NCT07754175RecruitingNot Applicable
A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial
Kang Stem Biotech Co., Ltd.2 sites in 1 country36 target enrollmentStarted: July 20, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Incidence of Adverse Event, AESI(Adverse Event of Special Interest)
Study Overview
Brief Summary
A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who received placebo in the K0701 clinical trial and completed the Long-term follow-up study
- •Participants who voluntarily provide written informed consent to participate in this extension study
Exclusion Criteria
- •Participants meeting any of the following criteria:
- •Participants whom the investigator considers unsuitable for participation in this extension study.
- •Pregnant or breastfeeding women, and women of childbearing potential or men who do not agree to use an appropriate method of contraception during the study
Outcomes
Primary Outcomes
Incidence of Adverse Event, AESI(Adverse Event of Special Interest)
Time Frame: 5 years follow-up after treatment
Secondary Outcomes
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)(Month 12, Month 24 after treatment)
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) score(Month 12, Month 24 after treatment)
- Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Changes in 100-mm VAS(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Changes in International Knee Documentation Committee Scoring System (IKDC)(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Evaluation of International K&L grade(X-ray)(Month 12, Month 24 after treatment)
Investigators
Study Sites (2)
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