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
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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