Nanochon chondrograft for knee cartilage lesions in adults 22–60

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human feasibility study to assess safety of the Nanochon Chondrograft implant as a primary surgical treatment for knee cartilage lesions. Eligible participants are adults 22 to 60 with MRI-confirmed knee cartilage lesions, evaluated in English or Spanish. The study is conducted at The Panama Clinic in Panama City and is sponsored by Nanochon, Inc. The trial focuses on safety outcomes and may provide information on implant performance in the knee joint.

Why it matters

Who can join: the full rules

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 and/or Spanish
* 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 it's running

• The Panama Clinic
  Panama City, Provincia de Panamá, Panama Recruiting

Study contacts

• Study coordinator: Chief Clinical Officer
• Email: Heather@Nanochon.com
• Phone: 615-483-7438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.