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Not surprisingly this comes from Osiris, an American adult stem cell therapy that has been around for a long time- just waiting to pounce on the American market, but being hindered by the heavy FDA regulations and process.
However, now it looks like they have found their way with this:The experimental drug is called Prochymal, which is a massive dose of mesenchymal cells given in a few doses through an IV.“Prochymal is a formulation of a particular kind of cell that's found in the bone marrow of children and, to a lesser extent, adults, and the cell is a mesenchymal cell, said C. Randal Mills, president and CEO of Osiris. “The mesenchymal stem cell is the cell in our body that enables us to respond appropriately to connective tissue injury. So what does that mean? If you burn yourself, if you cut yourself, if you break a bone, if you get an ulcer, the way you heal from those is mediated by the mesenchymal stem cells.When the mesenchymal cells realize there is a connective tissue injury, Mills said they come out of the bone marrow, travel to the injury and graft. If it is a broken bone, they will heal the bone, he said; if it is a burn, they will turn off the inflammation associated with the burn and heal the damage and any muscle damage.“They're a rather universal cell for how our body responds to injuries naturally, Mills said. “So what we'vebeen able to do is isolate that one cell out of healthy, young adult donors between the ages of 18 and 30 years old, so there's no ethical or political controversy around it, and we can actually grow the cell so it will expand and multiply, so we have from a single donation, we can actually make 10,000 doses of this product.The drug is being developed for several diseases, but two are in Stage III studies the final stage of safety and efficacy studies until it goes to the U.S. Food and Drug Administration for approval for use in the public. The graft-versus-host study is the furthest along, set for approval in the first half of 2009, Mills said, and the Crohn's disease study is a year or two behind.Osiris sets out to solve critical unmet medical needs, Mills said, with no acceptable current therapeutic alternatives.“Right now, Prochymal is set to if all goes well become the world's first stem cell product approved anywhere in the world for anything, Mills said. “And so certainly that is one of the goals we set out to do, is to bring to the market the world's first stem cell drug. But it's what we wanted to do that for that is important: To go in and solve an unmet medical disease like GVHD which literally kills little children, and they suffer a horrendous fate. It's going in and relieving that suffering and saving children's lives. It's the kind of thing we should be using stem cell technology for, and we feel very strongly about that.
Fantastic- "approved anywhere in the world for anything
"!!!!!! Imagine that. They are also testing Prochymal in diabetes and COPD. If you are interested in trying to get into one of their trials, you can- The company is still accepting volunteers for both the graft-versus-host study and the Crohn's study. For information or the possible participation, e-mail firstname.lastname@example.org.
Also, for all of you who say that the United States is falling behind in stem cell research
(you know who you are-embryonic profiteers)- that isn't the case. Actually the technology and research is here already: Adult Stem Cells. The United States is just so slow to implement their use. However, companies like Osiris are the future of medicine (and the future is now!)- and they didn't need a stem cell research bill passed to develop their product. Hint hint Michigan!Click here to read the full article