Ongoing Clinical Trials for Lower Limb Fracture
There is currently 1 ongoing clinical trial focused on lower limb fractures, specifically targeting cases where broken bones in the lower leg have not healed properly despite previous treatment attempts. This trial is testing a new implant made from the patient’s own stem cells to help promote bone healing.
Clinical trial locations
- Belgium
- Luxembourg
Study on the Safety and Effectiveness of NVD-003 Implant for Adults with Difficult-to-Heal Lower Leg Bone Fractures
This trial is investigating a new treatment approach for people whose lower leg bone fractures have failed to heal properly, a condition known as recalcitrant lower limb nonunion. When a broken bone doesn’t heal even after surgical repair attempts, it can cause ongoing pain, instability, and difficulty with walking and daily activities.
Who can participate:
- Adults aged 18 years or older
- People with X-ray evidence showing that a lower leg bone hasn’t healed over a certain period after surgery, with images taken within the last 3 months
- Those with a bone defect no larger than 4 centimeters
- Patients with normal or low bone density confirmed by a DEXA scan
- Individuals who are eligible to donate fat tissue and undergo liposuction
- Women of childbearing age must use effective birth control for 2 months before surgery and have a negative pregnancy test
- Patients must be able to follow the study plan, including post-surgery care and follow-up visits
Who cannot participate:
- Patients who do not have recalcitrant lower limb nonunion
- Individuals outside the specified age range
- People who are part of vulnerable populations, such as those unable to make decisions for themselves
What the trial involves:
The study is testing an innovative treatment called NVD-003, which is a specially designed implant made from the patient’s own fat-derived stem cells. The process begins with collecting fat tissue through liposuction. These cells are then used to create a 3D structure that supports new bone growth.
The trial follows a structured approach. First, participants undergo thorough assessment including medical history review, X-rays, and bone density scans. After eligibility is confirmed, fat tissue is collected from the patient. The NVD-003 implant containing the patient’s own stem cells is then surgically placed into the affected area of the bone that hasn’t healed.
Following surgery, participants attend regular follow-up visits where doctors monitor healing progress through X-rays and CT scans at 6 weeks, 3 months, 6 months, 12 months, and up to 24 months after surgery. During these visits, medical staff check vital signs, conduct physical examinations, and perform laboratory tests. They also assess the patient’s ability to bear weight on the affected leg and measure pain levels.
The study also evaluates how the treatment affects daily life through quality of life questionnaires that measure pain levels and overall well-being at various points throughout the trial. An extended safety follow-up period continues for up to 5 years in Belgium and 10 years in Luxembourg to monitor for any long-term effects.
The investigational treatment:
NVD-003 is classified as a regenerative medicine product. Unlike traditional treatments, it uses the patient’s own cells to promote bone healing, which may reduce the risk of rejection. The implant works at the molecular level to encourage new bone formation and repair in areas where the bone has failed to heal naturally.
Summary
Currently, there is one clinical trial available for patients with lower limb fractures that have not healed properly despite previous treatment. The trial is being conducted in two countries: Belgium and Luxembourg, offering opportunities for patients in these regions to access this experimental treatment.
The study represents an innovative approach using regenerative medicine, specifically the NVD-003 implant made from patients’ own stem cells. This personalized treatment strategy aims to address a challenging medical condition where traditional bone healing methods have not been successful. The trial includes comprehensive monitoring over an extended period, with safety follow-up lasting several years to ensure thorough evaluation of both short-term and long-term outcomes.
Patients interested in this trial should discuss with their healthcare provider whether they meet the eligibility criteria and whether participation would be appropriate for their specific situation.