Novadip Biosciences announced that the first U..S patient has been implanted with its investigational tissue regeneration product, NVD 003, in its Phase 1b/2a clinical trial in Congenital Pseudarthrosis of Tibia (CPT), a rare pediatric bone condition.
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An autologous therapy derived from a patient's own adipose stem cells (ASC), NVD 003 has the potential to accelerate healthy bone formation, restore mobility and avoid the need for amputation in children with CPT.
"This is an exciting moment to be able to treat one of our patients with NVD 003," said Philip K. McClure, MD, FAAOS, Director of the International Center for Limb Lengthening, Baltimore, Maryland and the principal investigator in the US on this trial.
"Three months after we collected the patient's adipose tissue in here in Baltimore, the NVD 003 graft, which was then manufactured in Belgium, was sent to us for implantation.
"With NVD 003, there's hope that the standard use of invasive iliac crest bone grafting, which can be very painful and lead to complications such as infection, bleeding and large scar formation, can be avoided.
"This is particularly important for patients who have had previous surgeries on the pelvis, making graft harvest of higher risk."
According to Novadip, this Phase 1b/2a trial has now reached full enrolment; 3 patients have been enrolled in Belgium, of whom 2 have already been grafted with NVD 003 by Professor Pierre Louis Docquier, MD, PhD, a specialist in pediatric surgery at the University Hospital Saint Luc in Brussels. The company is actively planning the pivotal trial to support NVD 003's approval by the US Food and Drug Administration (FDA).
Novadip also provided an update on NVD X3, their allogeneic off the shelf matrix product, which entered clinical development this past summer with two parallel Phase 1b/2a EU clinical trials.
Enrolment in the first trial, for the treatment of a distal radius fracture following trauma, is near completion with 9 of 10 patients already treated.
In addition, the first patient has been treated in the second trial investigating NVD X3 in spine fusion. ■