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Frailty SyndromePhase 1VinVitalNCT07856602

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

A Phase 1 study testing VinVital in people with Frailty Syndrome and Aging, run by Vinmec Research Institute of Stem Cell and Gene Technology.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Frailty Syndrome, Aging
What is being tested?
VinVital
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 30 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Liem Thanh Nguyen, MD, PhD contact

0986565015

liem.nt@vinuni.edu.vn

About this study

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

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.

Read the detailed description

Frailty is a common geriatric syndrome characterized by multi-system physiological decline, sarcopenia, and increased vulnerability to stressors. Currently, there are no specific pharmacological treatments for frailty. Preclinical studies have demonstrated that adipose-derived mesenchymal stem cell (AD-MSC) secretome (including extracellular vesicles and soluble growth factors) possesses anti-aging, anti-inflammatory, and regenerative properties, effectively improving physical function and reversing aging phenotypes in aged animal models.

This study aims to investigate the safety and preliminary clinical efficacy of VinVital (oral capsules containing AD-MSC secretome) in older adults with frailty. The trial will enroll 20 eligible patients diagnosed with frailty (Clinical Frailty Scale score 3-6 and meeting modified Fried criteria). Participants will take VinVital (2 capsules/day, equivalent to 4 mg protein/day) for 3 months. Safety and clinical outcomes-including the Short Physical Performance Battery (SPPB), handgrip strength, Clinical Frailty Scale (CFS), Multidimensional Fatigue Inventory (MFI), Pittsburgh Sleep Quality Index (PSQI), and 15D health-related quality of life-will be evaluated at baseline and at months 1, 3, and 6.

Being tested
VinVital
Keywords
Extracellular vesicles, Adipose-derived stem cell secretome, Exosomes, VinVital, Geriatric syndrome
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinVitalBiological

    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

Study groups in NCT07856602
Study groupRoleWhat they receive
VinVital GroupExperimentalParticipants 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
Receives: Biological: VinVital

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the first dose up to 6 months

Secondary outcomes (7)

  1. 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

    Measured: Baseline, Month 1, Month 3, and Month 6

  2. Change in Handgrip Strength

    Evaluation of muscle strength changes measured by a digital handgrip dynamometer from baseline to months 1, 3, and 6.

    Measured: Baseline, Month 1, Month 3, and Month 6

  3. 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

    Measured: Baseline, Month 1, Month 3, and Month 6

  4. 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

    Measured: Baseline, Month 1, Month 3, and Month 6

  5. Change in Pittsburgh Sleep Quality Index (PSQI) Score

    Assessment of changes in sleep quality and sleep disturbances using the PSQI from baseline to months 1, 3, and 6.

    Measured: Baseline, Month 1, Month 3, and Month 6

  6. Change in 15D Health-Related Quality of Life Score

    Evaluation of changes in health-related quality of life across 15 dimensions using the 15D instrument from baseline to months 1, 3, and 6.

    Measured: Baseline, Month 1, Month 3, and Month 6

  7. Change in Body Composition (BMI, Lean Mass, Fat Mass, and Bone Mineral Content)

    Evaluation of changes in body composition parameters-including body mass index (BMI), lean body mass, fat mass, and bone mass-measured using a medical-grade body composition analyzer (digital bioimpedance scale) from baseline to months 1, 3, and 6.

    Measured: Baseline, Month 1, Month 3, and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07856602
Sponsor's protocol ID
ISC24.28
Other IDs
2930/QĐ-BYT
Acronym
VinVital
Status last verified
Sep 2026
First submitted
28 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to protect patient confidentiality and privacy in accordance with institutional policy

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VinVital in people with Frailty Syndrome and Aging, run by Vinmec Research Institute of Stem Cell and Gene Technology.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liem Thanh Nguyen, MD, PhD (0986565015, liem.nt@vinuni.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the first dose up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07856602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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