CHU Helora
La Louviere, Belgium
Recruiting
Study on the Safety and Effectiveness of NVD-003 Implant for Adults with Difficult-to-Heal Lower Leg Bone Fractures
Fast replyInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition known as recalcitrant lower limb nonunion, which occurs when a broken bone in the lower leg does not heal properly even after attempts at surgical repair. The study is testing a new treatment called NVD-003, which is an implant made from the patient's own fat-derived stem cells. These cells are used to create a 3D structure that helps in bone reconstruction.
The purpose of the study is to evaluate the safety and initial effectiveness of the NVD-003 implant in helping bones heal. Participants in the study will receive the implant through a surgical procedure. After the surgery, they will be monitored over a period of time to check for any side effects and to see how well the bone is healing. This will involve regular check-ups and imaging tests like X-rays and CT scans to assess the progress of bone healing.
Throughout the study, the participants' overall health and quality of life will also be evaluated. This includes monitoring pain levels and any changes in daily activities. The study aims to provide valuable information on whether this new treatment can be a safe and effective option for people with this challenging bone condition.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Must be a male or female adult, aged 18 years or older.
- At the time of collecting fat tissue, tests for viruses like HIV, Hepatitis B, Hepatitis C, and syphilis must meet specific safety standards.
- Must understand the study, agree to its terms, and sign a consent form approved by the necessary ethics committee.
- Must be eligible to donate fat tissue and able to undergo a procedure called liposuction.
- Must have X-ray images, not older than 3 months, showing a condition called **lower limb nonunion**, which means the bone hasn't healed over a certain period after surgery.
- Must have a specific type of bone defect that is not larger than 4 cm.
- The affected limb must be able to be saved, and the patient must be eligible for the planned surgery according to hospital standards.
- Must have normal or low bone density, confirmed by a bone density scan called a **DEXA scan**.
- Must be able to follow the study plan, including after-surgery care and follow-up visits, according to the doctor's opinion.
- Women who can have children must use effective birth control for 2 months before the surgery and until a specific follow-up visit.
- Women who can have children must have a negative pregnancy test.
- At the start of the study, local lab test results must be safe for surgery, and virus test results must meet specific safety standards for donating body material.
Who cannot join the trial?
3 criteria
- Patients who are not experiencing a **recalcitrant lower limb nonunion**. This means the patient must have a specific type of bone healing problem in the lower leg that is not improving with usual treatments.
- Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
- Patients who are part of a vulnerable population. This means individuals who might need special protection or care, such as children or those unable to make decisions for themselves, are not eligible.
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Verified sites
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Verified Responsive Grand Hopital De Charleroi
Charleroi, BelgiumVerified University Childrens Hospital Queen Fabiola
Brussels, Belgium
Trial locations
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Investigated drugs
NVD-003 is an autologous 3D osteogenic implant used for bone reconstruction. It is designed to help patients with difficult-to-heal fractures in the lower limbs. The implant is made from the patient's own cells, which are processed to create a structure that can support new bone growth. This therapy aims to improve healing in cases where traditional treatments have not been successful.
What is already known about the treatment
NVD-003 – This medication is administered as an autologous 3D osteogenic implant, specifically designed for bone reconstruction. It is currently being evaluated in clinical trials for its safety and preliminary efficacy in treating recalcitrant lower limb nonunion, a condition where broken bones fail to heal properly. The main therapeutic indication is to aid in bone healing and reconstruction. At the molecular level, NVD-003 works by promoting bone growth and repair through the use of a patient's own cells, which are engineered to support new bone formation. It falls under the pharmacological classification of regenerative medicine products.
Investigated diseases
Recalcitrant Lower Limb Nonunion – This condition occurs when a fracture in the lower limb fails to heal properly over an extended period, despite treatment. It is characterized by the persistent lack of bone healing, which can lead to instability and pain in the affected area. The condition may arise due to inadequate blood supply, infection, or insufficient stabilization of the fracture. Patients often experience difficulty in bearing weight on the affected limb, which can significantly impact mobility. Over time, the nonunion may lead to further complications, such as deformity or joint stiffness. The healing process can be prolonged and may require additional interventions to promote bone union.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517762-42-01Protocol codeNVD003-CLN01Estimated enrolment11 patientsSponsorNovadip Biosciences
sourced from the EU Clinical Trials Register and site verification
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