Four children with Congenital Pseudarthrosis of Tibia (PCT), a rare bone disease, were successfully treated thanks to autologous therapy, the Belgian company Novadip Biosciences and Saint-Luc university clinics announced on Monday. The treatment is based on an implant (NVD003) which presents itself as a organic “plasticine”.
“As an inventor of this technology, I am extremely happy to see that NVD003 has made it possible to avoid amputation in these children,” said Dr. Denis Dufrane, co -founder and CEO of Novadip. “Our goal is clear: to make this solution accessible to the greatest number of children affected by this pathology. »»
The interventions were carried out in January 2018 by Pr Pierre-Louis Docquier, pediatric orthopedic surgeon in Saint-Luc, as part of compassionate use programs authorized by the Federal Agency for Medicines and Health Products (AFMPS).
The graft was directly established in the non -healing fracture in order to promote bone regeneration. After a follow -up of 4 to 7 years, the four children have a complete bone consolidation, without new fracture or adverse effect linked to treatment.
Novadip also announced new clinical trials at the start of the year, conducted with four other PCT patients. The first of them recently benefited from a monitoring visit at 24 months old and continues to be well. The Biotechnological Company now provides for the launch of a phase 3 clinical trial in June. The company provides for a marketing for NVD003 in 2027. “The results obtained after several years thanks to this innovative regenerative therapy in these young patients are simply exceptional”, said Professor Docquier.
Congenital pseudarthrosis of the tibia causes spontaneous fractures which do not heal naturally, which makes their care particularly complex. It touches between 1 newborn baby in 140,000 and 1 in 250,000.
