30 Participants Needed

NOVOCART 3D for Articular Cartilage Injury

Recruiting at 5 trial locations
SC
JS
AV
BL
Overseen ByBrad Larson, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Aesculap Biologics, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is the NOVOCART 3D treatment different from other treatments for articular cartilage injury?

NOVOCART 3D is unique because it is a matrix-based autologous chondrocyte implantation (ACI) that uses a biocompatible structure to support the growth of the patient's own cartilage cells, potentially reducing complications like graft hypertrophy (excessive tissue growth). This approach differs from traditional methods like microfracture, which involves creating small holes in the bone to stimulate cartilage growth, as it directly uses the patient's cells to repair the cartilage.12345

What data supports the effectiveness of the treatment NOVOCART 3D for articular cartilage injury?

The NeoCart implant, a similar autologous cartilage tissue treatment, showed positive short-term results in clinical trials, indicating it was safe and effective compared to microfracture for knee cartilage injuries.12346

Who Is on the Research Team?

RS

Robert Spiro, PhD

Principal Investigator

Octane Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Voluntary consent to participate in the study
You have experienced a failed microfracture procedure.
Participated in study AAG-G-H-1220

Exclusion Criteria

You have growths or injuries that are larger than 9 square centimeters and require implants.
I have had other cartilage repair procedures on my knee.
Non-compliance with requirements in study AAG-G-H-1220
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NOVOCART 3D matrix associated autologous chondrocyte implant

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • NOVOCART 3D
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NOVOCART 3DExperimental Treatment1 Intervention
Matrix associated autologous chondrocyte implant

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aesculap Biologics, LLC

Lead Sponsor

Trials
2
Recruited
260+

Published Research Related to This Trial

The new albumin-hyaluronan-based hydrogel, NInject, is projected to be cost-effective for treating knee cartilage defects compared to microfracture, with an incremental cost-effectiveness ratio (ICER) of ₤5,147.
In sensitivity analyses, NInject remained a favorable option against Spherox, with a 60% probability of being the most cost-effective treatment, although its final pricing is still undetermined.
Cost-effectiveness of a new ACI technique for the treatment of articular cartilage defects of the knee compared to regularly used ACI technique and microfracture.Snow, M., Mandalia, V., Custers, R., et al.[2023]
The MOCART 2.0 knee score shows improved interrater reliability compared to the original MOCART score, with an ICC of 0.875, making it a more reliable tool for assessing cartilage repair tissue in patients who have undergone various cartilage repair procedures.
This study, which included 114 patients with different types of cartilage lesions, found that the MOCART 2.0 score is effective for evaluating repair tissue across multiple techniques (like ACI and microfracture) and demonstrated better reliability for osteochondral lesions compared to chondral lesions.
Reliability of the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 knee score for different cartilage repair techniques-a retrospective observational study.Schreiner, MM., Raudner, M., Röhrich, S., et al.[2022]
The NeoCart implant, a tissue-engineered collagen matrix with autogenous chondrocytes, significantly reduced pain in patients with full-thickness cartilage injuries at 12 and 24 months post-implantation, indicating its efficacy in treating knee cartilage damage.
MRI evaluations showed that most patients (6 out of 8) achieved substantial defect fill (67% to 100%) and demonstrated stable integration of the implant without complications like arthrofibrosis or overgrowth, suggesting the safety and effectiveness of the NeoCart in cartilage repair.
An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years.Crawford, DC., Heveran, CM., Cannon, WD., et al.[2019]

Citations

Cost-effectiveness of a new ACI technique for the treatment of articular cartilage defects of the knee compared to regularly used ACI technique and microfracture. [2023]
Reliability of the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 knee score for different cartilage repair techniques-a retrospective observational study. [2022]
An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. [2019]
Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. [2019]
NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. [2022]
Graft hypertrophy of matrix-based autologous chondrocyte implantation: a two-year follow-up study of NOVOCART 3D implantation in the knee. [2022]
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