NCT05933434招募中1 期
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Observation (change) of adverse events
研究概览
简要总结
This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded (participant and investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
- •Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
- •Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
- •Medial, lateral or dual compartment OA as determined above
- •Danish speaker
- •Patients must be legally competent and must be able to sign the written consent
排除标准
- •Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- •Intraarticular tumor, infection or fracture
- •Pregnancy and breast feeding
- •Cognitive impairment
- •Treatment with cytostatic drugs
- •Previous intraarticular knee injection in the past 3 mo.
- •Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(>BMI 35)
- •Previous ligament reconstruction
- •Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
- •Diabetes mellitus type 1 and 2
- •Knee instability on physical examination
- •History of allergy to antibiotics
- •Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
- •Presence of other types of inflammatory arthritis
结局指标
主要结局
Observation (change) of adverse events
时间窗: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Pain Diary first 30 days after treatment, any reported adverse events after treatment
Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline
时间窗: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
(questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))
次要结局
- Observation (change) of cartilage regeneration compared to baseline(Baseline, 3 months, 12 months, 24 months)
- Observation (change) of quantitative cartilage regeneration compared to baseline(Baseline, 3 months, 12 months, 24 months)
- Improvement (change) during clinical examination with range of motion compared to baseline(Baseline, 3 months, 12 months, 24 months)
- Change in pain from baseline(Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline(Baseline, 3 months, 12 months, 24 months)
- Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline(Baseline, 3 months, 12 months, 24 months)
- Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline(Baseline, 3 months, 12 months, 24 months)
研究者
Rasmus Roost Aabling
MD
Aarhus University Hospital
研究点 (2)
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