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Study of NVD003 stem cell implant compared to bone graft for children with congenital pseudarthrosis of the tibia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children with Congenital Pseudarthrosis of the Tibia, a rare condition where the shin bone develops an abnormal connection that doesn't heal properly. The study will test a treatment called NVD003, which is made from a patient's own fat-derived stem cells and is surgically implanted into the affected bone area. This treatment will be compared to the current standard procedure that uses bone tissue taken from the hip bone.

The purpose of this research is to determine how well NVD003 works and how safe it is when used to treat children with this bone condition. The study involves a surgical procedure where either NVD003 or hip bone tissue will be implanted along with an internal rod to help stabilize the bone. The treatment will be monitored for 12 months to check how well the bone heals.

During the study, doctors will take X-rays and perform physical examinations to check bone healing. They will also assess the child's ability to walk and their overall quality of life. The study will track any side effects that might occur during and after the surgical procedure. Children participating in the study will need to visit the hospital several times over the course of one year for these evaluations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    A medical evaluation will determine if you meet the study requirements for treating congenital pseudarthrosis of the tibia (a condition where the shin bone doesn't heal properly).

    Blood tests will be performed to ensure eligibility, checking for specific viruses and infections.

    Your weight must be at least 5 kg/11 lb to participate.

  2. Step 2

    Pre-surgical preparation

    Your tissue sample will be collected for preparing NVD003 (a treatment made from your own fat-derived stem cells).

    The medical team will plan your surgery using internal fixation with an intramedullary rod (a metal rod placed inside the bone).

  3. Step 3

    Surgical procedure

    You will undergo surgery where NVD003 will be implanted.

    The procedure includes placement of an internal rod to stabilize the bone.

    The length of the surgery and hospital stay will be recorded.

  4. Step 4

    Follow-up evaluations

    You will need to attend check-ups at 3, 6, and 12 months after surgery.

    During these visits, the following will be evaluated:

    - X-rays to check bone healing

    - Pain assessment during weight-bearing

    - Walking ability test (when appropriate)

    - Quality of life questionnaire for parents of children 2 years and older

  5. Step 5

    Final assessment

    At 12 months, final healing will be evaluated based on:

    - X-ray results showing bone union

    - Ability to bear weight without pain

    - Whether additional procedures were needed to help bone healing

Who can join the trial?

14 criteria

  • Parent or legal guardian must provide written consent for the study (and child's agreement if age-appropriate)
  • Participants must be age 17 years or younger
  • Participants must weigh at least 5 kg (11 pounds)
  • Must have been diagnosed with congenital pseudarthrosis of the tibia (CPT), which is a rare bone condition affecting the shin bone
  • Must have a non-healing fracture of type 3 or 4 in the middle portion of the bone
  • Must be suitable for surgery using internal rod fixation based on fracture status and overall health
  • Must test negative for specific infectious diseases including HIV, hepatitis B, hepatitis C, and others
  • Must be able to provide required tissue samples
  • Must not be pregnant or breastfeeding
  • If able to have children, must use effective birth control methods throughout the study, such as:
    • Hormonal contraception (pills, vaginal rings, or skin patches)
    • Contraceptive implants or injections
    • Intrauterine devices
    • Having a partner who has had a vasectomy
    • Must be willing and able to attend all required study visits and follow-up evaluations

Who cannot join the trial?

10 criteria

  • Patient cannot be an adult - the study is only for pediatric patients (children)
  • Patient must have a confirmed diagnosis of congenital pseudarthrosis of the tibia (a rare condition where the shin bone does not form properly before birth)
  • Patient must not have any previous surgical procedures to treat this condition
  • Patient must not have any active infections at the surgical site
  • Patient must not have any blood disorders that could affect bone healing
  • Patient must not be participating in any other clinical trials
  • Patient must not have any allergies to the study medication or its components
  • Patient must not have any other medical conditions that could interfere with the treatment or evaluation
  • Patient's legal guardian must be able to understand and follow study procedures
  • Patient must not have any contraindications to surgery
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Investigated drugs

  • NVD003

    is an investigational treatment being studied for children who need surgery for congenital pseudarthrosis of the tibia (a condition where the shin bone fails to develop properly, causing a false joint). This treatment is being compared to the standard procedure of using bone graft taken from the patient's own hip bone (iliac crest). The treatment aims to help the bone heal properly after surgery.

  • Iliac crest bone graft

    is the current standard treatment that involves taking healthy bone tissue from the patient's hip bone and using it at the site of the shin bone surgery. This natural bone graft helps promote healing and provides structural support at the surgery site.

What is already known about the treatment

NVD003 - A medical product currently being investigated in Phase 3 clinical trials for the surgical treatment of congenital pseudarthrosis of the tibia (CPT) in pediatric patients. It represents an alternative to traditional iliac crest bone grafting, suggesting it may be a bone graft substitute or bone formation stimulant used during surgical procedures. The medication is being evaluated for its efficacy and safety in comparison to the standard treatment method, though its exact molecular mechanism of action is not specified in the available data. This investigational product is being studied specifically in the musculoskeletal and pediatric therapeutic areas, indicating its potential importance in treating rare congenital bone conditions.

Investigated diseases

Congenital Pseudarthrosis of the Tibia - A rare bone condition present at birth or early childhood where the shin bone (tibia) develops an abnormal structure that leads to fracture and poor healing. The affected bone segment becomes weak and bent, often resulting in a false joint (pseudarthrosis) formation at the site of the break. The condition typically becomes apparent when a child begins to bear weight on the affected leg, causing the weakened bone to break. Without intervention, the bone fragments fail to unite properly, leading to instability in the lower leg. The condition may be associated with neurofibromatosis type 1 in some cases.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-520998-39-00Protocol codeNVD003-CLN03Estimated enrolment8 patientsSponsorNovadip Biosciences

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).