Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT05279768
Status:
UNKNOWN
Last Update Posted:
2022-09-26
First Post:
2022-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089282', 'term': 'Secretome'}], 'ancestors': [{'id': 'D055442', 'term': 'Metabolome'}, {'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-03-06', 'lastUpdatePostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood serum sample', 'timeFrame': 'Follicular phase on day 10-12', 'description': "Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12."}, {'measure': 'Free Androgen index (FAI)', 'timeFrame': 'Follicular phase on day 10-12', 'description': 'Free Androgen index (FAI) is calculated by total testosterone x100/SHBG'}, {'measure': 'Insulin, Glucose Plasma, and Insulin Resistance', 'timeFrame': 'Follicular phase on day 10-12', '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.'}, {'measure': 'Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)', 'timeFrame': 'Follicular phase on day 10-12, and 1,3,6 months after stem cells', 'description': 'Parameter in testing the cytokine/adipokine/hormone profile'}, {'measure': 'Leptin and Adiponectine Profile', 'timeFrame': '1,3,6 months after stem cells', 'description': 'Parameter in testing the cytokine/adipokine/hormone profile'}, {'measure': 'TNFα, IL-1 β, IL-6, IL-10 Profile', 'timeFrame': '1,3,6 months after stem cells', 'description': 'Parameter in testing the cytokine/adipokine/hormone profile'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Umbilical Cord Mesenchymal Stem Cell', 'Secretome'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)\n* Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score \\>8)\n* Patients with Free Androgen Index (FAI) \\>4 and ovary polycystic from USG transvaginal\n* Patients with Homeostatic (HOMA) IR score ≥ 1.7\n\nExclusion Criteria:\n\n* Patients who are allergic to component of WJ-MSC or Secretome.\n* Patients who are not currently on hormon treatment of other resistance treatment.\n* Refusing or not participating in part / all of the research process.\n* Patients with positive diagnosis of hepatitis A,B,C, and HIV'}, 'identificationModule': {'nctId': 'NCT05279768', 'briefTitle': 'Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT. Prodia Stem Cell Indonesia'}, 'officialTitle': 'Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.', 'orgStudyIdInfo': {'id': 'CT/PCOS/PSI/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WJ-MSCs', '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.', 'interventionNames': ['Biological: UC-MSCs']}, {'type': 'EXPERIMENTAL', 'label': 'Secretomes', '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.', 'interventionNames': ['Biological: Secretomes']}, {'type': 'EXPERIMENTAL', 'label': 'WJ-MSCs and Secretomes', '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.', 'interventionNames': ['Biological: UC-MSCs and Secretomes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', '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.', 'interventionNames': ['Biological: Control']}], 'interventions': [{'name': 'UC-MSCs', 'type': 'BIOLOGICAL', '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.', 'armGroupLabels': ['WJ-MSCs']}, {'name': 'Secretomes', 'type': 'BIOLOGICAL', '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.', 'armGroupLabels': ['Secretomes']}, {'name': 'UC-MSCs and Secretomes', 'type': 'BIOLOGICAL', '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.', 'armGroupLabels': ['WJ-MSCs and Secretomes']}, {'name': 'Control', 'type': 'BIOLOGICAL', '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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'facility': 'PT Prodia StemCell Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Gunawan Dwi Prayitno', 'role': 'CONTACT', 'email': 'gunawan.spog04@gmail.com', 'phone': '08129004721'}, {'name': 'Cynthia Retna Sartika, Dr', 'role': 'CONTACT', 'email': 'c.sartika@gmail.com'}], 'overallOfficials': [{'name': 'Rima Haifa, B.Sc', 'role': 'STUDY_CHAIR', 'affiliation': 'Prodia Stem Cell Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT. Prodia Stem Cell Indonesia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}