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

July 7, 2023 updated by: R-Bio

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 05278
        • KyungHee University Gangdong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JOINTSTEM
Long Term Follow-up after Jointstem Transplantation
Biological: JOINTSTEM
Autologous Adipose Tissue derived MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 5 Years
Incidence of adverse events from baseline to 5 Years
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 Years
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)
5 Years
SF-36
Time Frame: 5 Years
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
5 Years
Measuring of Kellgren-Lawrence grade
Time Frame: 1, 2, 3, 4, 5 Years
Measuring of Kellgren-Lawrence grade through X-ray
1, 2, 3, 4, 5 Years
Measuring of Femoro-tibial anatomical angle(FTA)
Time Frame: 1, 2, 3, 4, 5 Years
Measuring of FTA through X-ray
1, 2, 3, 4, 5 Years
Measuring of Hip-Knee-Ankle angle(HKA)
Time Frame: 1, 2, 3, 4, 5 Years
Measureing of HKA through X-ray
1, 2, 3, 4, 5 Years
Measuring of Joint Space Width
Time Frame: 1, 2, 3, 4, 5 Years
measuring Joint Space Width through X-ray
1, 2, 3, 4, 5 Years
MRI scan
Time Frame: 1, 2, 3, 4, 5 Years
The cartilage defect area is measured using MRI
1, 2, 3, 4, 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Bio

Investigators

  • Principal Investigator: KANGIL KIM, KyungHee University Gangdong Hospital
  • Principal Investigator: WOOSUK LEE, Gangnam Severance Hospital
  • Principal Investigator: KICHEOR BAE, Keimyung University Dongsan Medical Center
  • Principal Investigator: YONG IN, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2020

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSR-CTph3-JS1_FU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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