Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis: a Randomized Controlled Trial, Ibn-Sina Hospital, Baghdad 2022
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- clinical
研究概览
简要总结
We present a randomized controlled trial (RCT) to assess the efficacy of autologous bone marrow aspirate concentrate BMAC of 1.8x 10 9 median cellular content in the treatment of early symptomatic knee OA. We use 2 injections 2 months apart (8).
详细描述
- To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis.
- To determine the potential of BMAC therapy to achieve disease modification, as detected through radiological examination using magnetic resonance imaging (MRI) techniques.
- Methodology:
A randomized controlled trial will be held in Ibn-Sina training hospital in Baghdad. All participants will complete written informed consent. The study will be a single centered trial.
The trial design will consist of 60 participant randomly and equally allocated to control and treatment group by simple random sampling. Participants will not be blinded to their treatment allocation. Control group will receive conventional treatment only. Intervention group will receive (2 injections) intra-articular injections of (4cc) per joint at (8 weeks' interval).
Intervention:
50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Radiological diagnosis of Osteoarthritis according to Kellgren and Lawrence Criteria stage II-III.
- •Radiological grading of osteoarthritis of the knee determined by qualified radiologist using MOAKS scoring system.
- •Primary osteoarthritis not responsive to conventional treatment and physiotherapy.
- •A minimum pain score of 5 on an 11-point numerical scale.
- •Age >55 years
排除标准
- •Pregnancy and breast feeding.
- •Knee symptom due to other condition like tumor or referred pain from lumbar spine.
- •MRI confirmed displaced meniscal tear
- •MRI confirmed Grade IV chondral loss.
- •Previous knee surgery within the last 12 months.
- •Previous intra-articular injectable therapies within the last 6 months
- •History of severe systemic illness.
- •Active neoplasm under treatment in the last 12 months- Health conditions including known allergy to local
- •Bleeding tendency.
结局指标
主要结局
clinical
时间窗: 6 months
improvement in pain scale WOMAC
次要结局
- radiological proof(6 months-1 year)
研究者
abdulmajeed hammadi
global stem cell center baghdad
Global Stem Cell Center, Baghdad