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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have growths or injuries that are larger than 9 square centimeters and require implants.You have experienced a failed microfracture procedure.I have had other cartilage repair procedures on my knee.I don't have any health issues that could affect my recovery or the assessment of the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: NOVOCART 3D
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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