NeoCart Phase 2 Clinical Trial

Histogenics Corporation30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Articular Cartilage Damage

Interventions

NeoCartBIOLOGICAL

autologous tissue implant

microfracturePROCEDURE

microfracture

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (6)

UCSF

San Francisco, California, United States

TRIA Orthopedic Center

Bloomington, Minnesota, United States

Hospital for Special Surgery

New York, New York, United States

Keller Army Community Hospital

West Point, New York, United States

Outcomes

Primary Outcomes

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

Time frame: One year

Secondary Outcomes

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

Time frame: One year

Data from ClinicalTrials.gov

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