EUCTR2015-005162-34-HR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12月15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 1 ) articulating joint
- •surface (no kissing lesions).
- •Patient has an intact meniscus (maximum 1/3-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.
- •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 (MRI) or
- •is sensitive to gadolinium
- •Patient has had prior surgical treatment of the target knee within 12
- •months using mosaicplasty and/or microfracture (Note: prior
- •diagnostic arthroscopy with debridement and lavage are acceptable
- •within 12 months). 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 an onset of symptoms of > 5 years.
- •Patient has a relevant meniscus tear. Partial meniscal removal
- •allowed, if not exceeding 1/3. Meniscus 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 arthritis.
- •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 (defined as bony substancedefect of >3mm depth). 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
- •The patient has a known history of HIV/AIDS. (Protection of staff)
- •The patient has a known history of Treponema pallidum (syphilis).
- •(Protection of staff)
- •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. (Protection of staff)
- •The patient has at the site of surgery an active systemic or local
- •microbial infection, eczematization or inflammable skin alterations
- •(including Protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-
- •Disease), 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.
- 另有 7 项未显示
研究者
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