Trial Outcomes & Findings for Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) (NCT NCT02298023)
NCT ID: NCT02298023
Last Updated: 2021-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 3 months after intervention
Results posted on
2021-10-19
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
Eight participants were assigned and one declined to participate before the intervention.
|
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
Intervention
|
7
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
Eight participants were assigned and one declined to participate before the intervention.
|
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
Baseline characteristics by cohort
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Pain during activity
|
5.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Pain during rest
|
3.9 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
|
58.9 units on a scale
STANDARD_DEVIATION 12.1 • n=5 Participants
|
64.7 units on a scale
STANDARD_DEVIATION 12.8 • n=7 Participants
|
54.7 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
59.5 units on a scale
STANDARD_DEVIATION 15.5 • n=4 Participants
|
|
University of California, Los Angeles(UCLA) Shoulder Score
|
20.3 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
19.0 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 3.4 • n=4 Participants
|
|
The Disabilities of the Arm, Shoulder and Hand(DASH) Score
|
32.3 units on a scale
STANDARD_DEVIATION 13.0 • n=5 Participants
|
35.2 units on a scale
STANDARD_DEVIATION 16.1 • n=7 Participants
|
37.6 units on a scale
STANDARD_DEVIATION 23.8 • n=5 Participants
|
35.1 units on a scale
STANDARD_DEVIATION 17.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months after interventionPain 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.
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Change of Pain During Activity From Baseline to 3 Months After Intervention
|
-1.4 units on a scale
Standard Deviation 2.9
|
-1.5 units on a scale
Standard Deviation 2.4
|
-3.0 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after interventionPain during rest assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome.
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Pain During Rest
baseline
|
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
|
|
Pain During Rest
week 6
|
4.0 units on a scale
Standard Deviation 2.1
|
2.2 units on a scale
Standard Deviation 2.0
|
3.0 units on a scale
Standard Deviation 1.7
|
|
Pain During Rest
month 3
|
2.8 units on a scale
Standard Deviation 2.7
|
1.9 units on a scale
Standard Deviation 1.7
|
2.7 units on a scale
Standard Deviation 1.8
|
|
Pain During Rest
month 6
|
2.9 units on a scale
Standard Deviation 1.9
|
1.4 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 2.1
|
|
Pain During Rest
month 12
|
2.9 units on a scale
Standard Deviation 3.5
|
1.8 units on a scale
Standard Deviation 2.4
|
1.3 units on a scale
Standard Deviation 1.3
|
|
Pain During Rest
year 2
|
2.0 units on a scale
Standard Deviation 2.2
|
0.8 units on a scale
Standard Deviation 1.3
|
0.5 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after interventionPain during activity assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Pain During Activity
baseline
|
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
|
|
Pain During Activity
week 6
|
6.0 units on a scale
Standard Deviation 1.9
|
3.2 units on a scale
Standard Deviation 2.1
|
4.6 units on a scale
Standard Deviation 2.8
|
|
Pain During Activity
month 3
|
4.4 units on a scale
Standard Deviation 2.9
|
3.2 units on a scale
Standard Deviation 1.6
|
3.6 units on a scale
Standard Deviation 2.0
|
|
Pain During Activity
month 6
|
4.3 units on a scale
Standard Deviation 2.7
|
2.8 units on a scale
Standard Deviation 2.3
|
4.3 units on a scale
Standard Deviation 2.8
|
|
Pain During Activity
month 12
|
3.7 units on a scale
Standard Deviation 2.7
|
3.2 units on a scale
Standard Deviation 2.3
|
3.1 units on a scale
Standard Deviation 2.4
|
|
Pain During Activity
year 2
|
4.4 units on a scale
Standard Deviation 3.0
|
3.2 units on a scale
Standard Deviation 2.1
|
1.1 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after interventionFunctional 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.
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
baseline
|
58.9 score on a scale
Standard Deviation 12.1
|
64.7 score on a scale
Standard Deviation 12.8
|
54.7 score on a scale
Standard Deviation 20.1
|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
week 6
|
52.4 score on a scale
Standard Deviation 21.0
|
70.6 score on a scale
Standard Deviation 19.9
|
65.9 score on a scale
Standard Deviation 15.8
|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
month 3
|
67.9 score on a scale
Standard Deviation 17.7
|
73.7 score on a scale
Standard Deviation 15.3
|
63.6 score on a scale
Standard Deviation 11.8
|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
month 6
|
63.4 score on a scale
Standard Deviation 19.6
|
76.7 score on a scale
Standard Deviation 12.7
|
63.9 score on a scale
Standard Deviation 14.9
|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
month 12
|
70.6 score on a scale
Standard Deviation 23.5
|
76.0 score on a scale
Standard Deviation 20.3
|
74.4 score on a scale
Standard Deviation 13.2
|
|
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
year 2
|
71.6 score on a scale
Standard Deviation 20.3
|
80.0 score on a scale
Standard Deviation 16.1
|
89.3 score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after interventionShoulder 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).
