Back to resultsFollow-up Study for Participants of Jointstem Investigator Initiated Trial by Arthroscopy
Primary Purpose
Degenerative Arthritis, Knee Arthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
JOINTSTEM
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Arthritis focused on measuring Stem cell, Adipose tissue derived mesenchymal stem cell, Osteoarthritis, degenerative arthritis, long term, Biostar, Rbio
Eligibility Criteria
Inclusion Criteria:
- Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1)
- Participants who signed informed consent document of this study
Exclusion Criteria:
- No applicable
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Long Term Follow-up after Jointstem Transplantation
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of adverse events from baseline to 60 months
Secondary Outcome Measures
Adverse Events (Special Attention Target)
Incidence of adverse events(special attention target: malicious tumor, autoimmune disease) from baseline to 60 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04825730
Brief Title
Follow-up Study for Participants of Jointstem Investigator Initiated Trial by Arthroscopy
Official Title
Long-Term Extension Study of Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy in Patients With K-L Grade III Knee Osteoarthritis After 『JOINTSTEM』 Administration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (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
This clinical trial is conducted to assess the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.
Detailed Description
JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
This clinical trial is planned to follow-up the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.
Subjects who participate in the BS-JS-IIT1 study and agree to this extension test in writing will be assessed for safety by conducting laboratory tests, vital signs, physical examinations and adverse events every 12 months after Visit 1.
However, after unblinding of the BS-JS-IIT1 investigator initiated trial, subjects in the control group (placebo administration) will terminate the follow-up of this extended clinical trial and conduct routine treatment for degenerative knee arthritis at the discretion of the researcher. Appropriate measures and follow-up observations shall be implemented for abnormal reactions occurred during this extended test period until they are terminated (such as the loss of the relevant adverse event or inability to conduct follow-up investigations).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Arthritis, Knee Arthritis
Keywords
Stem cell, Adipose tissue derived mesenchymal stem cell, Osteoarthritis, degenerative arthritis, long term, Biostar, Rbio
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Long Term Follow-up after Jointstem Transplantation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JOINTSTEM
Other Intervention Name(s)
autologous adipose-derived mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events from baseline to 60 months
Time Frame
60 Month
Secondary Outcome Measure Information:
Title
Adverse Events (Special Attention Target)
Description
Incidence of adverse events(special attention target: malicious tumor, autoimmune disease) from baseline to 60 months
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1)
Participants who signed informed consent document of this study
Exclusion Criteria:
No applicable
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Follow-up Study for Participants of Jointstem Investigator Initiated Trial by Arthroscopy
We'll reach out to this number within 24 hrs