Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07487766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of XytriX in the Treatment of Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': '6 months'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee pain', 'Stem Cell', 'Osteoarthritis', 'Arthritis'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Adult patients with knee osteoarthritis, as diagnosed from x-ray findings.\n\n\\-\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding subjects\n* Active cancer or cancer treated within the past year\n* Allergy to sulfur\n* Hemodynamic instability\n* Inability of the patient or authorized person to sign consent\n* Hypersensitivity to drug ingredients\n* Active infection\n* Immunocompromised state\n* Critical thrombocytopenia\n* Organ transplant receipients\n* Chronic multisystem organ failure\n* Clinically significant abnormalities on pre-treatment lab evaluation\n* Medical condition that would, on the basis of the opinion of the investigator, compromise patient safety'}, 'identificationModule': {'nctId': 'NCT07487766', 'briefTitle': 'The Safety and Efficacy of XytriX in the Treatment of Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'TricelX Inc.'}, 'officialTitle': 'The Safety and Efficacy of XytriX in the Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XytriX', 'description': 'Subjects in this arm are receiving the drug.', 'interventionNames': ['Drug: XytriX, umbilical cord-derived mesenchymal stem cell']}], 'interventions': [{'name': 'XytriX, umbilical cord-derived mesenchymal stem cell', 'type': 'DRUG', 'description': 'There are no other interventions in this study.', 'armGroupLabels': ['XytriX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Kathryn Dziedzic', 'role': 'CONTACT', 'email': 'kathryn@tricelx.com', 'phone': '855-874-2359'}], 'facility': 'TriCelX', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}], 'centralContacts': [{'name': 'Kathryn Dziedzic, MD', 'role': 'CONTACT', 'email': 'kathryn@tricelx.com', 'phone': '855-874-2359'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TricelX Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}