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OpenTrials
Completed

NCT Number: NCT00548119

NeoCart Phase 2 Clinical Trial

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

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Key information

Conditions

Articular Cartilage Damage

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSF, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeoCart

Biological

autologous tissue implant

Microfracture

Procedure

microfracture

Primary outcomes

  1. The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.

    Time frame: One year

Secondary outcomes

  1. This study will extend the experience derived from our Phase 1 study.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Histogenics Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2014
First posted
Oct 23, 2007
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.