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Disability of Arm, Shoulder and Hand (DASH) Score
baseline
|
32.3 score on a scale
Standard Deviation 13.0
|
35.2 score on a scale
Standard Deviation 16.1
|
37.6 score on a scale
Standard Deviation 23.8
|
|
Disability of Arm, Shoulder and Hand (DASH) Score
week 6
|
36.7 score on a scale
Standard Deviation 15.1
|
25.8 score on a scale
Standard Deviation 16.9
|
28.1 score on a scale
Standard Deviation 14.8
|
|
Disability of Arm, Shoulder and Hand (DASH) Score
month 3
|
24.0 score on a scale
Standard Deviation 15.0
|
19.2 score on a scale
Standard Deviation 14.1
|
28.3 score on a scale
Standard Deviation 10.7
|
|
Disability of Arm, Shoulder and Hand (DASH) Score
month 6
|
25.0 score on a scale
Standard Deviation 14.9
|
19.8 score on a scale
Standard Deviation 11.1
|
27.1 score on a scale
Standard Deviation 17.1
|
|
Disability of Arm, Shoulder and Hand (DASH) Score
month 12
|
31.1 score on a scale
Standard Deviation 20.8
|
20.5 score on a scale
Standard Deviation 16.2
|
20.3 score on a scale
Standard Deviation 13.7
|
|
Disability of Arm, Shoulder and Hand (DASH) Score
year 2
|
20.3 score on a scale
Standard Deviation 8.9
|
22.8 score on a scale
Standard Deviation 16.8
|
20.1 score on a scale
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after interventionShoulder 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.
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
University of California, Los Angeles(UCLA) Shoulder Score
baseline
|
20.3 score on a scale
Standard Deviation 3.7
|
19.0 score on a scale
Standard Deviation 3.4
|
17.5 score on a scale
Standard Deviation 3.0
|
|
University of California, Los Angeles(UCLA) Shoulder Score
week 6
|
20.0 score on a scale
Standard Deviation 6.4
|
22.3 score on a scale
Standard Deviation 6.2
|
22.9 score on a scale
Standard Deviation 5.9
|
|
University of California, Los Angeles(UCLA) Shoulder Score
month 3
|
26.4 score on a scale
Standard Deviation 6.8
|
23.6 score on a scale
Standard Deviation 6.0
|
21.4 score on a scale
Standard Deviation 5.4
|
|
University of California, Los Angeles(UCLA) Shoulder Score
month 6
|
22.7 score on a scale
Standard Deviation 6.5
|
23.6 score on a scale
Standard Deviation 5.9
|
22.8 score on a scale
Standard Deviation 4.9
|
|
University of California, Los Angeles(UCLA) Shoulder Score
month 12
|
23.6 score on a scale
Standard Deviation 8.3
|
24.5 score on a scale
Standard Deviation 7.2
|
28.0 score on a scale
Standard Deviation 4.1
|
|
University of California, Los Angeles(UCLA) Shoulder Score
year 2
|
24.4 score on a scale
Standard Deviation 6.7
|
24.6 score on a scale
Standard Deviation 6.
|
31.3 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: baseline and 3 months after interventionTear 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.
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Tear Size at 3 Months After Injection
stationary at month 3
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Tear Size at 3 Months After Injection
improved at month 3
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Tear Size at 3 Months After Injection
aggravated at month 3
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline and12 months after interventionTear 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.
Outcome measures
| Measure |
Mesenchymal Stem Cell Group
n=7 Participants
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 Participants
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 Participants
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Tear Size at 12 Months After Injection
stationary at month 12
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Tear Size at 12 Months After Injection
improved at month 12
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Tear Size at 12 Months After Injection
aggravated at month 12
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Mesenchymal Stem Cell Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Active Control (Fibrin Glue) Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control (Normal Saline )Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mesenchymal Stem Cell Group
n=7 participants at risk
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.
Eight participants were assigned and one declined to participate before the intervention.
|
Active Control (Fibrin Glue) Group
n=8 participants at risk
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
Eight participants were assigned and followed up throughout the study.
|
Control (Normal Saline )Group
n=8 participants at risk
Received only normal saline.
normal saline injection: Total 1cc of normal saline injection and range of motion exercise
Eight participants were assigned and followed up throughout the study except one who missed the last visit.
|
|---|---|---|---|
|
Psychiatric disorders
insomnia
|
0.00%
0/7 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
0.00%
0/8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
12.5%
1/8 • Number of events 1 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
|
Eye disorders
conjunctivitis
|
0.00%
0/7 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
0.00%
0/8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
12.5%
1/8 • Number of events 1 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
|
Musculoskeletal and connective tissue disorders
back pain
|
42.9%
3/7 • Number of events 3 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
0.00%
0/8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
0.00%
0/8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
14.3%
1/7 • Number of events 2 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
0.00%
0/8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
0.00%
0/8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
100.0%
7/7 • Number of events 8 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
100.0%
8/8 • Number of events 11 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
100.0%
8/8 • Number of events 11 • 2 years
All participants were asked the following open questions at every follow-up visit. 1. How are you feeling? 2. Have you had any kind of medical issue since the last visit? 3. Have you had or currently on any medication since the last visit? 4. Have you visited the emergency room or have been admitted to a hospital since the last visit?
|
Additional Information
Dr. Sun G. Chung
, Seoul National University Hospital
Phone: +82-2-2072-2560
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place