A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JointStem
Synvisc-One
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Subject who can give written informed consent
- Male or female of any race, aged 22-60
- Subject who had osteoarthritis of knee diagnosed at least six months prior to Screening
- Subject who has joint pain ≥ 40mm on VAS (Visual Analog Scale) at Screening
- Subject who has swelling, tenderness and active range of motion ≥ Grade I at Screening
- Subject who seeks invasive interventions of intra-articular injections
- Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study
- Subject who has radiographic evidence of grade 3 to 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
- Female subject who is neither pregnant nor lactating
- Subject who is able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
- Subject who has Body Mass Index (BMI) > 35 kg/m2
- Subject who has unstable knees
- Subject who took any NSAID within two weeks from Screening
- Subject who had any intra-articular injection therapy in any joint within 2 months from Screening
- Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial
- Subject who has inflammatory arthropathy (rheumatoid, psoriatic, or avascular necrosis), and post traumatic or septic arthritis
- Subject who has chondrocalcinosis, Paget's disease, Villonodular synovitis, and other non-OA joint diseases
- Subject who has HIV/viral hepatitis
- Subject who had knee surgery or radiation therapy in the affected joint within 6 months from Screening
- Subject who had CVA attack within 6 months from Screening
- Subject for whom the investigator judges the liposuction can cause any problem
- Subject who has significant lab abnormalities
- Subject who has history of local anesthetic allergy
- Subject who took immunosuppressants such as Cyclosporin A or azathioprine within 6 weeks from Screening
- (If a subject uses aspirin or plavix) Subject for whom it is determined that it would not be safe to stop the aspirin/plavix therapy for 2 weeks prior to Visit 2
- Subject who uses anticoagulants which cannot be stopped or corrected
- Subject who had oral or intra-muscular corticosteroids within 30 days from Visit 2
- Subject who had intra-articular corticosteroid injection in any joint within 30 days from Visit 2
- Subject who had intra-articular hyaluronic acid injection within 30 days from Visit 2
- Subject who has known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations or gram positive proteins
- Subject who has knee joint infections or skin diseases or infections in the area of the injection site
- Subject who has known systemic bleeding disorders
- Subject who is an active drug/EtOH abuser
- Subject who was enrolled in any other clinical trials within 2 months from Screening
- Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above
- Subject whose MRI scan results at screening do not demonstrate any sign of cartilage damage
Sites / Locations
- Orthopedic Pain Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
JointStem
Synvisc-One
Arm Description
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
hyaluronic acid
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
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
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.
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
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
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
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
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
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.
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.
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
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
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
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
Full Information
NCT ID
NCT02674399
First Posted
February 2, 2016
Last Updated
August 7, 2021
Sponsor
Nature Cell Co. Ltd.
Collaborators
KCRN Research, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02674399
Brief Title
A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Official Title
A Phase 2, Double-Blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Treatment of Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 16, 2016 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nature Cell Co. Ltd.
Collaborators
KCRN Research, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JointStem
Arm Type
Experimental
Arm Description
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
Arm Title
Synvisc-One
Arm Type
Active Comparator
Arm Description
hyaluronic acid
Intervention Type
Drug
Intervention Name(s)
JointStem
Intervention Type
Drug
Intervention Name(s)
Synvisc-One
Other Intervention Name(s)
Active Comparator
Primary Outcome Measure Information:
Title
Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group
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
Title
Change From Baseline on Visual Analog Scale (VAS) in JointStem Group
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
Title
MRI Improvement Evaluation in JointStem Group
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
Secondary Outcome Measure Information:
Title
Change From Baseline on WOMAC Between JointStem and Positive Control Groups
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
Title
Change From Baseline on VAS Between JointStem and Positive Control Groups
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
Title
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
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
Title
Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups
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
Title
Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups
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
Title
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
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
Title
Change From Baseline on WOMAC in JointStem Group
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
Title
Change From Baseline on VAS in JointStem Group
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
Title
Comparison of MRI Improvement Evaluation in JointStem Group
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
Title
Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
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
Title
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
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
Title
Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
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
Title
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject who can give written informed consent
Male or female of any race, aged 22-60
Subject who had osteoarthritis of knee diagnosed at least six months prior to Screening
Subject who has joint pain ≥ 40mm on VAS (Visual Analog Scale) at Screening
Subject who has swelling, tenderness and active range of motion ≥ Grade I at Screening
Subject who seeks invasive interventions of intra-articular injections
Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study
Subject who has radiographic evidence of grade 3 to 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
Female subject who is neither pregnant nor lactating
Subject who is able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
Subject who has Body Mass Index (BMI) > 35 kg/m2
Subject who has unstable knees
Subject who took any NSAID within two weeks from Screening
Subject who had any intra-articular injection therapy in any joint within 2 months from Screening
Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial
Subject who has inflammatory arthropathy (rheumatoid, psoriatic, or avascular necrosis), and post traumatic or septic arthritis
Subject who has chondrocalcinosis, Paget's disease, Villonodular synovitis, and other non-OA joint diseases
Subject who has HIV/viral hepatitis
Subject who had knee surgery or radiation therapy in the affected joint within 6 months from Screening
Subject who had CVA attack within 6 months from Screening
Subject for whom the investigator judges the liposuction can cause any problem
Subject who has significant lab abnormalities
Subject who has history of local anesthetic allergy
Subject who took immunosuppressants such as Cyclosporin A or azathioprine within 6 weeks from Screening
(If a subject uses aspirin or plavix) Subject for whom it is determined that it would not be safe to stop the aspirin/plavix therapy for 2 weeks prior to Visit 2
Subject who uses anticoagulants which cannot be stopped or corrected
Subject who had oral or intra-muscular corticosteroids within 30 days from Visit 2
Subject who had intra-articular corticosteroid injection in any joint within 30 days from Visit 2
Subject who had intra-articular hyaluronic acid injection within 30 days from Visit 2
Subject who has known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations or gram positive proteins
Subject who has knee joint infections or skin diseases or infections in the area of the injection site
Subject who has known systemic bleeding disorders
Subject who is an active drug/EtOH abuser
Subject who was enrolled in any other clinical trials within 2 months from Screening
Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above
Subject whose MRI scan results at screening do not demonstrate any sign of cartilage damage
Facility Information:
Facility Name
Orthopedic Pain Specialists
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
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