Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT06013306
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of AESI', 'timeFrame': '5 years follow-up after treatment'}, {'measure': 'Number of SS', 'timeFrame': '5 years follow-up after treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment', 'description': 'The higher the score, the worse the condition of the disease is.'}, {'measure': 'Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment', 'description': 'The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.'}, {'measure': 'Changes in 100-mm VAS', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment'}, {'measure': 'Changes in International Knee Documentation Committee Scoring System (IKDC)', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment', 'description': 'A higher score indicates better function and less symptomatic'}, {'measure': 'Evaluation of International K&L grade(X-ray)', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment', 'description': 'Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends'}, {'measure': 'Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment', 'description': 'A higher score indicates better function and less symptomatic'}, {'measure': 'Whole-Organ Magnetic Resonance Imaging Score (WORMS) score', 'timeFrame': '1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment', 'description': 'The higher the score means normal state.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj\n* Those who understand and voluntarily sign an informed consent form\n\nexclusion criteria\n\n* None'}, 'identificationModule': {'nctId': 'NCT06013306', 'briefTitle': 'Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kang Stem Biotech Co., Ltd.'}, 'officialTitle': 'Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study', 'orgStudyIdInfo': {'id': 'K0701-E'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chaeeun JEON', 'role': 'CONTACT', 'email': 'cejeon@kangstem.com', 'phone': '02-2036-7614'}, {'name': 'Hyeseung JEON', 'role': 'CONTACT', 'email': 'hsjeon@kangstem.com', 'phone': '02-888-1592'}], 'overallOfficials': [{'name': 'Kyoung-Ho Yoon, professor (CI)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital'}, {'name': 'Sang Hak Lee, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangdong Kyunghee University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kang Stem Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}