Osiris is a development stage company with no products currently on the market.

The company plans to ask for a priority review, meaning the agency would respond to its application within six months instead of the usual 10 months. Osiris is developing Prochymal with Genzyme Corp.

From the research side, the stem cell source we use is completely unregulated. In fact, you’re able to do whatever research you want on any kind of stem cell. The only restriction is that you can’t get federal funding for research involving embryonic stem cells, unless it comes from specific stem cell lines.

We get our stem cells from bone marrow of healthy young adults between the ages of 18 and 30. Bone marrow contains a number of different cells, but we use only the mesenchymal stem cell, or the MSC. Once we collect them, we’re able to expand the cells to produce 10,000 doses of our drug. The process by which we grow stem cells is a fairly standard GMP compliant biotechnology and manufacturing process.

We don’t get involved in the harvesting of the bone marrow. Many companies collect bone marrow, so we can literally buy it off the shelf. It’s inexpensive, noncontroversial, and we can get as much as we need. Because we mass produce the product at low costs, we’re able to transform this technology from interesting science into a business.

MSCs do three things: They downregulate inflammation, they work to regenerate the damaged connective tissue, and they prevent scarring or fibrosis. That’s the Holy Trinity of the mesenchymal stem cell. It’s the natural progression or sequence of how we respond to injury. When we’re young, that process works well. Children heal in miraculous ways. Conversely, an elderly person will die of something like a fractured hip. This is because children have 1,000-fold more MSC in their body than adults do. What happens is an adult ends up with a very exaggerated inflammatory response, a weak regenerative response, and a lot of scarring. We can reverse that trend by administering MSC.