TT-283 – Therapeutic Hybrid Implantable Devices

Cellular and tissue replacement therapy offers significantpromise as the future of regenerative medicine in prevalentdiseases and clinical conditions. Diseases, such as diabetes,immune system disorders, and Parkinson’s disease forexample, are from the inability of the patient’s own cells andtissues to produce normal levels of bio-factors. Suchconditions may be treated by cell/tissue transplants byproviding a safe and effective means to produce and deliverthese deficient bio-factors.Many challenges, however, continue to exist in the field ofcell/tissue replacement therapy. Transplanted cells andtissues have limited viability/functionality and are highlyinfluenced by matrix vascularization, mechanical protection,and immune reaction by the host. Although not ideal, long-termsystemic immunosuppressive drugs are given to patientswith cell/tissue transplants. Furthermore, successfulintegration of a cell and tissue transplant would requireingrowth of surrounding, native tissue through successfulvasculature before, during, and after implantation.Technology:This invention is a hybrid device that combines i) an implanted device containing a vascularized biological matrixused to support cell/tissue transplant product and ii) an external delivery system. The implanted device isencapsulated within a biocompatible material and designed to mechanically protect the cell/tissue product. It alsocontains porous membranes and conduits throughout the housing to allow for drug, nutrient, and waste delivery.The device is designed to be implanted as a single- or two-step surgical procedure: a single step surgicalprocedure would already contain the cell/tissue product within the implant, and a two-step surgical procedure wouldallow the device to be pre-vascularized by the patient’s body and then later implanted with transplanted cell/tissueproduct within the lumen established by the unique design of the device. The external delivery system is areservoir, or an external pump, used outside of the patient’s body to deliver a sustained release of drugs and/ordifferent media cartridges necessary to maintain the function and viability of the transplanted cell/tissue product.The reservoir can be tailored to the patient’s needs and can consist of interchangeable and disposable cartridges.The key advantages: Overcomes the limitation of requiring long-term systemic immunosuppression by providinglocal immune-regulatory substances to recipients of implants; local delivery of drugs and growth factors alsofacilitate cellular engraftment, growth, and therapeutic function. Peter Gutenberg 305-243-4604

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