Treatment of Tendon Injury Using Mesenchymal Stem Cells

Lateral Epicondylitis Clinical Trial

— ALLO-ASC  

Official title:

Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856140
• Other study ID #: SNUH-RM-SGChung-ASC-01
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2013
• Est. completion date: April 2018

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• clinically diagnosed as lateral epicondylitis (tennis elbow)
• 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:

• patient that underwent other injection treatment within 6 weeks
• 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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tendon Injuries
• Tennis Elbow

Intervention

Biological:
• ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medical Research Collaborating Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

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. Review. — View Citation

Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. Epub 2006 May 30. — View Citation

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. — View Citation

Sánchez M, Anitua E, Azofra J, Andía 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. Epub 2006 Nov 12. — View Citation

Sánchez M, Azofra J, Anitua E, Andía 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. — View Citation

Slater M, Patava J, Kingham K, Mason RS. Involvement of platelets in stimulating osteogenic activity. J Orthop Res. 1995 Sep;13(5):655-63. — View Citation

Sölveborn 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 6 weeks, 12 weeks after intervention
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.	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.	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.	Baseline, 6 weeks, and 12 weeks after the intervention