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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is for people who have already participated in a study on a different knee treatment. This new study is testing whether a different knee treatment called microfracture is effective.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
KOOS pain subdomain score
Secondary outcome measures
IKDC subjective scores
KOOS function subdomain score
VAS pain scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: NOVOCART 3DExperimental Treatment1 Intervention
Matrix associated autologous chondrocyte implant

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial cater to elderly patients?

"This trial is only open for patients aged 18 to 66. There are 7 other trials available for minors and 18 trials available for elderly patients."

Answered by AI

Are there any health risks associated with NOVOCART 3D?

"There is both efficacy and safety data from multiple sources supporting NOVOCART 3D, which our team has rated as a 3."

Answered by AI

Can qualified individuals still participate in this research?

"That is correct. The trial, which has been updated as recently as March 1st, 2022, is currently seeking 30 individuals to participate at 2 locations."

Answered by AI
~5 spots leftby Apr 2025