BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial

Objective: The efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was compared with microfracture alone at 1 year during a multicenter randomized controlled trial in the knee. This report was undertaken to investigate 5-year structural and clinical outcomes. Design: The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. Patients were randomized to receive BST-CarGel® treatment or microfracture alone, and followed standardized 12-week rehabilitation. Co-primary endpoints of repair tissue quantity and quality were evaluated by 3-dimensional MRI quantification of the degree of lesion filling (%) and T2 relaxation times. Secondary endpoints were clinical benefit measured with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaires and safety. General estimating equations were used for longitudinal statistical analysis of repeated measures. Results: Blinded MRI analysis demonstrated that BST-CarGel®-treated patients showed a significantly greater treatment effect for lesion filling (P = 0.017) over 5 years compared with microfracture alone. A significantly greater treatment effect for BST-CarGel® was also found for repair tissue T2 relaxation times (P = 0.026), which were closer to native cartilage compared to the microfracture group. BST-CarGel® and microfracture groups showed highly significant improvement at 5 years from pretreatment baseline for each WOMAC subscale (P \u3c 0.0001), and there were no differences between the treatment groups. Safety was comparable for both groups. Conclusions: BST-CarGel® was shown to be an effective mid-term cartilage repair treatment. At 5 years, BST-CarGel® treatment resulted in sustained and significantly superior repair tissue quantity and quality over microfracture alone. Clinical benefit following BST-CarGel® and microfracture treatment were highly significant over baseline levels

Morphological changes of human skin cells exposed to a DC electric field in vitro using a new exposure system

The human skin contains a physiological battery that could be implicated in the healing process, by creating an endogenous electric field. Skin cells undergo morphological changes in response to an external DC electric field (EF). We found that fibroblasts reorient their cell bodies in a manner perpendicular to the EF direction, for normal and above physiological intensities. Actin and tubulin filaments (cytoskeleton proteins) follow the same pattern of reorientation. Keratinocytes tend to elongate in the same direction, although to a lesser extent. The study of the response of human skin cells to an external EF is a first step toward a better understanding of the mechanisms involved in wound healing and eventually toward the improvement of wound repair.La peau humaine contient une batterie physiologique qui pourrait ětre impliquée dans le processus de guérison en produisant un champ électrique (CE) endogène au site de la plaie. Les cellules de la peau subissent des changements morphologiques lorsqu'elles sont soumises à un CE externe. Sous un CE d'intensité physiologique ou plus grand, les fibroblastes eéorientent leurs corps cellulaires de façon perpendiculaire au CE. Les filaments d'actine et de tubuline (protéines du cytosquelette) répondent de la měme façon. De façon moins évidente, les kératinocytes ont aussi tendance à s'allonger dans la měme direction. La réponse des cellules de la peau face à un CE est une premiére étape vers une meilleure compréhension et amélioration du processus de guérison des plaies

BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial

OBJECTIVE: The efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was compared with microfracture alone at 1 year during a multicenter randomized controlled trial in the knee. This report was undertaken to investigate 5-year structural and clinical outcomes. DESIGN: The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. Patients were randomized to receive BST-CarGel® treatment or microfracture alone, and followed standardized 12-week rehabilitation. Co-primary endpoints of repair tissue quantity and quality were evaluated by 3-dimensional MRI quantification of the degree of lesion filling (%) and T2 relaxation times. Secondary endpoints were clinical benefit measured with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaires and safety. General estimating equations were used for longitudinal statistical analysis of repeated measures. RESULTS: Blinded MRI analysis demonstrated that BST-CarGel®-treated patients showed a significantly greater treatment effect for lesion filling (P = 0.017) over 5 years compared with microfracture alone. A significantly greater treatment effect for BST-CarGel® was also found for repair tissue T2 relaxation times (P = 0.026), which were closer to native cartilage compared to the microfracture group. BST-CarGel® and microfracture groups showed highly significant improvement at 5 years from pretreatment baseline for each WOMAC subscale (P < 0.0001), and there were no differences between the treatment groups. Safety was comparable for both groups. CONCLUSIONS: BST-CarGel® was shown to be an effective mid-term cartilage repair treatment. At 5 years, BST-CarGel® treatment resulted in sustained and significantly superior repair tissue quantity and quality over microfracture alone. Clinical benefit following BST-CarGel® and microfracture treatment were highly significant over baseline levels

