Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 7:44 AM
Study NCT ID:
NCT05955235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term safety assessment', 'timeFrame': 'Up to 5 Years', 'description': 'Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).'}, {'measure': 'Mortality', 'timeFrame': 'Up to 5 Years', 'description': 'Ratio of subjects who died during long-term safety follow-up'}, {'measure': 'Ratio of subjects with malignant tumors formed during the long-term safety follow-up period', 'timeFrame': 'Up to 5 Years', 'description': 'The number, ratio, and number of cases of malignant tumor formation'}], 'secondaryOutcomes': [{'measure': 'Number of occurrences of Abnormal, clinically significant in laboratory results', 'timeFrame': 'Up to 5 Years', 'description': 'Perform if necessary.\n\n* Hematology: RBC, Hemoglobin, Hematocrit, Platelet count, WBC with Differential Count\n* Chemistry: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, ALT, AST, r-GT, ALP, LDH, glucose, Total cholesterol, Triglyceride, C-reactive protein\n* Urinalysis: Protein, Glucose, Urobilinogen, WBC, RBC Blood coagulation test: aPTT, PT'}, {'measure': 'Number of occurrences of Abnormal, clinically significant in Vital Signs', 'timeFrame': 'Up to 5 Years', 'description': 'Measure systolic blood pressure, diastolic blood pressure, pulse, and body temperature.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem Cell Therapy', 'SCM-AGH', 'Pancreatitis'], 'conditions': ['Pancreatitis, Acute']}, 'descriptionModule': {'briefSummary': 'This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.', 'detailedDescription': 'Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who provide written informed consent\n* Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05955235', 'briefTitle': 'A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SCM Lifescience Co., LTD.'}, 'officialTitle': 'A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study', 'orgStudyIdInfo': {'id': 'APT2001-LTFU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Not Applicable(Observation Study)', 'type': 'OTHER', 'description': 'Not Applicable(Observation Study)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14584', 'city': 'Bucheon-si', 'state': 'Gyenggi-do', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hosptial Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Medical School', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCM Lifescience Co., LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}