A Phase 3 Randomized, Controlled Study to Assess the Efficacy and Safety of NVD003 Compared With Iliac Crest Bone Graft in Pediatric Participants Treated Surgically for Congenital Pseudarthrosis of the Tibia
Novadip Biosciences
Summary
The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.
Description
CPT is a rare disorder affecting the tibia and/or the ipsilateral fibula in children. The disease is usually diagnosed during the first year of life and is characterized by nonunion of a tibial diaphyseal fracture that either develops spontaneously or after a history of trivial trauma in a previously dysplastic segment of the bone. The treatment of CPT remains a challenge, often due to failure of ICBG to achieve and maintain bone union, resulting in multiple revision surgeries and occasionally amputation of the lower leg. NVD003 is a novel 3-dimensional osteogenic graft that is derived from au…
Eligibility
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant's parent(s)/legal guardian(s) have provided written informed consent (and assent has been provided by the participant, depending on age) for the study. 2. Participant is of any sex, ≤17 years of age. 3. Participant has been diagnosed with CPT (with or without NF1). 4. Participant has a non-healing Paley type 3 or 4 diaphyseal fracture.4 5. Participant is a candidate for surgical treatment using an internal fixation approach (intramedullary rod) based on CPT fracture status and general health status. 6. Participant has serology and molecular test results at V…
Interventions
- BiologicalNVD003
Bone correction and grafting surgery
- ProcedureIliac Crest Bone Graft
Either a single-stage Grafting Surgery with internal fixation and cross-union or the 2-stage "induced membrane" Grafting Surgery approach, depending on the surgeon's own standard of care.
Locations (7)
- Phoenix Children's Hospital, Inc.Phoenix, Arizona
- Loma Linda University HealthLoma Linda, California
- LifeBridge Health - International Center for Limb LengtheningBaltimore, Maryland
- Mayo ClinicRochester, Minnesota
- Cliniques Universitaires Saint-Luc ASBL (CUSCL)Brussels, Brussels Capital
- CHU Amiens-PicardieAmiens, Picardie