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Active, Not Recruiting

NCT Number: NCT04427930

Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial

The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Keimyung University Dongsan Medical Center, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants of Jointstem Phase 3 Clinical Trial
  • Participates who signed informed consent document of this study

Exclusion criteria

  • No applicable

Treatment and study plan

JOINTSTEM

Biological

Autologous Adipose Tissue derived MSCs

Primary outcomes

  1. Adverse Events

    Time frame: 5 Years

    Incidence of adverse events from baseline to 5 Years

Secondary outcomes

  1. Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline

    Time frame: 5 Years

    Pain, stiffness, and physical function of the knee will be measured by the WOMAC score

  2. WOMAC 3 subscale score

    Time frame: 5 Years

    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

  3. SF-36

    Time frame: 5 Years

    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

  4. Measuring of Kellgren-Lawrence grade

    Time frame: 1, 2, 3, 4, 5 Years

    Measuring of Kellgren-Lawrence grade through X-ray

  5. Measuring of Femoro-tibial anatomical angle(FTA)

    Time frame: 1, 2, 3, 4, 5 Years

    Measuring of FTA through X-ray

  6. Measuring of Hip-Knee-Ankle angle(HKA)

    Time frame: 1, 2, 3, 4, 5 Years

    Measureing of HKA through X-ray

  7. Measuring of Joint Space Width

    Time frame: 1, 2, 3, 4, 5 Years

    measuring Joint Space Width through X-ray

  8. MRI scan

    Time frame: 1, 2, 3, 4, 5 Years

    The cartilage defect area is measured using MRI

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Registry information

Official study title

Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2020
Registry last updated
Jul 10, 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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