Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

PT. Prodia Stem Cell Indonesia

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Biological: Control; Biological: UC-MSCs; Biological: UC-MSCs and Secretomes; Biological: Secretomes

Study type: Interventional

Funder types: Industry

Identifiers

NCT05279768

CT/PCOS/PSI/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups, including a placebo group

WJ-MSCs

Experimental group

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.

Treatment:

Biological: UC-MSCs

Secretomes

Experimental group

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.

Treatment:

Biological: Secretomes

WJ-MSCs and Secretomes

Experimental group

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 (Secretomes) for 30 days.

Treatment:

Biological: UC-MSCs and Secretomes

Control

Placebo Comparator group

Description:

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.

Treatment:

Biological: Control