Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-28 @ 5:38 PM
Study NCT ID:
NCT03933995
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2019-04-28', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Evaluation assessed by Tumor Marker Test.', 'timeFrame': '5 year(+-30 days)', 'description': 'Tumor Marker Test(reported in ng/mL): PSA, AFP, CEA Tumor Marker Test is optional item, not mandatory.\n\nIn this study, tumor markers divided into which are classified as "Normal / Not clinical significant / Clinical significant" abnormalities and analysis the frequency and proportion.'}, {'measure': 'Safety Evaluation assessed by Serious Adverse Events, cancer incidence and recurrence of prostate cancer.', 'timeFrame': '5 year(+-30 days)', 'description': 'Safety Evaluation assessed by Tumor Marker Test, patient reporting and vital signs\n\nFor each subject who has had one or more serious adverse events since the ongoing clinical trial, the severity of the adverse reaction should be provided for each causal relationship, and the incidence of serious adverse events should be analyzed.'}, {'measure': 'Safety Evaluation assessed by Vital Signs.', 'timeFrame': '5 year(+-30 days)', 'description': 'Vital Sign : Blood pressure(reported in mmHg), Pulse(reported in time/min) Vital Sign is optional item, not mandatory.\n\nThe vital sign values obtained from this study were compared for each group. Baseline statistics (mean, standard deviation, median, maximum, and minimum) are presented, and clinically significant figures are summarized and presented based on the normal range for each value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).', 'detailedDescription': 'This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).\n\nThis trial is planned to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in patients with erectile dysfunction subject. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, Serious Adverse Events, cancer incidence, recurrence of prostate cancer and vital sign).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).\n2. Subjects who can agree to participate in the long term observation study by oneself.\n\nExclusion Criteria:\n\n* Not Applicable'}, 'identificationModule': {'nctId': 'NCT03933995', 'briefTitle': 'Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmicell Co., Ltd.'}, 'officialTitle': 'Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'PMC-P-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mesenchymal stem cell', 'description': 'Long-term follow up of Mesenchymal stem cell group', 'interventionNames': ['Other: no Intervention']}], 'interventions': [{'name': 'no Intervention', 'type': 'OTHER', 'description': 'no Intervention', 'armGroupLabels': ['Mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chungsu Kim, PhD', 'role': 'CONTACT', 'email': 'cskim@amc.seoul.kr'}, {'name': 'Chungsu Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JIYEOUN JEONG, bachelor', 'role': 'CONTACT', 'email': 'jyjeong@pharmicell.com', 'phone': '82-02-3496-0134'}], 'overallOfficials': [{'name': 'Chungsu Kim, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmicell Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}