Clinical trial • Not applicable • Musculoskeletal
NVDX3 for Distal radius fracture | Lumbar spondylolisthesis (low-grade degenerative)
Not applicable trial of NVDX3 for Distal radius fracture | Lumbar spondylolisthesis (low-grade degenerative). open-label. 20 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Distal radius fracture | Lumbar spondylolisthesis (low-grade degenerative)
- Trial Stage
- Not applicable
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 06-05-2024
- First CTIS Authorization Date
- 10-07-2024
Trial design
open-label Not applicable trial across 1 site in Luxembourg.
- Open Label
- Yes
- Target Sample Size
- 20
- Trial Duration For Participant
- 3650
Eligibility
Recruits 20 No vulnerable population selected; informed consent must be provided and signed by the patient (ICF documents available). No assent or other vulnerable-population-specific procedures are described..
- Vulnerable Population
- No vulnerable population selected; informed consent must be provided and signed by the patient (ICF documents available). No assent or other vulnerable-population-specific procedures are described.
Inclusion criteria
- {"criterion_text":"- Patient being implanted with NVDX3."}
- {"criterion_text":"- Previously participated to one of the NVDX3 core clinical trials."}
- {"criterion_text":"- Patient accepts to comply to a yearly follow-up safety visit for 10 additional years"}
- {"criterion_text":"- Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent."}
Exclusion criteria
- {"criterion_text":"- No exclusion criteria are applicable"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Description of all SAEs, NVDX3 related AEs and AE of special interest from screening till 120 months post- core study.","definition_or_measurement_approach":"Collection and documentation of all serious adverse events (SAEs), NVDX3-related adverse events (AEs) and AEs of special interest from screening until 120 months (10 years) after the core study."}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 140
- Consent Approach
- Informed consent must be provided and signed by the patient. Subject information and informed consent forms are available (documents list includes French and German ICFs and secondary use ICFs). No separate assent process described.
Methods
- Patients are recruited from prior participation in NVDX3 core clinical trials (targeting previous NVDX3 study participants); recruitment documented for Luxembourg with recruitment start 22-08-2024.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Luxembourg
- Earliest CTIS Part Ii Submission Date
- 21-05-2024
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 469
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Centre Hospitalier De Luxembourg
- Department Name
- Orthopedics and traumatology
- Principal Investigator Name
- Torsten Gerich
- Principal Investigator Email
- gerich.torsten@chl.lu
- Contact Person Name
- Torsten Gerich
- Contact Person Email
- gerich.torsten@chl.lu
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Novadip Biosciences
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- NVDX3
- Active Substance
- NVDX3
- Modality
- Cell therapy
- Routes Of Administration
- IMPLANTATION
- Route
- IMPLANTATION
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