Long-term Safety Evaluation of NVDX3 Osteogenic Implant in Patients with Low Grade Degenerative Lumbar Spondylolisthesis and Distal Radius Fracture

The primary objective of this clinical trial is to document the **long-term safety** of the NVDX3 implant, an osteogenic implant of human allogenic origin. This is clinically relevant as it aims to ensure the safety of the NVDX3 implant in patients with conditions such as low-grade degenerative lumbar spondylolisthesis by interbody spine fusion and distal radius fracture. The trial does not specify any secondary objectives.

The clinical trial involves participants diagnosed with **low grade degenerative lumbar spondylolisthesis** and distal radius fracture. The study population includes both male and female subjects, with an age range categorized under code 3, which typically represents adults. The trial does not focus on a vulnerable population. Participants were selected based on their previous involvement in one of the NVDX3 core clinical trials and their agreement to comply with a yearly follow-up safety visit for an additional 10 years. The sponsor has not provided information regarding the total number of participants. The trial does not specify any particular lifestyle considerations such as diet or physical activity. Key inclusion criteria include being implanted with the NVDX3 device and having signed the informed consent for long-term follow-up. The study aims to document the long-term safety of the NVDX3 implant.

The clinical trial is designed to evaluate the long-term safety of **NVDX3**, an osteogenic implant of human allogenic origin, in patients with low-grade degenerative lumbar spondylolisthesis by interbody spine fusion and distal radius fracture. This trial is structured as a randomized, double-blind, controlled study, with an estimated duration extending until April 2036. Participants will be involved in the study for a period of up to 10 years, with the primary objective being the documentation of all serious adverse events (SAEs), NVDX3-related adverse events (AEs), and AEs of special interest from the screening phase until 120 months post-core study.

The sequence of study visits includes an initial inclusion (screening) visit, where eligibility is confirmed based on criteria such as prior participation in NVDX3 core clinical trials and consent to comply with yearly follow-up safety visits. Follow-up visits are scheduled annually to monitor the long-term safety of the implant, with the end-of-study visit marking the conclusion of the participant's involvement. The expected length of participant involvement is 10 years, with conditions for early termination including withdrawal of consent or non-compliance with study procedures. The trial's methodology ensures rigorous monitoring and data collection to achieve its safety documentation objectives.

The clinical trial involves the use of **NVDX3**, an experimental medication developed by NOVADIP BIOSCIENCES. **NVDX3** is an osteogenic implant of human allogenic origin, classified as a structurally diverse substance used in cell therapy. The pharmaceutical form of **NVDX3** is an **IMPLANT**, and it is administered via **IMPLANTATION**. The primary objective of the trial is to document the long-term safety of the **NVDX3** implant. The product is not a pediatric formulation and is not classified as an orphan drug. The trial does not specify a maximum daily dose, total dose, or treatment period for the **NVDX3** implant.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are mentioned. The focus remains solely on the administration and evaluation of the **NVDX3** implant. Participant compliance monitoring and specific dosing schedules are not detailed in the provided data. The trial is designed to assess the safety profile of the **NVDX3** implant over an extended period, ensuring a comprehensive evaluation of its long-term effects.

The clinical trial will assess the efficacy of the **NVDX3** implant, an osteogenic implant of human allogenic origin, by evaluating the primary endpoint, which involves the description of all serious adverse events (SAEs), NVDX3-related adverse events (AEs), and AEs of special interest. These events will be monitored from the screening phase until 120 months post-core study. The trial is designed to document the long-term safety of the NVDX3 implant, with participants required to comply with a yearly follow-up safety visit for an additional 10 years. The trial will not include secondary endpoints. The efficacy assessments will be conducted through systematic collection and analysis of adverse event data over the specified duration, ensuring comprehensive documentation of the implant's safety profile.