Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:14 AM
Study NCT ID:
NCT07473232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Platelet-rich Plasma and Activated Cytokine-rich Serum Injection Treatments in Patients With Knee Osteoarthritis. (KOA PRP ACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel, randomized, single blinded'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual pain scale score', 'timeFrame': 'Visual pain scale score (min 0-max 10) will be measured at the beginning ofthe study, 1 week, 1month and 3 months after the injection.', 'description': 'Visual pain scale score (min 0-max 10), higher scores indicate better results'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'platelet rich plasma injection', 'conditioned serum injection', 'inflammation', 'cartilage'], 'conditions': ['Knee Arthritis Osteoarthritis', 'Platelet Rich Plasma Injection', 'Conditioned Serum']}, 'descriptionModule': {'briefSummary': 'The effects of single dose injection of platelet rich plasma or conditioned serum in the knee joint in patients with knee osteoarthritis will be compared', 'detailedDescription': "Patients with early grade bilateral knee osteoarthritis (Kellgren Lawrence grade 1 or 2) will be divided into 2 groups. One group of patients will be injected with single dose of autologous platelet rich plasma (PRP) in the knee joints. Other group of patients will be injected with eqiuvolume of autologous conditioned serum (CS) (also known as activated cytokine rich serum) in the knee joints. Patients' serum before injection, the treatment product (PRP and CS), patients serum 30 min after injection will be investigated for IL-1β, IL-1Ra, PDGF-BB, IGF-1, TGF-β and TNF-α. Patients' serum 1 week and 1 month after injection will be investigated for MMP-13, COMP by ELISA. Patients will also be investigated for visual pain scale, WOMAC (Western Ontorino and Mc Master) scale range of motion, ultrasonographic tibiofemoral cartilage thickness measurement and functional tests including the 30-second chair test, stair climb test, 40 meter fast paced walk test, timed up and go test, 6-minute walk test, and walking speed in the first week, first month and third month after injection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of knee osteoarthritis according to ACR criteria at least 6 months ago.\n2. Being between grade 1-2 according to the Kellgren-Lawrence radiological classification.\n3. Not having had PRP injection in the last year.\n4. Knee pain ≥ 5 according to the visual pain scale.\n\nExclusion Criteria:\n\n1. Those with significant neurological or cardiovascular disorders.\n2. Those with active thrombovascular disease.\n3. Those with joint or skin infections.\n4. Those who have recently had an infectious disease.\n5. Those infected with Hepatitis B, C, and HIV.\n6. Those who have received intra-articular knee injections (hyaluronic acid, PRP, corticosteroids, and others) within the last year.\n7. Those who use oral corticosteroids.\n8. Those who have used NSAIDs within the last week.\n9. Those who have used anti-platelet or anti-aggregant drugs within the last week.\n10. Those with coagulation disorders.\n11. Those with hemoglobin \\<10 g/dl and platelet count \\<100,000\n12. Those with cancer.\n13. Pregnant or breastfeeding women, drug addicts.\n14. Those scheduled for knee surgery or arthroscopy, or those who have undergone knee surgery or arthroscopy.\n15. Those with diseases causing secondary osteoarthritis:\n\n 1. post-traumatic,\n 2. congenital or developmental diseases\n\n 1. Local diseases (leg length discrepancy, varus, valgus deformities, hypermobility syndromes, scoliosis)\n 2. Generalized diseases (Bone dysplasias, Metabolic disorders (hemochromatosis, ochronosis, Gaucher disease, hemoglobinopathy, Ehlers-Danlos disease))\n 3. Calcium storage diseases (calcium pyrophosphate storage disease, etc.)\n 4. Other bone and joint diseases (avascular necrosis, rheumatoid arthritis, gouty arthritis, septic arthritis, Paget's disease, osteoporosis, osteochondritis)\n 5. Other diseases\n\n 1. Endocrine diseases (Diabetes mellitus, acromegaly, hypothyroidism, hyperthyroidism)\n 2. Neuropathic arthropathy (Charcot joint)\n 3. Other (Frost, Kashin-Beck disease, Caisson disease) -"}, 'identificationModule': {'nctId': 'NCT07473232', 'acronym': 'KOA PRP ACS', 'briefTitle': 'Comparison of Platelet-rich Plasma and Activated Cytokine-rich Serum Injection Treatments in Patients With Knee Osteoarthritis. (KOA PRP ACS)', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Comparison of Platelet-rich Plasma and Activated Cytokine-rich Serum Injection Treatments in Patients With Knee Osteoarthritis. (KOA PRP ACS)', 'orgStudyIdInfo': {'id': 'E-60116787-020- 61586'}, 'secondaryIdInfos': [{'id': '2025TIPF037', 'type': 'OTHER_GRANT', 'domain': 'PAU BAP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP group', 'description': 'patients with knee osteoarthritis who will be injected with autologous PRP', 'interventionNames': ['Drug: Autologous Platelet-Rich Plasma (PRP)']}, {'type': 'EXPERIMENTAL', 'label': 'conditioned serum group', 'description': 'patients with knee osteoarthritis who will be injected with autologous conditioned serum', 'interventionNames': ['Drug: Conditioned serum (CS)']}], 'interventions': [{'name': 'Autologous Platelet-Rich Plasma (PRP)', 'type': 'DRUG', 'description': 'Autologous Platelet-Rich Plasma (PRP) will be injected intra-articularly in patients with knee osteoarthritis', 'armGroupLabels': ['PRP group']}, {'name': 'Conditioned serum (CS)', 'type': 'DRUG', 'description': 'Autologous conditionedserum (CS) will be injected intra-articularly in patients with knee osteoarthritis', 'armGroupLabels': ['conditioned serum group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'GÜLİN FINDIKOĞLU, Professor, MD, PhD', 'role': 'CONTACT', 'email': 'gulin_dr@yahoo.com', 'phone': '+905334227076'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be shared until 3 years after the publication.', 'ipdSharing': 'YES', 'description': 'IPD will bw shared by the primary investigator upon personel contact.', 'accessCriteria': 'Researchers will be able to access upon personel caontavt by e-mail of the primary investgator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR GULIN FINDIKOGLU MD, PhD', 'investigatorFullName': 'GULIN FINDIKOGLU', 'investigatorAffiliation': 'Pamukkale University'}}}}