Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Overview
- Phase
- Phase 1
- Intervention
- UC-MSCs
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- PT. Prodia Stem Cell Indonesia
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Blood serum sample
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
WJ-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.
Intervention: UC-MSCs
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.
Intervention: Secretomes
WJ-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.
Intervention: UC-MSCs and Secretomes
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.
Intervention: Control
Outcomes
Primary Outcomes
Blood serum sample
Time Frame: 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)
Time Frame: 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
Time Frame: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
Free Androgen index (FAI)
Time Frame: Follicular phase on day 10-12
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Insulin, Glucose Plasma, and Insulin Resistance
Time Frame: 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
Time Frame: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile