- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427930
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
-
-
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Daegu, Korea, Republic of, 42601
- Keimyung University Dongsan Medical Center
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Korea, Republic of, 06273
- Gangnam Severance Hospital
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Seoul, Korea, Republic of, 05278
- KyungHee University Gangdong Hospital
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-
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
|
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
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Measuring of Kellgren-Lawrence grade through X-ray
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1, 2, 3, 4, 5 Years
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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
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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
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1, 2, 3, 4, 5 Years
|
MRI scan
Time Frame: 1, 2, 3, 4, 5 Years
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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
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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R-BioCompleted
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R-BioCompletedDegenerative ArthritisKorea, Republic of
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R-BioCompletedKnee Osteoarthritis | Degenerative ArthritisKorea, Republic of
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Nature Cell Co. Ltd.KCRN Research, LLCCompletedOsteoarthritis, KneeUnited States
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R-BioCompletedKnee Osteoarthritis | Degenerative ArthritisKorea, Republic of