NeoCart Phase 2 Clinical Trial | NCT00548119

Studies
NeoCart Phase 2 Clinical Trial

NCT00548119

Sponsor

Histogenics Corporation

Status

Completed

Last Update Posted

Apr 21, 2014Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Articular Cartilage Damage

Interventions

NeoCart
microfracture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Nov 2009Actual

Completion Date

Mar 2014Actual

First Submitted Date

Oct 19, 2007

First Submission Date that Met QC Criteria

Oct 19, 2007

First Posted Date

Oct 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 16, 2012

Certification/Extension First Submitted that Passed QC Review

Aug 16, 2012

Certification/Extension First Posted Date

Aug 23, 2012Estimated

Last Update Submitted Date

Mar 25, 2014

Last Update Posted Date

Apr 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NeoCart	Experimental		Biological: NeoCart
microfracture	Active Comparator		Procedure: microfracture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeoCart	Biological	autologous tissue implant	NeoCart
microfracture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF		San Francisco	California	94143	United States
TRIA Orthopedic Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28068480	Derived	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.

ID	Term
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures