What side effects are associated with this type of intervention?

Tissue-engineered cartilage grafts, such as NOVOCART 3D, may lead to side effects including graft failure, infection, and immune reactions, although these are relatively rare. Patients might also experience pain, swelling, and stiffness at the graft site. The microfracture technique, which involves creating small fractures in the underlying bone to stimulate cartilage growth, can result in side effects such as prolonged recovery time, pain, swelling, and the formation of fibrocartilage, which is less durable than normal cartilage. Both treatments require careful post-operative rehabilitation to optimize outcomes and minimize complications.

What prior FDA approvals exist?

The FDA has approved several treatments for articular cartilage defects, including autologous chondrocyte implantation (ACI) and matrix-induced autologous chondrocyte implantation (MACI). These treatments involve harvesting a patient's own cartilage cells, culturing them, and re-implanting them into the defect site to promote cartilage regeneration. Microfracture, a surgical technique that creates small fractures in the underlying bone to stimulate cartilage growth, is also widely used but does not require FDA approval as it is a surgical procedure rather than a drug or biologic product. NOVOCART 3D, a tissue-engineered cartilage graft, is currently being studied and represents a similar approach to ACI and MACI, aiming to provide a scaffold for new cartilage growth.

What other types of research exist?

Promising novel alternatives for treating articular cartilage defects include: 1) Intra-articular injections of recombinant human fibroblast growth factor 18 (rhFGF18), which has shown potential in promoting cartilage growth and repair. 2) Stem cell therapy, particularly using mesenchymal stem cells (MSCs), which can differentiate into cartilage cells and promote tissue regeneration. 3) Gene therapy approaches, such as using interleukin-1 receptor antagonists, which aim to reduce inflammation and promote cartilage repair. These alternatives are currently under investigation and may offer new treatment options for patients in 2024.

← Back to Search

NOVOCART 3D vs Microfracture for Knee Cartilage Defects (N3D Trial)

Phase 3

Waitlist Available

Research Sponsored by Aesculap Biologics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Isolated articular cartilage lesions on the femoral condyle 2-6 cm2

Greater than 18 years old

Must not have

Instability of the knee joint

Immune suppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two methods for treating damaged knee cartilage. It aims to see which method better reduces pain and improves knee function. The study will monitor patients over several years to evaluate safety and effectiveness.

Who is the study for?

This trial is for adults over 18 with specific knee cartilage defects between 2-6 cm². Participants must have a certain level of pain and dysfunction as measured by the KOOS questionnaire. It's not for those with arthritis, unstable knees, immune issues, prior similar knee surgeries (except debridement/lavage after three months), bone diseases, degenerative conditions that affect healing or evaluation, or autoimmune diseases.

What is being tested?

The study compares NOVOCART 3D (a tissue-engineered cartilage implant) to Microfracture surgery (a technique where small holes are made in the bone beneath the damaged cartilage to stimulate new growth). The goal is to see which treatment better improves pain and function in the knee.

What are the potential side effects?

While specific side effects aren't listed here, generally such procedures may cause joint pain, swelling, infection risk at the surgical site, blood clots in leg veins or lungs post-surgery and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a knee cartilage injury between 2-6 cm2.

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My knee is unstable.

Select...

I have a weakened immune system.

Select...

I do not have any conditions that could affect my healing or the assessment of my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain

Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NOVOCART 3DExperimental Treatment1 Intervention

Scaffold assisted autologous chondrocyte Implant

Group II: MicrofractureActive Control1 Intervention

considered a typical treatment for articular cartilage repair

0 / 5Eligibility criteria met

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

Tissue-engineered cartilage grafts, such as NOVOCART 3D, use bioengineered scaffolds seeded with chondrocytes or stem cells to regenerate durable and functional cartilage by mimicking natural cartilage structure. In contrast, the microfracture technique creates small fractures in the subchondral bone to release bone marrow cells, forming a less durable fibrocartilaginous repair tissue. Understanding these mechanisms helps patients and doctors choose the most suitable treatment based on defect severity, desired outcomes, and long-term joint health.