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

Sponsor

R-Bio (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04825730

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis Knee Arthritis	Drug: JOINTSTEM	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long Term Follow-up after Jointstem Transplantation	Drug: JOINTSTEM 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. Other Names: autologous adipose-derived mesenchymal stem cells

Arm

Intervention/Treatment

Experimental: Long Term Follow-up after Jointstem Transplantation

Drug: JOINTSTEM

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.

Other Names:

autologous adipose-derived mesenchymal stem cells

Outcome Measures

Primary Outcome Measures

Adverse Events [60 Month]
Incidence of adverse events from baseline to 60 months

Secondary Outcome Measures

Adverse Events (Special Attention Target) [60 months]
Incidence of adverse events(special attention target: malicious tumor, autoimmune disease) from baseline to 60 months