NCT01400607

Neocartilage Implant to Treat Cartilage Lesions of the Knee

Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: ISTO Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.

Detailed description

In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.

Conditions

• Articular Cartilage Disorder
• Degeneration; Articular Cartilage
• Chronic Cartilage Injury
• Acute Cartilage Injury
• Defect of Articular Cartilage

Interventions

Type	Name	Description
BIOLOGICAL	Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)	The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
OTHER	Microfracture	Marrow stimulation using the microfracture technique; performed arthroscopically

Timeline

• Start date: 2011-07-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2011-07-22
• Last updated: 2017-08-31

Locations

9 sites across 1 country: United States