Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell
NCT ID: NCT02755376
Last Updated: 2019-04-10
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-01-01
2018-12-01
Brief Summary
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Detailed Description
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2. 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
3. Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ACL reconstruction only
only ACL reconstruction without any injection
ACL reconstruction only
ACL reconstruction only without any injection under arthroscopy
ACL reconstruction + Cartistem(TM)
ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
Cartistem(TM)
ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
ACL reconstruction only
ACL reconstruction only without any injection under arthroscopy
ACL reconstruction + Hyaluronic acid
ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy
hyaluronic acid
ACL reconstruction and injection of hyaluronic acid under arthroscopy.
ACL reconstruction only
ACL reconstruction only without any injection under arthroscopy
Interventions
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Cartistem(TM)
ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
hyaluronic acid
ACL reconstruction and injection of hyaluronic acid under arthroscopy.
ACL reconstruction only
ACL reconstruction only without any injection under arthroscopy
Eligibility Criteria
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Inclusion Criteria
2. Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
3. prothrombin time (PT) (INR) \<1.5, activated partial thromboplastin time (aPTT) \<1.5 x control
4. Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
5. Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
6. No surgery and radiation therapy in recent 6 weeks
7. No pregnancy
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
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 researcher.
20 Years
50 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joon Ho Wang, MD, Ph D
Role: STUDY_CHAIR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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SMC 2013-07-117-002
Identifier Type: -
Identifier Source: org_study_id
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