NCT05279768

Brief Summary

The purpose of this study is to investigating the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely UC-MSCs treatment, secretomes treatment, UC-MSCs and secretomes treatment, and control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

February 20, 2022

Last Update Submit

February 23, 2026

Conditions

Polycystic Ovary Syndrome

Keywords

Umbilical Cord Mesenchymal Stem CellSecretome

Outcome Measures

Primary Outcomes (6)

  • Blood serum sample

    Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.

    Follicular phase on day 10-12

  • Free Androgen index (FAI)

    Free Androgen index (FAI) is calculated by total testosterone x100/SHBG

    Follicular phase on day 10-12

  • Insulin, Glucose Plasma, and Insulin Resistance

    insulin resistance is calculated by the method: HOMA: HOMA-IR = (insulin x glucose) / 22.5 and HOMA-ß = (20 x insulin) / glucose - 3.5.

    Follicular phase on day 10-12

  • Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)

    Parameter in testing the cytokine/adipokine/hormone profile

    Follicular phase on day 10-12, and 1,3,6 months after stem cells

  • Leptin and Adiponectine Profile

    Parameter in testing the cytokine/adipokine/hormone profile

    1,3,6 months after stem cells

  • TNFα, IL-1 β, IL-6, IL-10 Profile

    Parameter in testing the cytokine/adipokine/hormone profile

    1,3,6 months after stem cells

Study Arms (4)

WJ-MSCs

EXPERIMENTAL

Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.

Biological: UC-MSCs

Secretomes

EXPERIMENTAL

Patients will be given tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.

Biological: Secretomes

WJ-MSCs and Secretomes

EXPERIMENTAL

Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.

Biological: UC-MSCs and Secretomes

Control

PLACEBO COMPARATOR

Patients will be given Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.

Biological: Control

Interventions

UC-MSCsBIOLOGICAL

Treatment with tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.

WJ-MSCs
SecretomesBIOLOGICAL

Treatment with tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.

Secretomes
UC-MSCs and SecretomesBIOLOGICAL

Treatment with tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.

WJ-MSCs and Secretomes
ControlBIOLOGICAL

Treatment with Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.

Control

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
  • Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score \>8)
  • Patients with Free Androgen Index (FAI) \>4 and ovary polycystic from USG transvaginal
  • Patients with Homeostatic (HOMA) IR score ≥ 1.7

You may not qualify if:

  • Patients who are allergic to component of WJ-MSC or Secretome.
  • Patients who are not currently on hormon treatment of other resistance treatment.
  • Refusing or not participating in part / all of the research process.
  • Patients with positive diagnosis of hepatitis A,B,C, and HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PT Prodia StemCell Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Secretome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MetabolomeMetabolism

Study Officials

  • Rima Haifa, B.Sc

    Prodia Stem Cell Indonesia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 15, 2022

Study Start

September 1, 2022

Primary Completion

January 20, 2025

Study Completion

January 20, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

ID(1)