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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 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

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.

Find a Location

Who is running the clinical trial?

Aesculap Biologics, LLCLead Sponsor
1 Previous Clinical Trials
233 Total Patients Enrolled
Robert Spiro, PhDStudy DirectorAesculap Biologics
1 Previous Clinical Trials
233 Total Patients Enrolled

Media Library

NOVOCART 3D Clinical Trial Eligibility Overview. Trial Name: NCT03219307 — Phase 3
Articular Cartilage Injury Research Study Groups: NOVOCART 3D
Articular Cartilage Injury Clinical Trial 2023: NOVOCART 3D Highlights & Side Effects. Trial Name: NCT03219307 — Phase 3
NOVOCART 3D 2023 Treatment Timeline for Medical Study. Trial Name: NCT03219307 — Phase 3
~4 spots leftby Dec 2025
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