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

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: Active, not recruiting
• Conditions: Articular Cartilage of the Femoral Condyle Between 2-6cm2
• Intervention / Treatment: Biological: NOVOCART 3D; Procedure: Microfracture

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: Interventional
• Enrollment (Actual): 233
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain	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	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

• Sponsor: Aesculap Biologics, LLC
• Investigators: Study Director: Robert Spiro, PhD, Octane Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimated): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID 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