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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor tendinosis patients in comparison with a control treatment.
A phase II randomized placebo controlled trial will be done with following 3 groups. Each group will have 10 participants, so, the total patients will be 30 people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High concentration of Allo-ASC group | Experimental | High concentration of Allo-ASC 0.5cc (Total: 10 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection |
|
| Low concentration of Allo-ASC group | Experimental | Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection |
|
| Placebo Comparator (Fibrin) group | Placebo Comparator | Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High concentration of Allo-ASC | Biological | 10 million cells of Allo-ASC 0.5cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of pain visual analogue scale (VAS) during activity | Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be). | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of pain visual analogue scale (VAS) during activity | Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be). | baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months |
| Change of pain visual analogue scale (VAS) at rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Gun Chung, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26202898 | Background | Lee SY, Kim W, Lim C, Chung SG. Treatment of Lateral Epicondylosis by Using Allogeneic Adipose-Derived Mesenchymal Stem Cells: A Pilot Study. Stem Cells. 2015 Oct;33(10):2995-3005. doi: 10.1002/stem.2110. Epub 2015 Aug 6. | |
| 28291954 | Background | Lee SY, Kwon B, Lee K, Son YH, Chung SG. Therapeutic Mechanisms of Human Adipose-Derived Mesenchymal Stem Cells in a Rat Tendon Injury Model. Am J Sports Med. 2017 May;45(6):1429-1439. doi: 10.1177/0363546517689874. Epub 2017 Mar 14. |
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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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Not provided
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
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| Low concentration of Allo-ASC | Biological | 1 million cells of Allo-ASC 0.5cc |
|
| Fibrin glue | Drug | Fibrin glue 0.5cc |
|
|
| Normal saline | Drug | Normal saline 0.5cc |
|
|
Self reported pain intensity at rest will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be). |
| baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months |
| Change of Mayo elbow performance index (MEPI) | The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best) | baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months |
| Ultrasonographic assessment | Ultrasonographic findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). Sonographic images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement. | baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months |
| Shear wave elastography | Young modulus and shear wave speed will be obtained | baseline, 12 weeks and 24 months |
| Magnetic resonance image (MRI) assessment | MRI findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). MR images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement. | baseline, 12 weeks and 24 months |
| 22220180 | Background | Pascual-Garrido C, Rolon A, Makino A. Treatment of chronic patellar tendinopathy with autologous bone marrow stem cells: a 5-year-followup. Stem Cells Int. 2012;2012:953510. doi: 10.1155/2012/953510. Epub 2011 Dec 18. |
| 21773831 | Background | Ellera Gomes JL, da Silva RC, Silla LM, Abreu MR, Pellanda R. Conventional rotator cuff repair complemented by the aid of mononuclear autologous stem cells. Knee Surg Sports Traumatol Arthrosc. 2012 Feb;20(2):373-7. doi: 10.1007/s00167-011-1607-9. Epub 2011 Jul 20. |
| 24913770 | Background | Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7. |
| 27195010 | Background | Zhang X, Lin YC, Rui YF, Xu HL, Chen H, Wang C, Teng GJ. Therapeutic Roles of Tendon Stem/Progenitor Cells in Tendinopathy. Stem Cells Int. 2016;2016:4076578. doi: 10.1155/2016/4076578. Epub 2016 Apr 19. |
