Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- International Cartilage Repair Society (ICRS) grade improvement
研究概览
简要总结
The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint.
This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint.
Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
only case series of the treated patients
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age older than 30 years,
- •full-thickness cartilage lesion measuring at least 2 cm2,
- •femoro-tibial angle (varus or valgus) 5°< in the mechanical axis
排除标准
- •ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament),
- •metabolic arthritis
- •infectious condition
- •psychosis
- •serious medical illness
- •pregnancy
研究组 & 干预措施
Osteoarthritic knee patients
Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells.
干预措施: umbilical cord blood stem cell implantation for osteoarthritis treatment (Procedure)
结局指标
主要结局
International Cartilage Repair Society (ICRS) grade improvement
时间窗: at 24, 48, 96 weeks after surgery, score changes will be observed.
over grade 1 should be improved
次要结局
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(at 24, 48, 96 weeks after surgery, score changes will be observed.)
- Visual analogue scale (VAS)(at 24, 48, 96 weeks after surgery, score changes will be observed.)
- International Knee Documentation Committee (IKDC score)(at 24, 48, 96 weeks after surgery, score changes will be observed.)
研究者
Seckjung Kim
Professor
Uijeongbu St. Mary Hospital