Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-02 @ 6:22 PM
Study NCT ID:
NCT02665520
Status:
UNKNOWN
Last Update Posted:
2016-01-27
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D015187', 'term': 'Lipectomy'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events that occur during or after the procedure to measure safety and tolerability', 'timeFrame': '1 year', 'description': 'to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stem cells injections', 'erectile dysfunction'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Autologous Fat Derived Stem Cell treatment of ED.\n\nTo assess safety and primary efficacy of stem cell infusion in refractory ED.\n\nTo investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male 40 years old and older suffering from moderate to sever erectile dysfunction -\n\nExclusion Criteria:\n\n* Inability to give informed consent or attend follow up\n* Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease\n* Viral disease from infectivity viewpoint\n* Major penile fibrosis or severe Peyronie's disease\n* Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)\n* Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)\n* Prior systemic chemotherapy, or radiotherapy to donor or recipient area\n* Not in potentially active sexual relationship\n* Age less than 40 or over 70"}, 'identificationModule': {'nctId': 'NCT02665520', 'briefTitle': 'Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Elaj medical centers'}, 'officialTitle': 'Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'Elaj stem cells 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stem cells injection in penis', 'description': 'Treatment Injection of adipose derived cells into penis experimental;randomised', 'interventionNames': ['Procedure: liposuction for retrieval of own stem cells from fat cells']}, {'type': 'NO_INTERVENTION', 'label': 'controled arm'}], 'interventions': [{'name': 'liposuction for retrieval of own stem cells from fat cells', 'type': 'PROCEDURE', 'armGroupLabels': ['stem cells injection in penis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21463', 'city': 'Jeddah', 'state': 'Outside U.S./Canada', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Mohamad Habous', 'role': 'CONTACT', 'email': 'drmhabos@hotmail.com', 'phone': '+966599950131'}, {'name': 'Saleh Binsaleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elaj medical group', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Saleh Binsaleh, MD', 'role': 'CONTACT', 'email': 'surgon@hotmail.com', 'phone': '+966502100034'}], 'facility': 'kING SAUD UNIVERSITY', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'MOHAMAD HABOUS, M.D;FEBU', 'role': 'CONTACT', 'email': 'drmhabos@hotmail.com', 'phone': '+966599950131'}, {'name': 'Saleh Binsaleh, MD', 'role': 'CONTACT', 'email': 'surgon@hotmail.com', 'phone': '+966502100034'}], 'overallOfficials': [{'name': 'Saleh Binsaleh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'King Saud University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elaj medical centers', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Saud University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Mohamad Habous', 'investigatorFullName': 'Mohamad Habous', 'investigatorAffiliation': 'Elaj medical centers'}}}}