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A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674399
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : July 13, 2021
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
Nature Cell Co. Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Interventions Drug: JointStem
Drug: Synvisc-One
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description JointStem : autologous adipose tissue derived mesenchymal stem cells (AdMSC) 1x10e8 cells At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection. hyaluronic acid At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
Period Title: Overall Study
Started 19 9
Completed 17 9
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Arm/Group Title JointStem Synvisc-One Total
Hide Arm/Group Description

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One

 Total of all reporting groups
Overall Number of Baseline Participants 19 9 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 9 participants 28 participants
52.3  (6.98) 52.1  (9.56) 52.3  (7.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 9 participants 28 participants
Female
8
  42.1%
2
  22.2%
10
  35.7%
Male
11
  57.9%
7
  77.8%
18
  64.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 9 participants 28 participants
Hispanic or Latino
1
   5.3%
1
  11.1%
2
   7.1%
Not Hispanic or Latino
18
  94.7%
8
  88.9%
26
  92.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 9 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  10.5%
1
  11.1%
3
  10.7%
White
16
  84.2%
7
  77.8%
23
  82.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.3%
1
  11.1%
2
   7.1%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 19 participants 9 participants 28 participants
173.66  (9.222) 169.46  (10.073) 172.31  (9.527)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 19 participants 9 participants 28 participants
81.31  (14.642) 71.66  (20.569) 78.2  (17.01)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 9 participants 28 participants
26.903  (4.1938) 24.572  (4.6408) 26.154  (4.3971)
1.Primary Outcome
Title Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group
Hide Description Comparing the baseline and 6-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The primary endpoints were evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
-20.121  (21.0415)
2.Primary Outcome
Title Change From Baseline on Visual Analog Scale (VAS) in JointStem Group
Hide Description Comparing the baseline and 6-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The primary endpoints were evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
-32.5  (23.93)
3.Primary Outcome
Title MRI Improvement Evaluation in JointStem Group
Hide Description Comparing the baseline and 6-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The primary endpoints were evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 18 0
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
5
  27.8%
 0
No Change
5
  27.8%
 0
Progress
8
  44.4%
 0
4.Secondary Outcome
Title Change From Baseline on WOMAC Between JointStem and Positive Control Groups
Hide Description Comparing the changes of WOMAC scores between JointStem and positive control groups at 6 months Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 9
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-20.505  (3.665) -17.129  (5.3281)
5.Secondary Outcome
Title Change From Baseline on VAS Between JointStem and Positive Control Groups
Hide Description Comparing the changes of VAS scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 9
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-31.9  (4.90) -30.6  (7.13)
6.Secondary Outcome
Title Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
Hide Description Comparing the changes of KOOS values between JointStem and positive control groups at 6 months KOOS score = 100 - [{(average score of each item) * 100} / 4 ] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 9
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Symptoms 9.70  (2.888) 14.83  (4.22)
Pain 21.40  (3.975) 19.04  (5.78)
ADL 18.53  (3.937) 15.94  (5.72)
Sport/Rec 25.00  (5.123) 26.68  (7.482)
QOL 22.68  (5.383) 11.15  (7.884)
7.Secondary Outcome
Title Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups
Hide Description Comparing the changes of Lysholm Knee Scoring Scales between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 9
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
18.9  (3.97) 19.9  (5.78)
8.Secondary Outcome
Title Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups
Hide Description Comparing the changes of IKDC scores between JointStem and positive control groups at 6 months IKDC score = {(sum of each item score) / 87} * 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 9
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
55.74  (2.223) 54.24  (3.238)
9.Secondary Outcome
Title Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Hide Description Comparing the changes of RAND-36 scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 9
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Physical Functioning 17.2  (3.80) 14.9  (5.52)
Role Limitation (Physical) 20.7  (8.04) 17.4  (11.73)
Role Limitation (Emotional) 6.7  (6.615) -6.74  (9.654)
Energy/Fatigue 5.2  (3.91) 4.5  (5.76)
Emotional well-being -3.4  (2.31) 0.5  (3.45)
Social Functioning 14.71  (2.964) 16.16  (4.312)
Pain 21.59  (4.211) 14.7  (6.18)
General Health 2.91  (2.516) 3.13  (3.668)
10.Secondary Outcome
Title Change From Baseline on WOMAC in JointStem Group
Hide Description Comparing the baseline and 9-month/12-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Time Frame Baseline, 9 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from baseline at Month 9 -21.216  (20.9653)
Change from baseline at Month 12 -21.711  (19.7521)
11.Secondary Outcome
Title Change From Baseline on VAS in JointStem Group
Hide Description Comparing the baseline and 9-month/12-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Time Frame Baseline, 9 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from baseline at Month 9 -31.5  (25.52)
Change from baseline at Month 12 -35  (24.56)
12.Secondary Outcome
Title Comparison of MRI Improvement Evaluation in JointStem Group
Hide Description Comparing the baseline and 9-month/12-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.
Time Frame Baseline, 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 18 0
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6 Improved -> Month 12 Improved
3
  16.7%
Month 6 Improved -> Month 12 No Change
1
   5.6%
Month 6 Improved -> Month 12 Progress
1
   5.6%
Month 6 No Change -> Month 12 Improved
1
   5.6%
Month 6 No Change -> Month 12 No Change
2
  11.1%
Month 6 No Change -> Month 12 Progress
2
  11.1%
Month 6 Progress -> Month 12 Improved
2
  11.1%
Month 6 Progress -> Month 12 No Change
0
   0.0%
Month 6 Progress -> Month 12 Progress
6
  33.3%
13.Secondary Outcome
Title Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
Hide Description Comparing the baseline and 6-month/9-month/12-month Lysholm Knee Scoring Scale in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame Baseline, 6 months, 9 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from baseline at Month 6 18.3  (22.29)
Change from baseline at Month 9 16.1  (25.34)
Change from baseline at Month 12 17.1  (23.78)
14.Secondary Outcome
Title Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Hide Description Comparing the baseline and 6-month/9-month/12-month KOOS scores in JointStem group KOOS score = 100 - [{(average score of each item) * 100} / 4 ] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame baseline, 6 month, 9 month, 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from baseline at Month 6 (Symptoms) 9.02  (15.381)
Change from baseline at Month 9 (Symptoms) 15.03  (13.677)
Change from baseline at Month 12 (Symptoms) 15.41  (18.229)
Change from baseline at Month 6 (Pain) 21.65  (20.386)
Change from baseline at Month 9 (Pain) 23.98  (23.200)
Change from baseline at Month 12 (Pain) 25.31  (21.219)
Change from baseline at Month 6 (ADL) 18.66  (23.842)
Change from baseline at Month 9 (ADL) 18.42  (25.017)
Change from baseline at Month 12 (ADL) 21.90  (23.237)
Change from baseline at Month 6 (Sport/Rec) 25.53  (23.915)
Change from baseline at Month 9 (Sport/Rec) 28.42  (25.279)
Change from baseline at Month 12 (Sport/Rec) 33.68  (24.486)
Change from baseline at Month 6 (QOL) 23.36  (24.829)
Change from baseline at Month 9 (QOL) 29.95  (27.228)
Change from baseline at Month 12 (QOL) 28.96  (29.121)
15.Secondary Outcome
Title Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
Hide Description Comparing the baseline and 6-month/9-month/12-month IKDC scores in JointStem group IKDC score = {(sum of each item score) / 87} * 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame baseline, 6 month, 9 month, 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group.
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from baseline at Month 6 7.03  (11.379)
Change from baseline at Month 9 10.95  (12.047)
Change from baseline at Month 12 9.63  (10.380)
16.Secondary Outcome
Title Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Hide Description Comparing the baseline and 6-month/9-month/12-month RAND-36 scores in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time Frame baseline, 6 month, 9 month, 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was evaluated only in the JointsStem group
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description:

