CClinicalTrials.gg
Not yet recruitingNCT07139431DistributionUpdated Aug 24, 2025

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

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

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
40 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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 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.

02

Conditions studied

  • KOA

Keywords

  • MSC, KOA
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    NCR100 injection

    Subjects will receive a single injection of NCR100

    Biological: NCR100

Interventions

  • BiologicalNCR100

    Subjects will receive a single injection of NCR100

06

What researchers measure

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

    Time frame: Day2, Day8,Day12,and Day22

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07139431
Lead sponsor
Nuwacell Biotechnologies Co., Ltd.
Responsible party
Sponsor
First posted
Aug 24, 2025
Start date
Aug 29, 2025 (estimated)
Primary completion
Mar 6, 2026 (estimated)
Completion
Apr 21, 2028 (estimated)
Last update
Aug 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion