Development of novel strategy for treatment of anterior cruciate ligament(ACL) injury using stem cell.
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000917
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone formation on interface between bone tunnel and graft;Tunnel enlargement after anterior cruciate ligament reconstruction
- Secondary Outcome Measures
Name Time Method Arthrosocopy grading;Telos stress X-ray;KT-2000;Knee scoring (Lysholm, IKDC, KOOS, Tegner);Lachmann test, Pivot shift test