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
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 10, 2018
• Est. primary completion date: July 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear
• Tendon Injuries

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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* Note: There are 41 references in all — Click here to view all references

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