Knee Osteoarthritis
Conditions
Keywords
FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell
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
Interventions
None listed
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Event, AESI(Adverse Event of Special Interest) | 5 years follow-up after treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
South Korea
Contacts
CONTACTMoonkyoung Kim
CONTACTYeonsil Yu
PRINCIPAL_INVESTIGATORKyoung Ho Yoon, professor (CI)
Kyung Hee University Hospital
PRINCIPAL_INVESTIGATORSang Hak Lee, professor
Gangdong Kyunghee University Hospital
PRINCIPAL_INVESTIGATORJang Ki Mo, professor
Korea University Anam Hospital
PRINCIPAL_INVESTIGATORSang Gyun Kim, professor
National medical center
PRINCIPAL_INVESTIGATORSeok jung Kim, professor
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
PRINCIPAL_INVESTIGATORJae Young Park, professor
CHA University Bundang Medical Center
PRINCIPAL_INVESTIGATORSung Hwan Kim, professor
Severance Hospital, Yonsei University College of Medicine
Outcome results
None listed