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NCT Number: NCT06013306

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of AESI

    Time frame: 5 years follow-up after treatment

  2. Number of SS

    Time frame: 5 years follow-up after treatment

Secondary outcomes

  1. 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

    The higher the score, the worse the condition of the disease is.

  2. 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

    The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.

  3. Changes in 100-mm VAS

    Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment

  4. 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

    A higher score indicates better function and less symptomatic

  5. 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

    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

  6. 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

    A higher score indicates better function and less symptomatic

  7. 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

    The higher the score means normal state.

Study contacts

Contact information is provided by the study sponsor or research team.

Chaeeun JEON

CONTACT

[email protected]

02-2036-7614

Hyeseung JEON

CONTACT

[email protected]

02-888-1592

Sponsors and collaborators

Lead sponsor

Kang Stem Biotech Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Aug 28, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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