San Diego biotechnology and civic leaders threw their support behind stem cell research eight years ago, when the state’s voters approved Proposition 71, the $3 billion state stem cell initiative.Californians were promised that the research would lead to therapies for diseases and injuries that had no cure, such as spinal paralysis and diabetes. Once scientists had done the research, biotech companies in the field known as regenerative medicine would take over and bring the therapies to market.San Diego research centers banded together to bring in stem cell grants, getting more than $261 million. Local leaders calculated there would be commercial benefits as well, reinforcing San Diego’s stature as one of the world’s top biotech centers.Now, that commercialization is starting to take place. Local biotechs are testing stem cell therapies in patients, in the United States, in Europe and in China.Cures for diabetes, heart failure, and even baldness are being developed by San Diego companies; the last two already being tested in patients. While these treatments are still experimental – success is far from certain – they provide a preliminary indication that regenerative medicine is on the road to becoming a new growth area for the region’s large biotechnology industry.About a dozen San Diego-based companies, such as ViaCyte, Histogen and Medistem, are working on treatments with various kinds of stem cells, the “ancestral” cells that give rise to the various cells in the body. Some are using cells derived from human embryos, still a controversial practice to many. But most others are using cells derived from nonembryonic sources, such as skin and umbilical cord blood.These treatments are mostly in the early stages of clinical trials; meaning they will take years to get approval. But at least one local company, Cytori Therapeutics, has begun a “pivotal” trial of its stem cell treatment for heart failure, in Europe. A pivotal trial is designed to get the statistically significant evidence of effectiveness needed for regulatory
Cytori Therapeutics: Showtime for Stem Cells
approval.Other San Diego stem cell companies conducting clinical trials include Medistem, for heart attack and heart failure patients; Fate Therapeutics, for blood stem cell transplantation; and Stemedica for heart attacks. ViaCyte is preparing to start a clinical trial with its own stem cell-based diabetes treatment, bolstered by a $10.1 million grant last month from the state’s stem cell agency, the California Institute for Regenerative Medicine.To illustrate the challenges and opportunities facing local stem cell companies, the stories of Histogen, Medistem and Cytori are instructive. Histogen combines scientific acumen with hard-won business experience; Medistem has developed a technology around a special kind of stem cell; and Cytori has turned fat into something to be desired.
Histogen: First, find the market
Gail Naughton, Histogen’s chief executive, learned about the promise and pitfalls of regenerative medicine at Advanced Tissue Sciences. Naughton, who holds a doctorate in hematology, founded the privately held company in New York in 1986 and later moved it to San Diego.Advanced Tissue Sciences successfully developed a living skin replacement called Dermagraft now used to treat diabetic ulcers. But the company ultimately went bankrupt because of delays in getting insurer approvals for reimbursement. (Dermagraft is being sold today by Shire Regenerative Medicine, which makes it in San Diego.)
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