RecruitingCongenital Pseudarthrosis of Tibia
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Eligible age
Up to 17 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Novadip Biosciences
You may qualify if…
- ✓ 1. Participant's parent(s)/legal guardian(s) have provided written informed consent (and assent has been provided by the participant, depending on age) for the study.
- ✓ 2. Participant is of any sex, ≤17 years of age.
- ✓ 3. Participant has been diagnosed with CPT (with or without NF1).
- ✓ 4. Participant has a non-healing Paley type 3 or 4 diaphyseal fracture.4
- ✓ 5. Participant is a candidate for surgical treatment using an internal fixation approach (intramedullary rod) based on CPT fracture status and general health status.
- ✓ 6. Participant has serology and molecular test results at Visits 1 and 2 excluding the presence of human T-cell lymphoma virus, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and syphilis.
- ✓ 7. Participant can provide an adequate ATC sample volume.
- ✓ 8. Participant weighs ≥5 kg/11 lb at Screening and on Day 1.
You may not qualify if…
- ✕ 1. Participant has bilateral CPT.
- ✕ 2. Participant has evidence of plexiform neurofibroma of any size or nodular fibroma ≥1.2 inches/3 cm on the ipsilateral leg.
- ✕ 3. Participant has a clinically significant infection at the fracture site or systemic infection.
- ✕ 4. Participant's CPT fracture involves the metaphysis (i.e., not limited to the diaphysis).
- ✕ 5. Participant has a CPT fracture, for which the surgeon intends to use an external fixation system (e.g., Ilizarov, Taylor spatial frame, rail, etc.) instead of, or in addition to, internal fixation.
- ✕ 6. Participant has an autoimmune disease, with the exception of well-controlled type 1 diabetes or autoimmune thyroid disorders.
- ✕ 7. Participant has an active (malignant) tumor.
- ✕ 8. Participant has documented metabolic bone disease or any disorder, such as, but not limited, to osteogenesis imperfecta and osteomalacia, that could interfere with bone healing and bone metabolism.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07112443 · last updated 2026-04-01