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

September 23, 2022 updated by: PT. Prodia Stem Cell Indonesia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • PT Prodia StemCell Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WJ-MSCs
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.
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.
Experimental: Secretomes
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.
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.
Experimental: WJ-MSCs and Secretomes
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.
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.
Placebo Comparator: Control
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood serum sample
Time Frame: Follicular phase on day 10-12
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
Free Androgen index (FAI)
Time Frame: Follicular phase on day 10-12
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Follicular phase on day 10-12
Insulin, Glucose Plasma, and Insulin Resistance
Time Frame: Follicular phase on day 10-12
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
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
Time Frame: Follicular phase on day 10-12, and 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
Follicular phase on day 10-12, and 1,3,6 months after stem cells
Leptin and Adiponectine Profile
Time Frame: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
1,3,6 months after stem cells
TNFα, IL-1 β, IL-6, IL-10 Profile
Time Frame: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
1,3,6 months after stem cells

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/PCOS/PSI/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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