FDA clears IND application for cell therapy to treat congenital pseudarthrosis of the tibia
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The FDA cleared an investigational new drug application for NVD-003, a stem cell therapy for treatment of children with congenital pseudarthrosis of the tibia, according to the agent’s manufacturer.
NVD-003 (Novadip Biosciences) is a second-generation autologous cell therapy derived from adipose stem cells and comes as a moldable putty that is implanted by the treating physician. The investigational therapy uses Novadip’s proprietary tissue regeneration platform to culture a patient’s adipose stem cells and produce an osteogenic product that promotes bone formation.
The IND clearance will allow Novadip to begin a first-in-human, pilot study of NVD-003. The North America-based clinical trial will enroll children aged 2 to 8 years with congenital pseudarthrosis of the tibia, a shin bone fracture present at birth or during early childhood that fails to heal property on its own. The rare bone disease is associated with a significant risk for amputation, according to the press release.
The first-generation version of the cell therapy, NVD-001, is being evaluated in a phase 1/phase 2a trial of adults with large bone nonhealing fractures and a phase 1/phase 2a trial of patients with single-level spinal fusion.
Interim results from the study of nonhealing fractures showed “clinically and radiologically meaningful improvement in patients,” according to a press release from the manufacturer.
NVD-003 received orphan drug and rare pediatric disease designations by the FDA in December.
“Receiving IND approval for NVD-003 is a major milestone for Novadip and we are excited by the potential impact this novel therapy could have on patients with few alternative treatment options,” Denis Dufrane, MD, PhD, CEO and founder of Novadip, said in the release. “The results that we previously reported demonstrate that Novadip’s technology is able to stimulate bone formation and we believe that NVD-003 has the potential to become a new standard of care for people that require critical size bone defect reconstruction.”
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