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

Primary Purpose

Polycystic Ovary Syndrome

Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
UC-MSCs
Secretomes
UC-MSCs and Secretomes
Control
Sponsored by
PT. Prodia Stem Cell Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Umbilical Cord Mesenchymal Stem Cell, Secretome

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • PT Prodia StemCell IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

WJ-MSCs

Secretomes

WJ-MSCs and Secretomes

Control

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Blood serum sample
Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.
Free Androgen index (FAI)
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
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.
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
Parameter in testing the cytokine/adipokine/hormone profile
Leptin and Adiponectine Profile
Parameter in testing the cytokine/adipokine/hormone profile
TNFα, IL-1 β, IL-6, IL-10 Profile
Parameter in testing the cytokine/adipokine/hormone profile

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
September 23, 2022
Sponsor
PT. Prodia Stem Cell Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05279768
Brief Title
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Official Title
Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Umbilical Cord Mesenchymal Stem Cell, Secretome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WJ-MSCs
Arm Type
Experimental
Arm 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.
Arm Title
Secretomes
Arm Type
Experimental
Arm 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.
Arm Title
WJ-MSCs and Secretomes
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
UC-MSCs
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Secretomes
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
UC-MSCs and Secretomes
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood serum sample
Description
Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.
Time Frame
Follicular phase on day 10-12
Title
Free Androgen index (FAI)
Description
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Time Frame
Follicular phase on day 10-12
Title
Insulin, Glucose Plasma, and Insulin Resistance
Description
insulin resistance is calculated by the method: HOMA: HOMA-IR = (insulin x glucose) / 22.5 and HOMA-ß = (20 x insulin) / glucose - 3.5.
Time Frame
Follicular phase on day 10-12
Title
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
Description
Parameter in testing the cytokine/adipokine/hormone profile
Time Frame
Follicular phase on day 10-12, and 1,3,6 months after stem cells
Title
Leptin and Adiponectine Profile
Description
Parameter in testing the cytokine/adipokine/hormone profile
Time Frame
1,3,6 months after stem cells
Title
TNFα, IL-1 β, IL-6, IL-10 Profile
Description
Parameter in testing the cytokine/adipokine/hormone profile
Time Frame
1,3,6 months after stem cells

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gunawan Dwi Prayitno
Phone
08129004721
Email
gunawan.spog04@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Retna Sartika, Dr
Email
c.sartika@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rima Haifa, B.Sc
Organizational Affiliation
Prodia Stem Cell Indonesia
Official's Role
Study Chair
Facility Information:
Facility Name
PT Prodia StemCell Indonesia
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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