This study is in progress, not accepting new patients

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

a study on Knee Cartilage Injury Articular Cartilage Defect

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by C. Benjamin Ma

Description

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.

Official Title

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

Details

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.

Keywords

Articular Cartilage of the Femoral Condyle Between 2-6cm2, Microfracture, NOVOCART 3D

Eligibility

Locations

  • UCSF Orthopaedic Institute
    San Francisco California 94158 United States
  • Stanford Medicine
    Redwood City California 94063 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aesculap Biologics, LLC
ID
NCT01957722
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 233 people participating
Last Updated