Follow-up Study for Participants Jointstem Clinical Trial
Phase 2
Completed
- Conditions
- Knee Osteoarthritis
- Interventions
- Drug: Jointstem
- Registration Number
- NCT03509025
- Lead Sponsor
- R-Bio
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long Term Follow-up after Jointstem Transplantation Jointstem -
- Primary Outcome Measures
Name Time Method Adverse Events 60 months Incidence of adverse events from baseline to 60 months
- Secondary Outcome Measures
Name Time Method 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
WOMAC score Baseline and 12 months Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
Trial Locations
- Locations (2)
GangNam Severance Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Gangdong Hospital
🇰🇷Seoul, Korea, Republic of