Development of novel strategy for treatment of anterior cruciate ligament(ACL) injury using stem cell.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000917

Enrollment

Registered

2013-11-12

Start date

2014-01-07

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell, Procedure/Surgery : Subject: anterior cruciate ligament(ACL) injury patient 30 - ACL reconstruction 10 - ACL reconstruction + Human cord blood derived MSC and hyaluronic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Bone formation on interface between bone tunnel and graft;Tunnel enlargement after anterior cruciate ligament reconstruction	—

Secondary

Measure	Time frame
Arthrosocopy grading;Telos stress X-ray;KT-2000;Knee scoring (Lysholm, IKDC, KOOS, Tegner);Lachmann test, Pivot shift test	—

Countries

Korea, Republic of

Contacts

Public ContactJoon Wang

Samsung Medical Center

Outcome results