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Osiris Cleared by FDA to Begin Phase II Stem Cell Trial for the Treatment of Crohn's Disease
12-08-05
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Baltimore, Maryland - December 8, 2005 - Osiris Therapeutics, Inc. announced today that it has received
clearance from the U.S. Food and Drug Administration (FDA) to begin enrollment in a Phase II clinical trial to evaluate the safety and effectiveness of PROCHYMAL™ for the treatment of Crohn’s Disease. With the launch of this progra...
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Osiris Reaches Safety Milestone in Stem Cell Clinical Trial for Cardiac Patients
11-04-05
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Baltimore, MD, November 04, 2005 - Osiris Therapeutics, Inc. announced today that its multi-center, human clinical stem cell trial for the treatment of patients suffering from heart attacks has successfully passed the first safety milestone of the trial. Additionally, the novel stem cell therapy was cleared by the presiding independent saf...
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Stem Cell Drug Saves Baby From Blood Disorder
10-14-05
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New Stem Cell Drug Gives baby Second Chance
10-14-05
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New stem cell treatment being evaluated for critically ill bone marrow transplant patients
10-12-05
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BALTIMORE, Maryland October 12, 2005 Osiris Therapeutics, Inc. announced today that it has received clearance from the United States Food and Drug Administration (FDA) to conduct a Phase II trial to evaluate the safety and effectiveness of its lead investigational stem cell drug, Prochymal, for the rescue of patients with the most severe ...
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Osiris Launches the Osteocel Product Line
09-22-05
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BALTIMORE, Maryland - September 22, 2005 - Osiris Therapeutics, Inc. announced today that it has begun distribution of Osteocel a product indicated for the repair, replacement and/o reconstruction of bone defects. Osteocel is an allogeneic bone matrix containing viable stem cells. In developing the product, Osiris leveraged its extensive e...
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Osiris and JCR Pharmaceuticals Reach Milestone, Expand License Agreement
08-04-05
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BALTIMORE, Maryland August 4, 2005 - Osiris Therapeutics, Inc. announced today that it has expanded the terms of its license agreement with JCR Pharmaceuticals Co. Ltd. of Ashiya, Japan, allowing JCR to sell stem cells for use in the field of drug screening and evaluation in the territory of Japan. This technology will allow companies inv...
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Osiris Cleared by FDA to Begin Stem Cell Trial for Knee Repair
04-01-05
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Baltimore, MD, April 1, 2005 - Osiris Therapeutics, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration to begin enrollment in the first human clinical trial for a stem cell therapy targeted at injured tissue in knee surgery patients. Chondrogen, a formulation of adult mesenchymal stem cells, will...
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Osiris Launches the First Trial Using Adult Universal Stem Cells in Cardiac Patients.
03-31-05
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Baltimore, MD, March 31, 2005 Osiris Therapeutics, Inc. announced today that it has begun a multi-center, randomized clinical trial with Provacel, a novel therapeutic based on adult mesenchymal stem cells (MSCs).
“We are extremely enthusiastic about this study which represents the first use of an allogeneic adult stem cell t...
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Osiris First to Announce FDA Fast Track Designation for a Stem Cell Product.
01-31-05
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Baltimore, Maryland - January 31, 2005 - Osiris Therapeutics, Inc. announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Prochymal, an adult stem cell product formulated for the treatment of acute Graft vs. Host Disease or GVHD. Osiris believes FDA's decision makes the company the ...
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