Knee Cartilage LesionsNCT07249489
Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada
A study testing Nanochon Chondrograft in people with Knee Cartilage Lesions, run by Nanochon, Inc. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Knee Cartilage Lesions
- What is being tested?
- Nanochon Chondrograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Orthopaedic Clinic
Toronto, Ontario
Jihad Abouali, MD, 416-546-7373, info@torontosportsdoc.com
Jihad Abouali, MD
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
Study Coordinator, 604-553-3247, manuja.annthakumar@fraserhealth.ca
Alex Hoffer, MD
About this study
Official title: 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.
- Conditions
- Knee Cartilage Lesions
- Being tested
- Nanochon Chondrograft
- Keywords
- Knee cartilage lesions, Medial femoral condyle lesion, Lateral femoral condyle lesion, Trochlea articular cartilage lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanochon ChondrograftDevice
Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft
| Study group | Role | What they receive |
|---|---|---|
| Nanochon Chondrograft | Experimental | Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft Receives: Device: Nanochon Chondrograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Event Effects
Absence of Serious Adverse Device Event Effects (SADEs) through Month 12
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Cartilage LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo a mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanochon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249489
- Sponsor's protocol ID
- 101-2024-CAN
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07249489
- Acronym / sponsor ID
- 101-2024-CAN
- Conditions
- Knee Cartilage Lesions
- Keywords
- Knee cartilage lesions, Medial femoral condyle lesion, Lateral femoral condyle lesion, Trochlea articular cartilage lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nanochon, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo a mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft
| Arm | Type | Receives |
|---|---|---|
| Nanochon Chondrograft | Experimental | Device: Nanochon ChondrograftMini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanochon ChondrograftMini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft | Device | Nanochon Chondrograft |
Primary outcome
Serious Adverse Device Event Effects
Time frame: Month 12
Absence of Serious Adverse Device Event Effects (SADEs) through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided. Undecided at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanochon Chondrograft in people with Knee Cartilage Lesions, run by Nanochon, Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Clinical Officer (615-483-7438, Heather@Nanochon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Device Event Effects (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.