NCT01856140

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2013

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

March 18, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

April 26, 2013

Results QC Date

March 30, 2021

Last Update Submit

February 21, 2022

Conditions

Lateral Epicondylitis

Keywords

adipose derived mesenchymal stem cellallogeneic stem cell

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Modified Mayo Clinic Performance Index for the Elbow

    Baseline, 6 weeks, 12 weeks after the intervention

  • Defect Area of Tendon by Ultrasonography in Long Axis

    Baseline, 6 weeks, and 12 weeks after the intervention

  • Defect Area of Tendon by Ultrasonography in Short Axis

    Baseline, 6 weeks, and 12 weeks after the intervention

Study Arms (2)

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.

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

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.

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

Interventions

ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injectionBIOLOGICAL
1 million cells/ml of ALLO-ASC10 million cells/ml of ALLO-ASC

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University College of Medicine

Seoul, South Korea

Location

Related 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.

    PMID: 20970844BACKGROUND

  • 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.

    PMID: 1991216BACKGROUND

  • 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.

    PMID: 14523300BACKGROUND

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

    PMID: 17910298BACKGROUND

  • 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.

    PMID: 7634730BACKGROUND

  • 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: 21048180BACKGROUND

  • 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.

    PMID: 16735582BACKGROUND

  • 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.

    PMID: 19380129BACKGROUND

  • 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.

    PMID: 17099241BACKGROUND

  • 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.

    PMID: 7472743BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Injections

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Dr. Sang Yoon Lee
Organization
Seoul National University College of Medicine
rehabilee@gmail.com
028702673

Study Officials

  • Sun Gun Chung, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 17, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2016

Study Completion

April 1, 2018

Last Updated

March 18, 2022

Results First Posted

February 18, 2022

Record last verified: 2022-02

Locations

KR(1)