Novadip announces the implantation of the first two patients in its phase 3 pivotal trial of NVD003 in CPT

During February and March 2026, the first two patients enrolled in Novadip’s pivotal phase 3 trial for the treatment of Congenital Pseudarthrosis of the Tibia (CPT) were successfully implanted with NVD003 in Belgium and the US.

NVD003, an autologous bone graft created from a patient’s own adipose stem cells, is currently designed and manufactured in Belgium and then sent out to the trial centres for surgical implantation.

CPT is a rare and difficult-to-treat pediatric disease characterized by a non-healing fracture of the tibia that often leads to amputation. Following excision of the diseased bone tissue, NVD003 is implanted directly into the fracture site during bone reconstructive surgery to enable bone healing.

Pediatric orthopedic surgeon  Prof. Pierre-Louis Docquier performed the first of the two implants at Cliniques Universitaires Saint-Luc in Belgium in late February. He explained: “Having myself performed 7 of the 8 prior implantations of NVD003 in children with CPT during its early development, it was especially rewarding to perform the first graft surgery in this pivotal trial. I’m proud of the role I have played in bringing NVD003 this far”.

Dr. Melissa Esparza, together with Dr. Mohan Belthur, performed the trial’s second graft surgery in early March at Phoenix Children’s Hospital in the US, 8,000 km from Novadip’s facilities. “We’re happy and of course relieved that all went so smoothly with the procedure,” she said. “Currently, there are limited options available to treat these children. Based on the results that Prof. Docquier has achieved, we’re hopeful that NVD003 will provide us with a safe and efficacious option”.

The phase 3 trial (NCT07112443) 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.

The trial aims to enroll 12 children with CPT fractures by end of Q2 2026  at eight sites in the EU and US, including: 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), in addition to the sites at Cliniques Universitaires Saint-Luc and Phoenix Children’s Hospital.

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NOVADIP : Denis Dufrane – tel. +32 10 77 92 20, mob. +32 477 42 00 34 – denis.dufrane@novadip.com