Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KCRN Research, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a double-blind, randomized, controlled study with two arms to evaluate JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 30 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.Only subjects who are assigned will be requested to visit the study center for 9-month and 12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all subjects who complete Visit 6 will be requested to visit the study center at 24-month after the injection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JointStem | Experimental | autologous adipose tissue derived mesenchymal stem cells (AdMSC) |
|
| Synvisc-One | Active Comparator | hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JointStem | Drug |
| ||
| Synvisc-One |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group | 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 | Baseline and 6 months |
| Change From Baseline on Visual Analog Scale (VAS) in JointStem Group | 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. | Baseline and 6 months |
| MRI Improvement Evaluation in JointStem Group | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on WOMAC Between JointStem and Positive Control Groups | 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 | Baseline and 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Pain Specialists | Santa Monica | California | 90404 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | JointStem | 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. |
| FG001 | Synvisc-One | hyaluronic acid At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | JointStem | autologous adipose tissue derived mesenchymal stem cells (AdMSC) JointStem |
| BG001 | Synvisc-One | hyaluronic acid Synvisc-One |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group | 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 | The primary endpoints were evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JointStem | autologous adipose tissue derived mesenchymal stem cells (AdMSC) | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Nature Cell co., ltd | 02-545-4137 | tin50@stemcellbio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2018 | Jun 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2018 | Jun 21, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 30, 2018 | Jun 17, 2021 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C049816 | hylan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Change From Baseline on VAS Between JointStem and Positive Control Groups |
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. |
| Baseline and 6 months |
| Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | 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 | Baseline and 6 months |
| Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups | 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 | Baseline and 6 months |
| Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups | 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 | Baseline and 6 months |
| Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | 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 | Baseline and 6 months |
| Change From Baseline on WOMAC in JointStem Group | 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 | Baseline, 9 months and 12 months |
| Change From Baseline on VAS in JointStem Group | 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. | Baseline, 9 months and 12 months |
| Comparison of MRI Improvement Evaluation in JointStem Group | 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. | Baseline, 6 months and 12 months |
| Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12 | 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 | Baseline, 6 months, 9 months and 12 months |
| Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | 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 | baseline, 6 month, 9 month, 12 month |
| Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group | 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 | baseline, 6 month, 9 month, 12 month |
| Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | 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 | baseline, 6 month, 9 month, 12 month |
| Walnut Creek |
| California |
| 94598 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Change From Baseline on Visual Analog Scale (VAS) in JointStem Group | 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. | The primary endpoints were evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
|
|
| Primary | MRI Improvement Evaluation in JointStem Group | 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. | The primary endpoints were evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Change From Baseline on WOMAC Between JointStem and Positive Control Groups | 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 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline on VAS Between JointStem and Positive Control Groups | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | 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 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups | 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 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups | 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 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | 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 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline on WOMAC in JointStem Group | 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 | This measure was evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9 months and 12 months |
|
|
|
| Secondary | Change From Baseline on VAS in JointStem Group | 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. | This measure was evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9 months and 12 months |
|
|
|
| Secondary | Comparison of MRI Improvement Evaluation in JointStem Group | 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. | This measure was evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values. | Posted | Count of Participants | Participants | Baseline, 6 months and 12 months |
|
|
|
| Secondary | Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12 | 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 | This measure was evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 9 months and 12 months |
|
|
|
| Secondary | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | 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 | This measure was evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, 9 month, 12 month |
|
|
|
| Secondary | Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group | 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 | This measure was evaluated only in the JointsStem group. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, 9 month, 12 month |
|
|
|
| Secondary | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | 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 | This measure was evaluated only in the JointsStem group | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, 9 month, 12 month |
|
|
|
| 19 |
| 0 |
| 19 |
| 18 |
| 19 |
| EG001 | Synvisc-One | hyaluronic acid | 0 | 9 | 0 | 9 | 4 | 9 |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stiff knees | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| Progress |
|
| ADL |
|
| Sport/Rec |
|
| QOL |
|
| Role Limitation (Emotional) |
|
| Energy/Fatigue |
|
| Emotional well-being |
|
| Social Functioning |
|
| Pain |
|
| General Health |
|
| Month 6 No Change -> Month 12 Improved |
|
| Month 6 No Change -> Month 12 No Change |
|
| Month 6 No Change -> Month 12 Progress |
|
| Month 6 Progress -> Month 12 Improved |
|
| Month 6 Progress -> Month 12 No Change |
|
| Month 6 Progress -> Month 12 Progress |
|
|
|
| Change from baseline at Month 6 (Pain) |
|
| Change from baseline at Month 9 (Pain) |
|
| Change from baseline at Month 12 (Pain) |
|
| Change from baseline at Month 6 (ADL) |
|
| Change from baseline at Month 9 (ADL) |
|
| Change from baseline at Month 12 (ADL) |
|
| Change from baseline at Month 6 (Sport/Rec) |
|
| Change from baseline at Month 9 (Sport/Rec) |
|
| Change from baseline at Month 12 (Sport/Rec) |
|
| Change from baseline at Month 6 (QOL) |
|
| Change from baseline at Month 9 (QOL) |
|
| Change from baseline at Month 12 (QOL) |
|
|
|
| Change from baseline at Month 6 (Role Limitation_Physical) |
|
| Change from baseline at Month 9 (Role Limitation_Physical) |
|
| Change from baseline at Month 12 (Role Limitation_Physical) |
|
| Change from baseline at Month 6 (Role Limitation_Emotional) |
|
| Change from baseline at Month 9 (Role Limitation_Emotional) |
|
| Change from baseline at Month 12 (Role Limitation_Emotional) |
|
| Change from baseline at Month 6 (Energy/Fatigue) |
|
| Change from baseline at Month 9 (Energy/Fatigue) |
|
| Change from baseline at Month 12 (Energy/Fatigue) |
|
| Change from baseline at Month 6 (Emotional well-being) |
|
| Change from baseline at Month 9 (Emotional well-being) |
|
| Change from baseline at Month 12 (Emotional well-being) |
|
| Change from baseline at Month 6 (Social Functioning) |
|
| Change from baseline at Month 9 (Social Functioning) |
|
| Change from baseline at Month 12 (Social Functioning) |
|
| Change from baseline at Month 6 (Pain) |
|
| Change from baseline at Month 9 (Pain) |
|
| Change from baseline at Month 12 (Pain) |
|
| Change from baseline at Month 6 (General Health) |
|
| Change from baseline at Month 9 (General Health) |
|
| Change from baseline at Month 12 (General Health) |
|