A Study of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）

NCT06741098 | Not Yet Recruiting Phase 1

• 1 other identifier: NCR100-1002
• Study Type: interventional
• Target: 162
• 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 contains two parts dose-escalating, and blind random study in adult KOA subjects.

Conditions

Knee Osteoarthritis

Keywords

KOA; Mesenchymal Stromal Cells

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity(DLT)

  Number of participants with Dose-limiting toxicity in 28 days

  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

  48 weeks after first injection

Secondary Outcomes (4)

• Adverse Event(AE) or Serious Adverse Event(SAE)

  Within 48 weeks of the first infusion

• Visual analogue scale (VAS)

  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

  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

  24 weeks and 48 weeks

Study Arms (3)

NCR100 injection

EXPERIMENTAL

Subjects will receive four injections of NCR100

Biological: NCR100

0.9% Normal saline

PLACEBO COMPARATOR

Subjects will receive four injections of 0.9% Normal saline

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

Biological: NCR100; Other: 0.9% Normal saline

Interventions

NCR100 BIOLOGICAL

Subjects will receive multiple intra-articular NCR100 injections.

NCR100 injection; NCR100 injection and 0.9% Normal saline

0.9% Normal saline OTHER

Subjects will receive multiple intra-articular 0.9% Normal saline injections.

0.9% Normal saline; NCR100 injection and 0.9% Normal saline

Eligibility Criteria

• Age: 40 Years - 65 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: 40-65 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

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

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yanqiu Li, PHD

CONTACT

021-64369181; yqli@nuwacell.com

Changqing 021-64369181, PHD

CONTACT

021-64369181

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 15, 2028
• Last Updated: December 18, 2024

Record last verified: 2024-12