Knee Osteoarthritis
Conditions
Brief summary
The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.
Interventions
BIOLOGICALJOINTSTEM
Autologous Adipose Tissue derived MSCs
Sponsors
R-Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants of Jointstem Phase 3 Clinical Trial * Participates who signed informed consent document of this study
Exclusion criteria
* No applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 5 Years | Incidence of adverse events from baseline to 5 Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC 3 subscale score | 5 Years | Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC) |
| SF-36 | 5 Years | The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health. |
| Measuring of Kellgren-Lawrence grade | 1, 2, 3, 4, 5 Years | Measuring of Kellgren-Lawrence grade through X-ray |
| Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline | 5 Years | Pain, stiffness, and physical function of the knee will be measured by the WOMAC score |
| Measuring of Hip-Knee-Ankle angle(HKA) | 1, 2, 3, 4, 5 Years | Measureing of HKA through X-ray |
| Measuring of Joint Space Width | 1, 2, 3, 4, 5 Years | measuring Joint Space Width through X-ray |
| MRI scan | 1, 2, 3, 4, 5 Years | The cartilage defect area is measured using MRI |
| Measuring of Femoro-tibial anatomical angle(FTA) | 1, 2, 3, 4, 5 Years | Measuring of FTA through X-ray |
Countries
South Korea
Outcome results
None listed