A proof-of-concept study with NVDX3, an osteogenic implant of human allogenic origin, in the treatment of low grade degenerative lumbar spondylolisthesis by interbody spine fusion in adults.
This research is testing a new treatment called NVDX3. It's a special type of natural bone material designed to help bones in the spine fuse (grow together) for people who have a condition called low-grade degenerative lumbar spondylolisthesis. This condition means one of the bones in the lower back has slipped forward slightly, which can cause pain. Surgeons sometimes perform an operation called an interbody spine fusion to help stabilise the back. NVDX3 is hoped to help this fusion process. This is an early-stage study (Phase 1 and 2), meaning it’s one of the first times this treatment is being used in people. The main goals are to check if NVDX3 is safe and if it shows signs of working well.
At a glance
What is this study about?
This study is exploring a new approach for people who have a common back problem called degenerative lumbar spondylolisthesis. In simpler terms, this is when one of the bones (vertebrae) in your lower back slips forward a little. This can happen gradually over time as we get older and the parts of our spine start to wear down. When this causes pain or other symptoms, doctors sometimes suggest an operation called spinal fusion. This surgery aims to join two or more vertebrae together so they can't move against each other, which can help reduce pain and stabilise the spine.
In this operation, doctors often use something called a bone graft to help the bones fuse. This study is testing a new type of bone graft material called NVDX3. It's special because it comes from human bone that has been carefully processed. The idea behind NVDX3 is to encourage new bone to grow and help the fusion process in the spine. This study is important because it’s a “proof-of-concept” study, which means it’s one of the very first times this new material is being used in people. The main purpose is to see if NVDX3 is safe to use and if it looks like it can effectively help with spine fusion.
Finding new and better ways to help people recover from back pain and spinal surgery is really important. If NVDX3 proves to be safe and effective, it could offer another option for people needing spinal fusion for spondylolisthesis. This early research will provide doctors and scientists with vital information to decide if they should continue testing NVDX3 in larger studies.
Key takeaways
- This study is testing a new natural bone material (NVDX3) for spinal fusion surgery.
- It's for adults with a specific lower back condition called spondylolisthesis.
- This is an early-stage study to check for safety and if the treatment works.
- Participants will have NVDX3 used during their back surgery.
- Regular follow-up appointments will be needed to monitor recovery.
Who may be eligible?
This study is for adults aged 18 and over. It's specifically for people who have a condition called low-grade degenerative lumbar spondylolisthesis, which is when a bone in the lower back has slipped forward slightly due to wear and tear over time. They must also be candidates for a specific type of back surgery called interbody spine fusion.
Both men and women can take part. To be considered for this study, you would need to be in overall good health, apart from your back condition, and meet some other specific medical criteria that the study doctors would explain.
It's important to remember that not everyone with this back condition will be able to join the study. The study doctors need to make sure that participants are a good fit for the research and that it is safe for them to take part. They will review your medical history and conduct tests to confirm if you meet all the requirements.
- Are you 18 years old or older?
- Do you have low-grade degenerative lumbar spondylolisthesis?
- Are you scheduled to have interbody spine fusion surgery for this condition?
- Are you generally in good health apart from your back problem?
- Are you willing to attend regular follow-up appointments after surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the NVDX3 bone material during your planned interbody spine fusion surgery. After the surgery, you would have a number of visits to the hospital or clinic for check-ups and medical tests. These visits would help the study team monitor how you are recovering, how well the spine is fusing, and if you are experiencing any side effects from the treatment. These check-ups might include X-rays, scans, and physical examinations. The exact number and timing of visits, and the total duration of your involvement in the study, would be fully explained by the study team before you make any decisions.
Potential risks and benefits
Locations (1)
- —Luxembourg
Common questions
What is 'degenerative lumbar spondylolisthesis'?
It's a condition where a bone in your lower back (lumbar spine) slips forward slightly due to wear and tear over time, which can cause back pain.
What is 'interbody spine fusion' surgery?
It's an operation to join two or more bones in your spine together, usually to stabilise a painful area and stop them from moving against each other.
What is NVDX3?
NVDX3 is a new type of natural bone material, derived from human tissue, that is being tested to see if it helps bones in the spine fuse together after surgery.
Is this a new treatment?
Yes, this is an early-stage study (Phase 1/2), meaning it's one of the first times this specific NVDX3 material is being used in people.
What will happen if I join the study?
You would receive the NVDX3 during your back surgery and have regular follow-up appointments and tests to check your recovery and how the treatment is working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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