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

NCT06049342 | Unknown Phase 1

• 1 other identifier: NCR100-1001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

KOA; Mesenchymal Stromal Cells

Outcome Measures

Primary Outcomes (2)

• 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

  Week1,Week2,Week4

• Dose-Limiting Toxicity(DLT)

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

  4 weeks after injection

Secondary Outcomes (4)

• Maximum plasma concentration(Cmax)

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

• Elimination half life of drug(T1/2)

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

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

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

• Area under the plasma concentration-time curve(AUC)

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

Study Arms (1)

NCR100 injection

EXPERIMENTAL

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

Interventions

NCR100 injection BIOLOGICAL

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

NCR100 injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nuwacell Biotechnologies Co., Ltd.: lead
• Shanghai 6th People's Hospital: collaborator
• Beijing Luhe Hospital: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Changqing Zhang

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Gong

CONTACT

15221195602; xwgong@nuwacell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: January 25, 2024
• Primary Completion: June 1, 2024
• Study Completion: May 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share