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

JointStem

hyaluronic acid

Synvisc-One
Overall Number of Participants Analyzed 19 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from baseline at Month 6 (Physical Functioning) 17.4  (22.13)
Change from baseline at Month 9 (Physical Functioning) 18.7  (23.38)
Change from baseline at Month 12 (Physical Functioning) 17.1  (28.69)
Change from baseline at Month 6 (Role Limitation_Physical) 22.4  (36.22)
Change from baseline at Month 9 (Role Limitation_Physical) 30.3  (38.71)
Change from baseline at Month 12 (Role Limitation_Physical) 31.6  (40.69)
Change from baseline at Month 6 (Role Limitation_Emotional) 8.77  (33.048)
Change from baseline at Month 9 (Role Limitation_Emotional) 7.02  (30.604)
Change from baseline at Month 12 (Role Limitation_Emotional) 8.77  (33.048)
Change from baseline at Month 6 (Energy/Fatigue) 2.9  (20.70)
Change from baseline at Month 9 (Energy/Fatigue) 5.3  (16.45)
Change from baseline at Month 12 (Energy/Fatigue) 7.6  (18.81)
Change from baseline at Month 6 (Emotional well-being) -3.4  (10.61)
Change from baseline at Month 9 (Emotional well-being) -3.6  (11.31)
Change from baseline at Month 12 (Emotional well-being) -4.0  (14.79)
Change from baseline at Month 6 (Social Functioning) 13.82  (23.531)
Change from baseline at Month 9 (Social Functioning) 14.47  (20.943)
Change from baseline at Month 12 (Social Functioning) 7.24  (25.109)
Change from baseline at Month 6 (Pain) 23.16  (21.982)
Change from baseline at Month 9 (Pain) 23.95  (22.100)
Change from baseline at Month 12 (Pain) 24.34  (21.967)
Change from baseline at Month 6 (General Health) 3.51  (13.566)
Change from baseline at Month 9 (General Health) 5.71  (10.502)
Change from baseline at Month 12 (General Health) 2.85  (18.636)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title JointStem Synvisc-One
Hide Arm/Group Description autologous adipose tissue derived mesenchymal stem cells (AdMSC) hyaluronic acid
All-Cause Mortality
JointStem Synvisc-One
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/9 (0.00%) 
Hide Serious Adverse Events
JointStem Synvisc-One
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
JointStem Synvisc-One
Affected / at Risk (%) Affected / at Risk (%)
Total   18/19 (94.74%)   4/9 (44.44%) 
Gastrointestinal disorders     
Dyspepsia † 1  1/19 (5.26%)  0/9 (0.00%) 
General disorders     
Injection site pain † 1  9/19 (47.37%)  1/9 (11.11%) 
Injection site swelling † 1  1/19 (5.26%)  0/9 (0.00%) 
Pain † 1  1/19 (5.26%)  0/9 (0.00%) 
Infections and infestations     
Bronchitis † 1  2/19 (10.53%)  1/9 (11.11%) 
Nasopharyngitis † 1  2/19 (10.53%)  0/9 (0.00%) 
Hand-foot-and-mouth disease † 1  1/19 (5.26%)  0/9 (0.00%) 
Herpes simplex † 1  1/19 (5.26%)  0/9 (0.00%) 
Influenza † 1  1/19 (5.26%)  0/9 (0.00%) 
Lower respiratory tract infection † 1  1/19 (5.26%)  0/9 (0.00%) 
Pneumonia † 1  0/19 (0.00%)  1/9 (11.11%) 
Sinusitis † 1  1/19 (5.26%)  0/9 (0.00%) 
Upper respiratory tract infection † 1  1/19 (5.26%)  0/9 (0.00%) 
Urinary tract infection † 1  1/19 (5.26%)  0/9 (0.00%) 
Injury, poisoning and procedural complications     
Ligament sprain † 1  2/19 (10.53%)  1/9 (11.11%) 
Ligament rupture † 1  0/19 (0.00%)  1/9 (11.11%) 
Meniscus injury † 1  1/19 (5.26%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  7/19 (36.84%)  2/9 (22.22%) 
Joint swelling † 1  5/19 (26.32%)  0/9 (0.00%) 
Stiff knees † 1  4/19 (21.05%)  1/9 (11.11%) 
Back pain † 1  1/19 (5.26%)  0/9 (0.00%) 
Muscle spasms † 1  1/19 (5.26%)  0/9 (0.00%) 
Tendonitis † 1  0/19 (0.00%)  1/9 (11.11%) 
Nervous system disorders     
Headache † 1  1/19 (5.26%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  1/19 (5.26%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Project Manager
Organization: Nature Cell co., ltd
Phone: 02-545-4137
EMail: tin50@stemcellbio.com
Layout table for additonal information
Responsible Party: Nature Cell Co. Ltd.
ClinicalTrials.gov Identifier: NCT02674399    
Other Study ID Numbers: JS-OAP2-US01
First Submitted: February 2, 2016
First Posted: February 4, 2016
Results First Submitted: June 21, 2021
Results First Posted: July 13, 2021
Last Update Posted: August 10, 2021