NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia

Inclusion Criteria: * Diagnosed with congenital pseudarthrosis of the tibia (with or without NF1) and presenting with a non-healing Paley type 3 or 4 fracture. * Minimum weight of 5kg/11lbs. * Maximum 2 previous failed surgical orthopaedic interventions to treat the primary CPT fracture. * Acceptable serology and molecular test results excluding the presence of viruses * Satisfactory general health condition to undergo surgeries (ATC and GS) with anaesthesia as per local standards. * The patient's parent(s) and/or legal guardian(s) provided written informed consent and accepted the participation of the patient in the trial. Exclusion Criteria: * Bilateral CPT. * Presence of CPT without a fracture of the tibia (Paley type 1 and 2). * More than 2 failed surgical attempt(s) to treat the primary tibial fracture. * Evidence of plexiform neurofibroma of any size or nodular fibroma ≥ 1.2in/3cm on the ipsilateral leg. * Clinically significant infection at the target grafting site or systemic infection. * Presence of clinically significant hematologic, renal, hepatic, and coagulation laboratory abnormalities (i.e., CBC, PT/INR, Chem-7, and LFTs, etc.). * Presence of any auto-immune disease, with exception of well controlled diabetes type 1 or auto-immune thyroid disorders. * Any history of experimental therapy with another investigational drug within 60 days prior to screening. * Presence of active tumour. * 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. * 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.