Rotator Cuff Tear
Conditions
Keywords
adipose derived mesenchymal stem cell, allogeneic stem cell, Rotator cuff tear
Brief 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.
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.
Interventions
BIOLOGICALallogenic 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.
BIOLOGICALfibrin glue/normal saline injection
Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise
BIOLOGICALnormal saline injection
Total 1cc of normal saline injection and range of motion exercise
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain During Activity From Baseline to 3 Months After Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Activity | 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 |
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 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. |
| Disability of Arm, Shoulder and Hand (DASH) Score | 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). |
| Pain During Rest | 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. |
| Tear Size at 3 Months After Injection | 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. |
| Tear Size at 12 Months After Injection | 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. |
| University of California, Los Angeles(UCLA) Shoulder Score | 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. |
Countries
South Korea
Participant flow
Recruitment details
Recruitment flyers were posted in a tertiary hospital and volunteers were recruited between September 2014 and April 2016. The first participant was enrolled on January 13, 2015 and the last participant was enrolled in April 12. 2016.
Pre-assignment details
Volunteers were screened by a experienced physiatrist prior to enrollment. Of 26 potential participants, one refused to participate and another had incompatible findings in the baseline MRI. As a result, 24 participants met the inclusion/exclusion criteria and were enrolled and randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Mesenchymal Stem Cell Group Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.
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. | 7 |
| Active Control (Fibrin Glue) Group Received fibrin glue and normal saline.
fibrin glue/normal saline injection: Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise | 8 |
| Control (Normal Saline )Group Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise | 8 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Mesenchymal Stem Cell Group | Active Control (Fibrin Glue) Group | Control (Normal Saline )Group | Total |
|---|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 7.8 | 50.4 years STANDARD_DEVIATION 4.6 | 54.1 years STANDARD_DEVIATION 9.4 | 54.9 years STANDARD_DEVIATION 8.4 |
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 58.9 units on a scale STANDARD_DEVIATION 12.1 | 64.7 units on a scale STANDARD_DEVIATION 12.8 | 54.7 units on a scale STANDARD_DEVIATION 20.1 | 59.5 units on a scale STANDARD_DEVIATION 15.5 |
| Pain during activity | 5.7 units on a scale STANDARD_DEVIATION 1.6 | 4.7 units on a scale STANDARD_DEVIATION 2.6 | 6.6 units on a scale STANDARD_DEVIATION 2.4 | 5.7 units on a scale STANDARD_DEVIATION 2.3 |
| Pain during rest | 3.9 units on a scale STANDARD_DEVIATION 1.8 | 2.4 units on a scale STANDARD_DEVIATION 2.3 | 3.6 units on a scale STANDARD_DEVIATION 1.8 | 3.3 units on a scale STANDARD_DEVIATION 2 |
| Region of Enrollment South Korea | 7 participants | 8 participants | 8 participants | 23 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 6 Participants | 13 Participants |
| The Disabilities of the Arm, Shoulder and Hand(DASH) Score | 32.3 units on a scale STANDARD_DEVIATION 13 | 35.2 units on a scale STANDARD_DEVIATION 16.1 | 37.6 units on a scale STANDARD_DEVIATION 23.8 | 35.1 units on a scale STANDARD_DEVIATION 17.7 |
| University of California, Los Angeles(UCLA) Shoulder Score | 20.3 units on a scale STANDARD_DEVIATION 3.7 | 19.0 units on a scale STANDARD_DEVIATION 3.4 | 17.5 units on a scale STANDARD_DEVIATION 3 | 17.9 units on a scale STANDARD_DEVIATION 3.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 7 / 7 | 8 / 8 | 8 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: Baseline and 3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mesenchymal Stem Cell Group | Change of Pain During Activity From Baseline to 3 Months After Intervention | -1.4 units on a scale | Standard Deviation 2.9 |
| Active Control (Fibrin Glue) Group | Change of Pain During Activity From Baseline to 3 Months After Intervention | -1.5 units on a scale | Standard Deviation 2.4 |
| Control (Normal Saline )Group | Change of Pain During Activity From Baseline to 3 Months After Intervention | -3.0 units on a scale | Standard Deviation 2.6 |
Comparison: Null hypothesis: There is no difference between the three groups. Statistical power: 0.80p-value: 0.35Kruskal-Wallis
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.
Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mesenchymal Stem Cell Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | baseline | 58.9 score on a scale | Standard Deviation 12.1 |
| Mesenchymal Stem Cell Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | week 6 | 52.4 score on a scale | Standard Deviation 21 |
| Mesenchymal Stem Cell Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 3 | 67.9 score on a scale | Standard Deviation 17.7 |
| Mesenchymal Stem Cell Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 6 | 63.4 score on a scale | Standard Deviation 19.6 |
| Mesenchymal Stem Cell Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 12 | 70.6 score on a scale | Standard Deviation 23.5 |
| Mesenchymal Stem Cell Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | year 2 | 71.6 score on a scale | Standard Deviation 20.3 |
| Active Control (Fibrin Glue) Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | year 2 | 80.0 score on a scale | Standard Deviation 16.1 |
| Active Control (Fibrin Glue) Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | baseline | 64.7 score on a scale | Standard Deviation 12.8 |
| Active Control (Fibrin Glue) Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 6 | 76.7 score on a scale | Standard Deviation 12.7 |
| Active Control (Fibrin Glue) Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 12 | 76.0 score on a scale | Standard Deviation 20.3 |
| Active Control (Fibrin Glue) Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | week 6 | 70.6 score on a scale | Standard Deviation 19.9 |
| Active Control (Fibrin Glue) Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 3 | 73.7 score on a scale | Standard Deviation 15.3 |
| Control (Normal Saline )Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | week 6 | 65.9 score on a scale | Standard Deviation 15.8 |
| Control (Normal Saline )Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 3 | 63.6 score on a scale | Standard Deviation 11.8 |
| Control (Normal Saline )Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | year 2 | 89.3 score on a scale | Standard Deviation 11.5 |
| Control (Normal Saline )Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 6 | 63.9 score on a scale | Standard Deviation 14.9 |
| Control (Normal Saline )Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | baseline | 54.7 score on a scale | Standard Deviation 20.1 |
| Control (Normal Saline )Group | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | month 12 | 74.4 score on a scale | Standard Deviation 13.2 |
p-value: 0.835Mixed Models Analysis
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).
Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mesenchymal Stem Cell Group | Disability of Arm, Shoulder and Hand (DASH) Score | baseline | 32.3 score on a scale | Standard Deviation 13 |
| Mesenchymal Stem Cell Group | Disability of Arm, Shoulder and Hand (DASH) Score | week 6 | 36.7 score on a scale | Standard Deviation 15.1 |
| Mesenchymal Stem Cell Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 3 | 24.0 score on a scale | Standard Deviation 15 |
| Mesenchymal Stem Cell Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 6 | 25.0 score on a scale | Standard Deviation 14.9 |
| Mesenchymal Stem Cell Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 12 | 31.1 score on a scale | Standard Deviation 20.8 |
| Mesenchymal Stem Cell Group | Disability of Arm, Shoulder and Hand (DASH) Score | year 2 | 20.3 score on a scale | Standard Deviation 8.9 |
| Active Control (Fibrin Glue) Group | Disability of Arm, Shoulder and Hand (DASH) Score | year 2 | 22.8 score on a scale | Standard Deviation 16.8 |
| Active Control (Fibrin Glue) Group | Disability of Arm, Shoulder and Hand (DASH) Score | baseline | 35.2 score on a scale | Standard Deviation 16.1 |
