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Knee OsteoarthritisPhase 1NCR100NCT06049342

A Trial to Evaluate the Safety, Tolerability, and Efficacy of NCR100 Injection in the Treatment of Subjects With KOA

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It is a dose-escalating, open label study in adult KOA subjects. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
NCR100 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
25 Jan 2024to May 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before the enrolment;
  • Age: 40-80 years old, both genders;
  • Diagnosis of knee osteoarthritis based on American College of Rheumatology criteria;
  • Subjects with KOA who have persistent pain for more than six months, or aggravation or recurrence of osteoarthritis after routine medication;
  • Kellgren-Lawrence grade: II-III;
  • McMaster Universities Osteoarthritis Index (WOMAC): 24-72.

Who cannot join

  • Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention;
  • Subjects who suffering from other diseases that cause damage to knee joint function or affect joints;
  • Subjects who have received allogeneic mesenchymal progenitor (stem/stromal) cell therapy;
  • Subjects who have history of knee joint injury;
  • Subjects who have undergone knee arthroscopic surgery;
  • Subjects who received painkillers ( eg,opioids/nonsteroidal anti-inflammatory analgesics ) to treat knee osteoarthritis;
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  • Subjects who have orally taken traditional Chinese medicine;
  • Subjects who have received intra-articular drug injection to treat knee osteoarthritis;
  • Subjects with glucosamine, chondroitin sulfate, or diacetate therapy before investigational drug intervention
  • Subjects with acute reactive knee osteoarthritis;
  • Severe eversion deformity in target knee joint;
  • Known or suspected allergy or a history of allergies;
  • Subjects with abnormal results of laboratory examination: Hepatic Insufficiency (ALT > 2xULN or Aspartate aminotransferase（AST） > 2xULN), renal dysfunction (creatinine clearance rate ≤60ml/min or blood urea nitrogen(BUN) > 2× ULN), Coagulation Defects (INR > 1.5) or severe hematological diseases (Grade 3 or above anemia Hb < 8 g/dL, Grade 2 or above thrombocytopenia platelet count(PLT) < 75×10^9/L) ;
  • BMI≥30 kg/m^2 ;
  • Severe systemic infection or local knee joint infection;
  • Subjects who have received systemic glucocorticoid therapy before intervention or need to take systemic glucocorticoid therapy during the treatment;
  • Subjects who have history of acute myocardial infarction or with heart diseases e.g.uncontrolled angina pectoris, uncontrolled arrhythmias, severe heart failure (NYHA > III), QT prolongation, and are determined by investigators as not suitable to participate in this clinical trial;
  • Subjects with peripheral or central nervous system disorders that may interfere with knee joint pain and functional assessment,
  • Subjects who have contraindications to MRI;
  • Subjects who have poor physical condition and are unable to walk autonomously;
  • Subjects with alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
  • Subjects with infection with hepatitis B virus(HBV), hepatitis C virus(HCV), HIV, and treponema pallidum confirmed by laboratory tests;
  • Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;
  • Subjects who have participated in other clinical trials and have used other study products;
  • Subjects with severe and poorly controlled comorbidities and not suitable for this clinical trial;
  • Subjects who are not suitable for this clinical trial for other reasons.

Trial locations and contacts

No sites are listed yet.

Xiaowen Gong contact

15221195602

xwgong@nuwacell.com

About this study

Official title: A Phase I, Open Label, Single Arm, Multiple Center, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells (NCR100) Injection in the Treatment of Subjects With Knee Osteoarthritis

This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It is a dose-escalating, open label study in adult KOA subjects.

Read the detailed description

Knee osteoarthritis (KOA) is a kind of degenerative joint disease and there are over 300 million cases worldwide. The aim of this clinical trial is to evaluate the safety, tolerability, and efficacy of human pluripotent stem cell derived mesenchymal stromal cells (NCR100) injection in the treatment of subjects with knee osteoarthritis.

Being tested
NCR100 injection
Keywords
KOA, Mesenchymal Stromal Cells
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • NCR100 injectionBiological

    Subjects will receive a one-dose intra-articular NCR100 injection.

Study groups in NCT06049342
Study groupRoleWhat they receive
NCR100 injectionExperimentalCohort1:Low dose NCR100 injection; Cohort2:Mid-low dose NCR100 injection; Cohort3:Mid-high dose NCR100 injection; Cohort4:High dose NCR100 injection.
Receives: Biological: NCR100 injection

What is being measured

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

  1. Adverse Event(AE) or Serious Adverse Event(SAE)

    Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0

    Measured: Week1,Week2,Week4

  2. Dose-Limiting Toxicity(DLT)

    Number of participants with Dose-limiting toxicity in 28 days after injection

    Measured: 4 weeks after injection

Secondary outcomes (4)

  1. Maximum plasma concentration(Cmax)

    Measured: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration

  2. Elimination half life of drug(T1/2)

    Measured: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration

  3. Time after doing at which maximun plasma concentration is reached(Tmax)

    Measured: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration

  4. Area under the plasma concentration-time curve(AUC)

    Measured: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration

Timeline

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

  1. First posted22 Sep 2023
  2. Study start25 Jan 2024 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionMay 2025 (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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06049342
Sponsor's protocol ID
NCR100-1001
Acronym
NCR100
Status last verified
Jan 2024
First submitted
6 Sep 2023
Last updated
19 Jan 2024
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 injection in people with Knee Osteoarthritis, 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 6 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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?

Results are not available in the source record.

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

Contact Xiaowen Gong (15221195602, xwgong@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event(AE) or Serious Adverse Event(SAE) (time frame: Week1,Week2,Week4). The study lists 2 primary outcomes in all. 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 NCT06049342.

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 19 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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