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Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
Subject: Anterior cruciate ligament (ACL) injury 30 patients
Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL reconstruction only | Active Comparator | only ACL reconstruction without any injection |
|
| ACL reconstruction + Cartistem(TM) | Experimental | ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy. |
|
| ACL reconstruction + Hyaluronic acid | Experimental | ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cartistem(TM) | Biological | ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone formation on interface between bone tunnel and graft | Changes at 12 week, 24 week, 48 week after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joon Ho Wang, MD, Ph D | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
age, physical exam, lab, etc will be shared
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| hyaluronic acid | Biological | ACL reconstruction and injection of hyaluronic acid under arthroscopy. |
|
| ACL reconstruction only | Procedure | ACL reconstruction only without any injection under arthroscopy |
|
| 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 |