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

NCT07249489 | Recruiting DMC

• 1 other identifier: 101-2024-CAN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Knee Cartilage Lesions

Keywords

Knee cartilage lesions; Medial femoral condyle lesion; Lateral femoral condyle lesion; Trochlea articular cartilage lesion

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Device Event Effects

  Absence of Serious Adverse Device Event Effects (SADEs) through Month 12

  Month 12

Study Arms (1)

Nanochon Chondrograft

EXPERIMENTAL

Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Device: Nanochon Chondrograft

Interventions

Nanochon Chondrograft DEVICE

Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Nanochon Chondrograft

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• receiving workman's compensation
• receiving prescription narcotic medication
• active with litigation relating to musculoskeletal injuries or disorders
• 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

Sponsors & Collaborators

• Nanochon, Inc.: lead

Study Sites (2)

Fraser Orthopaedic Institute

New Westminster, British Columbia, V3L OE4, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

RECRUITING

Central Study Contacts

Chief Clinical Officer

CONTACT

615-483-7438; Heather@Nanochon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will undergo a mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CA (2)