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Proteonomix Receives FDA Permission to Initiate Company-Sponsored Phase 1 Clinical Trial with UMK-121 in Patients with …

Posted: Published on August 14th, 2012

MOUNTAINSIDE, N.J.--(BUSINESS WIRE)-- Proteonomix, Inc. (OTC/BB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to initiate a Phase 1 clinical trial with its mobilization technology UMK-121. The Proteonomix-sponsored trial will evaluate UMK-121 in patients with end-stage liver disease (ESLD). Permission by the FDA marks an important milestone in our plans to initiate a Company-sponsored clinical trial with UMK-121, following years of research and investment to advance development of this drug candidate, said Proteonomix Chief Technology Officer Steven Byle. We hope and anticipate that this trial will demonstrate the potential of UMK-121 to mobilize stem cells in order to improve liver function in patients with ESLD. We consider ourselves fortunate to be involved with a development-stage therapy that could improve the life expectancy for this class of terminally ill patients awaiting liver transplants. Proteonomix CEO Michael Cohen added, This is a significant step for our Company as this is the first FDA IND to be held by Proteonomix and demonstrates the ability of the Company to move basic research projects into clinical trials. UMK-121 is … Continue reading

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Stemedica International Receives Licenses From Swissmedic for Import and Export of Its Stemedyne(TM) Stem Cell Line

Posted: Published on August 14th, 2012

EPALINGES, Switzerland, Aug. 14, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica International, SA (Epalinges, Switzerland), a wholly owned subsidiary of Stemedica Cell Technologies, Inc. ("Stemedica"), a leader in adult stem cell research and manufacturing, announced today that it has been granted a series of licenses by Swissmedic (the Swiss equivalent of the United States Food and Drug Administration). These licenses specifically authorize the Company to import and export its Stemedyne(TM) stem cell products worldwide for human use in approved clinical trials. Granting of the license by Swissmedic marks the culmination of a two-year inspection process of Stemedica's United States and Swiss operations. The Swiss government's rigorous inspection and approval process has included: (1) a comprehensive, in-depth audit of Stemedica's processes and procedures; (2) the examination of Stemedica's quality systems; and (3) interviews with facility management and onsite inspections of the facilities. Stemedica currently produces two lines of ischemia-tolerant adult allogeneic stem cell products. These include Stemedyne(TM)-MSC, bone marrow derived mesenchymal stem cells and Stemedyne(TM)-NSC, neural stem cells. A third product, Stemedyne(TM) Retinal Pigment Epithelium (RPE) stem cells is currently in development. Stemedica now has full regulatory approval from the Swiss government to provide these cells to countries that can … Continue reading

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ReNeuron Group plc – Stroke Trial Update

Posted: Published on August 14th, 2012

ReNeuron Group (Berlin: RQE.BE - news) plc ("ReNeuron" or the "Company") ReNeuron receives DSMB clearance to progress to higher dose in stem cell clinical trial in stroke patients First (OTC BB: FSTC.OB - news) patient treated in this higher dose cohort Guildford, UK, 14 August 2012: ReNeuron Group plc (AIM: RENE) today provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, taking place in Scotland, ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The Company is pleased to report that the independent Data Safety Monitoring Board (DSMB) for the clinical trial has recommended that the trial advances to the evaluation of a higher dose of ReN001 in the third of four dose cohorts to be treated in the study. In arriving at this recommendation, the DSMB reviewed safety data from the first two dose cohorts of six patients treated with ReN001. Of these patients, two are through 18 month follow-up, one is through 12 … Continue reading

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This Groundbreaking Combination of Scientific Treatments Could Mean A Cure For Paralysis

Posted: Published on August 14th, 2012

This is part of a 30-part series called "Game Changers." This special series investigates the most remarkable advancements in science, energy and health and how they will impact the way we live. This series is brought to you by Samsung's Galaxy S3. Scientists in Switzerland treated paralyzed rats through a combination of chemical, electrical, and physical stimulation. They found that the paralyzed rats who underwent treatment could walk again some could even run. In the past, scientists have individually tested chemical, electrical, and physical training therapies on paralyzed humans but until now they have never tested a combination of all three technologies at once. NeuroscientistGregoire Courtine,the study's lead author, told ABC Newsthat the technique "will not make miracles" and it will not completely cure a spinal cord injury, but that it does offer "new therapeutic avenues for these very traumatic injuries" through the combination ofexisting therapies. First the researcherssevered halfway through the spinal cords of a group of rats in two areas separated by an inch on opposite sides of the cord. This left some tissue intact but no direct nerve connections so that the rats could not move their hind legs. A week later the rats were placed on … Continue reading

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InVivo Therapeutics Reports Second Quarter 2012 Financial Results, Provides Business Update

Posted: Published on August 14th, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today reported the financial results for the three and six months ended June 30, 2012 and provided a business update. InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovery and prognosis after a traumatic spinal cord injury. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion. The first six months of 2012 have been a time of tremendous progress for InVivo," said Frank Reynolds, InVivos Chief Executive Officer. "We are advancing multiple neurotrauma products based on our biopolymer scaffolding and hydrogel technologies. Our biopolymer scaffolding device for the treatment of acute SCI is poised to gain FDA clearance to commence human clinical studies. We recently engaged with the FDA for our hydrogel/methylprednisolone combination product and expect to submit hydrogel-based applications to the FDA for the treatments of SCI and pain later this year. Also, in July … Continue reading

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National Disability Institute and Acorda Therapeutics Launch Free Webinars on Financial Wellness for People with …

