Medical devices suitable for gene therapy regimens

A - Human Necessities – 61 – L

Patent

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Details

A61L 27/38 (2006.01) A61L 27/54 (2006.01)

Patent

CA 2404300

An implantable or insertable medical device suitable for gene or cell therapy regimens, and method of making and using same are disclosed. The medical device contains a biocompatible structure carrying a genetic material. The biocompatible structure includes a polymeric coating that coats at least a portion of the structure. The genetic material includes a first therapeutic agent comprising a vector containing a first polynucleotide sequence that establishes a gene expression sufficient to produce a therapeutically sufficient amount of one or more products encoded by said first polynucleotide; and a second therapeutic agent comprising at least one of (i) a second polynucleotide carried by a carrier; (ii) a protein; (iii) a non- genetic therapeutic agent; or (iv) cells. The medical device and method of this invention facilitate successful integration as and long term expression of one or more genetic-based and non-genetic based products within a patient's body.

La présente invention concerne, d'une part un dispositif médical implantable ou se posant en insert et convenant à des schémas posologiques de thérapie génique, et d'autre part un procédé pour réaliser et utiliser un tel dispositif. Ce dispositif médical contient une structure biocompatible portant un matériau génétique. Cette structure biocompatible comporte un enrobage polymère qui recouvre au moins une partie de la structure. Le matériau génétique est constitué de deux agents thérapeutiques. Le premier agent thérapeutique comprend un vecteur contenant une première séquence polynucléotide instaurant une expression génique suffisance à la production d'une quantité thérapeutiquement suffisante d'au moins un produit codé par le polynucléotide. Le second agent comprend au moins (i) un second polynucléotide porté par le vecteur, (ii) une protéine, (iii) un agent thérapeutique non génétique, ou (iv) des cellules. Le dispositif médical et le procédé de l'invention favorisent l'intégration réussie et l'expression à long terme à l'intérieur de l'anatomie d'un sujet d'au moins un produit de nature tant génétique que non génétique.

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