stemedica
Friday, April 2, 2010
Novelty Id Yonge Street
stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing has announced that it has submitted an investigation new drug (IND) to the Food and Drug Administration U.S. (FDA) for a clinical trial. The trial will evaluate the safety, tolerability and efficacy of high-power property Stemedica allogeneic mesenchymal stem cells from bone marrow-derived (human adults) as treatment for ischemic stroke.
The proposed clinical trial is a phase I / II dose escalation and safety trial using allogeneic bone marrow mesenchymal cells intravenously to patients with ischemic stroke. The patient population includes people with significant functional impairment or neurological problems related to ischemic stroke limiting the subject to a wheelchair or requires the subject to have home care of enfermeríao general assistance with activities of daily living. The proposed trial will be conducted at medical centers in the United States.
"Stemedica achieved another milestone in its development program from research to the bedside to help people suffering from stroke," said Nikolai Tankovich, MD, PhD, President and Chief Medical Stemedica in Chief. "In addition to the official licenses of our manufacturing facility in San Diego, California, we have now established our own way of clinical trials agreement FDB with the FDA and regulatory requirements. Stemedica goal is to receive regulatory approval of mesenchymal stem cells in this clinical indication. "
"We are pleased that Michael Levy, MD, PhD, chief of Pediatric Neurosurgery Rady Children's Hospital of San Diego and professor of surgery at the UCSD School of Medicine, is principal investigator leader in our clinical trial, "said Maynard A. Howe, PhD, Vice President and General Manager, adding: "Stemedica undertakes to develop, manufacture and distribute adult stem cells have the potential to save, restore and enhance human life. This mission is central to everything we do and Stemedica engaged in the execution of this mission with great pasióny scientific discipline. "
Stemedica license was granted by the State of California Department of Public Health, Division of Food and Drugs for the production of stem cells for clinical trials in July 2009 . The drug manufacturing Stemedica License grants the right to manufacture clinical-grade (for human use) or biological pharmaceuticals and recognizes Stemedica when complying with California law and applicable provisions of the Code of Federal Regulations.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a biopharmaceutical company committed to developing and manufacturing the best adult in-class stem cells and stem cell factors for use by institutions approved research and hospitals for pre-clinical trials and human. The company is currently developing regulatory systems for wound repair apoplejíay. Stemedica is headquartered in San Diego, California.
The proposed clinical trial is a phase I / II dose escalation and safety trial using allogeneic bone marrow mesenchymal cells intravenously to patients with ischemic stroke. The patient population includes people with significant functional impairment or neurological problems related to ischemic stroke limiting the subject to a wheelchair or requires the subject to have home care of enfermeríao general assistance with activities of daily living. The proposed trial will be conducted at medical centers in the United States.
"Stemedica achieved another milestone in its development program from research to the bedside to help people suffering from stroke," said Nikolai Tankovich, MD, PhD, President and Chief Medical Stemedica in Chief. "In addition to the official licenses of our manufacturing facility in San Diego, California, we have now established our own way of clinical trials agreement FDB with the FDA and regulatory requirements. Stemedica goal is to receive regulatory approval of mesenchymal stem cells in this clinical indication. "
"We are pleased that Michael Levy, MD, PhD, chief of Pediatric Neurosurgery Rady Children's Hospital of San Diego and professor of surgery at the UCSD School of Medicine, is principal investigator leader in our clinical trial, "said Maynard A. Howe, PhD, Vice President and General Manager, adding: "Stemedica undertakes to develop, manufacture and distribute adult stem cells have the potential to save, restore and enhance human life. This mission is central to everything we do and Stemedica engaged in the execution of this mission with great pasióny scientific discipline. "
Stemedica license was granted by the State of California Department of Public Health, Division of Food and Drugs for the production of stem cells for clinical trials in July 2009 . The drug manufacturing Stemedica License grants the right to manufacture clinical-grade (for human use) or biological pharmaceuticals and recognizes Stemedica when complying with California law and applicable provisions of the Code of Federal Regulations.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a biopharmaceutical company committed to developing and manufacturing the best adult in-class stem cells and stem cell factors for use by institutions approved research and hospitals for pre-clinical trials and human. The company is currently developing regulatory systems for wound repair apoplejíay. Stemedica is headquartered in San Diego, California.
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