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.
Male and female participants aged 60 to 75 years.
Clinical Frailty Scale (CFS) score between 3 (Managing Well) and 6 (Moderately Frail).
Meeting at least 3 out of 5 modified Fried criteria: (a) Unintentional weight loss, (b) Decreased handgrip strength, (c) Slow walking speed, (d) Low physical activity, (e) Self-reported persistent exhaustion.
Willing and able to provide written informed consent to participate in the study.
Mini-Mental State Examination (MMSE) score <= 20.
Currently on an organ transplant waiting list.
Significant abnormal laboratory values: hemoglobin < 10 g/dL, white blood cell count < 3,000/mm³, platelet count < 120,000/mm³, alkaline phosphatase > 3x ULN, total bilirubin > 1.5 mg/dL.
Major comorbidities: NYHA class III-IV heart failure, GOLD group C/D chronic obstructive pulmonary disease (COPD), stroke or history of stroke, end-stage renal disease, severe liver disease or active hepatitis (Child-Pugh B/C, acute hepatitis, active chronic hepatitis, or unexplained AST/ALT > 3x ULN), uncontrolled type 2 diabetes mellitus with HbA1c > 8.5%, HIV infection, active acute infection requiring systemic antibiotics, coagulation disorders, or grade 4 knee osteoarthritis.
Single group
VinVital
Biological/VaccineOral 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
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessment of the safety and tolerability of VinVital based on the occurrence, frequency, and severity of AEs and SAEs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 over 6 months.
Change in Short Physical Performance Battery (SPPB) Score
Evaluation of physical performance improvement using the SPPB test (including balance, 4-meter walk speed, and 5-times sit-to-stand test) from baseline to months 1, 3, and 6
Change in Handgrip Strength
Evaluation of muscle strength changes measured by a digital handgrip dynamometer from baseline to months 1, 3, and 6.
Change in Clinical Frailty Scale (CFS) Score
Assessment of the change in frailty severity levels (ranging from 1 to 9) using the Canadian Clinical Frailty Scale from baseline to months 1, 3, and 6
Change in Multidimensional Fatigue Inventory (MFI) Score
Evaluation of changes in multidimensional fatigue status using the MFI questionnaire from baseline to months 1, 3, and 6
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Vinmec Research Institute of Stem Cell and Gene Technology
Lead sponsor
VinUniversity
Collaborator
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