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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06049342
Recruitment Status : Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Shanghai 6th People's Hospital
Beijing Luhe Hospital
Information provided by (Responsible Party):
Nuwacell Biotechnologies Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: NCR100 injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: NCR100 injection
Cohort1:Low dose NCR100 injection; Cohort2:Mid-low dose NCR100 injection; Cohort3:Mid-high dose NCR100 injection; Cohort4:High dose NCR100 injection.
Biological: NCR100 injection
Subjects will receive a one-dose intra-articular NCR100 injection.

Primary Outcome Measures :
  1. Adverse Event(AE) or Serious Adverse Event(SAE) [ Time Frame: Week1,Week2,Week4 ]
    Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0

  2. Dose-Limiting Toxicity(DLT) [ Time Frame: 4 weeks after injection ]
    Number of participants with Dose-limiting toxicity in 28 days after injection

Secondary Outcome Measures :
  1. Maximum plasma concentration(Cmax) [ Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration ]
  2. Elimination half life of drug(T1/2) [ Time Frame: 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) [ Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration ]
  4. Area under the plasma concentration-time curve(AUC) [ Time Frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06049342

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Contact: Xiaowen Gong 15221195602

Sponsors and Collaborators
Nuwacell Biotechnologies Co., Ltd.
Shanghai 6th People's Hospital
Beijing Luhe Hospital
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Principal Investigator: Changqing Zhang Shanghai 6th People's Hospital
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Responsible Party: Nuwacell Biotechnologies Co., Ltd. Identifier: NCT06049342    
Other Study ID Numbers: NCR100-1001
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuwacell Biotechnologies Co., Ltd.:
Mesenchymal Stromal Cells
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases