Safety and Preliminary Efficacy of Adipose-Derived Stem Cell Secretome in Frailty (VinVital)

NCT07856602 | Not Yet Recruiting Phase 1

• 2 other identifiers: ISC24.282930/QĐ-BYT
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Frailty Syndrome; Aging

Keywords

Extracellular vesicles; Adipose-derived stem cell secretome; Exosomes; VinVital; Geriatric syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  From the first dose up to 6 months

Secondary Outcomes (7)

• Change in Short Physical Performance Battery (SPPB) Score

  Baseline, Month 1, Month 3, and Month 6

• Change in Handgrip Strength

  Baseline, Month 1, Month 3, and Month 6

• Change in Clinical Frailty Scale (CFS) Score

  Baseline, Month 1, Month 3, and Month 6

• Change in Multidimensional Fatigue Inventory (MFI) Score

  Baseline, Month 1, Month 3, and Month 6

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, Month 1, Month 3, and Month 6

Study Arms (1)

VinVital Group

EXPERIMENTAL

Participants will receive oral VinVital capsules (adipose-derived mesenchymal stem cell secretome), 2 capsules per day (total 4 mg protein/day), taken 30 minutes to 1 hour before breakfast and dinner for 3 months

Biological: VinVital

Interventions

VinVital BIOLOGICAL

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

VinVital Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 60 to 75 years.
• Diagnosed with frailty syndrome meeting the following criteria:
• 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.

You may not qualify if:

• 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.
• Active malignancy within the past 5 years.
• Life expectancy of less than 1 year.
• Symptomatic urinary tract stones requiring intervention.
• Current use of H1 or H2 receptor antagonists.
• History of autoimmune diseases requiring immunosuppressive or biologic therapy.
• Severe malnutrition or limb amputation.
• Chronic gastrointestinal diseases causing malabsorption syndrome.

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead
• VinUniversity: collaborator

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liem Thanh Nguyen, MD, PhD

CONTACT

0986565015; liem.nt@vinuni.edu.vn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share