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

Nanochon, Inc.

Status: Enrolling

Conditions: Knee Cartilage Lesions

Treatments: Device: Nanochon Chondrograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT07249489

101-2024-CAN

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 22 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Nanochon Chondrograft

Experimental group

Description:

Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft

Treatment:

Device: Nanochon Chondrograft