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Implant

Agili-C™ Implant for Knee Joint Problems

N/A
Waitlist Available
Led By Elizaveta Kon, MD
Research Sponsored by Cartiheal (2009) Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 21-75 years
Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
Must not have
Known insulin dependent diabetes mellitus
Any known history of inflammatory arthropathy or crystal-deposition arthropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative until 2 years postoperatively
Awards & highlights

Summary

This trial is testing the Agili-C implant, which helps repair damaged knee joints. It targets patients with various types of knee damage, including cartilage issues and mild to moderate osteoarthritis. The implant works by supporting and promoting the growth of new, healthy tissue in the knee. Agili-C™ is designed to support the knee's structure and function, helping to repair cartilage and bone.

Who is the study for?
This trial is for adults aged 21-75 with knee joint surface lesions or mild to moderate osteoarthritis, who haven't improved with physical therapy. Participants must be able to follow post-op rehab and attend check-ups. Exclusions include severe systemic diseases, certain medications, extreme pain levels, deep bony defects, other knee cartilage issues, obesity (BMI > 35), recent chemo or surgery in the affected knee.
What is being tested?
The study compares the Agili-C implant's effectiveness and safety against standard surgical care for various knee joint surface lesions. It includes patients with focal cartilage damage or early-stage osteoarthritis and assesses how well they recover after treatment.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical surgical complications such as infection risk at the implant site, inflammation around the area of surgery, allergic reactions to implant materials like calcium carbonate or hyaluronate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 75 years old.
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I have painful skin areas totaling 1-7 cm2.
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I have up to 3 severe knee joint surface lesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes and need insulin.
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I have a history of joint inflammation or crystal buildup in my joints.
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I had a meniscal transplant within the last 6 months.
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I have a tumor in my knee.
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I have had an infection in my knee joint or bone.
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My knee's cushioning is mostly gone, but a small part remains.
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My bone defect is deeper than 8mm as shown by an MRI, X-ray, or arthroscopy.
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My knee cartilage damage is severe (grade IVa or higher).
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My knee is significantly unstable, rated as abnormal or severely abnormal.
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I do not have any known bone or cartilage disorders like osteoporosis.
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I have not had knee surgery for cartilage issues in the last 6 months.
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I do not have a history of significant diseases like HIV or hepatitis.
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My lesion is not fully enclosed by a thick bone wall.
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My knee arthritis is severe, as per the Kellgren-Lawrence scale.
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I have not had chemotherapy in the last 12 months.
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My knee bends inward or outward more than 8 degrees.
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My knee pain score is either below 20 or above 65.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative until 2 years postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative until 2 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
KOOS Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Agili-CExperimental Treatment1 Intervention
Group II: Surgical Standard of Care (SSOC)Active Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for osteochondral defects include microfracture surgery, autologous chondrocyte implantation (ACI), and osteochondral autograft transplantation (OAT). Microfracture surgery involves creating small fractures in the underlying bone to stimulate the formation of new cartilage. ACI involves harvesting a patient's own cartilage cells, culturing them, and re-implanting them into the defect. OAT involves transplanting healthy cartilage and bone from a non-weight-bearing area to the defect site. These treatments aim to restore the cartilage surface, reduce pain, and improve joint function. The Agili-C implant, a regenerative cartilage implant, works similarly by promoting the repair of joint surface lesions, which is crucial for patients as it can potentially provide a more durable and effective solution for cartilage regeneration and joint function restoration.

Find a Location

Who is running the clinical trial?

Cartiheal (2009) LtdLead Sponsor
3 Previous Clinical Trials
228 Total Patients Enrolled
1 Trials studying Osteoarthritis
20 Patients Enrolled for Osteoarthritis
Elizaveta Kon, MDPrincipal InvestigatorIstituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
9 Previous Clinical Trials
809 Total Patients Enrolled
5 Trials studying Osteoarthritis
451 Patients Enrolled for Osteoarthritis

Media Library

Agili-C Implant (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03299959 — N/A
Osteoarthritis Research Study Groups: Agili-C, Surgical Standard of Care (SSOC)
Osteoarthritis Clinical Trial 2023: Agili-C Implant Highlights & Side Effects. Trial Name: NCT03299959 — N/A
Agili-C Implant (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03299959 — N/A
~32 spots leftby Sep 2025
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