Tag Archives: Food and Drug Administration

Walk again after 24 years on wheel chair using Stem Cells

From wheel chair to walk again

William Orr hasn’t always been in that wheelchair, 24 years ago he survived a tragic accident while riding his bike, leaving him paralyzed from the waist down. Today, he speaks with high hopes, optimism, and an emotional strength he will one day walk again, thanks to a Bonita Springs doctor.

Bill Orr is not quite walking. But he’s getting close. And his progress may be one of the best stories of 2010 for a whole lot of reasons.

The 50-year-old Aurora man has been a quadriplegic for half his life —
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Stem Cell Review: Biological Processes & Industrial Production

What are the biological processes that stem cells go through? What are the industrial processes we need to manufacturing? What do we know about cancer stem cells? How do iPS cells fit into the picture vs. embryonic stem cells? In this episode we investigate how the science and research of stem cells is being translated into industrial cell processes to create FDA approvable, and commercializable products. Differentiation, proliferation, migration, retro-differentiation, trans-differentiation, transformation into cancer cells, the role of tumors‘ micro environments and epigenetics and all reviewed here by the field’s foremost experts.

Researchers Connect New Genetic Signature to Leukemia

University of Rochester Medical Center scientists believe they are the first to identify genes that underlie the growth of primitive leukemia stem cells; and then to use the new genetic signature to identify currently available drugs that selectively target the rogue cells.

Although it is too early to attach significance to the drug candidates, two possible matches popped up: A drug in development for breast cancer (not approved by the Food and Drug Administration), and another experimental agent that, coincidentally, had been identified earlier by a URMC laboratory as an agent that targets leukemia cells.

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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