NCT06335394进行中（未招募）1 期
A Prospective Multicentre Single-arm Study in Adults 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 18
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
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.
详细描述
This is a first in man study conducted as a prospective, single-arm, non-randomized clinical study. A sample of 5 to 10 patients will be enrolled in the study in order to assess the safety of the use of NVD-003 bone graft implantation in patients with recalcitrant lower limb nonunion.
The sample size of 5 to 10 patients was considered sufficient to give a preliminary indication on the safety of the ATMP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •At screening, safety local laboratory test results are medically acceptable to undergo surgery (see Section 7.3.2) and serology results are in accordance with country specific requirements for donation of Human Body Material.
- •At time of adipose tissue collection, central laboratory serology and molecular tests panel for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and syphilis are in accordance with Belgian specific requirements for release of Human Body Material.
- •The subject has understood the nature of the study, agrees to its provisions, and has accepted to participate in the study and to follow all study procedures. This is acknowledged by signing the informed consent as approved by the required Institutional Review Board/Ethics Committee and the national competent authorities.
- •Patient fulfils the criteria to donate his human body material (adipose tissue) and is suitable to undergo a liposuction.
排除标准
- •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.
- •Multifocal or comminuted fractures.
- •A planned use of an external fixator is not allowed as of the grafting surgery (V1) until V
- •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).
- •Previous exposure to any experimental therapy with another investigational drug within 60 days prior to screening or enrolment in any concurrent study that may confound the results of this study.
- •Any signs or suspicion of an active local (area of the future surgical site), or systemic infection before the induced membrane surgery or the grafting surgery.
- •Known allergy to any antibiotics commonly used to treat Staphylococcus aureus (including methicillin-resistant Staphylococcus aureus) or coagulase-negative staphylococci.
- •Diagnosis of HIV, HBV (HBsAg or PCR positive), HCV, Human T-cell Lymphotropic Virus (HTLV) 1 or 2, or syphilis infection (as confirmed by serology and nucleic acid test (NAT) by Tissue Establishment).
- •Chronic use of immunosuppressive therapy (immunosuppressant/ immunotherapy) due to inflammatory or systemic disease.
- •Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the patient.
- •Subjects with poorly controlled diabetes mellitus type 2 as assessed by glycated haemoglobin (HbA1C) ≥ 10%.
- •Subjects with poorly controlled thyroid diseases (unstable despite proper medication).
- •Subjects with documented metabolic bone disease (based on the investigator judgment) such as, but not limited to, osteogenesis imperfecta or osteomalacia.
- •Chronic, current or planned during study use of any medications that might affect bone metabolism or the quality of bone formation such as, but not limited to, bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressant therapy or immunotherapy. However, short lasting surgery-related prophylactic treatments such as antibiotics, analgesics and low molecular heparin drugs may be administered according to hospital recommendations.
- •Existing malignant tumour in the vicinity of the graft or a resected one not cured for more than 5 years.
- •Any other illness which might reduce life expectancy to less than 2 years from screening.
- •The subject is a prisoner.
结局指标
主要结局
Safety - Adverse Events
时间窗: From graft implantation until completion of visit 24 months
All Adverse Events (AEs) including Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Procedure Related AE's (PRAE).
Safety - Abnormalities of vital signs
时间窗: 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
Vital signs abnormalities: blood pressure
Safety - Abnormalities of physical examination
时间窗: 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
Physical examinations abnormalities: cardiovascular system
Safety - Abnormalities of laboratories
时间窗: 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
Safety laboratories abnormalities: blood sampling: haematology (tests that yield information on the qualitative and quantitative composition of the cellular components of the blood)
次要结局
- Complications: rate of subsequent surgical interventions(At 12 and 24 months post-implant surgery)
- Healing efficacy: plain X-ray(At 6 weeks, 3 months, 6 months, 12 months, at additional visits (if no healing at 12 months after graft implant surgery) up to 24 months.)
- Quality of Life: overall treatment effect(At 3, 6, 12 and 24 months post-graft)
- General Pre-graft implantation safety: all SAEs, AESI and PRAE(Pre-graft implantation)
- Quality of Life: questionnaire EuroQol-5 Dimensions(At screening and at 6 weeks, 3, 6, 12 and 24 months post-graft)
- Healing efficacy: CT-scan(At 6, 12 and 24 months)
- Healing efficacy: investigator assessed clinical healing(From 6 weeks post-grafting onwards up to 24 months)
- Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing(Time from grafting surgery till first observation of investigator assessed clinical healing up to 24 months)
- Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing(Average time from IMP grafting surgery till first observation of plain X-ray and CT-scan up to 24 months)
- Quality of Life: pain evaluation(At screening and at 6 weeks, 3, 6, 12 and 24 months post-graft)
- All SAEs during the extended safety follow-up period(During the extended safety follow-up period (between 24 months FU visit and 5 years post-grafting surgery))
- Grafting Surgery parameters(Duration of grafting surgery (visit 1) and duration of hospitalization after grafting surgery (visit 2))
研究者
研究点 (18)
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