Treatment of Tendon Injury Using Mesenchymal Stem Cells
NCT ID: NCT01856140
Last Updated: 2022-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
12 participants
INTERVENTIONAL
2013-05-31
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Interventions
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ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Eligibility Criteria
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Inclusion Criteria
* recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
* symptom duration is over 6 months
* defect in common extensor tendon can be observed under ultrasound
* patient that can understand the clinical trials
Exclusion Criteria
* some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
* patient that enrolled other clinical trials within 30 days
* history of drug/alcohol addiction, habitual smoker
19 Years
90 Years
ALL
No
Sponsors
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Medical Research Collaborating Center, Seoul, Korea
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Sun Gun Chung
Professor
Principal Investigators
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Sun Gun Chung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Seoul National University College of Medicine
Seoul, , South Korea
Countries
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References
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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.
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.
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.
Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SNUH-RM-SGChung-ASC-01
Identifier Type: -
Identifier Source: org_study_id
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