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

NCT ID: NCT07249489

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nanochon Chondrograft

Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Group Type: EXPERIMENTAL

Nanochon Chondrograft

Intervention Type: DEVICE

Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Interventions

Nanochon Chondrograft

Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanochon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fraser Orthopaedic Institute

New Westminster, British Columbia, Canada

Countries

Canada

Central Contacts

Chief Clinical Officer

Role: CONTACT

Phone: 615-483-7438

Email: Heather@Nanochon.com

Facility Contacts

Study Coordinator

Role: primary

Other Identifiers

101-2024-CAN

Identifier Type: -

Identifier Source: org_study_id