Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:17 AM
Study NCT ID:
NCT07319533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single blinded randomized clinical trail with a placebo-controlled group, consisting 70 patients in total (35 patients in each arm)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-21', 'studyFirstSubmitDate': '2025-12-21', 'studyFirstSubmitQcDate': '2025-12-21', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IIEF-5 score', 'timeFrame': 'week 0, 7, 13, 25, 49', 'description': 'Erectile dysfunction of the patients during the study will be assessed by IIEF-5 questionnaire. It will done in a interview with the patients.'}], 'secondaryOutcomes': [{'measure': 'EHS score', 'timeFrame': 'week 0, 7, 13, 25, 49', 'description': 'Erectile Hardness Score It will be done in a interview with the patients.'}, {'measure': 'Peak Systolic Voulme', 'timeFrame': 'week 0, 7, 13', 'description': 'Peak systolic volum or arterial blood flow of the penis, which will be assessed by doppler sonography after papaverin injection'}, {'measure': 'End Diastolic Volume', 'timeFrame': 'week 0, 7, 13', 'description': 'end diastolic volume or venous blood flow of the penis which will be assessed by doppler sonography after papaverin injection'}, {'measure': 'Pulled length of penis', 'timeFrame': 'week 0, 7, 13, 25, 49', 'description': 'the pulled length of penis which will be assessed by clinician at each follow up session'}, {'measure': 'Erected length of Penis', 'timeFrame': 'week 0, 7, 13, 25, 49', 'description': 'erected length of penis which will be assessed at follow up sessions by clinician'}, {'measure': 'Side effects', 'timeFrame': 'week 1, 2, 3, 4, 5, 6', 'description': 'any immeadiate, or late onset local side effects at injection site. these will be reported both by the patients and assessed by the clinician.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'Exosome', 'Mesanchymal Stem Cell', 'MSC'], 'conditions': ['Erectile Dysfunction', 'Erectile Dysfunction Associated With Type 2 Diabetes Mellitus', 'Erectile Dysfunction Due to Arterial Disease', 'Erectile Dysfunction Due to Arterial Insufficiency', 'Erectile Dysfunction Due to General Medical Condition', 'Erectile Dysfunction Due to Neuropathy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is:\n\n• Is MSC-derived exosome safe and effective in treating patients with ED by improving IIEF-5 score?\n\nIf there is a comparison group: Researchers will compare the intervention group (Exosome receiving group) with control group (placebo receiving group) to see if exosomes are safe and effective in treating male adult patients with moderate-sever ED.\n\nParticipants will receive six weekly injections of normal saline or exosome (based on group), and will undergo necessarily follow up, and examinations and observation.', 'detailedDescription': 'Secondary outcomes are the folllowing:\n\nEHS score length of erected penis lenght of flacid penis (pulled) peak systolic volume (via dupler sonography) end diastolic volume (via dupler sonography) any adverse effects of exosome'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nModerate or severe erectile dysfunction (according to IIEF-5) Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history\n\nExclusion Criteria:\n\nKnown allergy or history of hyperactivity to biological substances Peyronie's plaque Existing medical condition (severe or uncontrolled) Use of psychiatric medication Use of thyroid medication Hyopgonadism Hypergonadism Cancer History of prostatectomy Prostitis Autoimmune disease Recent trauma or surgery Ongoing systemic infection Skin lesion or infection at the site of injection"}, 'identificationModule': {'nctId': 'NCT07319533', 'acronym': 'MSC', 'briefTitle': 'Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Labbafinejad Medical Center'}, 'officialTitle': 'Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'IR.SBMU.UNRC.REC.1403.015'}, 'secondaryIdInfos': [{'id': 'IRCT20160406027253N3', 'type': 'OTHER', 'domain': 'IRCT (Iranian Registary ofClinical Trials)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Exosome)', 'description': 'patients in this arm will be injected 5 ml of exosome in corpus cavernosa of each side (2.5 ml in each side at base of the penis). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.', 'interventionNames': ['Biological: exosomes derived from human umbilical cord mesenchymal stem cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control group: these patients will recieve 5 ml of intracavernosal normal saline (2.5 ml in each side of penile base). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.', 'interventionNames': ['Biological: Normal (0.9%) saline']}], 'interventions': [{'name': 'exosomes derived from human umbilical cord mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Intervention group: patients in this group will be injected 5 ml of exosome in corpus cavernosa of each side (2.5 ml in each side at base of the penis). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.', 'armGroupLabels': ['Intervention (Exosome)']}, {'name': 'Normal (0.9%) saline', 'type': 'BIOLOGICAL', 'description': 'Control group: these patients will recieve 5 ml of intracavernosal normal saline (2.5 ml in each side of penile base). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1666663111', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'contacts': [{'name': 'Amirhossein Kashi, Subspecialist', 'role': 'CONTACT', 'email': 'ahkashi@gmail.com', 'phone': '+982122567222'}], 'facility': 'Shahid Labbafinejad Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make this available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Labbafinejad Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Amirhossein Kashi', 'investigatorFullName': 'Amirhossein Kashi', 'investigatorAffiliation': 'Labbafinejad Medical Center'}}}}