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A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04368806
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Nature Cell Co. Ltd.

Study Description
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Brief Summary:
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: JointStem Other: Placebo Control Phase 2 Phase 3

Detailed Description:

Study Procedures:

  • Visit 1 (Week -7) - Screening
  • Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration)
  • Visit 3 (Week 0) - Treatment (Intra-articular injection)
  • Visit 4 (Week 4) - 4 weeks follow-up
  • Visit 5 (Week 12) - 12 weeks follow-up
  • Visit 6 (Week 24) - 24 weeks follow-up
  • Visit 7 (Week 36) - 36 weeks follow-up
  • Visit 8 (Week 48) - 48 weeks follow-up (End of Study)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)
 Drug: JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
Placebo Comparator: Placebo
Normal Saline with Autologous Serum
 Other: Placebo Control
Normal Saline with autologous Serum


Outcome Measures
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Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score [ Time Frame: Baseline and Week 48 ]
    Change from baseline in WOMAC function score at Week 48

  2. Visual Analog Scale (VAS) score [ Time Frame: Baseline and Week 48 ]
    Change from baseline on Visual Analog Scale (VAS) score at Week 48


Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function) [ Time Frame: Week 12, 24 and 36 ]
    Change from baseline in WOMAC subscale (Function) score at Week 12, 24, and 36

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Pain) [ Time Frame: Week 12, 24, 36, and 48 ]
    Change from baseline in WOMAC subscale (Pain) score at Week 12, 24, 36, and 48

  3. Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score [ Time Frame: Week 12, 24, 36, and 48 ]
    Change from baseline in total WOMAC score at Week 12, 24, 36, and 48

  4. Visual Analog Scale (VAS) score [ Time Frame: Week 12, 24 and 36 ]
    Change from baseline in VAS score at Week 12, 24 and 36

  5. International Knee Documentation Committee (IKDC) score [ Time Frame: Week 12, 24, 36, and 48 ]
    Change from baseline in IKDC score at Week 12, 24, 36, and 48

  6. 36-Item Short Form health survey questionnaires (SF-36) score [ Time Frame: Week12, 24, 36, and 48 ]
    Change from baseline in SF-36 score at Week 12, 24, 36, and 48

  7. Structural changes in knee joint [ Time Frame: Week 48 ]
    Change from baseline in structural changes to the knee joint determined by MRI at Week 48

  8. Kellgren-Lawrence grade [ Time Frame: Week 48 ]
    Change from baseline in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48

  9. Number and amount of rescue medication use [ Time Frame: Week 12, 24, 36, and 48 ]
    The number and amount of rescue medication use at Week 12, 24, 36, and 48


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)
  • Subject who has ≥ 34 on WOMAC function score at Screening and Baseline
  • Subject who has knee pain ≥ 50 mm out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline
  • Subject who has radiographic evidence of grade 3 osteoarthritis in one knee and grade 1 or 2 in the other knee based on the Kellgren and Lawrence radiographic criteria.
  • Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with non-operative treatment options
  • 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 is willing and able to give written informed consent for participation in the study

Exclusion Criteria:

  • Subject who has Body Mass Index (BMI) > 35 kg/m2
  • Subject who has any of following clinically significant disease or has a medical history of past
  • Uncontrolled comorbid disease under treatment
  • Kidney diseases (glomerulonephritis, chronic renal failure, etc.)
  • Liver diseases (acute and chronic liver diseases including fatty liver, liver cirrhosis, etc.)
  • Endocrine diseases (hypothyroidism/hyperthyroidism, thyroiditis, diabetes insipidus, Cushing's disease, etc.)
  • Subject who has any of following clinically significant disease
  • Autoimmune diseases
  • Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease
  • Genetic diseases (hyperkinesia, collagen gene abnormality, etc.)
  • Inflammatory joint disorders (e.g. rheumatoid inflammation)
  • Infectious joint disorders (e.g. septic arthritis)
  • Other joint disorders (e.g. gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis)
  • Subject who has a history of cancer or is diagnosed with cancer and currently receiving cancer treatment
  • Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis)
  • Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening
  • Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening
  • Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening
  • Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 12 months prior to Screening
  • Subject who has history of stem cell therapy

  • Subject who have significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):

    • Serum ALT and AST > 2 x upper limit of normal
    • Serum creatinine out of normal range
    • PT/INR out of normal range
    • Hemoglobin < 10 g/dL for female subject and hemoglobin < 11 g/dL for male subject
    • Platelets out of normal range
  • Subject for whom the investigator judges the lipoaspiration can cause any problem
  • Subject who has history of local anesthetic allergy
  • Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.)
  • Subject who is an active drug/alcohol abuser
  • Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method)
  • Subject who is enrolled in any other clinical trials within 3 months from Screening
  • Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368806


Contacts
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Contact: Hugh Lee 301-540-2600 hughlee@kcrnresearch.com
Contact: Christine Lee 301-540-2600 christinelee@kcrnresearch.com

Locations
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United States, California
TriWest Research Associates Recruiting
El Cajon, California, United States, 92020
Contact: Louis J. Levy Jr., M.D.    619-334-4735    llevy@triwestresearch.com   
Contact: David C. Ruiz, Phlebotomist    619-334-4735    dcampos@triwestresearch.com   
BioSolutions Clinical Research Center Recruiting
La Mesa, California, United States, 91942
Contact: Peter B. Hanson, M.D.    619-637-0770    drhanson@biosolutionresearch.com   
Contact: Tamara Packard, L.V.N.    619-637-0770    tamara@biosolutionresearch.com   
Source Healthcare Recruiting
Santa Monica, California, United States, 90403
Contact: Timothy T. Davis, M.D.    310-574-2777    tdavis@sourcehealthcare.com   
Contact: Afrida Sara, B.S.    310-574-2777    afridasara@g.ucla.edu   
United States, District of Columbia
International Spine Pain, and Performance Center Recruiting
Washington, District of Columbia, United States, 20006
Contact: Mehul Desai, M.D., M.P.H.    202-851-6845    drdesai@isppcenter.com   
Contact: Sidrah Sheikh, B.A.    202-808-8295    ssheikh@isppcenter.com   
United States, New Jersey
Rothman Orthopaedic Institute Not yet recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Bradford S. Tucker, M.D.    844-438-1354    bradford.tucker@rothmanortho.com   
Contact: Mitchee K. Freedman, D.O.    844-438-1354    lm5656@comcast.net   
United States, New York
Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Sabrina M. Strickland, M.D.    212-606-1000      
Contact: Connor F. Fletcher    212-606-1000    Cff43@cornell.edu   
Sponsors and Collaborators
Nature Cell Co. Ltd.
More Information
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Responsible Party: Nature Cell Co. Ltd.
ClinicalTrials.gov Identifier: NCT04368806    
Other Study ID Numbers: JS-OAP3-US01
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases