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Stem cell therapy is considered a potential regenerative strategy for patients with neurologic deficits. Studies involving animal models of ischemic stroke have shown that stem cells transplanted into the brain can lead to functional improvement. In addition, several clinical trials of the use of adult stem cells to treat ischemic stroke are ongoing. This review presents the status of our understanding of adult stem cells and results from clinical trials, and introduces ongoing clinical studies of adult stem cell therapy in the field of stroke. Stroke is one of the leading causes of death and physical disability among adults, with one-quarter to half of stroke survivors being left with complete or partial dependence on others. Stem cell therapy is an emerging paradigm in the field of stroke treatment, and is considered a potential regenerative strategy for patients with neurologic deficits.
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FDA Warns About Stem Cell Therapies | FDA
Jeffrey M. Gimble, Bruce A. Investigators have published a wealth of basic science and preclinical data documenting the potential utility, efficacy, and safety of MSCs. The majority of this work has focused on the bone marrow- or adipose-derived MSCs.
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Clinical Trials of Adult Stem Cell Therapy in Patients with Ischemic Stroke
The primary role of adult stem cells in humans is to maintain and repair the tissue in which they are found. Stem cells are very flexible cells, sometimes considered immature, that have not developed to a final specialized cell type like skin, liver, heart, etc. Since they have not yet specialized, stem cells can respond to different signals and needs in the body by becoming any of the various cell types needed, e. In that sense they are a bit like a maintenance crew that keeps repairing and replacing damaged or worn out cells in the body.
First randomized clinical trials have demonstrated that stem cell therapy can improve cardiac recovery after the acute phase of myocardial ischemia and in patients with chronic ischemic heart disease. Nevertheless, some trials have shown that conflicting results and uncertainties remain in the case of mechanisms of action and possible ways to improve clinical impact of stem cells in cardiac repair. In this paper we will examine the evidence available, analyze the main phase I and II randomized clinical trials and their limitations, discuss the key points in the design of future trials, and depict new directions of research in this fascinating field. A randomized clinical trial RCT, also clinical study is a research study in human volunteers to answer specific health questions. In other words, it is a rigorously controlled test of a new drug or a new invasive medical device on human subjects, in order to evaluate their effectiveness and safety by monitoring their effects on large groups of people.