Clinical trial · Interventional
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.
NCT05279768CI-TRIAL-00104057completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Biological | — | UNRESOLVED |
| Secretomes | Biological | — | UNRESOLVED |
| UC-MSCs | Biological | — | UNRESOLVED |
| UC-MSCs and Secretomes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- WJ-MSCs
- description
- 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.
- interventionNames
- Biological: UC-MSCs
- type
- EXPERIMENTAL
- label
- Secretomes
- description
- 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.
- interventionNames
- Biological: Secretomes
- type
- EXPERIMENTAL
- label
- WJ-MSCs and Secretomes
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.