Confirmatory Study of NeoCart in Knee Cartilage Repair

Histogenics Corporation

Status and phase: Terminated; Phase 3

Conditions: Articular Cartilage Defects in the Knee Joint

Treatments: Procedure: Microfracture; Biological: NeoCart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066702

8-01

Details and patient eligibility

About

This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.

Enrollment: 245 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• greater than 18 years old
• symptomatic articular cartilage lesion of the femur and/or trochlea

Exclusion criteria

• prior surgical intervention other than debridement
• arthritis
• clinically significant or symptomatic vascular or neurologic disorder of the lower extremities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

245 participants in 2 patient groups

NeoCart

Experimental group

Description:

Autologous cartilagenous tissue implant

Treatment:

Biological: NeoCart

Microfracture

Active Comparator group

Description:

surgical intervention

Treatment:

Procedure: Microfracture