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NCT02298023 Clinical Trial

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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02298023
Other study ID # ALLO-ASC_TR
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2014
Est. completion date April 10, 2018

Study information
Verified date September 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

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.
• fibrin glue/normal saline injection
Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise
• normal saline injection
Total 1cc of normal saline injection and range of motion exercise

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

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (41)

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Outcome
Type Measure Description Time frame Safety issue
Primary Change of Pain During Activity From Baseline to 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 Pain During Rest 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
Secondary Pain During Activity 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
Secondary American Shoulder and Elbow Surgeons (ASES) Shoulder Score 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
Secondary Disability of Arm, Shoulder and Hand (DASH) Score 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
Secondary University of California, Los Angeles(UCLA) Shoulder Score 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
Secondary Tear Size at 3 Months After Injection 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
Secondary Tear Size at 12 Months After Injection 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
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