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Safety and Preliminary Efficacy of Adipose-Derived Stem Cell Secretome in Frailty (VinVital)
Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Summary
This is a Phase I, open-label, non-randomized clinical trial to evaluate the safety and preliminary efficacy of adipose-derived mesenchymal stem cell secretome capsules (VinVital) in patients with frailty syndrome. A total of 20 participants aged 60 to 75 will receive oral VinVital for 3 months, with an additional 3-month follow-up period (total 6 months). The primary objective is to assess safety based on the frequency and severity of adverse events (AEs) and serious adverse events (SAEs) according to CTCAE v5.0.
Official title: A Phase I, Open-Label, Non-Randomized Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Adipose-Derived Mesenchymal Stem Cell Secretome Capsules (VinVital) in Patients With Frailty Syndrome
Key Details
Gender
All
Age Range
60 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-10-01
Completion Date
2027-09-30
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
VinVital
Oral capsules containing adipose-derived mesenchymal stem cell secretome (extracellular vesicles and soluble factors), administered at a dose of 2 capsules per day (total 4 mg protein/day) for 3 months