Tag Archives: Placebo-controlled study

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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