Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Tre… (NCT06335394) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion
Belgium11 participantsStarted 2018-08-02
Plain-language summary
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female adult subject (≥18 years).
✓. Radiographic images not older than 3 months, confirming lower limb nonunion, defined as the absence of clinical and radiographic progression towards healing over 3 consecutive months on serial radiographs and minimum 9 months after the first attempt of surgical bone repair, or minimum 6 months after the second (or any subsequent) attempt of surgical bone repair.
✓. Radiologic single, meta- and/or diaphyseal bone defect with a maximum size of 4 cm (in case of a void that does not transverse the whole width of the bone, the total volume cannot exceed the volume corresponding to the 4 cm gap).
✓. The impaired limb is salvageable, and the patient is eligible for the intended surgical procedure according to the standard hospital practice.
✓. Documented normal or low bone density: Bone density scan determined by Dual Energy X-Ray Absorptiometry DEXA scan on lumbar spine and hip (bone mineral density T-scores above -2.5). An examination ≤ 1-year-old before screening is acceptable.
✓. The subject is, in the Investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits.
✓. Use of an effective birth control method for 2 months prior to the date of the intended surgical intervention up to Visit V7 for women of childbearing potential.
✓. Negative urinary pregnancy test for women of childbearing potential.
Exclusion criteria
✕. The subject has a Body Mass Index (BMI) ≤ 20 kg/m² or ≥ 40 kg/m², or of ≥35 kg/m² with obesity-related health conditions, such as high blood pressure or diabetes.
What they're measuring
1
Safety - Adverse Events
Timeframe: From graft implantation until completion of visit 24 months
2
Safety - Abnormalities of vital signs
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
3
Safety - Abnormalities of vital signs
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
4
Safety - Abnormalities of physical examination
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
5
Safety - Abnormalities of physical examination
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
6
Safety - Abnormalities of physical examination
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
✕. A planned use of an external fixator is not allowed as of the grafting surgery (V1) until V7.
✕. Documented osteoporosis: bone density determined using DEXA scan on lumbar spine and hip: bone mineral density T-scores of -2.5 and below. An examination ≤ 1-year-old before screening is acceptable.
✕. Pregnant or breast-feeding woman.
✕. The subject shows signs of an active drug or alcohol dependence, serious current illness, mental illness or any other factors which, in the opinion of the investigator, will interfere with study conduct or the interpretation of the results.
✕. The patient has a history of solid organ transplant at any point in the past or is on the waiting list for future organ transplantation.
✕. The subject previously received a cellular therapy treatment at any point in time (as per protocol description).
Safety - Abnormalities of laboratories
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
8
Safety - Abnormalities of laboratories
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
9
Safety - Abnormalities of laboratories
Timeframe: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months