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.
Of the eight children with CPT treated to date in previous trials with NVD003, seven have shown to have achieved durable union after two to seven years of follow-up. Most had experienced multiple failed procedures prior to being treated with NVD003. For this trial, the pediatric patients will be enrolled whether it’s their first or fifth surgical procedure. They will undergo graft surgeries three months after adipose tissue procurement.
“I’m so proud of our team and all our colleagues involved in getting us to this point,” said Judy Ashworth, MD, chief medical officer of Novadip Biosciences. “Clinical development is challenging enough for more common diseases. It takes high motivation, commitment and resilience to implement a trial in a rare pediatric condition. But knowing that our work can have such a major impact on the lives of children with CPT, that’s what keeps us all focused on the endgame. We expect to complete recruitment for this trial by end of Q1 2026.”
Impacting less than 3.5 in 150,000 live births, CPT is a rare condition for which treatment is difficult. Children with CPT are typically born with a bowing of the tibia that progresses to a spontaneous fracture. Once a fracture occurs, subsequent fractures are likely. This often occurs between six and 18 months following minimal trauma or from weight-bearing as these children learn to walk. They commonly undergo multiple surgical procedures before the