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Startup SynGen gets FDA approval for cord blood-processing products

Posted: Published on July 17th, 2013

Buoyed by another round of multimillion-dollar financing, Sacramento-based startup SynGen Inc. has cleared a significant federal hurdle to get its cord blood-processing products on the market. The midtown Sacramento medical device startup, which develops stem cell harvesting systems, announced Monday that it has received U.S. Food and Drug Administration clearance to market three related products to process cord blood. All three are related to the company's SynGenX-1000 system, which harvests stem and progenitor cells from units of collected umbilical cord blood. The company says harvested cells can be used for treatment of numerous medical conditions, including leukemia, lymphoma and more than 70 genetic diseases. "We thank the FDA for guiding us through the ... clearance process. SynGen is dedicated to developing products that consistently exceed our customers' expectations," said Philip Coelho, company president and CEO. Last year, SynGen received $5 million from San Francisco venture capital firm Bay City Capital LLC to further develop what Coelho has called the next generation in stem cell harvesting systems. SynGen recently received additional financing of up to $3 million from Bay City. Established in 1997, Bay City bills itself as a "life sciences venture capital firm investing in opportunities across the various life … Continue reading

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ACT Secures Approval from Data Safety Monitoring Board to Complete Third Patient Cohort in All Three Clinical Trials

Posted: Published on July 17th, 2013

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT) (ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the companys three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of remaining two patients in the third cohort of each of the three clinical trials. The decision follows an interim review by the DSMB six weeks after the first patient was treated in the third cohort of each trial. ACT will proceed with screening and enrollment for the patients who, in keeping with trial protocol, will be injected with 150,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). We are pleased that the first patients treated with the higher dose of RPE cells are doing well and the DSMB sees fit for enrollment to continue in all three clinical trials, commented Gary Rabin, chairman and CEO of ACT. Even with several patients failing laboratory evaluations late in the inclusion/exclusion review process, which is not atypical in clinical trials, we have four of the six patient surgeries for the third cohorts scheduled, with two remaining … Continue reading

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BioTime CEO Dr. Michael West to Present at the Case Western Reserve University 6th Annual Regenerative Medicine …

Posted: Published on July 17th, 2013

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, announced that Chief Executive Officer Michael D. West, PhD will present today at the Case Western Reserve University in the meeting The Business of Regenerative Medicine: From Stem Cells to the Market Place in Cleveland, Ohio. Dr. Wests presentation titled Embryomics: Commercial Opportunities in the Increasing Complex Biology of Pluripotency is scheduled for 11:00 a.m. EDT. Dr. West will describe new data relating the company's PureStem technology and cell lines potentially useful in the treatment of Alzheimer's disease and for Alzheimer's disease research and will soon be made available for sale to the research community. The presentation is available on BioTimes website at http://www.biotimeinc.com/scientific-presentations. A discussion of the results presented in todays meeting is also discussed by Dr. West in his weekly video update available for viewing at http://www.biotimeinc.com/video-series/. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem … Continue reading

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Stem Cell Therapy Treatment for Autism by Dr Alok Sharma, Mumbai, India. Part 2 – Video

Posted: Published on July 17th, 2013

Stem Cell Therapy Treatment for Autism by Dr Alok Sharma, Mumbai, India. Part 2 Improvement seen in just 7 months after Stem Cell Therapy Treatment for Autism by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy 1. Emotional respons... By: Neurogen Brain and Spine Institute … Continue reading

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Mental Decline Seen Earlier When Epilepsy Present, Study Suggests

Posted: Published on July 17th, 2013

FRIDAY, July 12 (HealthDay News) -- People with epilepsy appear to show signs of mild memory problems or Alzheimer's disease earlier than those without epilepsy, according to a new study. "Careful identification and treatment of epilepsy in such patients may improve their clinical course," concluded Dr. Keith Vossel, of the Gladstone Institute of Neurological Disease in San Francisco, and colleagues. The researchers evaluated data on 54 patients and found that those with mild memory problems and epilepsy showed signs of mental decline nearly seven years earlier than those with mild memory problems who did not have epilepsy -- average age 64 years versus 71 years. In addition, Alzheimer's patients with epilepsy showed signs of mental decline about five years earlier than those with Alzheimer's who did not have epilepsy -- average age about 65 years versus 70 years, according to the findings published online July 8 in the journal JAMA Neurology. Alzheimer's increases a patient's risk of seizures, and patients with Alzheimer's and seizure disorders have greater mental impairment, more rapid progression of symptoms and show more severe loss of neurons at autopsy than those without seizures, the researchers noted in a journal news release. "Epileptic activity associated with Alzheimer's … Continue reading

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AurimMed Pharma Receives Epilepsy Foundation's Inaugural Award

