Methods comprising apoptosis inhibitors for the generation of transgenic pigs

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Stem Cell Related Patent Number US6692738

Title:Delivery of therapeutic biologicals from implantable tissue matrices
Inventors:MacLaughlin, David T.; Saugus, MA, USA
Vacanti, Joseph P.; Winchester, MA, USA
Donahoe, Patricia K.; Boston, MA, USA
Masiakos, Peter T.; Boston, MA, USA
Summary:Described herein is a treatment modality for any disorder characterized by excessive proliferation of tissue, via an implantable matrix with attached cells that stably express a gene encoding a biological modifier. The invention relates to a method for treating abnormal cell or tissue growth by implanting in the subject a cell-matrix structure in which the matrix is attached to allogeneic or autologous cells that have been genetically engineered. Further disclosed are methods by which normal cells, such as fibroblasts or other tissue or organ cell types, are genetically engineered to express biologically active, therapeutic agents such as proteins that are normally produced in small amounts, such as members of the TGF-beta family, Herceptin TM, interferons, and anti-angiogenic factors. Also provided are the means by which these cells are seeded into a matrix for implantation into a patient to be treated, after having been engineered to include a lethal gene so that implanted cells can be destroyed once treatment is completed. Methods of cellular implantation into a variety of matrices is described, including matrices that are biodegradable over a period of time equal to or less than the expected period of treatment, when cells engraft to form a functional tissue producing the desired biologically active agent. Further disclosed are methods by which matrices may be formed of synthetic or natural materials, by chemical coupling at the time of implantation, using standard techniques for the formation of fibrous matrices from polymeric fibers, and using micromachining or microfabrication techniques. Therapeutic applications are included, such as in the treatment of various types of cancer such as epidermoid carcinoma, cervical carcinoma, endometrial adenocarcinoma, ovarian adenocarcinoma, breast cancer, or in any abnormal cell or tissue growth that is vulvar.
Abstract:Normal cells, such as fibroblasts or other tissue or organ cell types, are genetically engineered to express biologically active, therapeutic agents, such as proteins that are normally produced in small amounts, for example, MIS, or other members of the TGF-beta family Herceptin.TM., interferons, andanti-angiogenic factors. These cells are seeded into a matrix for implantation into the patient to be treated. Cells may also be engineered to include a lethal gene, so that implanted cells can be destroyed once treatment is completed. Cells can be implanted in a variety of different matrices. In a preferred embodiment, these matrices are implantable and biodegradable over a period of time equal to or less than the expected period of treatment, when cells engraft to form a functional tissue producing the desired biologically active agent. Implantation may be ectopic or in some cases orthotopic. Representative cell types include tissue specific cells, progenitor cells, and stem cells. Matrices can be formed of synthetic or natural materials, by chemical coupling at the time of implantation, using standard techniques for formation of fibrous matrices from polymeric fibers, and using micromachining or microfabrication techniques. These devices and strategies are used as delivery systems via standard or minimally invasive implantation techniques for any number of parenterally deliverable recombinant proteins, particularly those that are difficult to produce in large amounts and/or active forms using conventional methods of purification, for the treatment of a variety of conditions that produce abnormal growth, including treatment of malignant and benign neoplasias, vascular malformations (hemangiomas), inflammatory conditions, keloid formation, abdominal or plural adhesions, endometriosis, congenital or endocrine abnormalities, and other conditions that can produce abnormal growth such as infection. Efficacy of treatment with the therapeutic biologicals is detected by determining specific criteria, for example, cessation of cell proliferation, regression of abnormal tissue, or cell death, or expression of genes or proteins reflecting the above.
US Patent Website:Click Here for Full Text of Patent
Title Number:US6692738
Application Number:US2001000770339
Date Filed:26/01/2001
Date Published:17/02/2004
Assignee:The General Hospital Corporation, Boston, MA, USA


 
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