Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04331327
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2020-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-03-27', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline WOMAC scores at 6 months', 'timeFrame': 'At baseline and after 6 months.', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores consist of 24 questions in 3 sections regarding; five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A sum of the scores for all three sub-scales gives a total WOMAC score. The higher scores mean a worse outcome.'}, {'measure': 'Change from Baseline structural outcomes scores at 6 months', 'timeFrame': 'At baseline and after 6 months.', 'description': 'Knee ultrasonography assessment of effusion, femoral cartilage, anterior horn medial meniscus, synovial hypertrophy'}], 'secondaryOutcomes': [{'measure': 'post injection complications of the intervention treatment', 'timeFrame': 'at each time following the injection', 'description': 'The patients of the intervention group were asked if they experienced any adverse events following the injection, with special concern on:\n\n1. Post-injection pain: Both the duration and intensity were documented. The pain intensity was measured by 0-10 visual analogue scale (VAS).\n2. General symptoms or signs related to infection and allergy such as fever, chills, pruritus, dyspnea, urticaria, or rash.\n3. Erythema, swelling, or abnormal discharge from the site of injection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'allogenic platelet rich plasma', 'lyophilization', 'growth factors'], 'conditions': ['Osteo Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '33754800', 'type': 'DERIVED', 'citation': 'El-Gohary R, Diab A, El-Gendy H, Fahmy H, Gado KH. Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study. Regen Med. 2021 Feb;16(2):113-115. doi: 10.2217/rme-2020-0104. Epub 2021 Mar 23.'}], 'seeAlsoLinks': [{'url': 'https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2018091713', 'label': 'A patent method describing the preparation of lyophilized growth factors from allogenic platelet rich plasma'}]}, 'descriptionModule': {'briefSummary': 'the study was conducted on 31-patients with symptomatic primary knee osteoarthritis. The patients were randomized into intervention and control groups. The control group was kept on their medications without intervention. The intervention group received two doses of allogenic lyophilized growth factors (L-GFs); at baseline and after 2 months.', 'detailedDescription': 'the study included 31 patients with symptomatic primary knee osteoarthritis (KOA) The study group was randomized into an intervention group and a control one. The control group patients were kept on their traditional medications without any intervention, while intervention group patients were instructed to stop using non-steroidal anti-inflammatory drugs (NSAID) at least 1 week before the assessment and throughout the study. All participants were subjected to baseline clinical, radiographic, and ultrasonography assessment. Follow up assessments was conducted after 6 months.\n\nPatients of the intervention group received two doses of intra-articular knee injections of allogenic lyophilized growth factors (L-GFs); one dose at the baseline and the other was after 2 months.\n\nLyophilized GFs were prepared at the Cairo Medical Centre Blood Bank from allogenic platelet rich plasma to according a previously published patented method.\n\nPrior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.\n\nThe injection was done under complete guidance of ultrasonography through lateral supra-patellar short axis in-plane approach under sterile aseptic conditions. After injection, local ice application and oral paracetamol were allowed if the patient felt pain. NSAIDs were completely avoided as they may inhibit the desired post-injection inflammatory process. Patients were encouraged to restrict vigorous knee activities for 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Clinical and radiographic diagnosis of primary knee osteoarthritis\n* Patients must be symptomatic\n\nExclusion Criteria:\n\n* Patients with secondary knee osteoarthritis\n* previous intra-articular steroid, or hyaluronic knee injection in last year\n* Patients with other disabling lower limb osteoarthropathy or myopathy'}, 'identificationModule': {'nctId': 'NCT04331327', 'briefTitle': 'Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Ultrasonographic Assessment of Effectiveness of Intra-articular Knee Injection Using Platelet Derived Lyophilized Growth Factors in Egyptian Patients With Symptomatic Primary Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '1/2016-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allogenic lyophilized growth factors', 'description': 'Two doses of intra-articular knee injections of lyophilized growth factors were received one dose at the baseline and the other was after 2 months.', 'interventionNames': ['Drug: allogenic lyophilized growth factors']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'The patients were kept on their traditional medications without any intervention'}], 'interventions': [{'name': 'allogenic lyophilized growth factors', 'type': 'DRUG', 'description': 'Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.', 'armGroupLabels': ['Allogenic lyophilized growth factors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'rheumatology and clinical immunology unit of internal medicine department of Kasr Al-ainy Hospital, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Kamel Gado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy School of Medicine, Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after publication', 'ipdSharing': 'YES', 'description': 'study protocol and statistical analysis plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rasmia Elgohary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer of internal medicine, subspecialty rheumatology and clinical immunology', 'investigatorFullName': 'Rasmia Elgohary', 'investigatorAffiliation': 'Cairo University'}}}}