Posted: Published on July 17th, 2013

PARK CITY, UT--(Marketwired - Jul 16, 2013) - AurimMed Pharma, Inc., a biopharmaceutical company with an innovative approach to R&D and a unique Central Nervous System compound, has been named the first recipient of an award for the groundbreaking product for people with epilepsy from the Epilepsy Foundation. The Epilepsy Innovation Seal of Excellence was awarded by the Epilepsy Foundation of America in recognition of AurimMed's innovative principal lead drug candidate designated AMP-X-0079. (http://www.epilepsy.com/etp/seal_of_excellence) "AurimMed has the highest respect for the Epilepsy Foundation and its leadership. We are pleased that they recognize our proprietary Privileged Structure Platform and our work towards the development of AMP-X-0079 for the treatment of epilepsy. This Award is an important and significant milestone in the evolution of AurimMed Pharma and the development of AMP-X-0079," said Amir Pesyan, Chairman and CEO of AurimMed. "The AMP-X-0079 program has all the characteristics that we seek for the Epilepsy Innovation Seal of Excellence award," notes Roger J. Porter, MD, Chief Scientific Officer of the Epilepsy Foundation. "This potential drug has very impressive data from the NIH-NINDS screening program and has been created using a proven platform for success in other disease states." Philip M. Gattone, President and CEO of … Continue reading

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Autism on the rise: How animals are helping – Video

Posted: Published on July 17th, 2013

Autism on the rise: How animals are helping GLENVILLE -- The Saratoga Therapeutic Equestrian Program (STEP) is a charitable, not-for-profit organization.The organization has been around since 1986 and ... By: CBS6Albany … Continue reading

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New TRICARE Rules Will Hurt Military Children With Autism, Advocates Say

Posted: Published on July 17th, 2013

Video Military Families With Autism Concerned About Tricare Changes New TRICARE rules set to take affect on July 25 would prevent military children with autism from getting much-needed treatment, according to an autism advocacy group. According to the Autism Speaks, the TRICARE changes require: -Standardized testing every 6 months in order to continue receiving care -Evidence of "measurable progress" as indicated by standardized testing results to receive continued therapy -Waivers to continue care beyond two years of treatment and after age 16 -New discharge criteria for failure to make progress, sustainable gains, or a parent's inability to participate in the treatment Critics of the TRICARE requirements say autistic children who don't show progress within six months would be denied care. U.S. Senators Kirsten Gillibrand and Patty Murray have taken up the cause, sending a letter to Assistant Secretary of Defense for Health Affairs and Director of TRICARE Management Activity, Dr. Jonathan Woodson. That letter reads, in part: "Given the impact family health care plays on military readiness, it is essential military families have assurances of continued health care. Policies inconsistent with good clinical practice only serve to limit, restrict, delay, and deny care. The apparent lack of understanding of the … Continue reading

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Military families plan demonstration against Tricare’s autism therapy coverage

Posted: Published on July 17th, 2013

Posted on: 7:19 pm, July 16, 2013, by Jessica Larche, updated on: 09:40pm, July 16, 2013 Beginning July 25, 2013, Tricare will make it a lot tougher for military families with autistic children to qualify for Applied Behavior Analysis therapy, or ABA. Families and providers have planned a demonstration this Sunday, July 21, 2013 at 1535 Amberly Forest Road in Virginia Beach. Click here for more information. Below is a statement from Tricare NewsChannel 3 has been waiting days to receive: The Department of Defense is greatly expanding applied behavior analysis (ABA) services with introduction of the ABA Pilot for non-active duty family members starting July 25. These changes are being made to provide non active duty family members, including retirees, with access to additional areas of ABA reinforcement. There is no change in the services available to active duty family members. Active Duty Family members Active duty family members (ADFMs) and Non Active Duty Family Members, such as retirees, continue to be eligible to receive medical and behavioral health services such treatment by a physician, psychological services and testing; occupational and physical therapy and other medical treatments under the TRICARE basic medical program. In addition, Active Duty Family Members … Continue reading

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Young children with autism benefit regardless of high-quality treatment model

Posted: Published on July 17th, 2013

July 16, 2013 Researchers at the University of North Carolina at Chapel Hill have found that preschoolers with Autism Spectrum Disorder (ASD) who receive high-quality early intervention benefit developmentally regardless of the treatment model used -- a surprising result that may have important implications for special-education programs and school classrooms across the country. "This is the first study designed to compare long-standing comprehensive treatment models for young children with ASD," said Brian Boyd, a fellow at UNC's Frank Porter Graham Child Development Institute (FPG) and one of the study's co-principal investigators. Boyd also is an assistant professor in occupational science and occupational therapy in UNC's School of Medicine. "We know that more children are being diagnosed with ASD each year, and that it can cost an estimated $3.2 million to treat each child over a lifetime. Understanding that a child can benefit from a high-quality program, rather than a specialized program, may help reduce those costs by decreasing the need for teachers and other school practitioners to be trained to deliver multiple specialized services," Boyd said. He stressed it remains important to ensure educators are trained to provide high-quality programs that meet the special behavioral, communication and other needs of … Continue reading

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