In Vivo Stem Cell Extraction Device Operational Under Hyperbaric Conditions

This submission describes techniques for extracting pluripotential, resident stem cells from patients requiring tissue engineered surgical reconstruction by inducing the release of those cells that is known to occur under altered ambient pressures. Fundamental to this goal is the design and construction of a hyperbaric-adapted aspiration and apheresis device. Elucidation of the most efficient chamber depth and ambient gas composition has not yet been defined by laboratory experiments. Therefore the range of environments where this device must work must initially be quite broad. Exploratory testing on the efficacy of maintaining the patient, and the proliferating stem cells, under these hyperbaric conditions (i.e. "saturation state") will be conducted. Further, preliminary testing on the ideal surfaces and enclosed matrices for the maturing engineered tissue can be conducted in the same chamber environment. Several lines of investigation will emerge from this Phase-I study, both in the laboratory and in clinical trials. All will need as their foundation the ability to release (perhaps even to induce) undifferentiated cells, and the to cull and nurture those cells. Currently tissue engineering has a luxury of elegant ideas and potential uses and a relative lack of raw materials. The product of this endeavor will help relieve that scarcity.