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临床试验/NCT05987033
NCT05987033已完成1 期

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.

Novadip Biosciences1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年8月8日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
11
试验地点
1
主要终点
Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

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 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male or female patients within the age range of ≥18 years to ≤80 years.
  • •Patient diagnosed with DRF with confirmed:
  • •Classification AO/ATO: C2 and C3 - Intra-articular & multifragmentation.
  • •Estimated volume of the targeted bone void should not exceed 5cc.
  • •Availability of diagnostic AP and LAT X-ray or CT scan.
  • •Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.
  • •Patient fulfills criteria for undergoing a surgical intervention.
  • •Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.

排除标准

  • •Open DRF or closed DRF with increased infection risk.
  • •Injury to the median nerve.
  • •Previous fracture of the target distal radius.
  • •Documented disease limiting mobility and functional assessments (eg. Grip strength test).
  • •Dependency on crutches or any comparable walking aids.
  • •Patient is overweight, has a BMI ≥
  • •Presence of clinically significant infection at the target implant site or systemic infection.
  • •History of allergic reaction or any anticipated hypersensitivity to any of the anticipated:
  • •Osteosynthesis materials (PEEK plate and screws).
  • •Anesthetic agents.
  • •Components of the NVDX3 implant.
  • •Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.
  • •Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.
  • •Presence of an active tumor.
  • •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.
  • •Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.
  • •Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening.
  • •Any history of experimental therapy with another investigational drug within 60 days prior to screening.
  • •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.
  • •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.
  • •Patient with historically elevated radiation exposure levels that could in the opinion of the investigator have introduced unacceptable radiation risks for the patient, when being accumulated with the radiological examinations planned in this study.

研究组 & 干预措施

NVDX3 implant

Experimental

干预措施: NVDX3 (Drug)

结局指标

主要结局

Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs

时间窗: Between the beginning of the implant surgery (IS) and 12 months post-IS

Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs

次要结局

  • Safety: Serious TEAEs and NVDX3-related TEAEs(Between the beginning of IS and 6 weeks post-IS)
  • Safety: Serious TEAEs and NVDX3-related TEAEs(Beyond 6 weeks post-IS till 12 months post-IS)
  • Safety: TEAEs(Between the beginning of IS and 6 weeks post-IS Beyond 6 weeks post-IS till 12 months post-IS Between the beginning of IS and 12 months post-IS)
  • Safety: Related and Unexpected TEAEs and Serious TEAEs(Between the beginning of IS and 12 months post-IS)
  • Safety: TEAEs of Special Interest(Between the beginning of IS and 12 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation(At 3 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation(At 12 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union(At 3 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union(At 12 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling(At 3 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling(At 12 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score(At 3 months post-IS)
  • Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score(At 12 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation(At 2 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation(At 6 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation(At 3 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation(At 6 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation(At 12 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union(At 2 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union(At 6 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union(At 3 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union(At 6 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union(At 12 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling(At 2 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling(At 6 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling(At 3 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling(At 6 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling(At 12 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score(At 2 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score(At 6 weeks post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score(At 3 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score(At 6 months post-IS)
  • Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score(At 12 months post-IS)
  • Efficacy: Clinical Assessments - Grip Strength(At 2 weeks post-IS)
  • Efficacy: Clinical Assessments - Grip Strength(At 6 weeks post-IS)
  • Efficacy: Clinical Assessments - Grip Strength(At 3 months post-IS)
  • Efficacy: Clinical Assessments - Grip Strength(At 6 months post-IS)
  • Efficacy: Clinical Assessments - Grip Strength(At 12 months post-IS)
  • Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)(At Hospital Discharge)
  • Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)(At 2 weeks post-IS)
  • Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)(At 6 weeks post-IS)
  • Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)(At 3 months post-IS)
  • Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)(At 6 months post-IS)
  • Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)(At 12 months post-IS)
  • Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)(At 2 weeks post-IS)
  • Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)(At 6 weeks post-IS)
  • Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)(At 3 months post-IS)
  • Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)(At 6 months post-IS)
  • Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)(At 12 months post-IS)
  • Efficacy: NRS-pain(At hospital discharge)
  • Efficacy: NRS-pain(At 2 weeks post-IS)
  • Efficacy: NRS-pain(At 6 weeks post-IS)
  • Efficacy: NRS-pain(At 3 months post-IS)
  • Efficacy: NRS-pain(At 6 months post-IS)
  • Efficacy: NRS-pain(At 12 months post-IS)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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