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

NCT02674399 | Completed Phase 2 Results

• 1 other identifier: JS-OAP2-US01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline and 6 months

• 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.

  Baseline and 6 months

• 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.

  6 months

Secondary Outcomes (13)

• Change From Baseline on WOMAC Between JointStem and Positive Control Groups

  Baseline and 6 months

• Change From Baseline on VAS Between JointStem and Positive Control Groups

  Baseline and 6 months

• Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups

  Baseline and 6 months

• Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups

  Baseline and 6 months

• Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups

  Baseline and 6 months

Study Arms (2)

JointStem

EXPERIMENTAL

autologous adipose tissue derived mesenchymal stem cells (AdMSC)

Drug: JointStem

Synvisc-One

ACTIVE COMPARATOR

hyaluronic acid

Drug: Synvisc-One

Interventions

JointStem DRUG

JointStem

Synvisc-One DRUG

Also known as: Active Comparator

Synvisc-One

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nature Cell Co. Ltd.: lead
• KCRN Research, LLC: collaborator

Study Sites (2)

Orthopedic Pain Specialists

Santa Monica, California, 90404, United States

Location

Unknown Facility

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

hylan

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Project Manager
• Organization: Nature Cell co., ltd

tin50@stemcellbio.com

02-545-4137

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 4, 2016
• Study Start: February 16, 2016
• Primary Completion: March 12, 2018
• Study Completion: December 28, 2018
• Last Updated: August 10, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Locations

US (2)