2023-503486-32-00招募中2 期
Efficacy of autologous bone marrow-derived mesenchymal stem cells seeded on a 3D scaffold in treatment of knee cartilage defects. A randomized, controlled, open-label, multi-centre clinical trial.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms).
研究概览
简要总结
Efficacy: To compare the treatment efficacy of a combination of conventional microfracture and autologous MSC seeded onto the acellular 3D scaffold as compared to the commonly used method of microfracture and application of the scaffold alone, in subjects with knee joint chondral lesion.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patients of either sex, age between 18 and 55 years.
- •Able to provide written informed consent.
- •Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration.
- •Defect is located in the weigh-bearing part of femoral condyle.
- •Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold).
- •Isolated chondral defect with a maximum size of 6 cm
- •No previous knee surgery due to a treatment of a chondral defect.
- •Preoperative level of hemoglobin at least 110 g per L.
- •Preoperative level of platelet count higher than 150 000 per mL.
- •Sexually active, nonsterile female patients need to use highly effective contraception during the whole study.
排除标准
- •Axial deformities over 10° on the study knee.
- •Systemic corticoid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the planned knee surgery). Intraarticular corticoid medication is not allowed within the same time period.
- •Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, diabetes and other serious metabolic disorders, drug abuse, etc.).
- •Concurrent or previous cancer.
- •Blood, plasma or platelet transfusion during previous 8 weeks.
- •Pregnant or lactating women.
- •BMI higher than
- •Clinical instability of the knee joint.
结局指标
主要结局
Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms).
Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms).
KOOS value, at 24 months post-operation (comparison of score changes between the study arms).
KOOS value, at 24 months post-operation (comparison of score changes between the study arms).
Pain according to VAS, at 24 months post-operation (comparison of score changes between the study arms).
Pain according to VAS, at 24 months post-operation (comparison of score changes between the study arms).
X-ray and MRI evaluation, at 24 months post-operation.
X-ray and MRI evaluation, at 24 months post-operation.
次要结局
- Lysholm knee function score, at 3, 6 and 12 months post-operation.
- KOOS value, at 3 , 6 and 12 months post-operation.
- Pain according to VAS, at 6 weeks, 3, 6 and 12 months post-operation.
- X-ray and MRI evaluation, at 12 months post-operation.
- Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months post-operation (comparison between the study arms).
研究者
Information service
Scientific
Bioinova a.s.
研究点 (3)
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