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

April 2, 2025 updated by: Sun Gun Chung, Seoul National University Hospital

Treatment of Intractable Common Extensor Tendon Injury Using Allogeneic Adipose-derived Mesenchymal Stem Cells (Allo-ASC): a Phase II Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

  1. High concentration of Allo-ASC group: stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc
  2. Low concentration of Allo-ASC group: stem cell 0.5cc (Total: 1 million cells) + Fibrin glue 0.5cc
  3. Placebo Comparator (Fibrin) group: Normal saline 0.5cc + Fibrin glue 0.5cc The investigators will compare the efficacy difference with visual analogue scale (VAS) during activity (primary outcome), VAS at rest, Mayo elbow performance index (MEPI), grip strength, ultrasonographic assessment at baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months after injection. Shear wave elastography (SWE) and magnetic resonance image (MRI) will be done at baseline, 12 weeks, 12 months and 24 months after injection

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High concentration of Allo-ASC group
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
10 million cells of Allo-ASC 0.5cc
Drug: Fibrin glue
Fibrin glue 0.5cc
Other Names:
  • Fibrin sealant
Experimental: Low concentration of Allo-ASC group
Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Drug: Fibrin glue
Fibrin glue 0.5cc
Other Names:
  • Fibrin sealant
Biological: Low concentration of Allo-ASC
1 million cells of Allo-ASC 0.5cc
Placebo Comparator: Placebo Comparator (Fibrin) group
Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Drug: Fibrin glue
Fibrin glue 0.5cc
Other Names:
  • Fibrin sealant
Drug: Normal saline
Normal saline 0.5cc
Other Names:
  • 0.9% Sodium Chloride Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pain visual analogue scale (VAS) during activity
Time Frame: baseline 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).
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pain visual analogue scale (VAS) during activity
Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
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
Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
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)
Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
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
Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
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
Time Frame: baseline, 12 weeks and 24 months
Young modulus and shear wave speed will be obtained
baseline, 12 weeks and 24 months
Magnetic resonance image (MRI) assessment
Time Frame: baseline, 12 weeks and 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Korea Health Industry Development Institute

Investigators

  • Principal Investigator: Sun Gun Chung, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

July 16, 2019

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-RM-SGChung-ASC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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