Tag Archives: Food and Drug Administration

Stem cell injections after a heart attack restore the heart to a healthy state

Until recently, when a patient suffering a heart attack arrived at a hospital, doctors could open the blocked blood vessel and restore blood flow to prevent further damage. But there was nothing they could do to reverse the harm already done. That damage — scarring that can kill up to 50 percent of the heart — leaves patients with difficulty breathing, loss of energy and the inability to do things such as walk up stairs. Some patients need transplants. And some end up with hearts so weak they die.

The solution: Now doctors can repair that damage. In
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Researchers aim to restore heart using stem cells

A first-of-its-kind study is just getting underway at University of Minnesota Physicians Heart at Fairview, in Minneapolis. The FDA-approved trial is designed to test the impact of stem cells on restoring the heart’s muscle function in patients suffering from advanced heart failure. The results of the trial could impact the future of health care in the area of heart disease, and may one day save lives (…)

“This trial is designed for heart failure patients in the end stage of heart failure, with no options for treatment,” explained Ganesh Raveendran, M.D., who is the principal investigator of the clinical trial.
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Neural Stem Cell Therapy – Swiss Agency Approves Clinical Trial

Aileen Anderson and Brian Cummings led the pre-clinical studies for the neural stem cell treatment

A therapy developed by Aileen Anderson and Brian Cummings of UC Irvine’s Sue & Bill Gross Stem Cell Research Center in collaboration with researchers at StemCells Inc. will be the basis of the world’s first clinical trial using human neural stem cells to treat spinal cord injury.

Swissmedic, the Swiss regulatory agency for therapeutic products, has authorized a Phase I/II clinical trial for chronic spinal cord injury, cases in which inflammation has stabilized and recovery has reached a
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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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