IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.
Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation (ACI) has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a need for improvement. A new cartilage repair technique should aim at decreasing surgical trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic phenotype of dedifferentiated articular chondrocytes. In addition, preserving the pericellular matrix of chondrocytes improves cartilage formation. These chondrons (chondrocytes with their pericellular matrix) have shown improved cartilage formation when combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This will reduce patient morbidity and improve patient care through immediate transplantation of a potent cell-based cartilage product. This is a phase I/II prospective monocenter study to evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage lesions of the knee.
Effusion (L) Knee
Knee Pain Swelling
Other: Cartilage repair surgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Instant MSC Product Accompanying Autologous Chondron Transplantation (IMPACT): Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.|
- Safety [ Time Frame: Multiple time points up to 18 months ] [ Designated as safety issue: Yes ]Adverse event rate non-inferior to standard treatment (autologous chondrocyte implantation) and leads to no serious adverse events such as a immunological response.
- Clinical improvement [ Time Frame: 18 months ] [ Designated as safety issue: No ]Clinical improvement as measured by patient reported outcome scores.
- Structural repair [ Time Frame: 12 months ] [ Designated as safety issue: No ]To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.
- Health care use and costs [ Time Frame: 18 months ] [ Designated as safety issue: No ]To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Cartilage repair surgery
Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
Other: Cartilage repair surgery
Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs
Please refer to this study by its ClinicalTrials.gov identifier: NCT02037204
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508GA|
|Study Director:||Tommy S. de Windt, MD||UMC Utrecht|
|Principal Investigator:||Daniel B.F. Saris, MD, PhD||UMC Utrecht|