NeoCart Phase 2 Clinical Trial

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548119

Enrollment

Registered

2007-10-23

Start date

2006-12-31

Completion date

2014-03-31

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Articular Cartilage Damage

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.

Interventions

BIOLOGICALNeoCart

autologous tissue implant

PROCEDUREmicrofracture

microfracture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026