NCT02755376已完成不适用
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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bone formation on interface between bone tunnel and graft
研究概览
简要总结
Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
详细描述
- Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
- Subject: Anterior cruciate ligament (ACL) injury 30 patients
- ACL reconstruction: 10
- ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic acid (Cartistem (TM)): 10
- ACL reconstruction + hyaluronic acid: 10
- Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
- •prothrombin time (PT) (INR) <1.5, activated partial thromboplastin time (aPTT) <1.5 x control
- •Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
- •Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
- •No surgery and radiation therapy in recent 6 weeks
- •No pregnancy
- •No combine ligament instability ≥ grade II in physical examination (grade 0: none, grade I: 0~5mm, grade II: 5~10mm, grade III: >10mm)
- •voluntary singed a consent form
排除标准
- •Degenerative osteoarthritis in knee
- •Revision or other surgery history (stem cell treatment)
- •Chronic inflammatory joint disease like rheumatoid arthritis
- •Infectious disease need to administration of parenteral antibiotics
- •Autoimmune disease
- •Myocardial infarction, congestive heart failure, other serious heart disease
- •Uncontrolled hypertension
- •Serious medical disease
- •Pregnancy and breast-feeding
- •psychiatric disorder and epilepsy
- •Alcohol overuse
- •Smoking overuse
- •Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test
- •Patient participating in other clinical trials in recent 4 weeks
- •Combined ligament instability ≥ grade II in physical test.
- •No allergy history to gentamicin antibiotics
- •Hypersensitivity patient to bovine protein, hyaluronic acid, and anesthetic agent
- •Inappropriate patient judged by researcher.
研究组 & 干预措施
ACL reconstruction + Hyaluronic acid
Experimental
ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy
干预措施: hyaluronic acid (Biological)
ACL reconstruction + Hyaluronic acid
Experimental
ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy
干预措施: ACL reconstruction only (Procedure)
ACL reconstruction only
Active Comparator
only ACL reconstruction without any injection
干预措施: ACL reconstruction only (Procedure)
ACL reconstruction + Cartistem(TM)
Experimental
ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
干预措施: Cartistem(TM) (Biological)
ACL reconstruction + Cartistem(TM)
Experimental
ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
干预措施: ACL reconstruction only (Procedure)
结局指标
主要结局
Bone formation on interface between bone tunnel and graft
时间窗: Changes at 12 week, 24 week, 48 week after surgery
次要结局
- Arthroscopic grading of graft(48 week after surgery)
- Instability assessing with physical examination(Changes at 12 week, 24 week, 48 week after surgery)
- Tunnel enlargement after anterior cruciate ligament reconstruction(Changes at 12 week, 24 week, 48 week after surgery)
- Telos stress X-ray(Changes at 12 week, 24 week, 48 week after surgery)
- KT-2000(Changes at 12 week, 24 week, 48 week after surgery)
- clinical knee scoring(Changes at 12 week, 24 week, 48 week after surgery)
研究者
研究点 (2)
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