Clostridium difficile infection, commonly referred to as C. diff, is generally acquired after antibiotic treatment or through environmental exposure in a hospital or nursing home setting. C. diff has grown to epidemic levels in the United States and other countries. While many patients can be treated successfully with antibiotics, there are still treatment failures. Also, reoccurrence after cessation of the antibiotic treatment is not uncommon. These patients may be good candidates for the restoration of normal gut flora through transplant of fecal microbiota. In this session, clinical activities will be thoroughly reviewed. The manufacture of this product, and non-attenuated products such as vaccines, present unique concerns related to contamination of the manufacturing facility with undesirable organisms. This session provides practical information related to the manufacturing controls necessary to ensure the ability to continue the manufacture of other cell therapy products within the same facility. The regulatory approach, including donor screening and testing requirements, necessary to submit an FDA accepted IND will be discussed in detail.