Tag Archives: Food and Drug Administration

StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial

StemCells Inc. today announced that the U.S. Food and Drug Administration (FDA) has authorized the initiation of a Phase I/II clinical trial of the Company’s proprietary HuCNS-SC® product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD), the most common form of AMD. AMD is the leading cause of vision loss and blindness in people over 55 years of age, and approximately 30 million people worldwide are afflicted with the disease. There are no approved treatments for dry AMD.

“With the approval of this trial, we have accomplished something truly unique in the stem cell field, which
Read More…

First Stem Cell Drug Fails 2 Late-Stage Clinical Trials

What might become the first drug derived from human stem cells failed in two late-stage clinical trials, dealing a setback to the drug’s developer and to the stem cell field (…)

Prochymal is a preparation of mesenchymal stem cells, which are obtained from the bone marrow of healthy young adults.
Because the cells are derived from adults, they sidestep the ethical issues stemming from the destruction of human embryos needed to make embryonic stem cells. Unlike most other types of adult stem cells, mesenchymal cells grow well in culture, so thousands of doses can be produced from a single donation.

Stem cells,
Read More…

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
Read More…

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
Read More…

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
Read More…