Background: In December 2016, MACI (autologous cultured chondrocytes on porcine collagen membrane) received approval from the US Food and Drug Administration for the treatment of symptomatic articular cartilage defects of the knee with or without bone involvement in adults. Purpose: To describe the cartilage defects and patient characteristics for 1000 adult patients treated with MACI for knee cartilage repair in the United States. Study Design: Case series; Level of evidence, 4. Methods: Data collected by Vericel for adult patients treated for articular cartilage defects of the knee were reconciled and summarized. Data were collected for 1000 consecutive patients starting on July 1, 2017, when Carticel (the prior generation of autologous cultured chondrocytes) was no longer available. Patient names were removed for confidentiality, and patients were identified by MACI lot number and surgery date. Safety data were derived from the pharmacovigilance database. Patient demographics, cartilage defect characteristics, concomitant surgical procedures, and adverse events were summarized with descriptive statistics. Results: A total of 1000 adults and 1010 knee joints were implanted with MACI by 372 surgeons. The male (49.6%)-to-female (50.4%) ratio was evenly split, and the mean age was 34.0 years. The majority of patients (68.1%) had a single cartilage defect treated, and the mean treated defect size was 4.7 cm2. The mean total treated lesion size, including multiple defects, was 5.8 cm2. The patella was the most commonly treated joint surface (32.7%), followed by the medial femoral condyle (31.3%). Most patients (92.4%) had concomitant surgical procedures at the time of cartilage biopsy acquisition. The most common concomitant procedures at the time of biopsy procurement included cartilage debridement (83.7%) and meniscal resection (11.3%). The most common planned concomitant surgeries at the time of MACI implantation were anterior tibial tubercleplasty (7.8%) and reconstruction of dislocating patella (5.5%). Few patients (2.6%) had adverse events. Conclusion: Patient age and mean total MACI-treated defect size in the United States are similar to the findings of the pivotal European SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) trial and other studies from outside the United States. Treatment of multiple cartilage defects is more frequent in the United States than elsewhere.

2007-09-01·Tissue Engineering

DNA Methylation Analysis as Novel Tool for Quality Control in Regenerative Medicine

Article

作者: Olek, Sven ; Wolfe, Leslie ; Baron, Udo ; Model, Fabian ; Rapko, Stephen ; Hoffmüller, Ulrich

Cell-based regenerative medicine, including tissue engineering, is a novel approach to reconstituting tissues that do not spontaneously heal, such as damaged cartilage, and to curing diseases caused by malfunctioning cells. Typically, manufacturing processes to generate cartilage for replacement therapies involve isolation and expansion of cells from cartilage biopsies. A challenge in the field is potential contamination by other cell types (e.g., fibroblast-like cells), which can overgrow the desired cells during culturing and may ultimately compromise clinical efficacy. No standard analytical system has been absolutely effective in ensuring the identity of these cell-based products. Therefore, we tested deoxyribonucleic acid methylation analysis as a quality assessment tool, applying it to Genzyme's Carticel product, a chondrocyte implant that the Food and Drug Administration has approved. We identified 7 potent discriminators by assaying candidate genomic regions derived from methylation discovery approaches and literature searches regarding a functional role of genes in chondrocyte biology. Using a support vector machine, we trained an optimal cell type classifier that was absolutely effective in discriminating chondrocytes from synovial membrane derived cells, the major potential contaminant of chondrocyte cultures. The abundant marker availability and high quality of this assay format also suggest it as a potential quality control test for other cell types grown or manipulated in vitro.

2007-04-01·Acta orthopaedica Belgica4区 · 医学

Autologous chondrocyte implantation: a comparison between an open periosteal-covered and an arthroscopic matrix-guided technique.

4区 · 医学

Article

作者: Faccini, Riccardo ; Manfredini, Massimiliano ; Gildone, Alessandro ; Zerbinati, Fabio

In this prospective study, the authors compared the Carticel method of autologous chondrocyte implantation with the Hyalograft C technique. The aim of the study was to compare the clinical outcomes of the two methods, to identify any complications and to analyse MRI images of the repair process. Seventeen patients who had received autologous chondrocyte implantation with the Carticel technique and ten treated with Hyalograft C were assessed. A statistically significant improvement was observed in both groups at six months (p < 0.001 for Carticel and p = 0.002 for Hyalograft C) and at twelve months after surgery (p < 0.001 both for Carticel and Hyalograft C), according to HSS (Hospital for Special Surgery) and ICRS (International Cartilage Repair Society) scores. There were no statistically significant differences between the two groups. MRI images obtained one year after surgery revealed the formation of well-integrated tissue similar to the surrounding healthy cartilage in most cases, in both Carticel and Hyalograft C groups. Six patients treated with Carticel technique were also assessed by second-look arthroscopy and histology of biopsies. The newly-formed tissue presented structural features similar to normal cartilage in most cases (84%). Molecular analysis was performed to assess mRNA levels of the various collagen molecules and proliferation and differentiation factors: the results showed that the implanted material undergoes progressive remodelling to regenerate hyaline cartilage. Both Carticel and Hyalograft C implantation techniques seem to lead to comparable short- and medium-term results. Moreover, this study confirmed that MRI is a valid tool in the follow-up evaluation of autologous chondrocyte implantation.

100 项与 Autologous cultured chondrocyte implant (Vericel) 相关的药物交易

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