“Latest Stem Cells News”

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 is the extension of clinical testing of our proprietary human neural stem cell platform to all three elements of the central nervous system: the brain, spinal cord and eye,” said Martin McGlynn, President and CEO of StemCells, Inc. “The preclinical data supporting our IND is particularly compelling and we look forward to getting this trial underway.”

The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial will be an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina. Patients’ vision will be evaluated using conventional methods of ophthalmological assessment at predetermined intervals over a one-year period. Patients will then be followed for an additional four years in a separate observational study.

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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 million in grants awarded Wednesday to California universities and companies represent a big step toward moving stem cells from basic research toward application in treating diseases like cancer and AIDS. Grant recipients are supposed to have a therapy ready for initial human testing in four years.

“But only four of the 14 projects involve embryonic stem cells. The others will use so-called adult stem cells or conventional drugs intended to kill cancer stem cells, which are thought to give rise to tumors.

“The grants thus represent a departure from the program’s original mission. California voters approved the 10-year, $3 billion effort in 2004 largely to get around restrictions on embryonic stem cell research imposed by the administration of President George W. Bush.”

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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, particularly in the form of bone marrow transplants, are already used in medicine. Osiris is hoping that Prochymal will become the first stem cell product approved by the Food and Drug Administration and sold as a mass-produced pharmaceutical product (…)

from http://www.nytimes.com/2009/09/09/health/research/09drug.html

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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 of endometrial cells in humans was one of the major forces behind the now growing field of endometrial stem cell research,” said Thomas Ichim, CEO of Medistem. “We strongly believe that Dr. Taylor’s deep scientific understanding of biological mechanisms occurring in the endometrium will serve as a foundation for our clinical development programs.”

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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 FDA has granted approval for the trial to advance to the final two groups of patients (three in each group), all of who will be transplanted in the cervical, or upper, region of the spinal cord.

“This represents a major accomplishment for the trial, meaning that we have achieved our stated goal of proving safety in the first 12 patients who received lumbar spinal injections,” says Jonathan Glass, MD, Professor of Neurology, Emory School of Medicine and director of the Emory ALS Center.

“Our next objective is to demonstrate that we can deliver the cells safely to the cervical spinal cord, which is particularly important because therapy in this region may help patients better maintain their ability to breathe.”

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In his latest defiance of the federal government, Gov. Rick Perry is trying to make Texas the nation’s top provider of an unlicensed therapy touted by some as the future of medicine but considered not close to ready for mainstream use by scientists in the field.

Perry this summer worked with his Houston doctor and a state legislator with multiple sclerosis to write legislation intended to commercialize the controversial therapy, which involves injecting patients with their own stem cells. Perry quietly got the therapy as part of back surgery in July.

“With the right policies in place, we can lead the nation in advancing adult stem cell research that will treat diseases, cure cancers and, ultimately, save lives,” Perry wrote the Texas Medical Board on July 25.

The board may squelch Perry’s hope of making stem cell therapy a thriving Texas industry anytime soon. It is scheduled to consider a new policy on Nov. 4 that would prevent doctors from providing stem cell therapy unless they had approval from an independent review committee that assesses research trials for patient safety. Perry’s therapy had no such oversight.

Such a policy likely would head off potential conflict with the Food and Drug Administration, which recently has begun to crack down on stem cell businesses in the United States. The FDA has not approved therapy using adult stem cells because their effectiveness and safety have not been established (…)

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