EUCTR2018-003470-27-NL进行中（未招募）1 期
Randomized controlled trial on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee - Instant MSC Product accompanying Autologous Chondron Transplantation 2 (IMPACT2)
MC Utrecht0 个研究点目标入组 60 人开始时间: 2018年11月19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
- 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
- •- Provides written informed consent, is able to understand the content
- •of the study, understands the requirements for follow-up visits and is
- •willing to provide the required information at follow-up visits and in the
- •questionnaires.
- •- Symptomatic articular cartilage lesion of the knee (femoral condyles
- •or trochlea).
- •- Age >18 and <45 years old
- •- Modified Outerbridge Grade III or IV isolated cartilage lesion of the
- •- A post-debridement size of the cartilage lesion > 2cm2 and = 8 cm2
- •- At least 50% of functional meniscus remaining. Meniscal repair or
- •resection is allowed during the IMPACT surgery provided that the
- •surgeon is able to confirm that at least 50% of functional meniscus
- •- Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).
- •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
- •- Malalignment of >5 degrees
- •- (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as
- •determined from appropriate X-ray.
- •- Concomitant inflammatory disease that affects the joint (rheumatoid
- •arthritis, metabolic bone disease, psoriasis, gout, symptomatic
- •chondrocalcinosis)
- •- (History of) Septic arthritis.
- •- (History of) Total menisectomy in the target knee joint.
- •- Any surgery in the knee joint 6 months prior to study inclusion.
- •- Risk groups for MRI scanning due to the magnetic field like patients
- •with pacemakers, nerve stimulators, metal particles, stents, clips or
- •implants, (possible) pregnancy or breast feeding.
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