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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279768
• Other study ID #: CT/PCOS/PSI/2022
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Gunawan Dwi Prayitno
• Phone: 08129004721
• Email: gunawan.spog04[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Indonesia	PT Prodia StemCell Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood serum sample	Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.	Follicular phase on day 10-12
Primary	Free Androgen index (FAI)	Free Androgen index (FAI) is calculated by total testosterone x100/SHBG	Follicular phase on day 10-12
Primary	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.	Follicular phase on day 10-12
Primary	Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)	Parameter in testing the cytokine/adipokine/hormone profile	Follicular phase on day 10-12, and 1,3,6 months after stem cells
Primary	Leptin and Adiponectine Profile	Parameter in testing the cytokine/adipokine/hormone profile	1,3,6 months after stem cells
Primary	TNFa, IL-1 ß, IL-6, IL-10 Profile	Parameter in testing the cytokine/adipokine/hormone profile	1,3,6 months after stem cells