EUCTR2016-004052-30-SE进行中（未招募）1 期
A randomized, placebo-controlled, patient and investigator blinded, Proof of Concept study investigating the safety, tolerability and preliminary efficacy of multiple intra-articular LNA043 injections in regenerating the articular cartilage of the knee in patients with articular cartilage lesions.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient is =18 and =55 years old at time of screening.
- •- Patient has a body mass index (BMI) <30 kg/m2 at screening.For
- •patients with a BMI >30 but = 33 kg/m2, eligibility will be decided by
- •consultation with the sponsor.
- •- Patient has a symptomatic, single, articular cartilage defect of one knee, grade II or IIIA according to the ICRS classification, localized to either the femoral condyles/femoral trochlea or to the patella, based on MRI or arthroscopy performed within 9 months before screening visit and confirmed by
- •screening 3T MRI.
- •- Patient has an onset of pain and impairment of function between two (2) months and two (2) years before screening.
- •- Patient reports a KOOS (sports and recreational activities subscale)
- •score of 60 or less at both screening and Day 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using
- •highly effective methods of contraception during dosing and for 15 days after stopping of investigational drug.
- •- Regular smokers (consummation of >5 cigarettes/day in the previous
- •3 months). Urine cotinine levels will be measured during screening for
- •all patients.
- •- Regular smokers will be defined as any patient who reports tobacco
- •use of > 5 cigarettes/day and/or who has a urine cotinine = 500 ng/mL.
- •- Patient has radiologically apparent degenerative joint disease in the
- •target knee as determined by Kellgren and Lawrence grade =2 based on X-ray evaluation performed within 9 months from screening.
- •- Patient has had surgical treatment of the target knee using
- •mosaicplasty, microfracture, meniscectomy >50% (Note: prior
- •diagnostic arthroscopy with debridement and lavage, <50%
- •meniscectomy, lateral release, patellar realignment, medial
- •patellofemoral ligament reconstruction are acceptable if performed at
- •least 2 months prior to screening; anterior cruciate ligament
- •reconstrucion is acceptable if performed 12 months prior to screening or less if restoration of joint function is evident and agreed by the sponsor).
- •-Patient has an unstable target knee joint (including but not limited to
- •posttraumatic or congenital laxity) or insufficiently reconstructed
- •ligaments based on medical history and physical examination by the
- •investigator.
- •- Patient has patellofemoral dysplasia Dejour Grade B-D based on X-ray
- •or MRI evaluation.
- •- Patient has malalignment (valgus- or varusdeformity) in the target
- •knee = 5° based on X-ray evaluation. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in postero-anterior (PA) projection.
- •Other protocol defined exclusion criteria's may apply
研究者
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