Alexander M Bailey

Learn More
Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential(More)
721 regenerative medicine products, as they comprise diverse and heterogeneous products with varying biological and technological complexity. For example, they often incorporate cell types with varied phenotypes isolated from diverse tissue sources (e.g., bone marrow, adipose tissue, placenta and fetal tissue2); manufacturing processes vary among product(More)
We summarize the public health response after the identification of 2 cases of pneumonia caused by Blastomyces dermatitidis infection in Colorado residents. The response to these cases emphasizes the need for physicians to add fungal infection to the list of differential diagnoses for patients who have refractory pneumonia, even those who live in areas of(More)
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations,(More)
  • 1