News Feature | August 20, 2014

FDA Consortium Studies Stem Cell-Based Treatments

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) has published a blog in the FDA Voice reporting that the agency has been busy studying stem cell therapy to ensure they are used safely in treating patients.

Stem cell products possess potential as regenerative medicine which could be used to repair not only wounds but heart, brain, or nerve damage. In particular, the multipotent marrow stromal cell (MSC), also known as the mesenchymal stem cell, has captured a lot of attention in stem cell research thanks to its flexibility and proliferation capacities. MSCs are obtained from bone marrow and fat and can be grown outside the body in large numbers to serve a variety of therapeutic purposes. However, manufacturing MSCs outside the body raises questions on its safety and effect on healing. The FDA said it believes answering these questions will help characterize MSCs and guide their future development into treatments.

The FDA’s Center for Biologics Evaluation and Research has assembled seven of its laboratories into the MSC Consortium to investigate stem cell based therapies as they go through the development process. With the help of bone-marrow derived MSCs from eight human donors, the consortium has published scientific discourses on a range of topics. Among these are:

  • Assessment of human MSCs’ ability to suppress certain types of immune cells in mice
  • Production of a 7753-strong MSC protein database to show large variability from samples
  • Designation of 84 proteins on the MSC surface which can be used for tracking MSCs
  • Development of quantification techniques for MSC multiplication and differentiation
  • Recognition of specific genes that could help in assessing quality of MSCs before being used in patients

Dr. Steve Bauer, chief of the Cellular and Tissues Therapy Branch, Division of Cellular and Gene Therapies, in the Office of Cellular, Tissue, and Gene Therapy at FDA’s Center for Biologics Evaluation and Research, and who wrote the FDA Voice blog, said, “My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine. Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

The post was published the same day that the FDA granted premarket notification clearance to a new therapy named Premvia from BioTime. Premvia belongs to the BioTime HyStem family of hydrogels that mimics the natural structure of the human body’s extracellular matrix and is indicated for the management of various types of wounds including ulcers, post-laser surgery, burns, and skin tears. BioTime has big plans for its HyStem technology, which it plans to use to formulate products that are manufactured from stem cells— in particular, pluripotent stem cells.