drugset / Trial / NCT07112443

A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.

NCT07112443 ↗

Phase 3 Recruiting 12 enrolled Novadip Biosciences
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.

Timeline

Start
2025-09-02
Primary completion
2026-10
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject NVD003 Cell therapy — —