NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)

March 19, 2025 updated by: Aesculap Biologics, LLC

A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared Ot Microfracture in the Treatment of Articular Cartilage Defects

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
233

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0H1
        • Simon Fraser Orthopaedic Fund
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E1
        • Dalhousie University
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Josephs Healthcare Hamilton
      • London, Ontario, Canada, N6C 2R5
        • Lawson Health Research Institute
  • United States
    • California
      • La Mesa, California, United States, 91942
        • Grossmont Orthopaedic Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA
      • Redwood, California, United States, 94063
        • Stanford Medicine
    • Colorado
      • Denver, Colorado, United States, 80222
        • CU Sports Medicine
      • Steamboat Springs, Colorado, United States, 80487
        • Yampa Valley Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Tenet Florida Physician Services
      • West Palm Beach, Florida, United States, 33407
        • Paley Orthopedic and Spine Institute
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Saint Alphonsus Medical Group
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health System
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • TRIA Orthopaedic Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Healthcare
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Faculty Practice Associates
      • New York, New York, United States, 10128
        • Plancher Orthopaedics & Sports Medicine
      • Port Jefferson, New York, United States, 11777
        • Long Island Bone and Joint Llp
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University Sports Medicine
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Tulsa Bone and Joint Associates
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny - Singer Research Institute
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions
    • Utah
      • North Logan, Utah, United States, 84341
        • Alpine Orthopaedics
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Orthopaedic Center of Central Virginia Inc
      • Richmond, Virginia, United States, 23294
        • Advanced Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Greater than 18 years old
  • Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
  • Minimum score on the KOOS questionnaire

Exclusion Criteria:

  • Instability of the knee joint
  • Arthritis
  • Autoimmune disease
  • Immune suppression
  • Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
  • Bone disease
  • Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
Biological: NOVOCART 3D
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Active Comparator: Microfracture
considered a typical treatment for articular cartilage repair
Procedure: Microfracture
Surgical procedure which creates a marrow clot in the prepare cartilage defect.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
Time Frame: 24 months post treatment
As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
24 months post treatment
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
Time Frame: 24 months post treatment
As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline
24 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aesculap Biologics, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Spiro, PhD, Octane Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAG-G-H-1220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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