NeoCart Phase 2 Clinical Trial

Histogenics Corporation

Status and phase: Completed; Phase 2

Conditions: Articular Cartilage Damage

Treatments: Procedure: microfracture; Biological: NeoCart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548119

6-01

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

NeoCart

Experimental group

Treatment:

Biological: NeoCart

microfracture

Active Comparator group

Treatment:

Procedure: microfracture