Knee OsteoarthritisPhase 1/2NCT06741098
A Study of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）
A Phase 1/2 study testing NCR100 and 0.9% Normal saline in people with Knee Osteoarthritis, run by Nuwacell Biotechnologies Co., Ltd..
Trial summary
This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random study in adult KOA subjects. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- NCR100 and 0.9% Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2025to 15 Nov 2028
- Phase
- Phase 1/2
- 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 65 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: 40-65 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
- Kellgren-Lawrence grade: II-III
Who cannot join
- Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention;
- Suffering from other diseases that impair knee function or joints;
- Have received stem cell therapy;
- Have knee injury history;
- Experienced knee surgery, or plan to undergo knee surgery;
- Received analgesics to relieve pain before Investigational Medicinal Product(IMP) injections;
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- 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 acute phase of knee osteoarthritis;
- Severe deformity of the knee;
- Known or suspected allergy or a history of allergies;
- Abnormal results of laboratory examination as follows: Hepatic Insufficiency （Alanine Aminotransferase>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≥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 a history of acute myocardial infarction or severe heart diseases,QT prolongation;
- Subjects with peripheral or central nervous system disorders that may interfere assessments;
- Have contraindications to Magnetic Resonance Imaging(MRI)
- Subjects who are unable to walk on his own;
- Subjects with alcohol/drug addiction/abuse or mental disorders;
- Pregnant or lactating, or unable to comply with contraceptives within 6 months after end of study;
- Have participated in other clinical trials within 12 weeks before the screening;
- Severe and poorly controlled comorbidities;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Changqing 021-64369181, PHD contact
About this study
Official title: A Study to Evaluate the Safety, Tolerability and Efficacy of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）
This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random 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.In China, the estimated number of patients diagnosed with KOA reached 37.35millon. The aim of this sudy 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- NCR100, 0.9% Normal saline
- 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.
NCR100Biological
Subjects will receive multiple intra-articular NCR100 injections.
0.9% Normal salineOther
Subjects will receive multiple intra-articular 0.9% Normal saline injections.
| Study group | Role | What they receive |
|---|---|---|
| NCR100 injection | Experimental | Subjects will receive four injections of NCR100 Receives: Biological: NCR100 |
| 0.9% Normal saline | Placebo comparator | Subjects will receive four injections of 0.9% Normal saline Receives: Other: 0.9% Normal saline |
| NCR100 injection and 0.9% Normal saline | Experimental | Subjects will receive two injections of 0.9% Normal saline and two injections of NCR100 Receives: Biological: NCR100; Other: 0.9% Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days
Measured: 4 weeks after first injection
The Western Ontario and McMaster Universities osteoarthritis index(WOMAC)
Differences of WOMAC scores in changes from baseline between the experimental group and the control group
Measured: 48 weeks after first injection
Secondary outcomes (4)
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 48 weeks of the first infusion
Visual analogue scale (VAS)
Differences in changes from baseline between experimental groups and the control group.
Measured: 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Differences in changes from baseline at 8 weeks, 12 weeks, 24 weeks and 36 weeks of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between the experimental groups and the control group
WOMAC scores include three subscale scores (pain, stiffness, and physical function)
Measured: 8 weeks, 12 weeks, 24 weeks and 36 weeks
Differences in changes from baseline to 24 weeks and 48 weeks in cartilages with various regions
Magnetic resonance imaging (MRI) is used to scan images of knees.
Measured: 24 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Feb 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 6th People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741098
- Sponsor's protocol ID
- NCR100-1002
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability and Efficacy of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）
- ClinicalTrials.gov ID
- NCT06741098
- Acronym / sponsor ID
- NCR100-1002
- Conditions
- Knee Osteoarthritis
- Keywords
- KOA, Mesenchymal Stromal Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random study in adult KOA subjects.
Detailed description
Knee osteoarthritis(KOA) is a kind of degenerative joint disease characterized by chronic inflammation loss of articular cartilage and subchondral bone remodeling.In China, the estimated number of patients diagnosed with KOA reached 37.35millon. The aim of this sudy 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NCR100 injection | Experimental | Biological: NCR100Subjects will receive four injections of NCR100 |
| 0.9% Normal saline | Placebo comparator | Other: 0.9% Normal salineSubjects will receive four injections of 0.9% Normal saline |
| NCR100 injection and 0.9% Normal saline | Experimental | Biological: NCR100, Other: 0.9% Normal salineSubjects will receive two injections of 0.9% Normal saline and two injections of NCR100 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before the enrolment;
- Age: 40-65 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
- Kellgren-Lawrence grade: II-III
Key exclusion criteria (24 listed)
- Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention;
- Suffering from other diseases that impair knee function or joints;
- Have received stem cell therapy;
- Have knee injury history;
- Experienced knee surgery, or plan to undergo knee surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCR100Subjects will receive multiple intra-articular NCR100 injections. | Biological | NCR100 injection, NCR100 injection and 0.9% Normal saline |
| 0.9% Normal salineSubjects will receive multiple intra-articular 0.9% Normal saline injections. | Other | 0.9% Normal saline, NCR100 injection and 0.9% Normal saline |
Primary outcome
Dose-Limiting Toxicity(DLT)
Time frame: 4 weeks after first injection
Number of participants with Dose-limiting toxicity in 28 days
The Western Ontario and McMaster Universities osteoarthritis index(WOMAC)
Time frame: 48 weeks after first injection
Differences of WOMAC scores in changes from baseline between the experimental group and the control group
4 secondary outcomes
Adverse Event(AE) or Serious Adverse Event(SAE)
Time frame: Within 48 weeks of the first infusion
Visual analogue scale (VAS)
Time frame: 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Differences in changes from baseline at 8 weeks, 12 weeks, 24 weeks and 36 weeks of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between the experimental groups and the control group
Time frame: 8 weeks, 12 weeks, 24 weeks and 36 weeks
Differences in changes from baseline to 24 weeks and 48 weeks in cartilages with various regions
Time frame: 24 weeks and 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changqing 021-64369181, PHD contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NCR100 and 0.9% Normal saline 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 5 inclusion and 24 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 18 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Yanqiu Li, PHD (021-64369181, yqli@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity(DLT) (time frame: 4 weeks after first injection). 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?
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 18 Dec 2024.