Stem cell immunomodulator ready for clinical trial
Celgene Cellular Therapeutics, a subsidiary of Celgene Corporation, has announced that the FDA has authorized clinical trials using PDA001, an immunomodulator based on placental stem cells, the method of isolation of which is patented by the company, to apply for registration of a new drug.
Phase I clinical trials will begin at the end of 2008 with a multicenter clinical trial in the United States involving patients with moderate to severe Crohn's disease in whom the use of oral corticosteroids, such as prednisone, as well as immunosuppressants proved ineffective.
Celgene Cellular Therapeutics (CCT) is the owner of a number of technologies aimed at obtaining new types of placental cells and cell populations, as well as methods for isolating, processing and storing various types of stem cells obtained from the placenta.
Robert Harry, Chairman of the Board of Celgene Cellular Therapeutics, said: "This is the first stage in our program to launch a clinical evaluation of indications for use, including not only Crohn's disease, but also other serious inflammatory and autoimmune diseases, such as multiple sclerosis and rheumatological disorders."
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