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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Biological: UC-MSCs
* Biological: Secretomes
* Biological: UC-MSCs and Secretomes
* Biological: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WJ-MSCs<br>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<br>* 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.<br>|
| Experimental: Secretomes<br>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<br>* 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.<br>|
| Experimental: WJ-MSCs and Secretomes<br>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<br>* 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.<br>|
| Placebo Comparator: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Cord Mesenchymal Stem Cell, Secretome