Knee Osteoarthritis
Conditions
Brief summary
This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.
Interventions
DRUGJointstem
JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
Sponsors
R-Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must consent in writing to participate in the study by signing and dating an informed consent document * Patients who transplanted Jointstem on phase 2b clinical trial
Exclusion criteria
* Preparing for Pregnancy or Pregnant women or lactating mothers. * Patients who the principal investigator considers inappropriate for the clinical tria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 60 months | Incidence of adverse events from baseline to 60 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC score | Baseline and 12 months | Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score |
| WOMAC 3 subscale score | Baseline and 12 months | Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score |
| X-ray | Baseline and 12 months | X-ray perform to measure with Kellgren-Lawrence grade |
Countries
South Korea
Outcome results
None listed