MotorGraft Clinical Trial for SMA Placed on FDA Clinical Hold
FSMA Press Release | February 8, 2011
In December, California Stem Cell, Inc. (CSC) announced that CSC filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for approval to commence a Phase I safety study on a jointly-developed stem cell-derived motor neuron transplantation therapy for Spinal Muscular Atrophy (SMA) Type I. Recently, CSC received an official response from the FDA. As anticipated the trial is on clinical hold. A summary of that FDA response from CSC is shown below.
California Stem Cell’s MotorGraft trial for the treatment of spinal muscular atrophy (SMA) has been placed on clinical hold by the Food and Drug Administration (FDA). A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial. Clinical holds are not uncommon, especially in cases of novel treatments such as this one. Similar holds were issued by the FDA to each of the previous applications for pluripotent stem cell therapeutics, such as those submitted by NeuralStem (ALS trial), Geron Corporation (spinal cord injury trial) and Advanced Cell Technology (macular degeneration trial), and all have since been lifted and advanced to clinical trials.
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Dr. Wiginton is among the 45 participants in a southwestern Utah-based clinical trials – the first of its kind in the south-west – to investigate the use of the delivery system for radiation. His post-lumpectomy therapy lasted one third of the length of a session of radiation typical of a patient with breast cancer.If you are willing to use the brain tumor, I think it’s a pretty safe bet for use in a breast, said Wiginton. Dr. Wiginton, including the study by Dr. Dan Garwood, associate professor of radiation oncology, said he hopes that the procedure will be successful and to offer new options of radiotherapy for breast cancer patients.`
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