Tag Archives: Food and Drug Administration

Aastrom Reports Interim Results From Critical Limb Ischemia Trial

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
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Autism and Stem Cells Clinical Trial

Sutter Neuroscience Institute in Sacramento, California, and Cord Blood Registry are launching the first FDA-regulated clinical trial to assess the use of a child’s own cord blood stem cells to treat select patients with autism. This first-of-its-kind placebo-controlled study is important because one in 88 children in the U.S. are diagnosed with autism spectrum disorders each year. The clinical trial will evaluate the ability of an infusion of cord blood stem cells to help improve language and behavior.

The study will enroll 30 children between the ages of two and seven, who meet the inclusion criteria for the
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Stanford’s Irving Weissman on the (lost?) promise of stem cells

Stanford stem cell researcher Irving Weissman, MD, published an article in Cell Stem Cell today discussing barriers to stem cell research:

While I am usually an optimist, I must admit that there is a possibility that we will continue to be in the Dark Ages of medicine for quite some time. I fear that therapies using purified tissue and organ-specific stem cells – the only self-renewing cells in a tissue or that can regenerate that tissue or organ for life – will remain elusive.

Weissman, who directs Stanford’s Institute for Stem Cell Biology and Regenerative Medicine, goes on to cover the
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Progress in Commercialization of Stem Cell Therapies

Stem cell therapies – treatments that involve the transplantation of stem cells, organs, or other cells into patients to improve the function of diseased or damaged tissues or organs – is a field that has been steadily advancing. Perhaps more than any other industry, stem cell therapies is poised to make a significant near-term impact on worldwide public health, and many individuals living today may experience stem cell-related therapies.

The most obvious use of stem cells is in cell-replacement therapies, but they are also valuable in disease modeling, drug discovery, and drug toxicity assessment. Stem cell therapies are currently being
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Gov. Rick Perry wants to put stem cells therapy to the test in Texas

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
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