Posted: Published on August 14th, 2012

ARDSLEY, N.Y.--(BUSINESS WIRE)-- National Disability Institute (NDI) and Acorda Therapeutics announced they will launch a free six-part webinar series on financial, tax and investment topics for people living with multiple sclerosis (MS), their families and care teams. The National Disability Institutes Financial Wellness Series sponsored by Acorda Therapeutics will begin this September and be led by top experts in tax, money management, benefits, employment, Social Security and other areas of personal finance. Due to the programs success last year, Acorda and NDI worked together to provide resources on a greater number of topics than last years four webinars. In 2011, NDI completed an online survey of 3,000 people living with MS. Sixty-seven percent of respondents reported that their financial positions declined after their MS diagnosis, while nearly 74 percent reported that they did not use financial planning programs or strategies to manage or stabilize their finances. Our survey showed that whether people had an MS diagnosis early or later in life, there is a critical lack of information to help people with MS understand how to manage their money, plan for their financial futures, access favorable tax provisions, effectively utilize public benefits and keep working, said Michael Morris, National Disability … Continue reading

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Stemedica International Receives Licenses From Swissmedic for Import and Export of Its Stemedyne(TM) Stem Cell Line

Posted: Published on August 14th, 2012

EPALINGES, Switzerland, Aug. 14, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica International, SA (Epalinges, Switzerland), a wholly owned subsidiary of Stemedica Cell Technologies, Inc. ("Stemedica"), a leader in adult stem cell research and manufacturing, announced today that it has been granted a series of licenses by Swissmedic (the Swiss equivalent of the United States Food and Drug Administration). These licenses specifically authorize the Company to import and export its Stemedyne(TM) stem cell products worldwide for human use in approved clinical trials. Granting of the license by Swissmedic marks the culmination of a two-year inspection process of Stemedica's United States and Swiss operations. The Swiss government's rigorous inspection and approval process has included: (1) a comprehensive, in-depth audit of Stemedica's processes and procedures; (2) the examination of Stemedica's quality systems; and (3) interviews with facility management and onsite inspections of the facilities. Stemedica currently produces two lines of ischemia-tolerant adult allogeneic stem cell products. These include Stemedyne(TM)-MSC, bone marrow derived mesenchymal stem cells and Stemedyne(TM)-NSC, neural stem cells. A third product, Stemedyne(TM) Retinal Pigment Epithelium (RPE) stem cells is currently in development. Stemedica now has full regulatory approval from the Swiss government to provide these cells to countries that can … Continue reading

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LifeCell gets 50,000 customers in stem cells banking

Posted: Published on August 14th, 2012

Chennai, Aug 14 (IBNS) Stem cells derived from the umbilical cord are known to have the potential to treat over 75 serious medical conditions. To enhance awareness, LifeCell partnered with model and actor Lisa Ray, who had undergone successful stem cell therapy for treatment of blood cancer. Lisa continues to endorse the brand. Whilst India is the worlds largest birthing country, the penetration of the stem cell storage has been a dismal 0.2pc compared to the global average which is between 5pc in the US to as high as 25pc in Singapore. LifeCell said it believes that poor awareness rate and per capita income are the primary reasons for low penetration in the Indian market, yet is optimistic that India would soon reach the global benchmarks. Mayur Abhaya, Managing Director and CEO said, When we launched our services in 2004 the medical fraternity was not even aware of the concept of stem cell banking. It was our responsibility to create awareness amongst both the doctors and the expectant parents about its enormous scope in the future." The stem cell storage industry is growing at a rate of 30-40pc per year. More and more innovative services have been launched in the … Continue reading

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Small caps round-up: ReNeuron, Eckoh, Healthcare Locums

Posted: Published on August 14th, 2012

LONDON (ShareCast) - Clinical-stage stem cell group ReNeuron surged on Tuesday after saying that the Data Safety Monitoring Board gave a favourable recommendation to proceed to the with a higher dose of its ReN001 stem cell therapy in a clinical trial. 'This represents a further important milestone for the study as we make our plans for a subsequent Phase II clinical trial application with ReNeuron's ReN001 cell-based treatment for stroke disability,' said ReNeuron's Chief Executive Michael Hunt. The therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke. The group also announced that one patient in the trial has now been successfully treated with ReN001 and discharge from hospital with no acute safety issues arising. Shares jumped 14.91% to 3.7p. Speech recognition and payment solutions group Eckoh (LSE: ECK.L - news) has secured a two-year contract with UK baby website Kiddicare to provide secure card payment services over the phone. "This is the second EckohPROTECT contract to be secured in quick succession through the new referral agreement with a global service provider that was announced in May 2012," the firm said. Shares were up 7.84% at 13.75p. … Continue reading

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Fresh cell therapy promises better health, sex and more

Posted: Published on August 14th, 2012

MANILA, Philippines Celebrity hairstylist Ricky Reyes, talent manager and host Lolit Solis, actress Lorna Tolentino and even former President Joseph Estrada are only among the prominent Filipinos who swear by the healing effects of fresh cell therapy, which involves the injection of live animal cells into the body. Reyes, who used to suffer from a rare disease which he called reading eye epilepsy, said he went to Germany last June for fresh cell therapy. After a number of sessions, the celebrity hairstylist can now read newspapers without suffering a seizure. It was gone immediately, he said. Pati arthritis ko. Naalis yung sakit, tapos gaganda at babata ka pa. Solis, 65, had fresh cell therapy after experiencing knee pain, and 75-year-old Estrada opted to undergo the procedure in Germany to keep healthy. Before them, several other well-known figures worldwide are said to have tried fresh cell treatments, among them the late English actor Charlie Chaplin. So how is this procedure done? Dr. Robert Janson-Muller, who runs a fresh cell therapy clinic in Germany, is in town to give Filipinos the lowdown on this decades-long treatment. Not stem cell treatment Before starting his lecture for members of the local media on Tuesday, … Continue reading

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