, A., James, P. F., Tester, A., Dixon, I., & Lichtfuss, G.
- Affiliations
- The University of Melbourne (AU)
- Exopharm Ltd Melbourne VIC Australia
- Corresponding author
- Lichtfuss, Gregor
- ORCID
- Venue
- Journal of Extracellular Vesicles
- Publisher
- Wiley
- Published
- 2023-06-23
- Volume
- 12
- Issue
- 7
- Pages
- e12332-e12332
- ISSN
- 2001-3078 (ISSN-L)
- PMC
- PMC10290200
- OpenAlex
- W4381839301
- Cited by
- 188
- References
- 50
- Citations by year
- 2026: 46 · 2025: 71 · 2024: 62 · 2023: 9
- FWCI
- 16.84
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Extracellular Vesicles (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Extracellular vesicles in disease
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Health Sciences › Medicine › Urology › Periodontal Regeneration and Treatments
- Keywords
- platelet-derived extracellular vesicles, delayed wound healing, chronic wounds, platelet activation, insulin-like growth factor, TGF-beta, angiogenesis, ERK signaling, Akt signaling, safety and tolerability, wound closure
- MeSH terms
- Extracellular Vesicles, Adult, Blood Platelets, Humans, Wound Healing, Hematopoietic Stem Cell Transplantation, Endothelial Cells
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