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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 : Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
Nature Cell Co. Ltd.

Tracking Information
First Submitted Date  ICMJE February 2, 2016
First Posted Date  ICMJE February 4, 2016
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE February 16, 2016
Actual Primary Completion Date March 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Change from baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) score in JointStem group [ Time Frame: Baseline and 6 months ]
    Comparing the baseline and 6-month WOMAC scores in JointStem group
  • Change from baseline on Visual Analog Scale (VAS) in JointStem group [ Time Frame: Baseline and 6 months ]
    Comparing the baseline and 6-month VAS scores in JointStem group
  • MRI Improvement Evaluation in JointStem group [ Time Frame: 6 months ]
    Comparing the baseline and 6-month MRI improvement values in JointStem group
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
Change from Baseline on MRI scan results [ Time Frame: Baseline and 6 months ]
Change History Complete list of historical versions of study NCT02674399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Change from baseline on WOMAC between JointStem and positive control groups [ Time Frame: Baseline and 6 months ]
    Comparing the changes of WOMAC scores between JointStem and positive control groups at 6 months
  • Change from baseline on VAS between JointStem and positive control groups [ Time Frame: Baseline and 6 months ]
    Comparing the changes of VAS scores between JointStem and positive control groups at 6 months
  • Change from baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) between JointStem and positive control groups [ Time Frame: Baseline and 6 months ]
    Comparing the changes of KOOS values between JointStem and positive control groups at 6 months
  • Change from baseline on Lysholm Knee Scoring Scale between JointStem and positive control groups [ Time Frame: Baseline and 6 months ]
    Comparing the changes of Lysholm Knee Scoring Scales between JointStem and positive control groups at 6 months
  • Change from baseline on International Knee Documentation Committee (IKDC) between JointStem and positive control groups [ Time Frame: Baseline and 6 months ]
    Comparing the changes of IKDC scores between JointStem and positive control groups at 6 months
  • Change from baseline on RAND-36 Score between JointStem and positive control groups [ Time Frame: Baseline and 6 months ]
    Comparing the changes of RAND-36 scores between JointStem and positive control groups at 6 months
  • Change from baseline on WOMAC in JointStem group [ Time Frame: Baseline, 9 months and 12 months ]
    Comparing the baseline and 9-month/12-month WOMAC scores in JointStem group
  • Change from baseline on VAS in JointStem group [ Time Frame: Baseline, 9 months and 12 months ]
    Comparing the baseline and 9-month/12-month VAS scores in JointStem group
  • Comparison of MRI improvement evaluation in JointStem group [ Time Frame: Baseline, 6 months and 12 months ]
    Comparing the baseline and 9-month/12-month MRI improvement values in JointStem group
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months ]
    Comparing safety values between JointStem and positive groups
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score [ Time Frame: Baseline, 1 month, 3 months and 6 months ]
  • Change from baseline on VAS (Visual Analog Scale) [ Time Frame: Baseline, 1 month, 3 months and 6 months ]
  • Change from baseline on KOOS (Knee Injury & Osteoarthritis Outcome Score) [ Time Frame: Baseline, 1 month, 3 months and 6 months ]
  • Change from baseline on Lysholm Knee Scoring Scale [ Time Frame: Baseline, 1 month, 3 months and 6 months ]
  • Change from baseline on IKDC (International Knee Documentation Committee [ Time Frame: Baseline, 1 month, 3 months and 6 months ]
  • Change from baseline on RAND-36 Score [ Time Frame: Baseline, 3 months and 6 months ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Baseline, 1 month, 3 months and 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: August 17, 2018)
Analysis of all efficacy scales and MRI results and the history of treatments and medications [ Time Frame: 24 months ]
Analyzing efficacy and safety variables at 24 months
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: JointStem
  • Drug: Synvisc-One
    Other Name: Active Comparator
Study Arms  ICMJE
  • Experimental: JointStem
    autologous adipose tissue derived mesenchymal stem cells (AdMSC)
    Intervention: Drug: JointStem
  • Active Comparator: Synvisc-One
    hyaluronic acid
    Intervention: Drug: Synvisc-One
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 28, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
45
Estimated Study Completion Date  ICMJE May 2019
Actual Primary Completion Date March 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02674399
Other Study ID Numbers  ICMJE JS-OAP2-US01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nature Cell Co. Ltd.
Study Sponsor  ICMJE Nature Cell Co. Ltd.
Collaborators  ICMJE KCRN Research, LLC
Investigators  ICMJE
Study Director: Hugh Lee, MS KCRN Research
PRS Account Nature Cell Co. Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP