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KOAPhase 1DistributionNCT07139431

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

A Phase 1 study testing NCR100 in people with KOA, run by Nuwacell Biotechnologies Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
KOA
What is being tested?
NCR100
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
29 Aug 2025to 21 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: A Study to Evaluate the Cellular Distribution of [89Zr]-Oxine-NCR100 Injection in the Treatment of Subjects With Knee Osteoarthritis

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.

Conditions
KOA
Being tested
NCR100
Keywords
MSC, KOA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NCR100Biological

    Subjects will receive a single injection of NCR100

Study groups in NCT07139431
Study groupRoleWhat they receive
NCR100 injectionExperimentalSubjects will receive a single injection of NCR100
Receives: Biological: NCR100

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day2, Day8,Day12,and Day22

Secondary outcomes (1)

  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

    Measured: Within 96 weeks of the infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2025
  2. Study start29 Aug 2025 (estimated)
  3. Primary completion6 Mar 2026 (estimated)
  4. Study completion21 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139431
Sponsor's protocol ID
NCR100-1003
Acronym
Distribution
Status last verified
Aug 2025
First submitted
17 Aug 2025
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NCR100 in people with KOA, run by Nuwacell Biotechnologies Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Standardized Uptake Values (SUV) and %ID (time frame: Day2, Day8,Day12,and Day22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07139431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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