Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)

September 30, 2021 updated by: Sun Gun Chung, Seoul National University Hospital

Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells: Phase II Double-Blind Placebo-Controlled Randomized Clinical Trials.

Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus partial thickness tear by ultrasonographic guided injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. Double blind Randomized placebo controlled study will be done with following 3 groups. Each group will have 8 people, so, the total patients will be 24 people.

  1. Stem cell treatment group : stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc + range of motion exercise
  2. Active control (fibrin glue) group : Normal saline 0.5cc + Fibrin glue 0.5cc + range of motion exercise
  3. Control (normal saline) group : Normal saline 0.5cc + Normal saline 0.5cc + range of motion exercise

The investigators will compare the efficacy difference with VAS(visual analog scale, primary outcome), ASES(American Shoulder and Elbow Surgeons) Score, UCLA(University of California, Los Angles) Shoulder Score, DASH(The Disabilities of the Arm, Shoulder and Hand) Score and change of tear size compared to the baseline image assessed by MRI. These measurement will be done at 6 and 12 weeks after injections and long-term follow-up will be also planned to 6 months, 12months and 24 months except for the evaluation of the tear size which will be done at baseline, 3 months and 24 months after the intervention.

Study Type

Interventional

Enrollment (Actual)

24

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University College of Medicine

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinically diagnosed as rotator cuff tear (supraspinatus partial thickness tear)
  • recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
  • symptom duration is over 3 months
  • supraspinatus partial thickness tear proven ultrasonography and magnetic resonance image(MRI)
  • patient that can understand the clinical trials

Exclusion Criteria:

  • patient that underwent other injection treatment within 6 weeks
  • some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,. arthritis of related joint to the target lesion, muscle weakness or atrophy, innervated by suprascapular nerve, paralysis of related joint to target lesion, proximal humeral fracture, infectious disease, bilateral rotator cuff tear, generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue and contraindication to MRI
  • patient that enrolled other clinical trials within 30 days
  • history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.

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: Mesenchymal stem cell group
Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.
Biological: allogenic adipose stem cell injection
Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.
Other Names:
  • experimental group
Active Comparator: Active control (fibrin glue) group
Received fibrin glue and normal saline.
Biological: fibrin glue/normal saline injection
Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise
Other Names:
  • active control group
Placebo Comparator: Control (normal saline )group
Received only normal saline.
Biological: normal saline injection
Total 1cc of normal saline injection and range of motion exercise
Other Names:
  • placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Pain During Activity From Baseline to 3 Months After Intervention
Time Frame: Baseline and 3 months after intervention
Pain during activity will be evaluated by visual analog scale (active pain VAS). The active pain visual analog scale change from baseline to 3 months after intervention is the primary outcome. Visual analog scale is scored 0 to 10, higher scored meaning worse outcome. Negative values in change of pain during activity indicate improvement in pain.
Baseline and 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain During Rest
Time Frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Pain during rest assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome.
Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Pain During Activity
Time Frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Pain during activity assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome
Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time Frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Functional score of the shoulder was assessed by American Shoulder and Elbow Surgeons shoulder score which is a questionnaire dedicated to the functional evaluation of the shoulder. It is scored from 0 to 100, higher scores meaning better outcome.
Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Disability of Arm, Shoulder and Hand (DASH) Score
Time Frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Shoulder function is assessed by DASH score which is questionnaire dedicated to evaluate the function of the upper extremity. It is scored from 0 (no disability) to 100 (most severe disability).
Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
University of California, Los Angeles(UCLA) Shoulder Score
Time Frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Shoulder function is assessed by UCLA shoulder score which is a composite of range of motion examination and questionnaire dedicated to evaluate the function of the shoulder. It is scored from 0 to 35, higher scores meaning better shoulder function.
Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
Tear Size at 3 Months After Injection
Time Frame: baseline and 3 months after intervention
Tear size was evaluated by 3-point Likert scale using MRI. The 3months follow-up images were compared to the baseline image and graded either; improved, stationary, and aggravated.
baseline and 3 months after intervention
Tear Size at 12 Months After Injection
Time Frame: baseline and12 months after intervention
Tear size was evaluated by 3-point Likert scale using MRI. The 12 months follow-up images were compared to the baseline image and graded either; improved, stationary, and aggravated.
baseline and12 months after intervention

Collaborators and Investigators

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

Sponsor

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)

September 1, 2014

Primary Completion (Actual)

July 19, 2016

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-ASC_TR

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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