A systematic review of published clinical studies using cell-derived extracellular vesicles: A focus on efficacy in COVID-19 and wound healing.
Summary
In the wound healing subset, no controlled studies of MSC-EVs were available and two controlled studies of non-MSC EVs showed no clear benefit, underscoring uncertainty of efficacy. EV administration appeared generally tolerable, but incomplete adverse event reporting precludes firm safety conclusions.
Key Findings
- Wound healing comprised 5 of 25 trials (20%), with no controlled studies of MSC-EVs.
- Two controlled studies of non-MSC EVs in wound healing reported no clear efficacy.
- Ultracentrifugation was the primary isolation method in 68% of trials, reflecting methodological heterogeneity.
- Safety reporting was often incomplete, limiting risk assessment.
Clinical Implications
EVs should not be adopted for wound healing outside trials; standardization of EV sourcing, isolation, dosing, and endpoints is essential before clinical use.
Why It Matters
Clarifies that current clinical evidence does not yet support EVs for wound healing and highlights methodological heterogeneity impeding translation.
Limitations
- No controlled MSC-EV trials in wound healing; small and heterogeneous studies.
- Outcome measures and safety reporting were not standardized.
Future Directions
Develop consensus standards for EV production and reporting; initiate randomized, controlled wound healing trials with mechanistic endpoints and long-term follow-up.
Study Information
- Study Type
- Systematic Review
- Research Domain
- Treatment
- Evidence Level
- I - Systematic synthesis of clinical EV trials; absence of controlled MSC-EV wound healing studies limits certainty.
- Study Design
- OTHER