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

Sponsor
PT. Prodia Stem Cell Indonesia (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05279768
Collaborator
(none)
20
1
3
12
1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to investigating the effect of Wharton's Jelly Mesenchymal Stem Cell (WJ-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely WJ-MSCs treatment, secretomes treatment, WJ-MSCs and secretomes treatment, and control.

Condition or Disease Intervention/Treatment Phase
  • Biological: WJ-MSCs
  • Biological: Secretomes
  • Biological: WJ-MSCs and Secretomes
Phase 1/Phase 2

Detailed Description

The investigator hypothesized that PCOS patients with insulin resistance given combination of WJ-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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Potential Use of Wharton's Jelly Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: WJ-MSCs

Patients will be given 0.3 million kg/bb WJ-MSCs, tablet (placebo), and nasal drop 0.5 ml/day (growth medium).

Biological: WJ-MSCs
Treatment with 0.3 million kg/bb WJ-MSCs, tablet (placebo), and nasal drop 0.5 ml/day (growth medium).

Experimental: Secretomes

Patients will be given tablet (placebo), infus placebo (NaCl 0.9%), and nasal drop 0.5 ml/day (Secretomes).

Biological: Secretomes
Treatment with tablet (placebo), infus placebo (NaCl 0.9%), and nasal drop 0.5 ml/day (Secretomes).

Experimental: WJ-MSCs and Secretomes

Patients will be given tablet (placebo), infus 0.3 million kg/bb WJ-MSCs, and nasal drop 0.5 ml/day (Secretomes).

Biological: WJ-MSCs and Secretomes
Treatment with tablet (placebo), infus 0.3 million kg/bb WJ-MSCs, and nasal drop 0.5 ml/day (Secretomes).

Outcome Measures

Primary Outcome Measures

  1. Blood serum sample [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.

  2. Free Androgen index (FAI) [Follicular phase on day 10-12]

    Free Androgen index (FAI) is calculated by total testosterone x100/SHBG

  3. Insulin, Glucose Plasma, and Insulin Resistance [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.

  4. Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH) [Follicular phase on day 10-12, and 1,3,6 months after stem cells]

    Parameter in testing the cytokine/adipokine/hormone profile

  5. Leptin and Adiponectine Profile [1,3,6 months after stem cells]

    Parameter in testing the cytokine/adipokine/hormone profile

  6. TNFα, IL-1 β, IL-6, IL-10 Profile [1,3,6 months after stem cells]

    Parameter in testing the cytokine/adipokine/hormone profile

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PT Prodia StemCell Indonesia Jakarta Indonesia

Sponsors and Collaborators

  • PT. Prodia Stem Cell Indonesia

Investigators

  • Study Chair: Rima Haifa, B.Sc, Prodia Stem Cell Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier:
NCT05279768
Other Study ID Numbers:
  • CT/PCOS/PSI/2022
First Posted:
Mar 15, 2022
Last Update Posted:
Mar 15, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PT. Prodia Stem Cell Indonesia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022