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

Not Applicable

Not yet recruiting

• Conditions: Degenerative Arthritis; Knee Arthritis
• Interventions: Drug: JOINTSTEM

• Registration Number: NCT04825730
• Lead Sponsor: R-Bio

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).

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• Study Start: 2023-12-01
• Primary Completion: 2028-12-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1)
• Participants who signed informed consent document of this study

Exclusion Criteria

• No applicable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long Term Follow-up after Jointstem Transplantation	JOINTSTEM	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	60 Month	Incidence of adverse events from baseline to 60 months

Secondary Outcome Measures

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