Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-21 @ 3:59 AM
Study NCT ID:
NCT03886402
Status:
WITHDRAWN
Last Update Posted:
2025-04-24
First Post:
2019-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'recruitment issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Partner Satisfaction Questionnaire', 'timeFrame': 'Pre-treatment and 30 days, 3 months and 6 months', 'description': 'This questionnaire asks the partner for their perceptions of effectiveness and overall satisfaction with the SVF treatment their partner received for erectile dysfunction. The questionnaire consists of 7 Likert scale questions (1 - 5), with a total score range of 7 to 35 with higher scores indicating more satisfaction. There are no subscales.'}], 'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': 'Monitoring of adverse events'}], 'secondaryOutcomes': [{'measure': 'International Index of Erectile Function (IIEF)', 'timeFrame': 'Pre-treatment, 30 days, 3 months and 6 months', 'description': 'The IIEF is a brief 15-item, self-administered questionnaire that was developed as a measure to detect treatment-related erectile function in patients in cross-cultural settings. Instrument includes 5 domains; erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS) and overall satisfaction (OS). The sub-scales scores range as follows: Erectile Function: 1-30 Orgasmic Function: 0-10 Sexual Desire: 2-10 Intercourse Satisfaction: 0-15 Overall Satisfaction: 2-10 The items are not weighted and total scores range from 5 to 75. On the Erectile Function sub-scale lower scores indicate worse erectile dysfunction, while on the remaining sub-scales higher scores indicate less dysfunction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* history of ED of at least 3 months' duration\n* have been taking a Phosphodiesterase type 5 (PDE5) inhibitor for at least 1 month prior and willing to stop taking any PDE5 inhibitor for duration of study\n* have an IIEF-EF domain score that is ≥11 and ≤25\n* have the same sexual partner for the duration of the study\n* subject and partner willing to voluntarily give consent\n* speak, read and understand English\n\nExclusion Criteria:\n\n* non-responders to PDE5 inhibitor\n* radical prostatectomy or other pelvic surgery or penile implant\n* currently taking blood thinners, cancer drugs or HIV drugs\n* allergic to lidocaine, epinephrine, valium\n* diminished decision-making capacity\n* use of tobacco\n* previous pelvic or abdominal radiation therapy\n* anti-androgen therapy\n* untreated hypogonadism\n* uncontrolled hypertension or hypotension\n* unstable cardiovascular disease\n* systemic autoimmune disorder"}, 'identificationModule': {'nctId': 'NCT03886402', 'briefTitle': 'Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GID BIO, Inc.'}, 'officialTitle': 'Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study', 'orgStudyIdInfo': {'id': 'GIDED-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months', 'interventionNames': ['Device: GID SVF-2']}], 'interventions': [{'name': 'GID SVF-2', 'type': 'DEVICE', 'otherNames': ['GIDZyme-2-50', 'GID Procedure Pack'], 'description': 'Treatment of erectile dysfunction with the subjects own cells', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'David Matthews MD', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GID BIO, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}