KCT0000917已完成未知
A randomized, single center, investigator initiated clinical trial to evaluate enhancement of healing between bone tunnel and graft in anterior cruciate ligament(ACL) injury using human umbilical cord blood derived mesenchymal stem cell.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- All
入选标准
- •1. age 20~50
- •2. Lachmann test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
- •3. PT (INR) <1.5, aPTT <1.5 x control
- •4. Creatinine =2.0 ?/?, protein uria(dipstick) = trace
- •5. Bilirubin =2.0 ?/?, AST/ALT =100 IU/L
- •6. No surgery and radiation therapy in recent 6 weeks
- •7. No pregrancy
- •8. No combine ligament instability = grade II in physical examination (grade 0: none, grade I: 0~5mm, grade II: 5~10mm, grade III: >10mm)
- •9. voluntary singed a consent form
排除标准
- •1. Degenerative osteoarthritis in knee
- •2. Revision or other surgery history (stem cell treatment)
- •3. Chronic inflammatory joint disease like rheumatoid arthritis
- •4. Infectious disease need to administration of parenteral antibiotics
- •5. Autoimmune disease
- •6. Myocardial infarction, congestive heart failure, other serious heart disease
- •7. Uncontrolled hypertension
- •8. Serious medical disease
- •9. Pregnancy and breast-feeding
- •10. psychiatric disorder and epilepsy
- •11. Alcohol overuse
- •12. Smoking overuse
- •13. Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test
- •14. Patient participating in other clinical trials in recent 4 weeks
- •15. Combined ligament instability = grade II in physical test.
- •16. No allergy history to gentamicin antibiotics
- •17. Hypersensitivity patient to bovine protein, hyaluronic acid, and
- •anesthetic agent
- •18. Inappropriate patient judged by reasercher.
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