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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04825730
Other study ID # BS-JS-IIT1-FU
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2029

Study information

Verified date September 2022
Source R-Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 14
Est. completion date December 31, 2029
Est. primary completion date December 1, 2028
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
R-Bio

Outcome

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