Polycystic Ovary SyndromePhase 1/2NCT05279768
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
A Phase 1/2 study testing UC-MSCs, Secretomes and UC-MSCs and Secretomes in people with Polycystic Ovary Syndrome, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- UC-MSCs, Secretomes and UC-MSCs and Secretomes
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2022to 20 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- UC-MSCs, Secretomes, UC-MSCs and Secretomes, Control
- Keywords
- Umbilical Cord Mesenchymal Stem Cell, Secretome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
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.
SecretomesBiological
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 SecretomesBiological
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.
ControlBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| WJ-MSCs | Experimental | 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. Receives: Biological: UC-MSCs |
| Secretomes | Experimental | 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. Receives: Biological: Secretomes |
| WJ-MSCs and Secretomes | Experimental | 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. Receives: Biological: UC-MSCs and Secretomes |
| Control | Placebo comparator | 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. Receives: Biological: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood serum sample
Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.
Measured: Follicular phase on day 10-12
Free Androgen index (FAI)
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Measured: Follicular phase on day 10-12
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.
Measured: Follicular phase on day 10-12
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
Parameter in testing the cytokine/adipokine/hormone profile
Measured: Follicular phase on day 10-12, and 1,3,6 months after stem cells
Leptin and Adiponectine Profile
Parameter in testing the cytokine/adipokine/hormone profile
Measured: 1,3,6 months after stem cells
TNFα, IL-1 β, IL-6, IL-10 Profile
Parameter in testing the cytokine/adipokine/hormone profile
Measured: 1,3,6 months after stem cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Sep 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rima Haifa, B.Sc, Study chair, Prodia Stem Cell Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279768
- Sponsor's protocol ID
- CT/PCOS/PSI/2022
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
- ClinicalTrials.gov ID
- NCT05279768
- Acronym / sponsor ID
- CT/PCOS/PSI/2022
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Umbilical Cord Mesenchymal Stem Cell, Secretome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WJ-MSCs | Experimental | Biological: UC-MSCsPatients 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. |
| Secretomes | Experimental | Biological: SecretomesPatients 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. |
| WJ-MSCs and Secretomes | Experimental | Biological: UC-MSCs and SecretomesPatients 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. |
| Control | Placebo comparator | Biological: ControlPatients 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UC-MSCsTreatment 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. | Biological | WJ-MSCs |
| SecretomesTreatment with 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 |
| UC-MSCs and SecretomesTreatment 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. | Biological | WJ-MSCs and Secretomes |
| ControlTreatment with 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 |
Primary outcome
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.
Free Androgen index (FAI)
Time frame: Follicular phase on day 10-12
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
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.
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
Leptin and Adiponectine Profile
Time frame: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rima Haifa, B.Sc study chair
Prodia Stem Cell Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UC-MSCs, Secretomes and UC-MSCs and Secretomes in people with Polycystic Ovary Syndrome, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood serum sample (time frame: Follicular phase on day 10-12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.