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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06013306

Enrollment

Registered

2023-08-28

Start date

2023-09-14

Completion date

2030-12-30

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of AESI	5 years follow-up after treatment
Number of SS	5 years follow-up after treatment

Secondary

Measure	Time frame	Description
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
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.
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.
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
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.

Contacts

Primary ContactChaeeun JEON

cejeon@kangstem.com02-2036-7614

Backup ContactHyeseung JEON

hsjeon@kangstem.com02-888-1592

Outcome results