NOVOCART 3D for Articular Cartilage Injury

Not currently recruiting at 5 trial locations

Overseen By Brad Larson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Aesculap Biologics, LLC

Disqualifiers: Other cartilage procedures, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called NOVOCART 3D, designed to aid individuals with knee cartilage injuries. It focuses on those who previously underwent a procedure called microfracture without success. The goal is to determine if NOVOCART 3D can more effectively repair damaged cartilage. Participants must have been part of a previous study testing microfracture treatment and need to consent to join this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that NOVOCART 3D is likely to be safe for humans?

Research shows that NOVOCART 3D is generally safe for individuals with knee cartilage problems. In earlier studies, researchers compared this treatment to microfracture, a common method for repairing cartilage. The results indicated that NOVOCART 3D is as safe as microfracture.

No major safety issues emerged. Most participants did not experience serious side effects. Some mild side effects, such as temporary pain or swelling at the treatment site, occurred but were usually not serious and resolved over time.

Ongoing research and past studies suggest that NOVOCART 3D is safe, especially with careful monitoring during trials. However, discussing any concerns with the clinical trial team before deciding to join is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for articular cartilage injury, which often involve microfracture surgery or osteochondral autograft transplantation, NOVOCART 3D stands out because it uses a matrix-associated autologous chondrocyte implant. This unique approach involves taking a patient’s own cartilage cells, expanding them, and then implanting them on a 3D scaffold to promote natural cartilage repair and regeneration. Researchers are excited about NOVOCART 3D because it potentially offers a more natural and long-lasting repair by leveraging the body’s own healing mechanisms, which could lead to better outcomes and less invasive procedures compared to traditional methods.

What evidence suggests that NOVOCART 3D is effective for articular cartilage injury?

Research has shown that NOVOCART 3D, which participants in this trial will receive, may help treat knee cartilage damage. In earlier studies, patients who received NOVOCART 3D experienced better knee function than those who underwent the usual microfracture surgery. This treatment uses a special implant made from the patient's own cartilage cells. Over 36 months, it proved safe and effective, with ongoing improvement in joint function. These results suggest that NOVOCART 3D could be a good option for repairing damaged knee cartilage. ^{1 2 3 4 5}

Who Is on the Research Team?

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

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?

Group I: NOVOCART 3D Experimental Treatment 1 Intervention

Matrix associated autologous chondrocyte implant

Who Is Running the Clinical Trial?

Aesculap Biologics, LLC

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The NeoCart implant, used to repair cartilage lesions, demonstrated significant safety and efficacy over a 60-month follow-up in 29 patients, with improvements in cartilage quality and patient-reported outcomes (PROs) such as pain and function.

MRI analysis showed that the repair tissue matured from hyperintense to hypointense signals over time, indicating a transition to denser tissue, while clinical improvements peaked at 24 months and remained stable through 60 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. Anderson, DE., Williams, RJ., DeBerardino, TM., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a randomized trial involving 30 patients, the NeoCart autologous cartilage tissue implant demonstrated greater clinical efficacy compared to microfracture surgery, with significant improvements in pain and quality of life scores at six, twelve, and twenty-four months post-treatment.

The safety profile of NeoCart was similar to that of microfracture, with no significant differences in adverse event rates, indicating that NeoCart is a safe and effective alternative for treating articular cartilage injuries in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Crawford, DC., DeBerardino, TM., Williams, RJ.[2022]

In a study of 41 patients with knee cartilage defects treated with NOVOCART 3D implants, graft hypertrophy occurred in 11 patients over a 2-year follow-up, particularly in those with defects resulting from acute trauma or osteochondritis dissecans (OCD).

The modified MOCART Score indicated significant improvement in the quality and integration of the NOVOCART 3D implants post-surgery, suggesting that while graft hypertrophy is a concern, the overall treatment shows positive outcomes in cartilage repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graft hypertrophy of matrix-based autologous chondrocyte implantation: a two-year follow-up study of NOVOCART 3D implantation in the knee. Niethammer, TR., Pietschmann, MF., Horng, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01656902

NCT01656902 | Phase III Study to Evaluate Safety and ... Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects (N3D). ClinicalTrials.gov ID NCT01656902.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12344510/

A non‐interventional study to evaluate the safety and ... The focus of this study was to evaluate the safety and efficacy of NOVOCART® 3D‐treatment over a period of 36 months post‐transplantation.

3. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2011-005798-22/results

EudraCT Number 2011-005798-22 - Clinical trial results A clinical study to evaluate the safety and effectiveness of NOVOCART® 3D plus compared to microfracture in the treatment of articular cartilage defects of the ...

4. trial.medpath.com trial.medpath.com/clinical-trial/46a233f3f8f0829d/euctr2011-005798-22-lv-clinical-study-novocart-3d-plus-knee-cartilage-defects

A clinical study to evaluate the safety and effectiveness of ... A clinical study to evaluate the safety and effectiveness of NOVOCART® 3D plus compared to the standard of care (microfracture) in the treatment of cartilage ...

5. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2022/01/13181-Autologous-Chondrocyte-Implant-for-Articular-Cartilage-Defects-V1.0-SEP2019-NON-CONF.pdf

NOVOCART 3D for articular cartilage defects of the knee NOVOCART 3D is in development for the treatment of knee joint cartilage defects. Articular cartilage damage in the knee can be caused directly by acute injury, ...