Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell

Study Overview
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Brief Summary
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Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.

Detailed Description
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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.

Official Title
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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

Conditions
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Deficiency of Anterior Cruciate Ligament

Intervention / Treatment
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* Biological: Cartistem(TM)
* Biological: hyaluronic acid
* Procedure: ACL reconstruction only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 50 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACL reconstruction only<br>only ACL reconstruction without any injection | Procedure: ACL reconstruction only<br>* ACL reconstruction only without any injection under arthroscopy<br>|
| Experimental: ACL reconstruction + Cartistem(TM)<br>ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy. | Biological: Cartistem(TM)<br>* ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.<br>Procedure: ACL reconstruction only<br>* ACL reconstruction only without any injection under arthroscopy<br>|
| Experimental: ACL reconstruction + Hyaluronic acid<br>ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy | Biological: hyaluronic acid<br>* ACL reconstruction and injection of hyaluronic acid under arthroscopy.<br>Procedure: ACL reconstruction only<br>* ACL reconstruction only without any injection under arthroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone formation on interface between bone tunnel and graft |  | Changes at 12 week, 24 week, 48 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthroscopic grading of graft |  | 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 | 
| 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 |