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

Phase 1

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Biological: UC-MSCs; Biological: UC-MSCs and Secretomes; Biological: Control; Biological: Secretomes

• Registration Number: NCT05279768
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-03-06
• Study First Posted: 2022-03-15
• Status Verified: 2022-09
• Study Start: 2022-09-01
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 Gallwey score >8)
• Patients with Free Androgen Index (FAI) >4 and ovary polycystic from USG transvaginal
• Patients with Homeostatic (HOMA) IR score ≥ 1.7

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WJ-MSCs	UC-MSCs	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.
WJ-MSCs and Secretomes	UC-MSCs and Secretomes	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.
Control	Control	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.
Secretomes	Secretomes	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.

Primary Outcome Measures

Name	Time	Method
Blood serum sample	Follicular phase on day 10-12	Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)	Follicular phase on day 10-12, and 1,3,6 months after stem cells	Parameter in testing the cytokine/adipokine/hormone profile
Leptin and Adiponectine Profile	1,3,6 months after stem cells	Parameter in testing the cytokine/adipokine/hormone profile
Free Androgen index (FAI)	Follicular phase on day 10-12	Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Insulin, Glucose Plasma, and Insulin Resistance	Follicular phase on day 10-12	insulin resistance is calculated by the method: HOMA: HOMA-IR = (insulin x glucose) / 22.5 and HOMA-ß = (20 x insulin) / glucose - 3.5.
TNFα, IL-1 β, IL-6, IL-10 Profile	1,3,6 months after stem cells	Parameter in testing the cytokine/adipokine/hormone profile

Trial Locations

Locations (1)

PT Prodia StemCell Indonesia; 🇮🇩 Jakarta, Indonesia