Phase 3 trial in adult patients also planned for 2026 with focus on limb sparing associated with bone non-union (BNU)
Novadip Biosciences, a late-stage clinical biotechnology company specializing in regenerative medicine, today announces the recruitment of the first pediatric patients for the pivotal phase 3 trial of its tissue regeneration product NVD003 in congenital pseudoarthrosis of the tibia (CPT).
Phoenix Children’s Hospital, (Phoenix, AZ, USA), and Cliniques universitaires Saint-Luc, (Brussels, Belgium) have each recruited one pediatric patient, a toddler aged 3 and a teenager respectively.
The trial in Belgium is spearheaded by Professor Pierre-Louis Docquier, pediatric orthopedic surgeon at the Cliniques universitaires Saint-Luc. He is also the coordinating investigator of this trial. Taking the lead at Phoenix Children’s Hospital is Dr. Mohan Belthur, pediatric orthopedic surgeon and clinical assistant professor, Department of Child Health, University of Arizona College of Medicine in Phoenix.
Other sites recruiting patients include: Loma Linda University Children’s Health (Loma Linda, CA, USA), LifeBridge Health (Baltimore, MD, USA) the Mayo Clinic (Rochester, MN, USA), the hospital Necker-Enfants Malades (Paris, France), the CHU Amiens-Picardie (Amiens, France), and the hospital Sant Joan de Déu (Barcelona, Spain).
At least 12 children with CPT fractures will be enrolled in this phase 3 trial by end of Q1 2026. The trial will measure clinical and radiological healing at 12 months post-graft surgery with NVD003. Consenting participants will be monitored for an additional four years to assess the durability and safety of NVD003.