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The objective of this study is to evaluate the safety and efficacy of allogeneic adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | ALLO-ASC-TI injection |
|
| Placebo | Placebo Comparator | Saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-TI | Biological |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Improvement of VAS pain score at 12 weeks compared to baseline per each group | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain score | Changes in the VAS pain score during activity per each group | week 2, week 6 and week 12 |
| Improvement rate of VAS pain score | Improvement rate of VAS pain score at rest per each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S G Chung, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Chung-Ang University Hosptal |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
|
| week 2, week 6 and week 12 |
| Modified Mayo Clinic Performance Index | Change in Modified Mayo Clinic Performance Index per each group | week 2, week 6 and week 12 |
| Ultrasonic photography | Change in analysis of lesion size per each group | week 6 and week 12 |
| Safety | Clinically measured abnormality of laboratory tests and adverse events | Week 12 |
| Seoul |
| South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Nanoori hospital | Seoul | South Korea |
| Samsung medical center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |