Knee Osteoarthritis Clinical Trial
Official title:
Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ⅱb Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
NCT number | NCT02658344 |
Other study ID # | Jointstem2b |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | December 2016 |
Verified date | June 2019 |
Source | R-Bio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 and older, male and female 2. Patients must consent in writing to participate in the study by signing and dating an informed consent document 3. Diagnosis of osteoarthritis by ACR osteoarthritis of the knee 4. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4 5. More than Grade 4 (0~10 point numeric scale) pain at least for 12 weeks 6. Diagnosis of osteoarthritis of class ?~? by ACR(American College of Rheumatology Criteria) Global functional criteria 7. Patient who agree with contraception Exclusion Criteria: 1. Preparing for Pregnancy or Pregnant women or lactating mothers. 2. Patients with Body Mass Index (BMI) > 35. 3. Patients with other disease including : Septic arthritis, Rheumatoid or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder 4. Patients with serious condition internal medicine disease 5. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection. 6. Patient with behavioral disorders, cognitive disorders and chronic mental symptoms 7. Patient with significant neurologic or psychiatric disorders 8. Patients who alcohol, drug abuse history 9. Patients who had participated in other clinical trials within 12 weeks prior to this study. 10. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment. 11. Patients who experienced as the knee joint cartilage and stem cell therapy 12. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above 13. Patients who penicillin hypersensitivity reactions - |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | GangNam Severance Hospital | Seoul | |
Korea, Republic of | KyungHee University Gangdong Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
R-Bio |
Korea, Republic of,
Lee WS, Kim HJ, Kim KI, Kim GB, Jin W. Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial. Stem Cells Transl Med. 2019 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WOMAC score | Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC) | 24 weeks | |
Secondary | WOMAC 3 subscale | Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC) | 24 weeks | |
Secondary | KOOS (Knee Injury & Osteoarthritis Outcome Score) | Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS) | 24 weeks | |
Secondary | SF(Short Form)-36 Score | The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health. | 24 weeks | |
Secondary | Global assessment of disease activity | Change From Baseline in Patient's & Physician's Global Assessment of Disease Activity Score at 12,24 weeks by 100mm VAS(Visual Analogue Scale) | 24 weeks | |
Secondary | Overall satisfaction | Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale) | 24 weeks | |
Secondary | X-ray | X-ray perform to measure with Kellgren-Lawrence grade | 24 weeks | |
Secondary | MRI scan | MRI perform to measure cartilage defect size change from baseline up to 24weeks | 24 weeks | |
Secondary | Arthroscopy evaluation | Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection | 24 weeks | |
Secondary | Histological evaluation | Biopsy specimens subject to safranin-O staining and immunohistochemistry for type I and II collagen. Thickness of the articular cartilage before and after injection measure, and specimens evaluate with ICRS(International Cartilage Repair Society) II by a blind histopathologist. | 24 weeks | |
Secondary | VAS | Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS) | 24 weeks | |
Secondary | IKDC | Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC) | 24 weeks | |
Secondary | ROM | change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination | 24 weeks | |
Secondary | Quadriceps power | Change from baseline in quadriceps power at 12,24 weeks by physical examination | 24 weeks | |
Secondary | effusion | Change from baseline in 4-grade knee effusion at 12,24 weeks | 24 weeks | |
Secondary | Crepitus | Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination | 24 weeks | |
Secondary | Ligament laxity | Change from baseline in ligament laxity at 12,24 weeks by physical examination | 24 weeks | |
Secondary | Medial joint line tenderness | Change from baseline in 4-grade(none, mild, moderate, severe) medial joint line tenderness at 12,24 weeks by physical examination | 24 weeks | |
Secondary | Pes tenderness | Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination | 24 weeks |
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