| Active Control (Fibrin Glue) Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 6 | 19.8 score on a scale | Standard Deviation 11.1 |
| Active Control (Fibrin Glue) Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 12 | 20.5 score on a scale | Standard Deviation 16.2 |
| Active Control (Fibrin Glue) Group | Disability of Arm, Shoulder and Hand (DASH) Score | week 6 | 25.8 score on a scale | Standard Deviation 16.9 |
| Active Control (Fibrin Glue) Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 3 | 19.2 score on a scale | Standard Deviation 14.1 |
| Control (Normal Saline )Group | Disability of Arm, Shoulder and Hand (DASH) Score | week 6 | 28.1 score on a scale | Standard Deviation 14.8 |
| Control (Normal Saline )Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 3 | 28.3 score on a scale | Standard Deviation 10.7 |
| Control (Normal Saline )Group | Disability of Arm, Shoulder and Hand (DASH) Score | year 2 | 20.1 score on a scale | Standard Deviation 20.7 |
| Control (Normal Saline )Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 6 | 27.1 score on a scale | Standard Deviation 17.1 |
| Control (Normal Saline )Group | Disability of Arm, Shoulder and Hand (DASH) Score | baseline | 37.6 score on a scale | Standard Deviation 23.8 |
| Control (Normal Saline )Group | Disability of Arm, Shoulder and Hand (DASH) Score | month 12 | 20.3 score on a scale | Standard Deviation 13.7 |
p-value: 0.977Mixed Models Analysis
Secondary
Pain During Activity
Pain during activity assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome
Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mesenchymal Stem Cell Group | Pain During Activity | baseline | 5.7 units on a scale | Standard Deviation 1.6 |
| Mesenchymal Stem Cell Group | Pain During Activity | week 6 | 6.0 units on a scale | Standard Deviation 1.9 |
| Mesenchymal Stem Cell Group | Pain During Activity | month 3 | 4.4 units on a scale | Standard Deviation 2.9 |
| Mesenchymal Stem Cell Group | Pain During Activity | month 6 | 4.3 units on a scale | Standard Deviation 2.7 |
| Mesenchymal Stem Cell Group | Pain During Activity | month 12 | 3.7 units on a scale | Standard Deviation 2.7 |
| Mesenchymal Stem Cell Group | Pain During Activity | year 2 | 4.4 units on a scale | Standard Deviation 3 |
| Active Control (Fibrin Glue) Group | Pain During Activity | year 2 | 3.2 units on a scale | Standard Deviation 2.1 |
| Active Control (Fibrin Glue) Group | Pain During Activity | baseline | 4.7 units on a scale | Standard Deviation 2.6 |
| Active Control (Fibrin Glue) Group | Pain During Activity | month 6 | 2.8 units on a scale | Standard Deviation 2.3 |
| Active Control (Fibrin Glue) Group | Pain During Activity | month 12 | 3.2 units on a scale | Standard Deviation 2.3 |
| Active Control (Fibrin Glue) Group | Pain During Activity | week 6 | 3.2 units on a scale | Standard Deviation 2.1 |
| Active Control (Fibrin Glue) Group | Pain During Activity | month 3 | 3.2 units on a scale | Standard Deviation 1.6 |
| Control (Normal Saline )Group | Pain During Activity | week 6 | 4.6 units on a scale | Standard Deviation 2.8 |
| Control (Normal Saline )Group | Pain During Activity | month 3 | 3.6 units on a scale | Standard Deviation 2 |
| Control (Normal Saline )Group | Pain During Activity | year 2 | 1.1 units on a scale | Standard Deviation 1.5 |
| Control (Normal Saline )Group | Pain During Activity | month 6 | 4.3 units on a scale | Standard Deviation 2.8 |
| Control (Normal Saline )Group | Pain During Activity | baseline | 6.6 units on a scale | Standard Deviation 2.4 |
| Control (Normal Saline )Group | Pain During Activity | month 12 | 3.1 units on a scale | Standard Deviation 2.4 |
p-value: 0.882Mixed Models Analysis
Secondary
Pain During Rest
Pain during rest assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome.
Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mesenchymal Stem Cell Group | Pain During Rest | month 3 | 2.8 units on a scale | Standard Deviation 2.7 |
| Mesenchymal Stem Cell Group | Pain During Rest | baseline | 3.9 units on a scale | Standard Deviation 1.8 |
| Mesenchymal Stem Cell Group | Pain During Rest | month 6 | 2.9 units on a scale | Standard Deviation 1.9 |
| Mesenchymal Stem Cell Group | Pain During Rest | year 2 | 2.0 units on a scale | Standard Deviation 2.2 |
| Mesenchymal Stem Cell Group | Pain During Rest | week 6 | 4.0 units on a scale | Standard Deviation 2.1 |
| Mesenchymal Stem Cell Group | Pain During Rest | month 12 | 2.9 units on a scale | Standard Deviation 3.5 |
| Active Control (Fibrin Glue) Group | Pain During Rest | week 6 | 2.2 units on a scale | Standard Deviation 2 |
| Active Control (Fibrin Glue) Group | Pain During Rest | month 3 | 1.9 units on a scale | Standard Deviation 1.7 |
| Active Control (Fibrin Glue) Group | Pain During Rest | month 6 | 1.4 units on a scale | Standard Deviation 1.3 |
| Active Control (Fibrin Glue) Group | Pain During Rest | month 12 | 1.8 units on a scale | Standard Deviation 2.4 |
| Active Control (Fibrin Glue) Group | Pain During Rest | baseline | 2.4 units on a scale | Standard Deviation 2.3 |
| Active Control (Fibrin Glue) Group | Pain During Rest | year 2 | 0.8 units on a scale | Standard Deviation 1.3 |
| Control (Normal Saline )Group | Pain During Rest | year 2 | 0.5 units on a scale | Standard Deviation 0.8 |
| Control (Normal Saline )Group | Pain During Rest | month 12 | 1.3 units on a scale | Standard Deviation 1.3 |
| Control (Normal Saline )Group | Pain During Rest | month 6 | 2.4 units on a scale | Standard Deviation 2.1 |
| Control (Normal Saline )Group | Pain During Rest | baseline | 3.6 units on a scale | Standard Deviation 1.8 |
| Control (Normal Saline )Group | Pain During Rest | week 6 | 3.0 units on a scale | Standard Deviation 1.7 |
| Control (Normal Saline )Group | Pain During Rest | month 3 | 2.7 units on a scale | Standard Deviation 1.8 |
p-value: 0.662Mixed Models Analysis
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.
Time frame: baseline and12 months after intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mesenchymal Stem Cell Group | Tear Size at 12 Months After Injection | improved at month 12 | 1 Participants |
| Mesenchymal Stem Cell Group | Tear Size at 12 Months After Injection | stationary at month 12 | 4 Participants |
| Mesenchymal Stem Cell Group | Tear Size at 12 Months After Injection | aggravated at month 12 | 2 Participants |
| Active Control (Fibrin Glue) Group | Tear Size at 12 Months After Injection | improved at month 12 | 3 Participants |
| Active Control (Fibrin Glue) Group | Tear Size at 12 Months After Injection | stationary at month 12 | 3 Participants |
| Active Control (Fibrin Glue) Group | Tear Size at 12 Months After Injection | aggravated at month 12 | 2 Participants |
| Control (Normal Saline )Group | Tear Size at 12 Months After Injection | stationary at month 12 | 4 Participants |
| Control (Normal Saline )Group | Tear Size at 12 Months After Injection | aggravated at month 12 | 2 Participants |
| Control (Normal Saline )Group | Tear Size at 12 Months After Injection | improved at month 12 | 2 Participants |
p-value: 0.892Chi-squared
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.
