Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-22 @ 5:40 AM
Study NCT ID:
NCT03307668
Status:
UNKNOWN
Last Update Posted:
2017-10-12
First Post:
2017-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054544', 'term': 'Arthroplasty, Subchondral'}], 'ancestors': [{'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-10-06', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Difference of MOCART score change from baseline between groups', 'timeFrame': '12 months'}, {'measure': 'Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups', 'timeFrame': '12 months'}, {'measure': 'Difference of Lysholm score change from baseline between groups', 'timeFrame': '12 months'}, {'measure': '"Good""Moderate""Poor" rates according to Lysholm score', 'timeFrame': '12 months'}, {'measure': 'Effective rate according to Lysholm score', 'timeFrame': '12 months'}, {'measure': 'Total efficiency according to Lysholm score', 'timeFrame': '12 months'}, {'measure': 'Incidence of treatment-related adverse events', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cartilage Defects']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.', 'detailedDescription': 'CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.\n\nThe physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged from 18 to 55 years old;\n2. Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy, and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is Outerbridge IV degree or III degree but approximate to IV degree;\n3. Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;\n4. Normal lower limb mechanical force line (varus or valgum \\< 5°);\n5. Skeletal mature;\n6. 18Kg/M2 ≤ BMI ≤ 30Kg/M2;\n7. Agree to sign the informed consent form;\n8. Can cooperate in a post-operative rehabilitation program.\n\nExclusion Criteria:\n\n1. Superficial cartilage defects;\n2. Concomitant with subchondral bone defect;\n3. Varus or valgum \\> 5°;\n4. Serious meniscus injury;\n5. Fractures around the knee;\n6. Cannot join in the post-operative rehabilitation program;\n7. The contralateral lower-limb cannot stand weight-bearing;\n8. A history of knee surgery within 6 months;\n9. Secondary arthritis affecting cartilage;\n10. Serious arthrocleisis;\n11. Undergoing clinical trial;\n12. Serious illness of the heart, lung, and other vital organs;\n13. Liver function test equal to two times or greater than the upper normal limits; serum creatinine equal to two times or greater than the upper normal limit;\n14. Have a contagious disease;\n15. Allergic to the agents;\n16. Lactating or pregnant women;\n17. Serious neuropathy or mental disease;\n18. Be addicted with drug or alcohol.'}, 'identificationModule': {'nctId': 'NCT03307668', 'briefTitle': 'Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthro-Anda Tianjin Biologic Technology Co., Ltd.'}, 'officialTitle': 'Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial', 'orgStudyIdInfo': {'id': '3.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CaReS-1S', 'interventionNames': ['Device: CaReSR-1S']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microfracture', 'interventionNames': ['Device: Microfracture']}], 'interventions': [{'name': 'CaReSR-1S', 'type': 'DEVICE', 'description': 'CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.', 'armGroupLabels': ['CaReS-1S']}, {'name': 'Microfracture', 'type': 'DEVICE', 'description': 'Microfracture is an articular cartilage repair surgical technique that works by creating tiny fractures in the underlying bone. This causes new cartilage to develop from a so-called super-clot.', 'armGroupLabels': ['Microfracture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang-hua Lei', 'role': 'CONTACT'}], 'facility': 'Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Dong-xing Xie, PhD', 'role': 'CONTACT', 'email': '491703175@qq.com', 'phone': '86073189753006'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthro-Anda Tianjin Biologic Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}