Immunosuppressive therapy procedure

The first in human trial (FIH) for cell-based therapies is in patients often with no available alternative therapies rather than in normal volunteers. These are also populations where clinical effects are less easy to manifest themselves and where adverse events may be difficult to distinguish from disease-associated events. The surgical procedures and use of immunosuppressants may also contribute to the adverse event profile. Therefore it is even more important to understand the nature and extent of the pathological process underlying the disease symptoms of the patients enrolled in the early clinical trials. 

The appearance in debilitated patients of opportunistic fungal infections after therapy with antibiotics and corticosteroids or other immunosuppressive agents continues to be emphasized.Since these medicaments are vital in procedures such as the transplantation of organs, antifungal agents become more important for prophylactic or therapeutic use. All indications are that they will continue to increase in importance. 

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