Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT06839651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-18', 'releaseDate': '2025-09-02'}], 'estimatedResultsFirstSubmitDate': '2025-09-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-16', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'one hour and one year', 'description': 'A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.'}, {'measure': 'Hematomes', 'timeFrame': 'one hour', 'description': 'Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.'}, {'measure': 'Bleeding', 'timeFrame': 'one hour', 'description': 'Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.'}, {'measure': 'Erection hardness score', 'timeFrame': 'one year', 'description': 'Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile dysfunction', 'secretome', 'UC-MSC'], 'conditions': ['Erectile Dysfunctions']}, 'descriptionModule': {'briefSummary': 'The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.', 'detailedDescription': 'The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Male patients with severe erectile dysfunction non-responsive sildenafil', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.\n* Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7\n* History of undergoing treatment with sildenafil 100 mg for four sessions.\n* Evaluation of IIEF-5 score \\< 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4\n* Type II Diabetes Melitus with an HbA1c test result of \\< 7%.\n* Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.\n* Patients with undergoing treatment with antidepressant.\n\nExclusion Criteria:\n\n* Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.\n* Active and significant systemic or local infection.\n* History of bleeding or blood clotting disorder therapy.\n* History of systemic autoimmune disorders and immunosuppressive treatment\n* History of prostate surgery, history of malignancy, or a PSA level \\> 4 ng/mL.\n* Untreated hypogonadism or low serum total testosterone (\\<200 ng/dL).\n* Uncontrolled hypertension or hypotension (systolic blood pressure \\>170 or \\<90 mmHg, and diastolic blood pressure \\>100 or \\<50 mmHg).\n* Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure)."}, 'identificationModule': {'nctId': 'NCT06839651', 'briefTitle': 'Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients with Severe Erectile Dysfunction Non-responsive to Sildenafil', 'orgStudyIdInfo': {'id': 'KET-1862/ETIK/PPM.00.02/2024'}, 'secondaryIdInfos': [{'id': 'PUTI Q1 Universitas Indonesia', 'type': 'OTHER', 'domain': 'Universitas Indonesia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection', 'description': 'postreatment group: severe eretile dysfunction non responsive Sildenafil with injection', 'interventionNames': ['Combination Product: uc-msc secretome intra cavernous injection']}], 'interventions': [{'name': 'uc-msc secretome intra cavernous injection', 'type': 'COMBINATION_PRODUCT', 'description': 'UC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg/ml.\n\nThe intervention was the administration of 0.5 mL/site of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection.', 'armGroupLabels': ['pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ria Margiana, M.D, PhD', 'role': 'CONTACT', 'email': 'ria.marrgiana11@gmail.com', 'phone': '+62 811-1775-515'}, {'name': 'Tania Graciana, M.D', 'role': 'CONTACT', 'email': 'taniagraciana@gmail.com', 'phone': '+6285624458456'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ria Margiana, MD, M.Biomed, PhD', 'investigatorFullName': 'Ria Margiana', 'investigatorAffiliation': 'Indonesia University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-02', 'type': 'RELEASE'}, {'date': '2025-09-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ria Margiana, Ria Margiana, MD, M.Biomed, PhD, Indonesia University'}}}}