Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)

NCT03449082 | Completed Phase 2

• 1 other identifier: SNUH-RM-SGChung-ASC-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis

Keywords

adipose derived mesenchymal stem cell; allogeneic stem cell

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change of pain visual analogue scale (VAS) during activity

  baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

• Change of pain visual analogue scale (VAS) at rest

  baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

• Change of Mayo elbow performance index (MEPI)

  baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

• Ultrasonographic assessment

  baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

• Shear wave elastography

  baseline, 12 weeks and 24 months

Study Arms (3)

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

Biological: High concentration of Allo-ASC; Drug: Fibrin glue

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

Biological: Low concentration of Allo-ASC; Drug: Fibrin glue

Placebo Comparator (Fibrin) group

PLACEBO COMPARATOR

Normal saline 0.5cc \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection

Drug: Fibrin glue; Drug: Normal saline

Interventions

High concentration of Allo-ASC BIOLOGICAL

10 million cells of Allo-ASC 0.5cc

High concentration of Allo-ASC group

Low concentration of Allo-ASC BIOLOGICAL

1 million cells of Allo-ASC 0.5cc

Low concentration of Allo-ASC group

Fibrin glue DRUG

Fibrin glue 0.5cc

Also known as: Fibrin sealant

High concentration of Allo-ASC group; Low concentration of Allo-ASC group; Placebo Comparator (Fibrin) group

Normal saline DRUG

Normal saline 0.5cc

Also known as: 0.9% Sodium Chloride Solution

Placebo Comparator (Fibrin) group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically diagnosed as lateral epicondylosis (tennis elbow)
• symptom duration is over 12 months
• pain visual analogue scale (VAS) during activity ≥ 5
• recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
• common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity)
• patient that can understand the clinical trials

You may not qualify if:

• patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks
• patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI)
• patient that enrolled other clinical trials within 30 days
• current pregnancy or breast-feeding, planning for pregnancy
• history of drug/alcohol addiction, habitual smoker
• operation history of affected elbow
• previous clinical trial involving stem cell administration
• other severe medical illness or bleeding tendency
• size of intramural calcification over 2.0 mm under ultrasound evaluation

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (25)

• 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.

  PMID: 26202898 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.

  PMID: 28291954 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.

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• 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.

  PMID: 21773831 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.

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• 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.

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• 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.

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• 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.

  PMID: 27706825 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.

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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.

  PMID: 20970844 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.

  PMID: 21048180 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.

  PMID: 20448192 BACKGROUND

• Tobita M, Orbay H, Mizuno H. Adipose-derived stem cells: current findings and future perspectives. Discov Med. 2011 Feb;11(57):160-70.

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• 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.

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• 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.

  PMID: 17200313 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.

  PMID: 18593247 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.

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• 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.

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• 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.

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  PMID: 11879861 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.

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MeSH Terms

Conditions

Tennis Elbow

Interventions

Fibrin Tissue Adhesive; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sun Gun Chung, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 28, 2018
• Study Start: March 15, 2018
• Primary Completion: July 16, 2019
• Study Completion: March 8, 2021
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)