Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage (Nose2Knee)
|Cartilage Lesion Degenerative Lesion of Articular Cartilage of Knee||Biological: Tissue engineered cartilage graft||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage in the Knee After Traumatic Injury - a Phase I Clinical Trial-|
- 1-Safety for the patient [ Time Frame: until 24 months ]Safety will be assessed by the incidence of adverse reactions and adverse events. Expected postoperative complications also occurring in the standard procedure are: pain, swelling and hematoma, casually post-anesthetic nausea, vomiting or fever.
- 2- Stability of the graft [ Time Frame: until 24 months ]It will be assessed by Magnetic Resonance Imaging (MRI) technique at 6, 12 and 24 months indicating if the graft is in place and if there are signs of complications. Parameters to be evaluated are: filling of the defect, integration of the border zone to the adjacent cartilage, intactness of the subchondral lamina, intactness of the subchondral bone, and relative signal intensities of the repair tissue compared to the adjacent native cartilage.
- Subjective pain relief [ Time Frame: until 24 months ]Subjective relief of pain for the patient will be assessed using the International Cartilage Repair Society (ICRS) Cartilage Injury Evaluation Package which includes the pre- and postsurgical evaluation of general medical conditions, pain, activity level as well as functional and morphological status.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2018|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
|Experimental: Implantation of cartilage graft||
Biological: Tissue engineered cartilage graft
Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605201
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Marcel Jakob, Prof. Dr.||University Hospital, Basel, Switzerland|