Tag Archives: Food and Drug Administration

Geron explains stop on stem cell study

MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application
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FDA approves ALS clinical trial

The U.S. Food and Drug Administration has approved the start of a mid-stage clinical trial of an adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS) according to its developer, BrainStorm Cell Therapeutics Inc. The Phase II clinical trial will be launched initially at UMass Medical School and Massachusetts General Hospital in Boston.

BrainStorm, an Israel-based biotech company developing stem cell technology to provide treatments for currently incurable neurodegenerative diseases, has been working with Robert H. Brown Jr., DPhil, MD, the Leo P. and Theresa M. LaChance Chair in Medical Research and chair and professor of neurology, to
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Video: StemCells Inc. using Neural Stem Cells for their Neuroprotective Effect

Discover StemCells, Inc. A pioneer in the field of neural stem cells, StemCells Inc was founded by the renown Irving Weissman, Fred Gage, and David Anderson. Martin McGlynn, CEO, presents StemCells Inc’s use of neural stem cells, and clinical development strategy based on the neuroprotective effect of neural stem cells.

Stem Cells Inc is preparing a BLA for NCL (a.k.a. Batten’s Disease). Martin reveals the source of the stem cells used, as well as the quantity of cells needed for the treatment of various diseases. StemCells Inc’s next clinical trials (PMD, spinal cord, macular degeneration) and milestones are also presented
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Why Germany is REALLY ahead in stem cell treatments

A husband and wife pair in western Washington state are trying to raise money for him to go to Germany for a stem cell transplant for his failing heart. Erik and Jenn Gelhar have already raised $40,000 of the $100,000 they need to get him to Germany for the treatment at XCELL Centre in Dusseldorf Germany.

So why does an American have to travel to Germany to get such a treatment? Why are they farther ahead than the United States in adult stem cell treatments for heart disease? According to this article that quotes Dr. Charles Murray of University of
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Adult Stem Cell Research Shows Promise

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA’s Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function (…)