“Latest Stem Cells News”

Aastrom Biosciences, Inc. (Nasdaq:ASTMD), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported results from a planned interim analysis of the company’s multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. According to the interim analysis the safety profile was similar between the treatment and placebo arms.

Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, wound size and gangrene), Aastrom’s autologous vascular repair cells (VRCs) were more effective than placebo (P<0.05). Other clinically meaningful endpoints (e.g., major amputation rate, complete wound closure) approached but did not reach statistical significance at interim analysis. Forty-six critical limb ischemia (CLI) patients who had at least 6-month follow up, including 33 patients with 12-month follow up, contributed to the interim analysis.

Discover StemCells, Inc. A pioneer in the field of neural stem cells, StemCells Inc was founded by the renown Irving Weissman, Fred Gage, and David Anderson. Martin McGlynn, CEO, presents StemCells Inc’s use of neural stem cells, and clinical development strategy based on the neuroprotective effect of neural stem cells.

Stem Cells Inc is preparing a BLA for NCL (a.k.a. Batten’s Disease). Martin reveals the source of the stem cells used, as well as the quantity of cells needed for the treatment of various diseases. StemCells Inc’s next clinical trials (PMD, spinal cord, macular degeneration) and milestones are also presented here. We conclude this interview with Martin’s comments on successfully dealing with the complexity of regularity matters, beyond FDA approval.

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.”

A husband and wife pair in western Washington state are trying to raise money for him to go to Germany for a stem cell transplant for his failing heart. Erik and Jenn Gelhar have already raised $40,000 of the $100,000 they need to get him to Germany for the treatment at XCELL Centre in Dusseldorf Germany.

So why does an American have to travel to Germany to get such a treatment? Why are they farther ahead than the United States in adult stem cell treatments for heart disease? According to this article that quotes Dr. Charles Murray of University of Washington, it is because of Bush’s funding restrictions on embryonic stem cell research and cloning:

Erik Gelhar is unable to get treatment in the United States because they are not as advanced as Germany in stem cell research. Germany has cutting edge technology and the people’s view about stem cell therapy is different, Jenn Gelhar said.

Dr. Charles Murry, co-director at the University of Washington’s Institute for Stem Cell and Regenerative Medicine, said the U.S. is still in the early stages of stem cell research. He said the ban that the Bush administration put on federal funding for the research slowed down the progression since it was a controversial and political issue (…)

The reason Germans are so far ahead in adult stem cell treatments is because they don’t waste time or money on stem cell research that does not now, and may never, treat patients i.e. embryonic stem cell research and cloning. (Imagine where the United States would be if millions of dollars that are spent on embryo destructive research were put into adult stem cell research instead.)

Gelhar also has to fly to Germany because the Food and Drug Administration (FDA) in the U.S. has ruled that harvesting one’s own stem cells and using them as treatment, a procedure called an autologous stem cell transplant, falls under the same strict guidelines as a new drug. This means that an autologous stem cell transplant, like the one Eric wants, has to go through long years of clinical trials.

I wish the Gelhars all the best in their efforts. (If I lived closer I would go to the concert they are putting on to help raise money.) I pray that Erik gets his stem cell transplant and gets to live a long and happy life. I hope he will not fall victim to the politics of embryonic stem cell research.

from http://www.marymeetsdolly.com/blog/index.php?/archives/904-Why-Germany-is-REALLY-ahead-in-stem-cell-treatments.html

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.

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