Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Define safety of BM extraction and stem cell joint infusion.
研究概览
简要总结
Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups:
- The control group will receive Acetaminophen 750mg orally every 8 hours
- The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow (BMASC)
Signed informed consent is required, as well as answering a questionnaire.
Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. The patient will remain in the recovery room while the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to the joint under local anesthesia.
The procedure is ambulatory.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
- •Age > 30 years
排除标准
- •Neurodegenerative, autoimmune, genetic or psychiatric diseases
- •Active infection
- •Recent joint infection
- •Knee surgery history
- •Knee joint fracture history
研究组 & 干预措施
Control
Patients treated with Acetaminophen
干预措施: Acetaminophen (Drug)
Experimental
Patients who underwent a BMASC extraction and joint infusion
干预措施: Bone Marrow Autologous Stem Cells Infusion (Procedure)
结局指标
主要结局
Define safety of BM extraction and stem cell joint infusion.
时间窗: 1 week
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes at first week to the baseline questionnaire.
次要结局
- Efficacy of BMSC joint infusion at 4 weeks(4 weeks)
- Efficacy and final outcome of BMSC joint infusion at 6 months.(24 weeks)
研究者
Consuelo Mancias Guerra
Head of Hematology Service
Hospital Universitario Dr. Jose E. Gonzalez