Cell therapy is the introduction of cells in an organism to generate, replace or repair injured, missing, degenerated, scarred or diseased tissues and shows tremendous potential in treating human disease, degeneration and injuries. Cell therapy has expanded drastically in the last few years, mainly because of the recent surge in stem cell research, one important source of which has been cord blood. In fact, clinicaltrials.gov shows more than about 1500 completed clinical trials employing stem cells, and another 1500 trials that are actively recruiting patients. Thus, tissue banks that collect and process tissues, cells and fluids for these uses are of growing importance to realize the potential of this promising new therapy.
Currently there are two types of banks for storing human material. Private banks are available for paying customers to store their own material, e.g., cord blood, semen, or blood products, for later private use. Public banks, in contrast, collect and store human material for research and development and for public health uses. To our knowledge, there are few, if any, combination facilities of this kind, e.g., hybrid banks with both public and private, clean room tissue, fluid or cell processing facilities, but we believe that such a structure provides increased efficiencies and economies of scale, as well as providing material for both kinds of users.
However promising the potential of cell therapies, especially stem cell therapies, the results to date have not been as good as anticipated. We believe this is attributable in large part to bad workflow and suboptimal bioprocessing and cell manufacturing at the various banks where such human materials are collected, processed and stored. Cells as therapeutic products are the essence of the bioprocess through which they are manufactured, and sloppy procedures, insufficient sample size, variable storage conditions, and the like can only hurt therapeutic outcomes.
There are many problems in the field that make the manufacturing of these cells suboptimal in their therapeutic potential. Manufacturers of cells can be defined as either of the following: 1. a private or family manufacturer (autologous product manufacturer) that collects, processes and stores stem cells taken from, e.g., a baby's umbilical cord for the purpose of use by the same baby or a first or second degree relative to the baby. 2. A public manufacturer (allogeneic product manufacturer) that collects, processes and stores stem cells taken from a baby's umbilical cord, among other materials, for the purpose of therapeutic use by any public individual that is compatible or matches immunologically with such cells.
Regulation governing these two manufacturers differs in stringency of testing and the environment in which these products are made. In general, there is more leniency on the autologous product manufacturer than the allogeneic product manufacturer. For example, eligibility determination and compatibility tests are not required for an autologous product. Clean room manufacturing is not required for either type of manufacturer, and the efficacy tests required for both manufacturing types are suboptimal.
Working in an unclassified room increases the chances of contaminating the cellular product. A random or complicated workflow is also doomed to increase the risk of mislabeling, reduce the safety of the operation, and erodes the controls. An air quality with low particle count or what is known as a classified clean room reduces the chances of air borne agents like viruses and bacteria and other particulates damaging the product or contaminating tools that touch the product.
Thus, what is needed in the art, is a much more rigorous production of human material for therapeutic uses, and the facilities needed to optimize the production of such materials.
USPTO Backgrounds
USPTO Backgrounds