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Confirmatory Study of NeoCart in Knee Cartilage Repair

NCT01066702 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2019-03-29

No results posted yet for this study

Summary

This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.

Conditions

  • Articular Cartilage Defects in the Knee Joint

Interventions

BIOLOGICAL

NeoCart

implantation of an cartilagenous tissue implant derived from the patients own cells.

PROCEDURE

Microfracture

holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.

Sponsors & Collaborators

  • Histogenics Corporation

    lead INDUSTRY

Principal Investigators

  • Andrea Belschner · Histogenics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2019-03-31
Completion
2019-03-31

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 NCT01066702 on ClinicalTrials.gov