Study on the Safety and Effectiveness of NVD-003 Implant for Adults with Difficult-to-Heal Lower Leg Bone Fractures

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What is this study about?

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.

1 initial assessment and preparation

The process begins with an initial assessment to confirm eligibility for the study. This includes a review of medical history and a series of tests to ensure the patient meets the criteria for participation.

Radiographic images are required to confirm the presence of recalcitrant lower limb nonunion. These images must be no older than three months and demonstrate a lack of healing over a specified period.

A DEXA scan is performed to assess bone density, ensuring it is within acceptable limits.

For women of childbearing potential, a negative pregnancy test is required, and effective birth control must be used for two months prior to the surgical intervention.

2 adipose tissue collection

Adipose tissue is collected from the patient through a procedure known as liposuction. This tissue is used to derive autologous adipose-derived stem cells for the implant.

3 implantation surgery

The NVD-003 implant, containing the patient’s own stem cells, is surgically implanted into the affected area. This procedure is intended to aid in bone reconstruction.

The duration of the surgery and subsequent hospitalization is recorded as part of the study parameters.

4 post-surgery monitoring and follow-up

Following the surgery, the patient undergoes regular follow-up visits to monitor recovery and assess the safety and efficacy of the implant.

Vital signs, physical examinations, and laboratory tests are conducted at each visit to identify any abnormalities.

Healing is evaluated through X-rays and CT scans at specified intervals: 6 weeks, 3 months, 6 months, 12 months, and up to 24 months post-surgery.

The patient’s ability to bear weight, pain levels, and overall clinical healing are assessed by the investigator.

5 quality of life assessments

The patient’s quality of life is evaluated using specific questionnaires, such as the Brief Pain Inventory and the EuroQol-5 Dimensions, at various points throughout the study.

These assessments help determine the impact of the treatment on the patient’s daily life and overall well-being.

6 extended safety follow-up

An extended safety follow-up period is conducted to monitor for any serious adverse events. This period lasts up to 5 years post-surgery in Belgium and 10 years in Luxembourg.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Grand Hopital De Charleroi	Charleroi	Belgium
Chirec	Brussels	Belgium
CHU Helora	La Louviere	Belgium
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Centre Hospitalier de Luxembourg	Luxembourg	Luxembourg

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.08.2018
Luxembourg	Recruiting	02.08.2018

Trial locations

Investigated drugs:

Autologous Adipose-Derived Stem Cells

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.

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 ID:

2024-517762-42-01

Protocol code:

NVD003-CLN01

NCT ID:

NCT06335394

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of NVD-003 Implant for Adults with Difficult-to-Heal Lower Leg Bone Fractures

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?