Actively Recruiting
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Led by Novadip Biosciences · Updated on 2026-04-01
12
Participants Needed
7
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal guardian has provided written informed consent, and assent from the participant if applicable
- Participant of any sex aged 17 years or younger
- Diagnosed with Congenital Pseudarthrosis of the Tibia (CPT), with or without neurofibromatosis type 1
- Has a non-healing Paley type 3 or 4 fracture of the tibia
- Candidate for surgical treatment using internal fixation with an intramedullary rod
- Negative test results for certain infections including HIV, hepatitis B and C, syphilis, and human T-cell lymphoma virus
- Able to provide sufficient sample of adipose tissue cells
- Weighs at least 5 kg (11 lb) at screening and on day 1
- Not pregnant or breastfeeding
- If of childbearing potential, uses highly effective contraception from screening through study end
- Willing and able to attend all study visits and follow-ups
You will not qualify if you...
- Has bilateral Congenital Pseudarthrosis of the Tibia
- Presence of plexiform neurofibroma or nodular fibroma larger than 3 cm on the same leg
- Active infection at the fracture site or systemic infection
- Fracture involves metaphysis instead of diaphysis
- Planned use of external fixation devices instead of or in addition to internal fixation
- Has autoimmune diseases except well-controlled type 1 diabetes or autoimmune thyroid disorders
- Has active malignant tumor
- Has metabolic bone diseases or disorders affecting bone healing
- Uses medications affecting bone metabolism during the study, except certain bisphosphonates allowed in some cases
- History of allergic reaction to anesthetics or components of NVD003 or surgical materials
- Received any investigational product within 60 days before enrollment
- Concurrent participation in another clinical study
- Significant laboratory abnormalities in blood, kidney, liver, or clotting tests
- Has unstable medical or psychiatric conditions, recent substance abuse, or unable to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Phoenix Children's Hospital, Inc.
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
3
LifeBridge Health - International Center for Limb Lengthening
Baltimore, Maryland, United States, 21117
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Cliniques Universitaires Saint-Luc ASBL (CUSCL)
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
6
CHU Amiens-Picardie
Amiens, Picardie, France, 80000
Actively Recruiting
7
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
Research Team
J
Judy Ashworth, MD
CONTACT
L
Lola TOME
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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