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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Cartilage Lesions
• Intervention / Treatment: Device: Nanochon Chondrograft

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chief Clinical Officer; Phone Number: 615-483-7438; Email: Heather@Nanochon.com

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L OE4
      • Recruiting
      • Fraser Orthopaedic Institute
      • Principal Investigator: Parth Lodhia, MD
      • Contact: Study Coordinator; Phone Number: 604-553-3247; Email: kyrsten.butterfield@fraserhealth.ca
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • Recruiting
      • University of British Columbia
      • Contact: Study Coordinator; Phone Number: 604-553-3247; Email: manuja.annthakumar@fraserhealth.ca
      • Contact: Mansi Patel
      • Principal Investigator: Alex Hoffer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nanochon Chondrograft; Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft	Device: Nanochon Chondrograft; Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Device Event Effects	Absence of Serious Adverse Device Event Effects (SADEs) through Month 12	Month 12

Collaborators and Investigators

• Sponsor: Nanochon, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Knee cartilage lesions; Medial femoral condyle lesion; Lateral femoral condyle lesion; Trochlea articular cartilage lesion
• Other Study ID Numbers: 101-2024-CAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No