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

Launched by NOVADIP BIOSCIENCES · Jan 11, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called NVD-003 for children with congenital pseudarthrosis of the tibia (CPT), a condition where a bone in the lower leg does not heal properly. The study involves children from various countries who are undergoing surgery to repair their tibia fracture. The goal is to see if this new treatment can help their bones heal better.

To be eligible for the trial, children must be diagnosed with CPT and have a specific type of non-healing fracture. They should weigh at least 5 kg (about 11 lbs) and have had no more than two previous surgeries for the same issue. Parents or guardians must give their consent for their child to participate. If children meet these criteria, they can expect to receive the treatment during their surgery and will be closely monitored throughout the process. It's important to note that certain conditions, like having multiple failed surgeries or specific infections, may prevent a child from joining the study. This trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• 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.