What side effects are associated with this type of intervention?

Common treatments for articular cartilage injury, such as microfracture, autologous chondrocyte implantation (ACI), and mosaicplasty, have several known side effects. Microfracture can lead to issues such as pain, swelling, and the formation of fibrocartilage, which is less durable than normal cartilage. ACI may result in complications like graft hypertrophy, delamination, and potential for infection. Mosaicplasty, which involves transplanting small plugs of bone and cartilage, can cause donor site morbidity, pain, and potential for plug dislocation or integration failure. Overall, while these treatments aim to repair cartilage, they come with risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for articular cartilage injury, focusing on regenerative and cell-based therapies. Microfracture is a common technique that stimulates cartilage growth by creating small fractures in the underlying bone. Similar treatments include autologous chondrocyte implantation (ACI), which involves harvesting and re-implanting a patient's own cartilage cells, and matrix-induced autologous chondrocyte implantation (MACI), which uses a scaffold to support cell growth. Additionally, platelet-rich plasma (PRP) injections and hyaluronic acid injections have been used to promote cartilage repair and reduce inflammation. These treatments aim to enhance the body's natural healing processes and improve joint function.

What other types of research exist?

Promising novel alternatives to microfracture for articular cartilage injury include: 1) Intra-articular injections of sprifermin (recombinant human fibroblast growth factor 18), which has shown efficacy in reducing cartilage loss and increasing cartilage gain. 2) Platelet-rich plasma (PRP) injections, which provide growth factors that may enhance cartilage repair and reduce inflammation. 3) Intra-articular injections of etanercept or infliximab, which have shown potential in treating small-joint arthritis and chronic gonarthritis, respectively. 4) Matrix metalloproteinase inhibitors, which are being investigated for their role in preventing cartilage degradation. These treatments are supported by recent clinical trials and studies, making them viable options for patients in 2024.

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NOVOCART 3D for Articular Cartilage Injury

Phase 3

Recruiting

Research Sponsored by Aesculap Biologics, LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Other cartilage repair procedures performed on target knee

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial focuses on patients who did not respond to initial Microfracture treatment. The Microfracture procedure creates small holes in the bone to stimulate new cartilage growth, helping repair knee damage. Microfracture is a widely used technique for treating cartilage defects in the knee by creating small holes in the bone to stimulate new cartilage growth.

Who is the study for?

This trial is for people who were in a previous study (AAG-G-H-1220) and had an unsuccessful microfracture treatment on their knee. They must be willing to participate further and not have other health issues that could affect healing or the assessment of the treatment.

What is being tested?

The NOVOCART 3D, a cartilage repair approach, is being tested as a follow-up intervention for those whose microfracture surgery didn't work. This single-arm extension study focuses on patients from one group of the prior trial.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include typical surgical complications such as infection, pain at the implant site, swelling, and problems with knee function.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have had other cartilage repair procedures on my knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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 pain subdomain score

Secondary study objectives

IKDC subjective scores

KOOS function subdomain score

VAS pain scale

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

1Treatment groups

Experimental Treatment

Group I: NOVOCART 3DExperimental Treatment1 Intervention

Matrix associated autologous chondrocyte implant

0 / 1Eligibility 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

Common treatments for Articular Cartilage Injury, such as microfracture, work by stimulating the body's natural repair mechanisms. Microfracture creates small fractures in the underlying bone, releasing bone marrow elements that form a clot and differentiate into new cartilage tissue. Platelet-rich plasma (PRP) injections deliver growth factors to the injury site, promoting tissue repair and reducing inflammation. Stem cell therapy aims to regenerate damaged cartilage by differentiating into chondrocytes, although its efficacy for tendon disorders is still under review. Understanding these mechanisms helps patients make informed decisions about their treatment options, balancing potential benefits and limitations.