None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : - Experimental(Jointstem) : Autologous Adipose Tissue derived MSCs
- Placebo comparator(Saline solution) : Sodium chloride 9mg/ml
Sponsors
R-bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18 or 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(American College of Rheumatology Criteria) 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
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, Rheumatoidal 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 aclcohol, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC(Western Ontario and McMaster Universities ) score | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC(Western Ontario and McMaster Universities ) 3 subscale;KOOS (Knee Injury & Osteoarthritis Outcome Score);SF(Short Form)-36 Score;Global assessment of disease activity;Overall satisfaction;ROM(Range of Motion);Quadriceps power;Effusion;Crepitus;Ligament laxity;Medial joint line tenderness;Pes tenderness;MRI sacn;Arthroscopy evaluation;Histological evaluation;VAS(Visual Analogue Scale);IKDC(International Knee Documentation Committee) | — |
Countries
Korea, Republic of
Contacts
Public ContactKIM KANGIL
Kyung Hee University Hosipital at Gangdong
Outcome results
None listed