EUCTR2015-005162-34-DE进行中（未招募）1 期
Randomized, multi-center phase II clinical trial for the regeneration of cartilage lesions in the knee using nasal chondrocyte-based tissue (NTEC) or nasal chondrocyte-based cell (N-CAM)-therapies - Nose to Knee II
niversity Hospital Basel0 个研究点目标入组 108 人开始时间: 2016年10月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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 =65 years old at time of screening.
- •Patient has a localized articular cartilage defect of the femoral condyle and/or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is = 8 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with N-CAM or N-TEC.
- •Patient has a defect of grade 3 or 4 according to the ICRS classification.
- •Patient has a defect size =2 and =8 cm2 as assessed by MRI/arthroscopy.
- •Patient has an opposite intact (=ICRS Grade 2) articulating joint surface (no kissing lesions).
- •Patient has an intact meniscus (maximum 1/2-resection).
- •Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair
- •has to be done during the operation or within 6 weeks of the planned cartilage treatment.
- •Patient has a maximum baseline score of 75/100 in the KOOS subjective knee evaluation.
- •Patient is willing and able to give written informed consent to participate in the study and to
- •comply with all study requirements, including attending all follow-up visits and assessments and to complete postoperative rehabilitation regimen.
- •Patient has free range of motion of the affected knee joint or = 10° of extension and flexion loss.
- •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 108
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient is unable to understand the patient information
- •Patient is unable to undergo magnetic resonance imaging or is sensitive to gadolinium
- •Patient has had prior surgical treatment of the target knee within 12 months using
- •mosaicplasty and/or microfracture. Anterior cruciate ligament repair is accepted, if the target knee is stable or a primary ACL reconstruction is performed within 6 weeks of the planned cartilage treatment.
- •Patient has a relevant meniscus tear. Partial meniscal removal allowed, if not exceeding 1/2.
- •Suture of meniscocapsular separation is allowed. Suture of meniscus tear is allowed if the
- •same compartment is not afflicted by symptomatic cartilage injury, and the graft is planned for
- •trochlea and/or contralateral compartment. If the same compartment is
- •afflicted, suture is not allowed in parallel, but if successful, cartilage treatment might be added
- •12 months later.
- •Patient has radiologically apparent degenerative joint disease in the target knee as
- •determined by Kellgren and Lawrence grade >2.
- •Patient has evidence of joint disease e.g. chronic inflammatory arthritis, and/or infectious
- •Patient has an unstable knee joint or insufficiently reconstructed ligaments. If ligament repair
- •is necessary, the repair has to be performed during the operation or within 6 weeks of the
- •planned cartilage treatment.
- •Patient has malalignment (no valgus- or varus-deformity) in the target knee = 5°. In suspected
- •cases, the mechanical axis must be established radiographically through complete leg
- •imaging during standing and in a.p. or rather p.a. projection. If alignment surgery is necessary,
- •surgery has to be performed within 6 weeks of the planned cartilage treatment.
- •Patient has an osteochondral defect which cannot be reconstructed. Bone marrow edema is allowed.
- •Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would
- •interfere with evaluation of the afflicted knee.
- •Patient has a known systemic connective tissue disease.
- •Patient has a known autoimmune disease.
- •Patient has a known immunological suppressive disorder or is taking immunosuppressives.
- •Patient is currently systemically or intra-articularly taking steroids and/or has used steroids
- •within the 30 days prior to the planned treatment.
- •The patient has a known history of HIV/AIDS.
- •The patient has a known history of Treponema pallidum
- •The patient has an active hepatitis B or C infection with verified antigens. Patients with a
- •cured hepatitis B or C infection and/or verified antibodies are not excluded.
- •The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations, Leishmaniasis, persistent bacterial infections, such as Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy, Recurrent Fever, Melioidosis or Tularaemia).
- •Patient has a known history of cancer.
- •Patient has a known history of primary hyperparathyroidism, hyperthyroidism, reduced kidney
- •function (GFR < 80 ml/min), or prior pathological fractures, independent of the genesis.
- •Patient has any degenerative muscular, vascular or neurological condition that would interfere
- •with evaluation of outcome measures including but not limited to Parkinson's disease,
- •amyotrophic lateral sclerosis (ALS), or multiple sclerosis (MS).
- •Patient has a body mass index (BMI) >35 kg/m2.
- •Patient is pregnant, lactating or anticipates becoming pregnant within 24 months after
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