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Recruiting Not applicable NCT07249489

Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada

No applicable phase (e.g. observational)
Conditions: Knee Cartilage Lesions

Sponsor: Nanochon, Inc.

trial.available_in: БГ
Overview
The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee. This study will include males and females between the ages of 22 and 60.
Who can participate
Inclusion Criteria: * Male or female ≥22 years and ≤ 60 years of age * MRI knee evaluation completed within 6 months prior to enrollment * Participant must be able to read and speak English * Participant must voluntarily sign the REB approved informed consent form (ICF) Exclusion Criteria: * Any known systemic cartilage and/or bone disorder, such as, but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta * Requires bilateral knee surgery * Pregnancy, planning to become pregnant or breast feeding * Any significant illness (metastasis cancer of any type) that decreases the probability of the participant's survival to 12 months * Known insulin dependent diabetes mellitus * Steroid treatment (oral or IV) within the past 6 months * Participant is: 1. receiving workman's compensation 2. receiving prescription narcotic medication 3. active with litigation relating to musculoskeletal injuries or disorders 4. a prisoner or pending incarceration * Comorbidities that could impact study participation or results (e.g., autoimmune disorder, HIV, neuropathic pain or fibromyalgia, restless leg syndrome, active infection, or pain requiring chronic pain management), in the opinion of the investigator at the time of enrollment * Significant psychiatric disorders (e.g., major depression, anxiety disorders, bipolar disorder, and schizophrenia) * Substance and/or alcohol dependence and/or abuse based on clinical history, physical exam and participant presentation * Current participation in another drug or device study that, in the opinion of the investigator at the time of enrollment, would interfere with participation in this study * Participant has claustrophobia or implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI * Known allergy or hypersensitivity to any investigational device materials.
Interventions
Nanochon Chondrograft
DEVICE
Locations 2
Canada (2)
Fraser Orthopaedic Institute
New Westminster , British Columbia
University of British Columbia
Vancouver , British Columbia
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
22 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.08.2027
Registry ID
NCT07249489
Source
clinicaltrials.gov
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