Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical study is to evaluate the biodistribution of [89Zr]-Oxine-NCR100 injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of zirconium-labeled cells at the injection site and various organs or tissues. It is a single-dose, open-label study in adult KOA subjects.
Knee osteoarthritis(KOA) is a kind of degenerative joint disease characterized by chronic inflammation loss of articular cartilage and subchondral bone remodeling. This clinical trial aims to evaluate the biodistribution of 89Zr-labeled human pluripotent stem cell derived mesenchymal stromal cells ([89Zr]-Oxine-NCR100) injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of the zirconium-labeled cells at the injection site and in various organs or tissues.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCR100 injection | Experimental | Subjects will receive a single injection of NCR100 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCR100 | Biological | Subjects will receive a single injection of NCR100 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Standardized Uptake Values (SUV) and %ID | The SUV and %ID of the injection site and various organs or tissues after PET/CT imaging examination after local injection of [89Zr]-Oxine-NCR100 injection in subjects with knee osteoarthritis | Day2, Day8,Day12,and Day22 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(AE) or Serious Adverse Event(SAE) | Number of participants with treatment-related adverse events or serious adverse events assessed by CTCAE v5.0 | Within 96 weeks of the infusion |
Not provided
Inclusion Criteria:
Subjects with KOA who have persistent pain for more than six months, Kellgren-Lawrence grade: II-III; McMaster University's Osteoarthritis Index (WOMAC) of the study-side knee joint: 60-180.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided