Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Study Details
Study Description
Brief Summary
The purpose of this study is to investigating the effect of Wharton's Jelly Mesenchymal Stem Cell (WJ-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely WJ-MSCs treatment, secretomes treatment, WJ-MSCs and secretomes treatment, and control.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
The investigator hypothesized that PCOS patients with insulin resistance given combination of WJ-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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: WJ-MSCs Patients will be given 0.3 million kg/bb WJ-MSCs, tablet (placebo), and nasal drop 0.5 ml/day (growth medium). |
Biological: WJ-MSCs
Treatment with 0.3 million kg/bb WJ-MSCs, tablet (placebo), and nasal drop 0.5 ml/day (growth medium).
|
Experimental: Secretomes Patients will be given tablet (placebo), infus placebo (NaCl 0.9%), and nasal drop 0.5 ml/day (Secretomes). |
Biological: Secretomes
Treatment with tablet (placebo), infus placebo (NaCl 0.9%), and nasal drop 0.5 ml/day (Secretomes).
|
Experimental: WJ-MSCs and Secretomes Patients will be given tablet (placebo), infus 0.3 million kg/bb WJ-MSCs, and nasal drop 0.5 ml/day (Secretomes). |
Biological: WJ-MSCs and Secretomes
Treatment with tablet (placebo), infus 0.3 million kg/bb WJ-MSCs, and nasal drop 0.5 ml/day (Secretomes).
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
- TNFα, IL-1 β, IL-6, IL-10 Profile [1,3,6 months after stem cells]
Parameter in testing the cytokine/adipokine/hormone profile
Eligibility Criteria
Criteria
Inclusion Criteria:
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PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
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Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score >8)
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Patients with Free Androgen Index (FAI) >4 and ovary polycystic from USG transvaginal
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Patients with Homeostatic (HOMA) IR score ≥ 1.7
Exclusion Criteria:
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Patients who are allergic to component of WJ-MSC or Secretome.
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Patients who are not currently on hormon treatment of other resistance treatment.
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Refusing or not participating in part / all of the research process.
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Patients with positive diagnosis of hepatitis A,B,C, and HIV
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | PT Prodia StemCell Indonesia | Jakarta | Indonesia |
Sponsors and Collaborators
- PT. Prodia Stem Cell Indonesia
Investigators
- Study Chair: Rima Haifa, B.Sc, Prodia Stem Cell Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT/PCOS/PSI/2022