A Phase 1 interventional study of NCR100 in KOA, sponsored by Nuwacell Biotechnologies Co., Ltd.. Not yet recruiting. Open to male participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Nuwacell Biotechnologies Co., Ltd. · Phase 1, Interventional, and Treatment
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.
Nuwacell Biotechnologies Co., Ltd. is the lead sponsor of 9 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Subjects will receive a single injection of NCR100
Biological: NCR100
Subjects will receive a single injection of NCR100
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
Time frame: Day2, Day8,Day12,and Day22
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
Time frame: Within 96 weeks of the infusion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Nuwacell Biotechnologies Co., Ltd.