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Completed

NCT Number: NCT03509025

Follow-up Study for Participants Jointstem Clinical Trial

This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GangNam Severance Hospital, Seoul, 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

  • Patients must consent in writing to participate in the study by signing and dating an informed consent document
  • Patients who transplanted Jointstem on phase 2b clinical trial

Exclusion criteria

  • Preparing for Pregnancy or Pregnant women or lactating mothers.
  • Patients who the principal investigator considers inappropriate for the clinical tria

Treatment and study plan

JointStem

Drug

JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

Other names: autologous adipose-derived mesenchymal stem cells

Primary outcomes

  1. Adverse Events

    Time frame: 60 months

    Incidence of adverse events from baseline to 60 months

Secondary outcomes

  1. WOMAC score

    Time frame: Baseline and 12 months

    Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score

  2. WOMAC 3 subscale score

    Time frame: Baseline and 12 months

    Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score

  3. X-ray

    Time frame: Baseline and 12 months

    X-ray perform to measure with Kellgren-Lawrence grade

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Registry information

Official study title

Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2018
Registry last updated
Sep 28, 2022

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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