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| Name | Class |
|---|---|
| Medical Research Collaborating Center, Seoul, Korea | OTHER |
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Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.
Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).
The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 million cells/ml of ALLO-ASC | Experimental | 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. |
|
| 10 million cells/ml of ALLO-ASC | Active Comparator | 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks | Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome. | Baseline, 6 weeks, 12 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Mayo Clinic Performance Index for the Elbow | The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function. | Baseline, 6 weeks, 12 weeks after the intervention |
| Defect Area of Tendon by Ultrasonography in Long Axis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Gun Chung, MD, PhD | Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University College of Medicine | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20970844 | Background | Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21. | |
| 1991216 | Background | Price R, Sinclair H, Heinrich I, Gibson T. Local injection treatment of tennis elbow--hydrocortisone, triamcinolone and lignocaine compared. Br J Rheumatol. 1991 Feb;30(1):39-44. doi: 10.1093/rheumatology/30.1.39. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Million Cells/ml of ALLO-ASC | 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection |
| FG001 | 10 Million Cells/ml of ALLO-ASC | 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Million Cells/ml of ALLO-ASC | 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection |
| BG001 | 10 Million Cells/ml of ALLO-ASC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks | Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 12 weeks after intervention |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Million Cells/ml of ALLO-ASC | 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling at injection site | Musculoskeletal and connective tissue disorders | Systematic Assessment | Although mild swelling was seen at the injection site in six participants (three in group 1 and three in group 2) within 48 hours after injection, the regional swelling subsided spontaneously (without any treatment) within 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sang Yoon Lee | Seoul National University College of Medicine | 028702673 | rehabilee@gmail.com |
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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 |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area. With the patient supine position with the elbow in 30' flexion and full pronation, the cephalic end of the ultrasound transducer was placed on the lateral epicondyle and the long axis of the transducer was aligned with the long axis of radius. The alignment of the transducer and radius was achieved by visualizing contours of the bony structures. Multiple cross-sectional images were saved by shifting the transducer medio-laterally by 2mm at a time. Acquiring images were repeated three times. Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged. |
| Baseline, 6 weeks, and 12 weeks after the intervention |
| Defect Area of Tendon by Ultrasonography in Short Axis | Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area. With the patient supine position with the elbow in 30' flexion and full pronation, the transducer was placed on the proximal forearm just distal to the radial head, aligning the long axis of the transducer perpendicular to the long axis of the forearm. Viewing the round radius at the horizontal center, the transducer was shifted proximally by 2mm and multiple images were saved after the transducer passed the radial head until it slid over the prominence. Acquiring images were repeated three times. Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged. | Baseline, 6 weeks, and 12 weeks after the intervention |
| 14523300 | Background | Sanchez M, Azofra J, Anitua E, Andia I, Padilla S, Santisteban J, Mujika I. Plasma rich in growth factors to treat an articular cartilage avulsion: a case report. Med Sci Sports Exerc. 2003 Oct;35(10):1648-52. doi: 10.1249/01.MSS.0000089344.44434.50. |
| 17910298 | Background | Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8. |
| 7634730 | Background | Solveborn SA, Buch F, Mallmin H, Adalberth G. Cortisone injection with anesthetic additives for radial epicondylalgia (tennis elbow). Clin Orthop Relat Res. 1995 Jul;(316):99-105. |
| 21048180 | Background | Maffulli N, Longo UG, Denaro V. Novel approaches for the management of tendinopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2604-13. doi: 10.2106/JBJS.I.01744. |
| 16735582 | Background | Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30. |
| 19380129 | Background | Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19. |
| 17099241 | Background | Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12. |
| 7472743 | Background | Slater M, Patava J, Kingham K, Mason RS. Involvement of platelets in stimulating osteogenic activity. J Orthop Res. 1995 Sep;13(5):655-63. doi: 10.1002/jor.1100130504. |
10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Modified Mayo Clinic Performance Index for the Elbow | The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function. | Posted | Median | Standard Deviation | score on a scale | Baseline, 6 weeks, 12 weeks after the intervention |
|
|
|
|
| Secondary | Defect Area of Tendon by Ultrasonography in Long Axis | Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area. With the patient supine position with the elbow in 30' flexion and full pronation, the cephalic end of the ultrasound transducer was placed on the lateral epicondyle and the long axis of the transducer was aligned with the long axis of radius. The alignment of the transducer and radius was achieved by visualizing contours of the bony structures. Multiple cross-sectional images were saved by shifting the transducer medio-laterally by 2mm at a time. Acquiring images were repeated three times. Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged. | Posted | Mean | Standard Deviation | mm^2 | Baseline, 6 weeks, and 12 weeks after the intervention |
|
|
|
|
| Secondary | Defect Area of Tendon by Ultrasonography in Short Axis | Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area. With the patient supine position with the elbow in 30' flexion and full pronation, the transducer was placed on the proximal forearm just distal to the radial head, aligning the long axis of the transducer perpendicular to the long axis of the forearm. Viewing the round radius at the horizontal center, the transducer was shifted proximally by 2mm and multiple images were saved after the transducer passed the radial head until it slid over the prominence. Acquiring images were repeated three times. Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged. | Posted | Mean | Standard Deviation | mm^2 | Baseline, 6 weeks, and 12 weeks after the intervention |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 10 Million Cells/ml of ALLO-ASC | 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection | 0 | 6 | 0 | 6 | 3 | 6 |
|
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| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| Post-injection 12 weeks |
|
| Wilcoxon (Mann-Whitney) |
| 0.573 |
| Other |
| Wilcoxon (Mann-Whitney) | 0.588 | Other |
| Post-injection 12 weeks |
|
| Wilcoxon (Mann-Whitney) |
| 0.631 |
| Other |
| Null hypothesis: There is no difference between the two groups at post-injection 12 weeks. | Wilcoxon (Mann-Whitney) | 0.796 | Other |
| Post-injection 12 weeks |
|
| Wilcoxon (Mann-Whitney) |
| 0.078 |
| Other |
| Null hypothesis: There is no difference between the two groups at post-injection 12 weeks. | Wilcoxon (Mann-Whitney) | 0.439 | Other |