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

Study Description

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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 45 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the database will be locked and the blinding will be open for the statistical analysis. Subjects will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).

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
Estimated Primary Completion Date :	September 2017
Estimated Study Completion Date :	March 2018

Arms and Interventions

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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

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Primary Outcome Measures :

1. Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score in JointStem group [ Time Frame: Baseline and 6 months ]
2. Change from baseline on VAS (Visual Analog Scale) in JointStem group [ Time Frame: Baseline and 6 months ]
3. MRI Improvement Evaluation in JointStem group [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Change from baseline on WOMAC between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
2. Change from baseline on VAS (Visual Analog Scale) between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
3. Change from baseline on KOOS (Knee Injury & Osteoarthritis Outcome Score) between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
4. Change from baseline on Lysholm Knee Scoring Scale between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
5. Change from baseline on IKDC (International Knee Documentation Committee) between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
6. Change from baseline on RAND-36 Score between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
7. Change from baseline on WOMAC in JointStem group [ Time Frame: Baseline, 9 months and 12 months ]
8. Change from baseline on VAS (Visual Analog Scale) in JointStem group [ Time Frame: Baseline, 9 months and 12 months ]
9. Comparison of MRI improvement evaluation in JointStem group [ Time Frame: Baseline, 6 months and 12 months ]
10. Change from baseline on KOOS in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
11. Change from baseline on Lysholm Knee Scoring Scale in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
12. Change from baseline on IKDC in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
13. Change from baseline on RAND-36 Score in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
14. Incidence of adverse events and laboratory abnormalities [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 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

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Locations

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

Study Director:	Hugh Lee, MS	KCRN Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 29, 2017
Last Verified:	August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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