Polycystic Ovary Syndrome
Conditions
Keywords
Umbilical Cord Mesenchymal Stem Cell, Secretome
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.
Interventions
BIOLOGICALUC-MSCs
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.
BIOLOGICALSecretomes
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.
BIOLOGICALUC-MSCs and Secretomes
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.
BIOLOGICALControl
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.
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Contacts
STUDY_CHAIRRima Haifa, B.Sc
Prodia Stem Cell Indonesia
Outcome results
None listed