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NOVOCART®3D for Treatment of Articular Cartilage of the Knee

NCT01957722 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2025-03-21

No results posted yet for this study

Summary

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.

Conditions

  • Articular Cartilage of the Femoral Condyle Between 2-6cm2

Interventions

PROCEDURE

Microfracture

Surgical procedure which creates a marrow clot in the prepare cartilage defect.

BIOLOGICAL

NOVOCART 3D

combination product- biologic (autologous chondrocytes) /device (scaffold) implant

Sponsors & Collaborators

  • Aesculap Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Robert Spiro, PhD · Octane Biotherapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2025-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01957722 on ClinicalTrials.gov