TrialPhase 1Not yet recruiting
Safety and Preliminary Efficacy of Adipose-Derived Stem Cell Secretome in Frailty (VinVital)
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
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology (Academic or other)
- Enrolment
- 20 planned
- Conditions
- Frailty Syndrome; Aging
- Interventions
- VinVital
- Ages
- adults, older adults
- Registry
- NCT07856602
From the registry
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.
Primary outcomes
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)