Knee Arthritis Clinical Trial
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
Verified date | September 2022 |
Source | R-Bio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
R-Bio |
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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