Part 2/3 preclinical: Safety of intensive doses of MSC-EV testing on monkeys
Project Title: Investigating the safety of mesenchymal stem cell-derived extracellular vesicles in non-human primates: Intensive intravenous administration
Project Description:
This study extends the prior research “Evaluation of safety of mesenchymal stem cell secretome in monkeys”. It assesses the safety of VinEV through 90 injections evenly distributed over 9 months (10 consecutive injections per month). Animal safety was monitored via daily health observations, adverse event statistics, and periodic vital signs measurements. Blood parameters were periodically collected and thoroughly analyzed for complete blood count, liver/kidney function, and inflammation markers.
The study preliminarily investigates anti-aging improvements in aged animals compared to aged controls and young injection groups, through indicators such as reduced telomere shortening rate, decreased senescence gene expression, and enhanced cellular metabolism.
Significance:
Goals:
- Evaluate the safety of VinEV on monkeys at high doses through 9 injection cycles.
- Evaluation of initial effect of anti-aging of VinEV
Innovation:
Our study introduces an intensive, high-dose EV dosing regimen in macaques that has not been previously reported. Our study, spanning over 9 months, is far exceeding prior studies in both dose density and duration and enable a more rigorous safety assessment. By combining high daily dosing with long-term monitoring, this model better reflects chronic clinical use and addresses key gaps in existing EV safety data. Consequently, our findings are positioned to provide robust, clinically relevant evidence to de-risk and guide future MSC-EV trials in humans.