Trials / Completed
CompletedNCT05279768
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- PT. Prodia Stem Cell Indonesia · Industry
- Sex
- Female
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UC-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. |
| BIOLOGICAL | Secretomes | 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. |
| BIOLOGICAL | UC-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. |
| BIOLOGICAL | Control | 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. |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2025-01-20
- Completion
- 2025-01-20
- First posted
- 2022-03-15
- Last updated
- 2026-02-25
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05279768. Inclusion in this directory is not an endorsement.