Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study

Knee Osteoarthritis Clinical Trial

Official title:

Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06013306
• Other study ID #: K0701-E
• Status: Not yet recruiting
• Start date: September 14, 2023
• Est. completion date: December 30, 2030

Study information

• Verified date: August 2023
• Source: Kang Stem Biotech Co., Ltd.
• Contact: Chaeeun JEON
• Phone: 02-2036-7614
• Email: cejeon[@]kangstem.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 30, 2030
• Est. primary completion date: November 7, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of AESI		5 years follow-up after treatment
Primary	Number of SS		5 years follow-up after treatment
Secondary	Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)	The higher the score, the worse the condition of the disease is.	1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Secondary	Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)	The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.	1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Secondary	Changes in 100-mm VAS		1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Secondary	Changes in International Knee Documentation Committee Scoring System (IKDC)	A higher score indicates better function and less symptomatic	1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Secondary	Evaluation of International K&L grade(X-ray)	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	1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Secondary	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)	A higher score indicates better function and less symptomatic	1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Secondary	Whole-Organ Magnetic Resonance Imaging Score (WORMS) score	The higher the score means normal state.	1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment