NeoCart Phase 2 Clinical Trial

March 25, 2014 updated by: Histogenics Corporation

A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF
    • Minnesota
      • Bloomington, Minnesota, United States
        • TRIA Orthopedic Center
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • West Point, New York, United States
        • Keller Army Community Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Sports Medicine Center
    • Oregon
      • Portland, Oregon, United States
        • OHSU

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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.

Exclusion Criteria:

  • Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeoCart
Biological: NeoCart
autologous tissue implant
Active Comparator: microfracture
Procedure: microfracture
microfracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
This study will extend the experience derived from our Phase 1 study.
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Histogenics Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 6-01

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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