NCT01605201

Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage

Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage in the Knee After Traumatic Injury - a Phase I Clinical Trial-

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or trochlea of the knee after a traumatic injury.

Detailed description

Articular cartilage injuries are a prime target for regenerative techniques, since spontaneous healing is poor and untreated defects predispose to osteoarthritis. Common current strategies such as arthroscopic debridement, microfracture, autologous osteochondral grafting, use of allografts and autologous chondrocytes implantation (ACI) still have drawbacks such as long and complex rehabilitation times, technically challenging operation techniques, defect-size limitations, donor-site morbidity, limited graft material and high costs. Furthermore many techniques show unsatisfactory long term results due to inferior quality of repair tissue as compared to native cartilage or have yet to prove the cost versus benefit. These drawbacks could be overcome by using a tissue engineered nasal cartilage graft, thereby reducing donor site morbidity without introducing additional risk of complication or technically challenging techniques. This study is a phase I, prospective, uncontrolled, investigator initiated clinical trial involving 25 patients, with the objective of demonstrating safety and feasibility in the use of engineered nasal cartilage grafts for repair of articular cartilage. The specific surgical target of the trial is the repair of one or two full-thickness cartilage defects from 2 cm2 to 8 cm2 (per lesion, not exceeding a total of 8 cm2 for all lesions) due to traumatic injury on the femoral condyle and/or trochlea of the knee.

Conditions

• Cartilage Lesion
• Degenerative Lesion of Articular Cartilage of Knee

Interventions

Type	Name	Description
BIOLOGICAL	Tissue engineered cartilage graft	Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold

Timeline

• Start date: 2012-08-29
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2012-05-24
• Last updated: 2018-08-27

Locations

1 site across 1 country: Switzerland