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the science- Altucap’s Micro Encapsulation Features and Benefits

1. Microcapsules, formulated with polymers of sodium alginate, a natural polysaccharide extracted from brown seaweeds, over layered or not with poly amino acids, are gel microspheres that serve for micro-containers of a variety of cells. Their equatorial diameter measures an average 500 microns (half millimeter). Highly specialized cells, such as for instance, pancreatic islet beta cells, secreting insulin, may be encapsulated with full retention of the entrapped cells viability and function. When containing secretory cells, the microcapsules constitute a bio-hybrid organ for bioactive molecules delivery.

2. Microcapsules available through Altucell, Inc. After 30 years of study, through the university of Perugia with extensively published papers in the international literature, are fabricated with ultra-purified ("clinical grade") alginic acid polymers that comply with FDA specifications for human use; in fact these capsules are highly biocompatible, selectively permeable and retrievable upon graft.

3. When containing pancreatic islets of Langerhans, the microcapsules may be transplanted in recipients with insulin-dependent diabetes mellitus and have been proven able to reverse hyperglycemia in pre-clinical animal models with spontaneous or artificially induced diabetes mellitus (rodents, dogs, primates).

4. Microcapsules formulated with ultra-purified alginates and poly-L-ornithine have reached the standards (permission obtained from European and Italian Agency for Drugs) for use in patients with type 1 diabetes: 4 transplanted patients with long standing type 1 diabetes have shown evidence of grafted encapsulated islet cells function throughout 5 years of post-transplant follow-up.

5. Depending upon the cell types that are lodged within microcapsules, the microencapsulated cells have been proven effective not only in the treatment of diabetes mellitus, but also of other chronic, including neurodegenerative (muscular dystrophy, chorea of Huntington etc.) diseases.

6. The microcapsules formulated with highly purified alginate have been shown to clearly prolong the life span of the encapsulated cells and are suitable for long-haul transportation with no loss of cell viability. These microcapsules are very easy to handle and transplant (easy injectable in the peritoneal cavity under local anesthesia).

7. Microcapsules Endotoxin content <(0.5Eu/g), meets FDA threshold for human transplant PCT/1B2009/050221