First human use of the Nanochon Chondrograft knee implant in Canada
A First in Human (FIH) Early Feasibility Study (EFS) to Evaluate the Safety and Performance of the Nanochon Chondrograft™ Implant for Re-surfacing of Cartilage Lesions
This study will test if the Nanochon Chondrograft implant is a safe surgical option for adults aged 22–60 who have focal knee cartilage lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years to 60 Years |
| Sex | All |
| Sponsor | Nanochon, Inc. Industry-sponsored |
| Locations | 2 sites (New Westminster, British Columbia and 1 other locations) |
| Trial ID | NCT07249489 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, single-arm surgical study implanting the Nanochon Chondrograft into focal cartilage lesions of the femoral condyles or trochlea. Eligible adults (22–60 years) must have a recent knee MRI and be able to consent and communicate in English. Participants will undergo the implant procedure at one of two British Columbia centers and be followed postoperatively for safety and clinical outcomes. Key exclusions include systemic bone or cartilage disorders, bilateral knee surgery needs, recent systemic steroids, insulin-dependent diabetes, pregnancy, active litigation or compensation claims, and significant comorbid illness limiting 12‑month survival.
Who should consider this trial
Good fit: Adults aged 22–60 with a single focal cartilage lesion of the medial or lateral femoral condyle or trochlea, able to undergo MRI and surgery, and able to read and speak English are the intended candidates.
Not a fit: Patients with systemic cartilage or bone disorders, those requiring bilateral knee surgery, insulin-dependent diabetes, recent steroid use, pregnancy, active litigation/workers' compensation or severe comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the implant could offer a new surgical option to repair focal knee cartilage defects and potentially reduce pain and improve function.
How similar studies have performed: While other cartilage repair approaches (e.g., matrix-based chondrocyte implants and osteochondral grafts) have shown variable success, this Nanochon Chondrograft represents a novel first-in-human application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Westminster, British Columbia and 1 other locations
- Fraser Orthopaedic Institute — New Westminster, British Columbia, Canada (Recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Chief Clinical Officer
- Email: Heather@Nanochon.com
- Phone: 615-483-7438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.