A Study of [89Zr]-Oxine-NCR100 Injection for the Cellular Distribution

NCT07139431 | Not Yet Recruiting Phase 1

• 1 other identifier: NCR100-1003
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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 zirconium-labeled cells at the injection site and various organs or tissues. It is a single-dose, open-label study in adult KOA subjects.

Conditions

KOA

Keywords

MSC, KOA

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Adverse Event(AE) or Serious Adverse Event(SAE)

  Within 96 weeks of the infusion

Study Arms (1)

NCR100 injection

EXPERIMENTAL

Subjects will receive a single injection of NCR100

Biological: NCR100

Interventions

NCR100 BIOLOGICAL

Subjects will receive a single injection of NCR100

NCR100 injection

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuwacell Biotechnologies Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: August 29, 2025
• Primary Completion: March 6, 2026
• Study Completion (Estimated): April 21, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share