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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04825730

Enrollment

Registered

2021-04-01

Start date

2023-12-01

Completion date

2029-12-31

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Arthritis, Knee Arthritis

Keywords

Stem cell, Adipose tissue derived mesenchymal stem cell, Osteoarthritis, degenerative arthritis, long term, Biostar, Rbio

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).

Interventions

DRUGJOINTSTEM

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No applicable

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	60 Month	Incidence of adverse events from baseline to 60 months

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026