NeoCart Phase 2 Clinical Trial

NCT ID: NCT00548119

Last Updated: 2014-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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Conditions

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Articular Cartilage Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NeoCart

Group Type EXPERIMENTAL

NeoCart

Intervention Type BIOLOGICAL

autologous tissue implant

microfracture

Group Type ACTIVE_COMPARATOR

microfracture

Intervention Type PROCEDURE

microfracture

Interventions

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NeoCart

autologous tissue implant

Intervention Type BIOLOGICAL

microfracture

microfracture

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Histogenics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF

San Francisco, California, United States

Site Status

TRIA Orthopedic Center

Bloomington, Minnesota, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Keller Army Community Hospital

West Point, New York, United States

Site Status

Duke Sports Medicine Center

Durham, North Carolina, United States

Site Status

OHSU

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Anderson DE, Williams RJ 3rd, DeBerardino TM, Taylor DC, Ma CB, Kane MS, Crawford DC. Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. Am J Sports Med. 2017 Mar;45(4):875-883. doi: 10.1177/0363546516677255. Epub 2017 Jan 9.

Reference Type DERIVED
PMID: 28068480 (View on PubMed)

Other Identifiers

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6-01

Identifier Type: -

Identifier Source: org_study_id

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