Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 7:08 AM
Study NCT ID:
NCT05344157
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory outcome: Change in Visual Analogue Scale (VAS) for pain compared to baseline', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in KOOS compared to baseline', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in EQ-5D-5L compared to baseline', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in 40 m fast paced walk test compared to baseline', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in whole knee health compared to baseline, based on MRI', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis', 'timeFrame': '24 months after injection'}, {'measure': 'Exploratory outcome: Change in joint space narrowing based on x-ray compared to baseline', 'timeFrame': '24 months after injection'}], 'primaryOutcomes': [{'measure': 'Safety and tolerability: Adverse events (AEs)', 'timeFrame': 'From start of study until 24 months after injection', 'description': 'Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)'}, {'measure': 'Safety and tolerability: 12-lead electrocardiogram (ECG)', 'timeFrame': 'From start of study until 18 months after injection', 'description': 'Change in 12-lead electrocardiograms (ECGs) compared to baseline.'}, {'measure': 'Safety and tolerability: Laboratory examinations', 'timeFrame': 'From start of study until 18 months after injection', 'description': 'Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.'}, {'measure': 'Safety and tolerability: Physical examinations', 'timeFrame': 'From start of study until 18 months after injection', 'description': 'Changes in physical examination compared to baseline.'}, {'measure': 'Safety and tolerability: Vital signs', 'timeFrame': 'From start of study until 18 months after injection', 'description': 'Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.'}], 'secondaryOutcomes': [{'measure': 'Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis', 'timeFrame': 'From start of study until 18 months after injection'}, {'measure': 'Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline', 'timeFrame': 'From start of study until 18 months after injection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major inclusion criteria:\n\n* Aged ≥40 and ≤75 years at Screening\n* Radiological evidence of predominantly medial osteoarthritis in the knee, uni- or bilateral, of KL grade II to III\n* Moderate to severe pain associated with osteoarthritis in the knee as measured by a VAS pain score of ≥35 and ≤90 mm\n\nMajor exclusion criteria:\n\n* Body mass index (BMI) of ≥35 at Screening\n* Ongoing signs or symptoms of systemic or local infection\n* Known knee infection in the study knee within 6 months of Screening\n* History of clinically relevant concomitant joint disease, clinically-relevant knee deformities, or any clinically significant medical history of the ligament, or realignment surgery or joint replacement surgery\n* Medical history of any autoimmune disease\n* History of surgery in the study knee that occured within 6 months of Screening\n* Treatment with immunosuppressive therapy (systemic or local) or any medication affecting the bone or cartilage metabolism within 6 months of Screening\n* Patients who are immunocompromised as caused by a disease'}, 'identificationModule': {'nctId': 'NCT05344157', 'briefTitle': 'A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xintela AB'}, 'officialTitle': 'A First-in-Human Open-Label Phase 1/2a Study to Evaluate Safety, Tolerability and Efficacy of a Single Intra-Articular Injection of Allogeneic Mesenchymal Stem Cells Selected for Integrin α10β1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'XIN-XSTEM-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XSTEM-OA', 'description': 'Single intra-articular injection of XSTEM-OA', 'interventionNames': ['Biological: XSTEM-OA']}], 'interventions': [{'name': 'XSTEM-OA', 'type': 'BIOLOGICAL', 'description': 'XSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis.', 'armGroupLabels': ['XSTEM-OA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2292', 'city': 'Broadmeadow', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Genesis Research Services', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}], 'overallOfficials': [{'name': 'Per Norlén, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xintela AB'}, {'name': 'Stephen Hall, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emeritus Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xindu Pty Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Xintela AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}