Follow-up Study for Participants of Jointstem Investigator Initiated Trial by Arthroscopy

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Knee Arthritis, Degenerative Arthritis

Intervention / Treatment
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* Drug: JOINTSTEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1) Participants who signed informed consent document of this study Exclusion Criteria: No applicable

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long Term Follow-up after Jointstem Transplantation<br> | Drug: JOINTSTEM<br>* 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.<br>* Other names: autologous adipose-derived mesenchymal stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of adverse events from baseline to 60 months | 60 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (Special Attention Target) | Incidence of adverse events(special attention target: malicious tumor, autoimmune disease) from baseline to 60 months | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell, Adipose tissue derived mesenchymal stem cell, Osteoarthritis, degenerative arthritis, long term, Biostar, Rbio