Food for thought: the US FDA and the development of regenerative medicine products

What do you think about regulation of stem cells?

As a relatively new field, stem cells and regenerative medicine are in need of careful and regulated investigation and use to ensure practice is effective, safe and ethical. To date the FDA has only approved one stem cell-based product for use: cord blood-derived hematopoietic progenitor cells for certain indications such as certain blood cancers and some inherited metabolic and immune system disorders.

Steve Bauer, chief of the Cellular and Tissues Therapy Branch, Division of Cellular and Gene Therapies at the FDA’s Center for Biologics Evaluation and Research (CBER), blogged this week about the FDA’s approach to investigating stem cells as therapy, with a focus on MSCs — a type of adult stem cell popular in regenerative medicine research. The CBER has formed a consortium of laboratories to answer key questions on MSCs such as how manufacturing the cells in vitro may affect their efficacy and safety.

However, there have been some negative feelings towards the FDA over stem cell regulation — discussions in blogs, and court cases between the government and stem cell companies for example. Would you change how the stem cell research is regulated in the USA or do you feel that regulations in place for this fast-developing field are appropriate?

Please see the FDA blog post here.