Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-30 @ 5:18 AM
Study NCT ID:
NCT05693558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2022-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011542', 'term': 'Pseudarthrosis'}], 'ancestors': [{'id': 'D005599', 'term': 'Fractures, Ununited'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single arm, multi-country, multi-center study in pediatric patients, suffering from congenital pseudarthrosis of the tibia (CPT), treated during the primary surgical intervention with NVD-003, an autologous 3D scaffold free osteogenic graft.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary objective: safety short (≤3 months) and mid long-term (>3-12 months): : Descriptive analysis', 'timeFrame': 'Up to 12 months post-grafting surgery', 'description': 'Assess number of patients with NVD-003 related (S)AEs'}], 'secondaryOutcomes': [{'measure': 'Long term Safety long-term (>12-24 months): Descriptive analysis', 'timeFrame': '12-24 months post grafting surgery', 'description': 'Assess number of patients with NVD-003 related SAEs'}, {'measure': 'Tibial length evaluation', 'timeFrame': '3-, 6-, 12- and 24-months post-GS', 'description': 'Assess evolution tibial length (using CT-Scan)'}, {'measure': 'Bone formation', 'timeFrame': '3-, 6-, 12- and 24-months post-GS', 'description': 'Assess changes in bone formation (Using Lane and Sandhu Scoring on CT-Scan)'}, {'measure': 'Bone remodeling', 'timeFrame': '3-, 6-, 12- and 24-months post-GS', 'description': 'Assess changes in bone remodeling (using Lane and Sandhu Scoring on CT-scan)\n\nBased on Dual Energy CT-scan (DECT or Spectral CT), information of low- and high-energy photons is collected, allowing to uncover differences in energy-dependent attenuation, facilitating composition of NVD 003 and surrounding tissue and define bone mineral density) at 3-, 6-, and 12-months post-GS'}, {'measure': 'Bone union', 'timeFrame': '3-, 6-, 12- and 24-months post-GS', 'description': 'Assess changes in bone union (using Lane and Sandhu Scoring on CT-scan)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue Engineered Therapy', 'bone graft', 'autologous', 'pediatric', 'congenital', 'non-union', 'pseudarthrosis', 'Cellular therapy'], 'conditions': ['Congenital Pseudarthrosis of Tibia']}, 'referencesModule': {'references': [{'pmid': '30996736', 'type': 'BACKGROUND', 'citation': 'Paley D. Congenital pseudarthrosis of the tibia: biological and biomechanical considerations to achieve union and prevent refracture. J Child Orthop. 2019 Apr 1;13(2):120-133. doi: 10.1302/1863-2548.13.180147.'}, {'pmid': '29113460', 'type': 'BACKGROUND', 'citation': 'Dufrane D. Impact of Age on Human Adipose Stem Cells for Bone Tissue Engineering. Cell Transplant. 2017 Sep;26(9):1496-1504. doi: 10.1177/0963689717721203.'}]}, 'descriptionModule': {'briefSummary': 'A single arm, multi-country, multi-center study in pediatric patients, suffering from congenital pseudarthrosis of the tibia (CPT), treated during the primary surgical intervention with NVD-003, an autologous 3D scaffold free osteogenic graft.', 'detailedDescription': 'Congenital pseudarthrosis is a rare disorder of unknown aetiology and variable history that manifests itself as a non-union or pseudarthrosis of fractures that develop spontaneously or following minor trauma. It can be defined as a disorder of the diaphysis which is revealed by either pseudarthrosis at birth or by a pathological fracture presenting in bone with modifications such as bowing, narrowing of the medullary canal or a cyst. Although uncommon, CPT is the most frequently observed type of congenital pseudarthrosis. Its incidence is reported to be between 1:140,000 to 1:250,000 live births.\n\nAutologous bone grafting is considered the gold standard approach as this material vascularizes and integrates with surrounding bone, minimizing the risk of infection, dislodgement, or break-down.\n\nNVD-003 is a scaffold free 3D osteogenic graft derived from autologous adipose stem cells which become embedded in their extracellular matrix and combined with hydroxyapatite/beta-tricalcium phosphate (HA/βTCP) particles.\n\nNVD-003 is intended to promote bone formation, supporting the physiological bone healing process in severe pathophysiological conditions such as hypoxia, lack of mineralized callus formation, bone resorption and low osteogenicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with congenital pseudarthrosis of the tibia (with or without NF1) and presenting with a non-healing Paley type 3 or 4 fracture.\n* Minimum weight of 5kg/11lbs.\n* Maximum 2 previous failed surgical orthopaedic interventions to treat the primary CPT fracture.\n* Acceptable serology and molecular test results excluding the presence of viruses\n* Satisfactory general health condition to undergo surgeries (ATC and GS) with anaesthesia as per local standards.\n* The patient's parent(s) and/or legal guardian(s) provided written informed consent and accepted the participation of the patient in the trial.\n\nExclusion Criteria:\n\n* Bilateral CPT.\n* Presence of CPT without a fracture of the tibia (Paley type 1 and 2).\n* More than 2 failed surgical attempt(s) to treat the primary tibial fracture.\n* Evidence of plexiform neurofibroma of any size or nodular fibroma ≥ 1.2in/3cm on the ipsilateral leg.\n* Clinically significant infection at the target grafting site or systemic infection.\n* Presence of clinically significant hematologic, renal, hepatic, and coagulation laboratory abnormalities (i.e., CBC, PT/INR, Chem-7, and LFTs, etc.).\n* Presence of any auto-immune disease, with exception of well controlled diabetes type 1 or auto-immune thyroid disorders.\n* Any history of experimental therapy with another investigational drug within 60 days prior to screening.\n* Presence of active tumour.\n* Documented metabolic bone disease or any disorder, such as but not limited to osteogenesis imperfecta and osteomalacia, that could interfere with the bone healing and bone metabolism.\n* Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressant therapy or immunotherapy."}, 'identificationModule': {'nctId': 'NCT05693558', 'briefTitle': 'NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novadip Biosciences'}, 'officialTitle': 'A Proof-of-concept Study With NVD-003, an Autologous Osteogenic Bone Graft, in the Treatment of Congenital Pseudarthrosis of the Tibia in Pediatric Patients.', 'orgStudyIdInfo': {'id': 'NVD003-CLN02 CPT'}, 'secondaryIdInfos': [{'id': '2022-001282-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVD-003 bone graft implant', 'description': 'The study includes 2 important surgical procedures, the Adipose Tissue Collection (ATC) and the Grafting Surgery (GS) and 3 stages\n\n* Stage 1: A screening, adipose tissue collection \\& NVD 003 manufacturing period.\n* Stage 2: Grafting surgery and 12-month post-GS follow-up period.\n* Stage 3: long-term safety follow-up period (from post-month 12 to month 24).', 'interventionNames': ['Biological: NVD-003, an autologous 3D scaffold free osteogenic graft']}], 'interventions': [{'name': 'NVD-003, an autologous 3D scaffold free osteogenic graft', 'type': 'BIOLOGICAL', 'description': 'Bone correction and grafting surgery', 'armGroupLabels': ['NVD-003 bone graft implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Adult/Pediatric Limb Lengthening and Reconstruction - International Center for Limb Lengthening - Rubin Institute for Advanced Orthopedics Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Philip McClure, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Center for Limb Lengthening Baltimore'}, {'name': 'Pierre-Louis Docquier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL St.Luc Brussels'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novadip Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}