Status:
NOT_YET_RECRUITING
A Study of [89Zr]-Oxine-NCR100 Injection for the Cellular Distribution
Lead Sponsor:
Nuwacell Biotechnologies Co., Ltd.
Conditions:
KOA
Eligibility:
MALE
40-70 years
Phase:
PHASE1
Brief Summary
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 zirconi...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before enrolment; Age: 40-70 years old, both genders; Men without reproductive intentions; Diagnosis of knee osteoarthritis based on American College of Rheumatology 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
- Subjects previously diagnosed with secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention; Subjects previously diagnosed with secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention; Have received stem cell therapy; Experienced knee surgery, or plan to undergo knee surgery; Have used traditional Chinese medicine to treat KOA within 4 weeks; Have used intra-articular injection of drugs to treat KOA within 12 weeks; Received glucosamine, chondroitin sulfate, or diacetate therapy before investigational drug intervention within 12 weeks; Subjects with the acute phase of knee osteoarthritis; severe deformity of the knee; BMI≥30kg/m\^2; Severe systemic infection or local knee joint infection; Have received systemic glucocorticoid therapy before intervention or need to take systemic glucocorticoid therapy during the treatment; Have serious heart disease； Subjects with peripheral or central nervous system disorders that may interfere with assessments; Have contraindications to Magnetic Resonance Imaging(MRI); Subjects with alcohol/drug addiction/abuse or mental disorders; Have participated in other clinical trials within 12 weeks before the screening; Subjects with infection with hepatitis B virus(HBV), hepatitis C virus(HCV), HIV, and Treponema pallidum confirmed by laboratory tests; Subjects with a history of allergic reaction to any component of the trial drug or to acetaminophen; Subjects who are not suitable for PET/CT examination.
Key Trial Info
Start Date :
August 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2028
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT07139431
Start Date
August 29 2025
End Date
April 21 2028
Last Update
August 24 2025
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