Tag Archive for 'Clinical trial'

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 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.

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Cord Blood Stem Cells Trial for Cerebral Palsy

Medical College of Georgia
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AUGUSTA, Ga. – Medical College of Georgia researchers are conducting the first FDA-approved clinical trial to determine whether an infusion of stem cells from umbilical cord blood can improve the quality of life for children with cerebral palsy.

The study will include 40 children age 2-12 whose parents have stored cord blood at the Cord Blood Registry in Tucson, Ariz.
Umbilical cord blood is rich in stem cells, which can divide and morph into different types of cells throughout the body, said Dr. James Carroll, professor and chief of pediatric neurology in MCG School of Medicine and principal investigator on the study.

Cerebral palsy, caused by a brain injury or lack of oxygen in the brain before birth or during the first few years of life, can impair movement, learning, hearing, vision and cognitive skills. Two to 3 children in 1,000 are affected by it, according to the Centers for Disease Control.
Animal studies indicate that infused stem cells help injured brain cells recover and replace brain cells that have died, Dr. Carroll said.

The IOBA presents the results of clinical trials with cell therapy for corneal blindness

Ayala carefully prepares to put a contact lens
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Health Counselor Board, Javier Alvarez Guisasola, launched on Wednesday a clinical trial coordinated by Professor Margarita Calonge, IOBA’s on cell therapy applied to treat corneal blindness.
This study was coordinated by the IOBA and IBGM to demonstrate the long-term effectiveness of the epithelial stem cell transplantation of the cornea, previously cultivated to restore corneal blindness. Stem cells come from a healthy eye of the patient or family support.

First U.S. stem cells transplanted into spinal cord

For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday.

Doctors injected stem cells from 8-week-old fetal tissue into the spine of a man in his early 60s who has advanced ALS, or amyotrophic lateral sclerosis. It was part of a clinical trial designed to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe (…)

China surpasses Canada in stem cell advances

Chinese researchers have become the world’s fifth most prolific contributors to peer-reviewed scientific literature on Regenerative Medicine (RM), according to an international study published on Friday (…)
Regenerative Medicine is an emerging interdisciplinary field of research and clinical applications focused on the repair, replacement or regeneration of cells, tissues, or organs, which uses a combination of approaches including gene therapy, stem cell transplantation, tissue engineering, and the reprogramming of cell and tissue types.

But as the stem cell research develops fast in recent years, RM becomes more and more dependent on this side, and shared some ethic criticism against stem cell research since it involves the usage of human embryos.

Synthetic artery developed using stem cells

A team of researchers from UCL has won a £500,000 grant to develop a synthetic artery that mimics a natural artery – and could revolutionise the treatment of coronary heart disease.

Professor Alexander Seifalian (UCL Surgery and Interventional Science) and Professor George Hamilton (UCL Surgery and Interventional Science & Royal Free Hospital) and their team will use the Wellcome Trust grant to take their work from the laboratory to a pre-clinical trial.

The team has been developing a new nanomaterial with mechanical properties similar to that of human arteries.

The nanomaterial’s inner surface has been modified to attract stem cells from blood circulating inside the body.

It converts these primary cells to endothelial cells, a type of cell that covers the interior of the natural blood vessel and protects it from blockage.

The breakthrough offers hope for sufferers of heart disease who are unable to donate suitable substitute blood vessels for bypass surgery.

Professors Seifalian and Hamilton, experts in nanotechnology, regenerative medicine and vascular surgery, explained: “Coronary heart disease is a condition where one or more blood vessels of the heart become narrowed or blocked. This causes the heart muscle to be starved of oxygen causing damage often leading to a heart attack and muscle death. This interferes with the heart’s ability to pump blood around the body, leading to infirmity and possibly death.

“The current treatment of the disease is to create a new route for blood to circulate, most often by balloon dilatation and stent (stent angioplasty). In many patients however this intervention cannot be performed and in this situation an operation called bypass surgery is needed which can either use substitute blood vessels from another part of the patient or made from a plastic material.

read more: http://www.ucl.ac.uk/news/news-articles/0908/09081101

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