Not yet recruiting NCT06013306
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study
Primary outcome measures
- Number of AESI [Time frame: 5 years follow-up after treatment]
- Number of SS [Time frame: 5 years follow-up after treatment]
Secondary outcome measures (7)
- Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Changes in 100-mm VAS [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Changes in International Knee Documentation Committee Scoring System (IKDC) [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Evaluation of International K&L grade(X-ray) [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI) [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) score [Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06013306 · K0701-E