Tag Archives: Food and Drug Administration

CIRM awards $25 million to support spinal cord injury trial, $37.7 million for basic stem cell science

The Governing Board of the California Institute for Regenerative Medicine, the State Stem Cell Agency, approved a $25 million award to support the first FDA-approved clinical trial based on cells derived from human embryonic stem cells.

The award to Menlo Park-based Geron, Corp, will support the company’s on-going early phase trial for people with spinal cord injury. This is the first time the agency, which was created by the passage of proposition 71 in 2004, has funded a human clinical trial testing a stem cell-derived therapy.

“Supporting the Geron trial is a landmark step for CIRM,” said Robert Klein, CIRM
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FDA Information on Stem Cells

Are any stem cell treatments approved in the U.S.?

FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications including certain blood cancers and some inherited metabolic and immune system disorders.

What should consumers know before being treated with therapies derived from stem cells?

As is the case with any investigational treatment, consumers should speak with their doctor to learn about the potential risks and benefits from being treated with a stem cell-based product. Consumers should seek assurance from their treating physician that necessary FDA approval has been
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FDA Approves Continuation of ALS Stem Cell Trial

Emory University researchers have received approval from the Food and Drug Administration (FDA) to advance to the next phase of a landmark trial to treat patients with Amyotrophic Lateral Sclerosis (ALS) using human neural stem cells.

The Phase I trial, currently underway exclusively at Emory University, is designed to assess the safety of implanting neural stem cells into the spinal cord in up to 18 people with ALS and began in January 2010. The first 12 patients received neural stem cell transplants in the lumbar, or lower, region of the spinal cord. After reviewing safety data from these patients, the
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California Stem-cell Institute Makes First Development Grants

Five years after the passage of Proposition 71, the California Institute of Regenerative Medicine is awarding grants for stem-cell research targeted at clinical applications. In what both the San Diego Union-Tribune and Knight Science Journalism Tracker are calling an “irony,” ten of the 14 grants are going to researchers working with adult stem-cells.

On Thursday, October 29, the New York Times reported: “In a tacit acknowledgment that the promise of human embryonic stem cells is still far in the future, California’s stem cell research program on Wednesday awarded grants intended to develop therapies using mainly other, less controversial cells.

“The $230
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Deadly Progression of ALS Reversed in an Amazing Stem Cell First

39-year-old Ted Harada was diagnosed with ALS, also known as Lou Gehrig‘s disease. It’s one of the worst diagnoses anyone could get.
He and his doctors expected his health to have severely declined by now. But thanks to an experimental stem cell treatment, he has tossed his cane and is once again playing in the pool with his three kids (…)

Then his neurologist told him about an experiment at Emory University that was recruiting ALS patients to test a stem cell treatment.
The surgeons told Harada that injecting the stem cells into his spine likely would not help him personally, and
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