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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
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.
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.
PT Prodia StemCell Indonesia
Jakarta, Indonesia
RECRUITINGBlood serum sample
Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.
Time frame: Follicular phase on day 10-12
Free Androgen index (FAI)
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Time frame: 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.
Time frame: Follicular phase on day 10-12
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
Parameter in testing the cytokine/adipokine/hormone profile
Time frame: 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
Time frame: 1,3,6 months after stem cells
TNFα, IL-1 β, IL-6, IL-10 Profile
Parameter in testing the cytokine/adipokine/hormone profile
Time frame: 1,3,6 months after stem cells
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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.