NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia
Status unconfirmed · Phase 1
Conditions studied: Congenital Pseudarthrosis of Tibia
In brief
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.
Key facts
- Study ID
- NCT05693558
- Run by
- Novadip Biosciences
- People needed
- 4
- Starts
- 2022-11-24
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2024-01-26
Who can join
Age: 2 and older, up to 8. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Adult/Pediatric Limb Lengthening and Reconstruction - International Center for Limb Lengthening - Rubin Institute for Advanced Orthopedics Baltimore — Baltimore, Maryland, United States
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
Full record on ClinicalTrials.gov
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