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

• Sponsor: Nature Cell Co. Ltd.
• Collaborator: KCRN Research, LLC
• Information provided by (Responsible Party): Nature Cell Co. Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Drug: JointStem; Drug: Synvisc-One	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Actual Study Start Date :	February 16, 2016
Actual Primary Completion Date :	March 12, 2018
Estimated Study Completion Date :	March 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: JointStem; autologous adipose tissue derived mesenchymal stem cells (AdMSC)	Drug: JointStem
Active Comparator: Synvisc-One; hyaluronic acid	Drug: Synvisc-One; Other Name: Active Comparator

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. MRI Improvement Evaluation in JointStem group [ Time Frame: 6 months ]
   Comparing the baseline and 6-month MRI improvement values in JointStem group

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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

Other Outcome Measures:

1. 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

Eligibility Criteria

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Ages Eligible for Study:	22 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Locations

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United States, California
Orthopedic Pain Specialists
Santa Monica, California, United States, 90404
Walnut Creek, California, United States, 94598

Sponsors and Collaborators

Nature Cell Co. Ltd.

KCRN Research, LLC

Investigators

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Study Director:	Hugh Lee, MS	KCRN Research

More Information

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Responsible Party:	Nature Cell Co. Ltd.
ClinicalTrials.gov Identifier:	NCT02674399 History of Changes
Other Study ID Numbers:	JS-OAP2-US01
First Posted:	February 4, 2016
Last Update Posted:	August 21, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases	Rheumatic Diseases; Hylan; Viscosupplements; Protective Agents; Physiological Effects of Drugs