NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia

NCT05693558 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-01-26

No results posted yet for this study

Summary

A single arm, multi-country, multi-center study in pediatric patients, suffering from congenital pseudarthrosis of the tibia (CPT), treated during the primary surgical intervention with NVD-003, an autologous 3D scaffold free osteogenic graft.

Conditions

  • Congenital Pseudarthrosis of Tibia

Interventions

BIOLOGICAL

NVD-003, an autologous 3D scaffold free osteogenic graft

Bone correction and grafting surgery

Sponsors & Collaborators

  • Novadip Biosciences

    lead INDUSTRY

Principal Investigators

  • Philip McClure, MD · International Center for Limb Lengthening Baltimore

  • Pierre-Louis Docquier · UCL St.Luc Brussels

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2025-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693558 on ClinicalTrials.gov