Time frame: baseline and 3 months after intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mesenchymal Stem Cell Group | Tear Size at 3 Months After Injection | improved at month 3 | 2 Participants |
| Mesenchymal Stem Cell Group | Tear Size at 3 Months After Injection | stationary at month 3 | 5 Participants |
| Mesenchymal Stem Cell Group | Tear Size at 3 Months After Injection | aggravated at month 3 | 0 Participants |
| Active Control (Fibrin Glue) Group | Tear Size at 3 Months After Injection | improved at month 3 | 2 Participants |
| Active Control (Fibrin Glue) Group | Tear Size at 3 Months After Injection | stationary at month 3 | 5 Participants |
| Active Control (Fibrin Glue) Group | Tear Size at 3 Months After Injection | aggravated at month 3 | 1 Participants |
| Control (Normal Saline )Group | Tear Size at 3 Months After Injection | stationary at month 3 | 5 Participants |
| Control (Normal Saline )Group | Tear Size at 3 Months After Injection | aggravated at month 3 | 1 Participants |
| Control (Normal Saline )Group | Tear Size at 3 Months After Injection | improved at month 3 | 2 Participants |
p-value: 0.916Chi-squared
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.
Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mesenchymal Stem Cell Group | University of California, Los Angeles(UCLA) Shoulder Score | baseline | 20.3 score on a scale | Standard Deviation 3.7 |
| Mesenchymal Stem Cell Group | University of California, Los Angeles(UCLA) Shoulder Score | week 6 | 20.0 score on a scale | Standard Deviation 6.4 |
| Mesenchymal Stem Cell Group | University of California, Los Angeles(UCLA) Shoulder Score | month 3 | 26.4 score on a scale | Standard Deviation 6.8 |
| Mesenchymal Stem Cell Group | University of California, Los Angeles(UCLA) Shoulder Score | month 6 | 22.7 score on a scale | Standard Deviation 6.5 |
| Mesenchymal Stem Cell Group | University of California, Los Angeles(UCLA) Shoulder Score | month 12 | 23.6 score on a scale | Standard Deviation 8.3 |
| Mesenchymal Stem Cell Group | University of California, Los Angeles(UCLA) Shoulder Score | year 2 | 24.4 score on a scale | Standard Deviation 6.7 |
| Active Control (Fibrin Glue) Group | University of California, Los Angeles(UCLA) Shoulder Score | year 2 | 24.6 score on a scale | — |
| Active Control (Fibrin Glue) Group | University of California, Los Angeles(UCLA) Shoulder Score | baseline | 19.0 score on a scale | Standard Deviation 3.4 |
| Active Control (Fibrin Glue) Group | University of California, Los Angeles(UCLA) Shoulder Score | month 6 | 23.6 score on a scale | Standard Deviation 5.9 |
| Active Control (Fibrin Glue) Group | University of California, Los Angeles(UCLA) Shoulder Score | month 12 | 24.5 score on a scale | Standard Deviation 7.2 |
| Active Control (Fibrin Glue) Group | University of California, Los Angeles(UCLA) Shoulder Score | week 6 | 22.3 score on a scale | Standard Deviation 6.2 |
| Active Control (Fibrin Glue) Group | University of California, Los Angeles(UCLA) Shoulder Score | month 3 | 23.6 score on a scale | Standard Deviation 6 |
| Control (Normal Saline )Group | University of California, Los Angeles(UCLA) Shoulder Score | week 6 | 22.9 score on a scale | Standard Deviation 5.9 |
| Control (Normal Saline )Group | University of California, Los Angeles(UCLA) Shoulder Score | month 3 | 21.4 score on a scale | Standard Deviation 5.4 |
| Control (Normal Saline )Group | University of California, Los Angeles(UCLA) Shoulder Score | year 2 | 31.3 score on a scale | Standard Deviation 3.1 |
| Control (Normal Saline )Group | University of California, Los Angeles(UCLA) Shoulder Score | month 6 | 22.8 score on a scale | Standard Deviation 4.9 |
| Control (Normal Saline )Group | University of California, Los Angeles(UCLA) Shoulder Score | baseline | 17.5 score on a scale | Standard Deviation 3 |
| Control (Normal Saline )Group | University of California, Los Angeles(UCLA) Shoulder Score | month 12 | 28.0 score on a scale | Standard Deviation 4.1 |
p-value: 0.867Mixed Models Analysis