Before new treatments can reach patients, they must be tested in clinical trials. This is our second brief update on some stem-cell-related trials currently under way or recently approved.
This update looks at trials for amyotrophic lateral sclerosis (ALS) or motor neurone disease, as well as the latest news on how the trials we told you about in September are progressing. Weve included details of one or two new trials for some of the conditions we focussed on last time: spinal injury, Stargardts macular dystrophy and stroke. Well post more updates on other themes in future, so tell us if theres an area you really want to know about.
Clinical trials are carried out in four phases:
The company Neuralstem Inc and researchers at Emory University in Atlanta, USA have received approval from the Food and Drug Administration (FDA) to advance to the second stage of their trial investigating the safety of using human neural stem cells to treat patients with amyotrophic lateral sclerosis (ALS). Amyotrophic lateral sclerosis is also known as motor neurone disease, or sometimes Lou Gehrigs disease. In ALS, the nerve cells that control movement degenerate and die. These nerve cells are found both in the spinal cord and in the brain.
The Neuralstem Inc/Emory clinical trial started in January 2010 and is designed to assess the safety of implanting neural stem cells derived from human fetal tissue into the spinal cord in up to 18 people with ALS. The first 12 patients received neural stem cells in the lumbar, or lower, region of the spinal cord. Following a review of the safety data in autumn 2011, the FDA granted approval to transplant neural stem cells in the cervical (upper) region of the spinal cord.
Phase and objective: This is a phase I trial. The objective is to evaluate the feasibility and safety of transplanting human spinal-cord-derived neural stem cells into the spinal cord of patients with amyotrophic lateral sclerosis. Dates: January 2010 October 2012 Enrollment status: Recruiting. 12 patients already recruited. Aims to enroll up to18 patients. More information on this study More about Amyotrophic Lateral Sclerosis
The State Food and Drug Administration in China authorised a phase II trial on the use of umbilical cord mesenchymal stem cells in amyotrophic lateral sclerosis. The cells will be injected by lumbar puncture: a hollow needle is inserted between the bones of the lower back into the fluid around the lower part of the spinal cord. The trial is being run by the General Hospital of Chinese Armed Police Forces. The researchers hope that the injected stem cells will release small proteins called trophic factors that help keep motorneurons healthy and working properly.
Phase and objective: This is a phase II trial. The objective is to evaluate the safety and efficacy of transplanting umbilical cord mesenchymal stem cells by lumbar puncture into patients with ALS. Dates: January 2012 April 2015 Enrollment status: Not yet open for participant recruitment. Aims to enroll up to 30 patients. More information on this study More about Amyotrophic Lateral Sclerosis
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Clinical trials news: January 2012 update | Europe's stem ...
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