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Sunday, May 25, 2014 11:09:18 AM
Capsules composed of cellulose sulphate and polydimethyldiallyl ammonium have excellent mechanical properties and can be manufactured to consistent diameter and pore size.
The encapsulated cells can be cultivated in a normal cell culture medium (the nature of which depends on the encapsulated cells) at standard conditions of humidity, temperature and CO2 concentration. During this culture period production of antibodies from the capsules into the cell culture medium can be demonstrated with either Western Blot or Elisa technology using specific antigens and can furtheron be quantitated using second antibodies conjugated to fluorogenic dyes.
After a suitable period in culture (normally not less than 1 hour and not exceeding 30 days), the cell containing capsules can be surgically implanted either directly, or by injection using a syringe into various areas of the body.
The antibodies produced by the encapsulated cells according to the invention can be based on any immunglobulin class useful for therapy, including but not limited to genetically modified antibodies.
The encapsulated cells according to the invention can be cells taken from patients or from any other source, including human and animal cells, that have been genetically modified for the production of cloned antibodies.
The encapsulated cells and capsules, respectively, are especially used for the implantation into a living animal body, including a human, for the treatment of diseases or disorders responsive to the antibodies released from said capsules. After implantation of capsules into an animal body intraperitoneally and subcutaneously it has been found that the capsules, especially cellulose sulphate capsules, offer an obvious advantage with respect to mechanical resistance over, for instance, alginate capsules since there are found intact as long as 10 months post-implantation regardless of whether they are implanted subcutaneously or intraperitoneally.
Additionally, it has been observed that subcutaneous and intraperitoneal implantations of cell-containing cellulose sulphate capsules revealed differences with respect to at least two points. First, the amount of antibody released in the bloodstream was markedly higher in the former situation. A very likely explanation for this difference resides in the fact that capsules are rapidly vascularized when implanted subcutaneously and are not vascularized at all when implanted intraperitoneally. The beneficial effect of vascularization might be two-fold, firstly facilitating antibody uptake by blood and, secondly, ensuring a better supply of nutrients favoring cell survival since viability of cells within intraperitoneally implanted capsules was reproducibly observed to be lower. In addition to extensive vascularization, which showed no significant alteration over the 10 months of the follow-up, the clustering of cells within a connective pouch after subcutaneous implantation would allow removal of capsules through an easy onestep surgical ablation of the whole neorgan should this prove necessary. Finally, it is important to underline that development of isolating fibrosis around implanted cellulose sulphate capsules is not systematic. This observation contrasts with what has been reported in the case of alginate-poly(L)-alginate microcapsules around which a host reaction with fibrosis developed probably as a result of potent macrophage activation by the encapsulating polymer (Pueyo, M. E, et al., J. Biomater Sci. Polym. Ed., Vol. 5, 197-203 (1993)).
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