Clinical trial NCT05987033: Proof-of-concept Study with NVDX3 for Treatment of Distal Radius Fractures.
Official title: A First-in-human Proof-of-concept Study with NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Distal Radius Fractures
Lead sponsor: Novadip Biosciences
Sponsor class: INDUSTRY
Collaborators: name: PrimeVigilance
name: Data Investigation Company Europe (DICE)
First posted: 2023-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.

Detailed description: This is a prospective, single arm, monocentric first-in-human PoC study in adult patients, suffering from a distal radius fracture, treated during the surgical intervention with NVDX3, an osteogenic implant from human allogeneic origin.

As per standard of care, patients with DRF are followed up to 3 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 12 months post-implant surgery.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients within the age range of ≥18 years to ≤80 years.
2. Patient diagnosed with DRF with confirmed:

   1. Classification AO/ATO: C2 and C3 - Intra-articular \& multifragmentation.
   2. Estimated volume of the targeted bone void should not exceed 5cc.
   3. Availability of diagnostic AP and LAT X-ray or CT scan.
3. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.
4. Patient fulfills criteria for undergoing a surgical intervention.
5. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.

Exclusion Criteria:

1. Open DRF or closed DRF with increased infection risk.
2. Injury to the median nerve.
3. Previous fracture of the target distal radius.
4. Documented disease limiting mobility and functional assessments (eg. Grip strength test).
5. Dependency on crutches or any comparable walking aids.
6. Patient is overweight, has a BMI ≥35.
7. Presence of clinically significant infection at the target implant site or systemic infection.
8. History of allergic reaction or any anticipated hypersensitivity to any of the anticipated:

   1. Osteosynthesis materials (PEEK plate and screws).
   2. Anesthetic agents.
   3. Components of the NVDX3 implant.
9. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.
10. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.
11. Presence of an active tumor.
12. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism.
13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.
14. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening.
15. Any history of experimental therapy with another investigational drug within 60 days prior to screening.
16. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study.
17. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results.

Primary outcomes:
measure: Primary Endpoint: evaluation of SAEs and NVDX3 related AEs
timeFrame: Between screening (V1) and 12-months post- IS (V8)
Secondary outcomes:
measure: Safety: all acute SAEs and NVDX3 related AEs
timeFrame: Between screening (V1) and 6 weeks post-IS (V5)
measure: Safety: all SAEs and NVDX3 related AEs
timeFrame: Beyond 6 weeks (V5 excluded) until 12 months post-IS
measure: Safety: TEAEs
timeFrame: a. Between screening and week 6 (V5 included) b. Between week 6 (V5 excluded) till month 12 (V8 included) c. through study completion
measure: Safety: related and unexpected (S)AEs
timeFrame: Between inclusion and 13 months post-IS
measure: Safety: AESI
timeFrame: Between inclusion and 13 months post-IS
measure: Safety: lab data
timeFrame: Between inclusion and 13 months post-IS
measure: Safety: vital signs
timeFrame: Between inclusion and 13 months post-IS
measure: Efficacy: Radiological assessments on Computed Tomography (CT) data using the extended Lane and Sandhu Scoring tool (eLSS)
timeFrame: At 3 and 12-months post-IS
measure: Efficacy: Radiological assessments on X-ray using the eLSS tool
timeFrame: At HD, 2-, 6-weeks, 3-,6- and 12-months post-IS
measure: Efficacy: Clinical assessments
timeFrame: At 2-,6 weeks, 3-, 6-, and 12-months post- IS
measure: Efficacy: Clinical assessments
timeFrame: At 2-,6 weeks, 3-, 6-, and 12-months post- IS
measure: Efficacy: Clinical assessments
timeFrame: At 2-,6 weeks, 3-, 6-, and 12-months post- IS
measure: Efficacy: NRS-pain
timeFrame: At HD, 2-,6 weeks, 3-, 6-, and 12-months post-IS
measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
timeFrame: At 3-, and 12-months post-IS
measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
timeFrame: At 3-, and 12-months post-IS
measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
timeFrame: At 3-, and 12-months post-IS
measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
timeFrame: At 3-, and 12-months post-IS
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
Study officials:
affiliation: Centre Hospitalier du Luxembourg
name: Torsten Gerich, MD
role: PRINCIPAL_INVESTIGATOR
References: