Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
Study Details
Study Description
Brief Summary
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Number of AESI [5 years follow-up after treatment]
- Number of SS [5 years follow-up after treatment]
Secondary Outcome Measures
- Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
The higher the score, the worse the condition of the disease is.
- Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.
- Changes in 100-mm VAS [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Changes in International Knee Documentation Committee Scoring System (IKDC) [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
A higher score indicates better function and less symptomatic
- Evaluation of International K&L grade(X-ray) [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI) [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
A higher score indicates better function and less symptomatic
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) score [1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
The higher the score means normal state.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
-
Those who understand and voluntarily sign an informed consent form
exclusion criteria
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kang Stem Biotech Co., Ltd.
Investigators
- Principal Investigator: Kyoung-Ho Yoon, professor (CI), Kyung Hee University Hospital
- Principal Investigator: Sang Hak Lee, professor, Gangdong Kyunghee University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K0701-E