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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WJ-MSCs | Experimental | 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. |
|
| Secretomes | Experimental | 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. |
|
| WJ-MSCs and Secretomes | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSCs | Biological | 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. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rima Haifa, B.Sc | Prodia Stem Cell Indonesia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT Prodia StemCell Indonesia | Jakarta | Indonesia |
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| Secretomes | Biological | 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. |
|
| UC-MSCs and Secretomes | Biological | 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. |
|
| Control | Biological | 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. |
|
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D055442 | Metabolome |
| D008660 | Metabolism |
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