Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

Last updated: February 23, 2026
Sponsor: PT. Prodia Stem Cell Indonesia
Overall Status: Completed

Phase

1/2

Condition

Diabetes Prevention

Diabetes And Hypertension

Hormone Deficiencies

Treatment

Control

Secretomes

UC-MSCs and Secretomes

Clinical Study ID

NCT05279768
CT/PCOS/PSI/2022
  • Ages 20-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 Gallweyscore >8)

  • Patients with Free Androgen Index (FAI) >4 and ovary polycystic from USGtransvaginal

  • Patients with Homeostatic (HOMA) IR score ≥ 1.7

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 44
Treatment Group(s): 4
Primary Treatment: Control
Phase: 1/2
Study Start date:
September 01, 2022
Estimated Completion Date:
January 20, 2025

Study Description

The investigator hypothesized that PCOS patients with insulin resistance given combination of UC-MSCs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle and fertility. All group will be observed every 1,3, and 6 months after injection.

Connect with a study center

  • PT Prodia StemCell Indonesia

    Jakarta,
    Indonesia

    Site Not Available

  • PT Prodia StemCell Indonesia

    Jakarta 1642911,
    Indonesia

    Site Not Available

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