Review of the clinical development of alipogene tiparvovec gene therapy for lipoprotein lipase deficiency

Alipogene tiparvovec (AAV1-LPLS447X) gene therapy is developed to prevent complications and decrease the clinical morbidity of lipoprotein lipase deficiency (LPLD). LPLD is an autosomal recessive disease associated with severe hypertriglyceridemia (hyperTG), severe chylomicronaemia, and low HDL. Acute pancreatitis, the most frequent serious clinical LPLD complication, is a complex and heterogeneous inflammatory condition having many causes including hyperTG and chylomicronaemia. In many patients, low fat diet and currently available lipid lowering drugs are ineffective to prevent hyperTG or pancreatitis in LPLD. The clinical development program of alipogene tiparvovec includes observational studies as well as phase I/II and II/III clinical trials. Pooled data are collected on safety and efficacy issues, including the incidence of pancreatitis

Osteochondral Biopsy Analysis Demonstrates That BST-CarGel Treatment Improves Structural and Cellular Characteristics of Cartilage Repair Tissue Compared With Microfracture

OBJECTIVE: The efficacy and safety of BST-CarGel, a chitosan-based medical device for cartilage repair, was compared with microfracture alone at 1 year during a multicenter randomized controlled trial (RCT) in the knee. The quality of repair tissue of osteochondral biopsies collected from a subset of patients was compared using blinded histological assessments. METHODS: The international RCT evaluated repair tissue quantity and quality by 3-dimensional quantitative magnetic resonance imaging as co-primary endpoints at 12 months. At an average of 13 months posttreatment, 21/41 BST-CarGel and 17/39 microfracture patients underwent elective second look arthroscopies as a tertiary endpoint, during which ICRS (International Cartilage Repair Society) macroscopic scoring was carried out, and osteochondral biopsies were collected. Stained histological sections were evaluated by blinded readers using ICRS I and II histological scoring systems. Collagen organization was evaluated using a polarized light microscopy score. RESULTS: BST-CarGel treatment resulted in significantly better ICRS macroscopic scores (P = 0.0002) compared with microfracture alone, indicating better filling, integration, and tissue appearance. Histologically, BST-CarGel resulted in a significant improvement of structural parameters—Surface Architecture (P = 0.007) and Surface/Superficial Assessment (P = 0.042)—as well as cellular parameters—Cell Viability (P = 0.006) and Cell Distribution (P = 0.032). No histological parameters were significantly better for the microfracture group. BST-CarGel treatment also resulted in a more organized repair tissue with collagen stratification more similar to native hyaline cartilage, as measured by polarized light microscopy scoring (P = 0.0003). CONCLUSION: Multiple and independent analyses in this biopsy substudy demonstrated that BST-CarGel treatment results in improved structural and cellular characteristics of repair tissue at 1 year posttreatment compared with microfracture alone, supporting previously reported results by quantitative magnetic resonance imaging

La jeunesse n'est plus ce qu'elle était

« La jeunesse n'est plus ce qu'elle était... » Voilà la formule qui a valeur d'antienne quand ont est jeune ou que, en avançant en âge, on se fait vieux en se scandalisant de ce qu'est devenue la jeunesse ! Qui n'a pas eu ces mots à la bouche pour regretter la jeunesse d'antan ou, au contraire, pour se féliciter qu'elle ait changé. C'est sous cette bannière que des dizaines de chercheurs se sont réunies au Centre culturel de Cerisy-la-Salle, du 23 au 30 juin 2009, afin de pouvoir échanger sur les sujets à l'ordre du jour et cela dans l'intention de savoir si véritablement la « jeunesse n'est plus ce qu'elle était ». Le présent recueil s'efforce dans cette voie de brosser un tableau d'ensemble de la jeunesse en croisant les regards des principaux chercheurs en la matière issus de l'anthropologie, de l'histoire, de la sociologie et des autres sciences sociales.Les lecteurs - jeunes ou moins jeunes - trouveront entre autres des études sur les parcours scolaires, sur l'insertion dans le marché du travail, sur la mobilité géographique, sur l'entrée dans la vie adulte, et sur la culture teintée des couleurs du cosmopolitisme des jeunes évoluant dans les sociétés francophones que représentent la France, le Québec, la Belgique et l'Acadie