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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT06049342
• Date of registration: 06/09/2023
• Prospective Registration: Yes
• Primary sponsor: Nuwacell Biotechnologies Co., Ltd.
• Public title: A Trial to Evaluate the Safety, Tolerability, and Efficacy of NCR100 Injection in the Treatment of Subjects With KOA NCR100
• Scientific 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
• Date of first enrolment: January 25, 2024
• Target sample size: 12
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT06049342
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Contacts

• Name: Changqing Zhang
• Affiliation: Shanghai 6th People's Hospital

• Name: Xiaowen Gong

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;

- 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Knee Osteoarthritis

Intervention(s)

Biological: NCR100 injection

Primary Outcome(s)

Adverse Event(AE) or Serious Adverse Event(SAE) [Time Frame: Week1,Week2,Week4]

Dose-Limiting Toxicity(DLT) [Time Frame: 4 weeks after injection]

Secondary Outcome(s)

Elimination half life of drug(T1/2) [Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration]

Area under the plasma concentration-time curve(AUC) [Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration]

Maximum plasma concentration(Cmax) [Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration]

Time after doing at which maximun plasma concentration is reached(Tmax) [Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration]

Secondary ID(s)

NCR100-1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing Luhe Hospital

Shanghai 6th People's Hospital