Back to resultsFollow-up Study for Participants of Jointstem Phase 3 Clinical Trial
Primary Purpose
Knee Osteoarthritis
Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JOINTSTEM
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Participants of Jointstem Phase 3 Clinical Trial
- Participates who signed informed consent document of this study
Exclusion Criteria:
- No applicable
Sites / Locations
- Keimyung University Dongsan Medical Center
- KyungHee University Gangdong Hospital
- Gangnam Severance Hospital
- The Catholic University of Korea, Seoul ST. Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JOINTSTEM
Arm Description
Long Term Follow-up after Jointstem Transplantation
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of adverse events from baseline to 5 Years
Secondary Outcome Measures
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
Pain, stiffness, and physical function of the knee will be measured by the WOMAC score
WOMAC 3 subscale score
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
SF-36
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Measuring of Kellgren-Lawrence grade
Measuring of Kellgren-Lawrence grade through X-ray
Measuring of Femoro-tibial anatomical angle(FTA)
Measuring of FTA through X-ray
Measuring of Hip-Knee-Ankle angle(HKA)
Measureing of HKA through X-ray
Measuring of Joint Space Width
measuring Joint Space Width through X-ray
MRI scan
The cartilage defect area is measured using MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04427930
Brief Title
Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
December 23, 2026 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JOINTSTEM
Arm Type
Experimental
Arm Description
Long Term Follow-up after Jointstem Transplantation
Intervention Type
Biological
Intervention Name(s)
JOINTSTEM
Intervention Description
Autologous Adipose Tissue derived MSCs
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events from baseline to 5 Years
Time Frame
5 Years
Secondary Outcome Measure Information:
Title
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
Description
Pain, stiffness, and physical function of the knee will be measured by the WOMAC score
Time Frame
5 Years
Title
WOMAC 3 subscale score
Description
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time Frame
5 Years
Title
SF-36
Description
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Time Frame
5 Years
Title
Measuring of Kellgren-Lawrence grade
Description
Measuring of Kellgren-Lawrence grade through X-ray
Time Frame
1, 2, 3, 4, 5 Years
Title
Measuring of Femoro-tibial anatomical angle(FTA)
Description
Measuring of FTA through X-ray
Time Frame
1, 2, 3, 4, 5 Years
Title
Measuring of Hip-Knee-Ankle angle(HKA)
Description
Measureing of HKA through X-ray
Time Frame
1, 2, 3, 4, 5 Years
Title
Measuring of Joint Space Width
Description
measuring Joint Space Width through X-ray
Time Frame
1, 2, 3, 4, 5 Years
Title
MRI scan
Description
The cartilage defect area is measured using MRI
Time Frame
1, 2, 3, 4, 5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants of Jointstem Phase 3 Clinical Trial
Participates who signed informed consent document of this study
Exclusion Criteria:
No applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KANGIL KIM
Organizational Affiliation
KyungHee University Gangdong Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
WOOSUK LEE
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KICHEOR BAE
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YONG IN
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
KyungHee University Gangdong Hospital
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial
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