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
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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,
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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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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.

Yale Endometrial Stem Cell Expert Joins Medistem’s Scientific Advisory Board

Medistem Inc. announced the appointment of Dr. Hugh S. Taylor to its Scientific Advisory Board. Dr. Taylor is the first scientist to identify the bone marrow origin of endometrial tissue, and performed independent experiments demonstrating that endometrial stem cells are capable of treating diabetes and Parkinson’s Disease in animal models.

Dr. Taylor is Professor of Obstetrics, Gynecology, and Reproductive Sciences; Section Chief, Reproductive Endocrinology and Infertility; Director, Yale Center for Endometrium and Endometriosis and Director of the Yale Center for Reproductive Biology.

“Dr. Taylor has literally defined the field of endometrial stem cells. His fundamental discovery of the bone marrow origin
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