| 21139155 | Background | Clarke AW, Alyas F, Morris T, Robertson CJ, Bell J, Connell DA. Skin-derived tenocyte-like cells for the treatment of patellar tendinopathy. Am J Sports Med. 2011 Mar;39(3):614-23. doi: 10.1177/0363546510387095. Epub 2010 Dec 7. |
| 27706825 | Background | Leong DJ, Sun HB. Mesenchymal stem cells in tendon repair and regeneration: basic understanding and translational challenges. Ann N Y Acad Sci. 2016 Nov;1383(1):88-96. doi: 10.1111/nyas.13262. Epub 2016 Oct 5. |
| 24057354 | Background | Muller SA, Todorov A, Heisterbach PE, Martin I, Majewski M. Tendon healing: an overview of physiology, biology, and pathology of tendon healing and systematic review of state of the art in tendon bioengineering. Knee Surg Sports Traumatol Arthrosc. 2015 Jul;23(7):2097-105. doi: 10.1007/s00167-013-2680-z. Epub 2013 Sep 21. |
| 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. |
| 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. |
| 20448192 | Background | Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445. |
| 21356171 | Background | Tobita M, Orbay H, Mizuno H. Adipose-derived stem cells: current findings and future perspectives. Discov Med. 2011 Feb;11(57):160-70. |
| 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. |
| 17200313 | Background | Chong AK, Ang AD, Goh JC, Hui JH, Lim AY, Lee EH, Lim BH. Bone marrow-derived mesenchymal stem cells influence early tendon-healing in a rabbit achilles tendon model. J Bone Joint Surg Am. 2007 Jan;89(1):74-81. doi: 10.2106/JBJS.E.01396. |
| 18593247 | Background | Nixon AJ, Dahlgren LA, Haupt JL, Yeager AE, Ward DL. Effect of adipose-derived nucleated cell fractions on tendon repair in horses with collagenase-induced tendinitis. Am J Vet Res. 2008 Jul;69(7):928-37. doi: 10.2460/ajvr.69.7.928. |
| 22065114 | Background | Guadalajara H, Herreros D, De-La-Quintana P, Trebol J, Garcia-Arranz M, Garcia-Olmo D. Long-term follow-up of patients undergoing adipose-derived adult stem cell administration to treat complex perianal fistulas. Int J Colorectal Dis. 2012 May;27(5):595-600. doi: 10.1007/s00384-011-1350-1. Epub 2011 Nov 9. |
| 18267891 | Background | Guest DJ, Smith MR, Allen WR. Monitoring the fate of autologous and allogeneic mesenchymal progenitor cells injected into the superficial digital flexor tendon of horses: preliminary study. Equine Vet J. 2008 Mar;40(2):178-81. doi: 10.2746/042516408X276942. |
| 18725118 | Background | Hohendorff B, Siepen W, Spiering L, Staub L, Schmuck T, Boss A. Long-term results after operatively treated Achilles tendon rupture: fibrin glue versus suture. J Foot Ankle Surg. 2008 Sep-Oct;47(5):392-9. doi: 10.1053/j.jfas.2008.05.006. Epub 2008 Jul 14. |
| 11879861 | Background | Smidt N, van der Windt DA, Assendelft WJ, Deville WL, Korthals-de Bos IB, Bouter LM. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002 Feb 23;359(9307):657-62. doi: 10.1016/S0140-6736(02)07811-X. |
| 23621906 | Background | Jindal N, Gaury Y, Banshiwal RC, Lamoria R, Bachhal V. Comparison of short term results of single injection of autologous blood and steroid injection in tennis elbow: a prospective study. J Orthop Surg Res. 2013 Apr 27;8:10. doi: 10.1186/1749-799X-8-10. |
| 24866611 | Background | Jacobson JA, Chiavaras MM, Lawton JM, Downie B, Yablon CM, Lawton J. Radial collateral ligament of the elbow: sonographic characterization with cadaveric dissection correlation and magnetic resonance arthrography. J Ultrasound Med. 2014 Jun;33(6):1041-8. doi: 10.7863/ultra.33.6.1041. |
| 16435354 | Background | Scutt N, Rolf CG, Scutt A. Glucocorticoids inhibit tenocyte proliferation and Tendon progenitor cell recruitment. J Orthop Res. 2006 Feb;24(2):173-82. doi: 10.1002/jor.20030. |
| 29153963 | Background | Dirrichs T, Quack V, Gatz M, Tingart M, Rath B, Betsch M, Kuhl CK, Schrading S. Shear Wave Elastography (SWE) for Monitoring of Treatment of Tendinopathies: A Double-blinded, Longitudinal Clinical Study. Acad Radiol. 2018 Mar;25(3):265-272. doi: 10.1016/j.acra.2017.09.011. Epub 2017 Nov 16. |
| 28765991 | Background | Domenichini R, Pialat JB, Podda A, Aubry S. Ultrasound elastography in tendon pathology: state of the art. Skeletal Radiol. 2017 Dec;46(12):1643-1655. doi: 10.1007/s00256-017-2726-2. Epub 2017 Aug 1. |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |