Stem Cell Clinic

Cell Medica opens a central European manufacturing facility in Berlin–Buch (Germany)

LONDON--(BUSINESS WIRE)--

Cell Medica, a leading T cell therapeutics company, today announced the opening of its European commercial manufacturing facility at the Max-Delbrck-Center of Molecular Medicine within the biotechnology park of Campus Berlin-Buch (Germany). This state-of-the-art facility for the GMP production of cell and gene therapies includes approximately 350 m2 clean room space.

Initial manufacturing will focus on Cytovir CMV an innovative treatment which uses the immune cells of a healthy donor to restore viral immunity against Cytomegalovirus infections in patients who are immunocompromized following allogeneic hematopoietic stem cell (bone marrow) transplant. The commercial launch of this product is planned in early 2014 and will confirm Cell Medicas position as one of the leaders in the development and market delivery of T cell therapeutics a new paradigm for the treatment of cancer and infections.

Dr. Rainer Knaus, Managing Director of Cell Medica GmbH and Head of the Companys global manufacturing operations, commented: This facility has been designed and equipped to provide high quality GMP compliant production of patient-specific cell and gene therapies for distribution across Europe. We are also very fortunate to have attracted highly educated and well-trained personnel who are keen to help shape this new era of cell-based therapeutics, says Dr. Knaus. These manufacturing specialists are preparing the facility for the supply of Cytovir CMV in early 2014.

The facility in Berlin-Buch will also be important for Cell Medicas planned CITADEL study for the investigation of Cell Medicas T cell therapy for the treatment of EBV-associated lymphomas. The provision of investigational medicinal products for European study centers will be undertaken following the required regulatory approvals.

The financing of Cell Medicas investment in the Berlin-Buch facility is supported in part by the Investitionsbank Berlin (IBB), the business development and promotional bank of the Federal Land of Berlin.

Notes toEditors

About CellMedica

Cell Medica is a cellular therapeutics company engaged in the development, manufacturing and marketing of T cell immunotherapy approaches for the treatment of infections and cancers related to oncogenic viruses. The Companys lead cell product, CytovirCMV, for the treatment and prevention of cytomegalovirus (CMV) infections in patients following allogeneic bone marrow transplant, is available in the UK and is under development in other territories. Cytovir ADV is being developed for the treatment of adenovirus infections in pediatric patients following bone marrow transplantation. Cell Medica is also working with the Center for Cell and Gene Therapy, Baylor College of Medicine, to develop a cancer cellular therapeutic for the treatment of malignancies associated with the oncogenic Epstein BarrVirus.

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Cell Medica opens a central European manufacturing facility in Berlin–Buch (Germany)

Canadian stem cell technology expected to offer new options for blood stem cell transplants

Peter Zandstra receives the 2013 Till & McCulloch Award

OTTAWA, Sept. 25, 2013 /CNW/ - A Canadian technology that has the potential to boost the number of stem cells given to patients undergoing transplants of the blood-forming system has been recognized as the most impactful stem cell research paper authored by a Canadian in the past year. Dr. Peter Zandstra has been given the 2013 Till & McCulloch Award in recognition of this contribution to global stem cell research. Dr. Zandstra will accept the award and present a lecture entitled "Engineering pluripotent stem cell derived microtissues" as part of the Till & McCulloch Meetings, Canada's premier stem cell event.

Dr. Michael Rudnicki, Scientific Director of the Stem Cell Network, who launched the Till & McCulloch Award in 2005 and will make the award presentation, says the Zandstra group's publication was chosen due to the impact their technology is expected to have. "This technology will hasten the promise of regenerative medicine and the therapeutic possibilities of umbilical cord blood and hematopoietic stem cells in particular. It is very likely that Fed-Batch technology will improve the outcome of blood system transplants for many patients. We are proud to award the 2013 lecture to Dr. Zandstra for his pioneering work."

First author Elizabeth Csaszar, Zandstra and his team have developed a new culture system that has the ability to dramatically expand the clinical applications of hematopoietic (blood) stem cells (HSCs). Their breakthrough discovery is based on a Fed-Batch bioreactor technology and has the potential to improve the viability and success of cord blood stem cell transplantation by allowing for better-matched donors and increasing the number of stem cells in a transplant unit.

This new system will accelerate the possibilities of using HSC transplantation in clinical settings, especially in the treatment of certain forms of leukemia. The success rate of blood system transplantation is strongly correlated to the number of cells used. Dr. Zandstra's Fed-Batch technology can produce over 11 times more HSCs than originally existed and is designed to be adaptively scaled-up for human transplantations in clinical settings.

The article for which the award was granted, published in the February 2012 issue of Cell Stem Cell, entitled "Rapid Expansion of Human Hematopoietic Stem Cells by Automated Control of Inhibitory Feedback Signaling," explains this novel discovery to expand cord blood cells. Dr. Zandstra is a professor at the University of Toronto'sInstitute for Biomaterials & Biomedical Engineering, a principal investigator with the McEwen Centre for Regenerative Medicine and the Chief Scientific Officer at the Centre for Commercialization of Regenerative Medicine.

Dr. Zandstra, the Canadian Research Chair in Stem Cell Bioengineering, was very pleased to learn he had been chosen for this honour. "When I was told I would be receiving the 2013 lecture award, I was very honoured to be recognized in this way by the scientific community. I am thrilled to be in the same company as the previous winners, who are all exceptional researchers in our field and help to drive advances in health care that will improve the lives of many. This technology, and others being supported and developed through the Stem Cell Network, the Leukemia and Lymphoma Society and CCRM funding, represents an exciting opportunity for Canadian leadership in the clinically important area of cell transplantation to treat leukemia."

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Canadian stem cell technology expected to offer new options for blood stem cell transplants

International Stem Cell Corporation to Present New Data From Parkinson's Disease Program at the American Neurological …

CARLSBAD, CA--(Marketwired - Sep 25, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell based therapies, announced today that its chief scientific officer, Dr. Ruslan Semechkin, will present the latest results from its Parkinson's disease program at the American Neurological Association's 2013 Annual Meeting October 13 - 15, 2013 in New Orleans, LA.

Conducted in collaboration with the Sanford Burnham Medical Research Institute, the presentation will include new data and results from ISCO's first primate study, including an outline of neural stem cells' unique mechanism of action, data on the fate of the cells and a detailed analysis of the primate's immune response to the implantation.The presentation will be at the following session:

Date: Monday, October 14, 2013 Time: 11:00 am - 7:00 pm Title: The Use of Neural Stem Cells for the Treatment of Parkinson's Disease in a Non-Human Primate Model

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. The hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (1) differentiate into dopaminergic neurons and (2) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new and revolutionary opportunity for the treatment of Parkinson's disease, especially in cases where current dopamine-replacement approaches fail to adequately control the symptoms.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products.ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos.ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

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Pets Best Insurance Announces Stem Cell Therapy and Regenerative Veterinary Medicine by Vet-Stem, Inc. Covered by …

Poway, California (PRWEB) September 24, 2013

Vet-Stem, Inc., the world's leading Regenerative Veterinary Medicine company, is pleased to announce that Pets Best Insurance plans provide coverage for Regenerative Stem Cell Therapy. Pets Best Insurance knows that with pets come vet bills, especially when a pet is suffering from the pain of injury or arthritis. Pets Best Insurance wants the best for pets and their owners and Vet-Stem offers the best in regenerative medicine for them. Pets suffering from pain of osteoarthritis, joint issues, and injuries of the muscle, tendon and ligament can now be given stem cell therapy.

Vet-Stem first offered stem cell therapy for dogs and cats in 2007. One of the success stories and stem cell advocates is part of the Pets Best Insurance family, Jetta, owned by Greg McDonald, CEO of Pets Best Insurance.

Jack L. Stephens, DVM and President/Founder of Pets Best Insurance talks about Gregs experience: "Our CEO had a wonderful experience utilizing Vet-Stem therapy in his twelve year old lab. He loved throwing, and she loved chasing, a ball every evening. But as she aged, she just could not do it due to severe arthritis. Surgery was not a viable alternative and he asked me about stem cell therapy. I told him we had seen claims with the treatment and it was covered with our insurance. He had it done, her condition very much improved and she was able to chase the ball again. Pets Best Insurance provides full coverage for Vet-Stem Regenerative Cell Therapy, in fact we were early adopters of providing coverage and paying for the therapy. Any procedure performed by practicing veterinarians that helps pets, we are in favor of.

"We are proud that so many dog owners and veterinarians have placed their trust in Vet-Stem Cell therapy. We feel a great sense of accomplishment knowing that there are thousands of dogs and dog owners who have experienced the benefit of stem cell technology. This practical and beneficial application of technology puts stem cell therapy into the present day instead of a future theoretical concept. The fact that Pets Best provides coverage for our therapy is an added plus and makes this a viable treatment option for many more pet owners," said Robert Harman, DVM, MPVM, Founder and CEO of Vet-Stem.

For more information about Pets Best Insurance visit http://www.petsbest.com

About Vet-Stem, Inc. Vet-Stem, Inc. was formed in 2002 to bring regenerative medicine to the veterinary profession. The privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem, Inc. pioneered the use of regenerative stem cells in veterinary medicine. The company holds exclusive licenses to over 50 patents including world-wide veterinary rights for use of adipose derived stem cells. In the last decade over 10,000 animals have been treated using Vet-Stem, Inc.s services, and Vet-Stem is actively investigating stem cell therapy for immune-mediated and inflammatory disease, as well as organ disease and failure. For more on Vet-Stem, Inc. and Veterinary Regenerative Medicine visit http://www.vet-stem.com or call 858-748-2004.

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Pets Best Insurance Announces Stem Cell Therapy and Regenerative Veterinary Medicine by Vet-Stem, Inc. Covered by ...

Unlicensed doc gets prison in Vegas stem cell scam

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Unlicensed doc gets prison in Vegas stem cell scam

Disease-specific human embryonic stem cell lines placed on NIH registry

Sep. 24, 2013 Scientists from King's College London have announced that 16 human embryonic stem (hES) cell lines have been approved by the US National Institutes of Health (NIH) and placed on their Stem Cell Registry, making them freely available for federally-funded research in the USA. The stem cell lines, which carry genes for a variety of hereditary disorders such as Huntington's disease, spinal muscular dystrophy and cystic fibrosis, are considered to be ideal research tools for designing models to understand disease progression, and ultimately in helping scientists develop new treatments for patients.

King's is now one of the five biggest providers of disease-specific human embryonic stem cells lines on the NIH Registry, and the largest from the UK. The development is a significant milestone for King's and keeps the university at the forefront of global research into regenerative medicine.

Embryonic stem cell lines are grown from frozen embryos donated by patients undergoing preimplantation genetic diagnosis (PGD) in conjunction with IVF treatment. Unlike 'adult' stem cells, embryonic stem cells can differentiate into any type of cell within the body and are considered to be more useful for stem cell-based therapies. Disease-specific stem cell lines are created from embryos found to be affected with genetic disorders and therefore not suitable for implantation, but offer huge potential for research into disease development.

King's has already developed eight clinical-grade and more than 30 research-grade stem cell lines, which were approved by the UK Stem Cell Steering Committee to be deposited with the UK Stem Cell Bank (UKSCB) and distributed worldwide.

The sixteen lines of stem cells on the NIH Registry carry genes for various hereditary disorders including Duchenne Muscular Dystrophy, Huntington's disease, cystic fibrosis, and rarer conditions such as Von Hippel-Lindau Syndrome, Wiskott-Aldrich syndrome, spinal muscular atrophy, myotonic dystrophy and neurofibromatosis.

'Major contribution to global stem cell research'

Professor Peter Braude, Emeritus Professor of Obstetrics and Gynaecology, King's College London; and former director of the Stem Cell Programme and the Pre-Implantation Genetic Diagnosis Programme, Guy's and St Thomas' NHS Foundation Trust, said: 'We are delighted that the NIH has found our lines useful and their procurement and consents in line with the strict guidelines that they have set. This achievement is the culmination of over ten years of painstaking research and consistent belief in the scientific usefulness of these very special cells to improve our understanding of genetic disease processes.

'This is a huge milestone for King's, and will allow us to make a major contribution to global stem cell research by having these stem cell lines available to scientists in the USA.

'These research-grade stem cell lines are essential not only to address basic questions in development and disease, but to test and implement technical improvements in culture conditions that might affect hES cell viability and pluripotency.'

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Disease-specific human embryonic stem cell lines placed on NIH registry

Stem cell guidelines inadequate, docs say

MANILA, PhilippinesThe new Food and Drug Administration (FDA) guidelines regulating stem cell therapy in the Philippines are sorely inadequate and grossly misleading, according to a group of doctors.

The Philippine College of Physicians (PCP), the umbrella organization of Filipino doctors specializing in internal medicine, said it was disappointed with the FDA and Department of Health for failing to decisively act on the dangers posed by unregulated stem cell therapy in the country.

The recent guidelines released by the FDA fell short and will not stop the proliferation of stem cell therapy for ailments that were not subjected to scientific study or clinical trials, PCP president Prescilla Limpin said in a statement

We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families, said Dr. Prescilla Caguioa, the PCP president.

The FDA guidelines require that all stem cell and cellular-based treatments offered in the country should first pass the agencys standards for safety, efficacy and quality.

Beginning Sept. 1, 2013, all unregistered stem cell products would be considered as illegal and in violation of the law, the FDA said.

However, Maricar Limpin, the head of the PCP advocacy committee, warned that the FDA guidelines might be used by unscrupulous people to continue offering unproven steam cell therapies to the public.

She noted that the FDA rules cited hematopoietic (pertaining to the formation and development of blood cells) stem cell transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells as recognized standards of healthcare.

This is grossly misleading because the FDA gave recognition to these procedures but failed to specify the ailments or indications where these were proven to be safe and effective, Limpin said.

It is the responsibility of the government to inform the public that the effectiveness and safety of stem cell therapy are still unproven in heart, lung, neurologic, skin, rheumatologic, kidney and gastrointestinal diseases, diabetes mellitus, hypertension, autism, cancer, aging and aesthetics, HIV, AIDS and other conditions, she said.

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Stem cell guidelines inadequate, docs say

Cease and desist order against stem cell ads sought

The Philippine College of Physicians (PCP) asked the Food and Drug Administration (FDA) to issue a cease and desist order with sanctions against all forms of advertisement on stem cell therapy until the government has come up with conclusive studies on its efficacy on diseases.

In a media briefing, the doctors said FDAs efforts in governing the use and practice of stem cell treatment in the country is not enough to stop those who offer them despite the absence of clear and conclusive clinical trials on it.

The recent guidelines released by the FDA fell short and will not stop the proliferation of storm cell therapy for ailments that were not subjected to scientific study or clinical trials. We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families, Dr. Prescilla Caguioa, PCP president said.

Tony Leachon, PCP Vice President also urged the FDA to stop unaccredited health and commercial facilities to offer the treatment.

Recently, the FDA released an order asking health facilities offering stem cell therapy to file their application for accreditation until August 31. This follows a similar order in June where FDA issued circular no. 2013-0017 that required all human cells, tissues and cellular and tissue-based products to be registered as well.

As of August 31, FDA said only 47 medical institutions have applied for accreditation.

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Cease and desist order against stem cell ads sought

Complete 2012-13 Induced Pluripotent Stem Cell Industry Report (Updated)

Dublin, Sept. 24, 2013 (GLOBE NEWSWIRE) -- Research and Markets (http://www.researchandmarkets.com/research/qzbnvh/complete_201213) has announced the addition of the "Complete 2012-13 Induced Pluripotent Stem Cell Industry Report" report to their offering.

Stem cell research and experimentation has been in process for well over five decades, as stem cells have the unique ability to divide and replicate repeatedly. In addition, their unspecialized nature allows them to differentiate into a wide variety of specialized cell types. The possibilities arising from these characteristics has caused great commercial interest, with potential applications ranging from the use of stem cells in reversal or treatment of disease, to targeted cell therapy, tissue regeneration, pharmacological testing on cell-specific tissues, and more. Diseases such as Huntington's Chorea, Parkinson's Disease, and spinal cord injuries are examples of clinical applications in which stem cells could offer benefits in halting or even reversing damage.

Traditionally, scientists have worked with both embryonic and adult stem cells as research tools. While the appeal of embryonic cells has been their ability to differentiate into any type of cell, there has been significant ethical, moral and spiritual controversy surrounding their use for research purposes. Although some adult stem cells do have differentiation capacity, it is often limited nature, which creates narrow options for use. Thus, induced pluripotent stem cells represent a promising combination of adult and embryonic stem cell characteristics.

A distinctive feature of this report is an end-user survey of 293 researchers (181 U.S. / 112 International) that identify as having induced pluripotent stem cells as their core research focus. These survey findings reveal iPSC researcher needs, technical preferences, key factors influencing buying decisions, and more. They can be used to make effective product development decisions, create targeted marketing messages, and produce higher prospect-to-client conversion rates.

Remember, to benefit from this lucrative product market, you need to anticipate and serve the needs of your clients, or your competitors will.

Key Findings Include:

In summary, this is a must-read industry report for research supply companies to optimally position themselves to sell iPSC products. To profit from this lucrative and rapidly expanding market, you need to understand your key strengths relative to the competition, intelligently position your products to fill gaps in the market place, and take advantage crucial iPSC trends. Claim this report now to profit from this expanding market - or your competition will.

Table of Contents

I. ABSTRACT

II. BACKGROUND

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Complete 2012-13 Induced Pluripotent Stem Cell Industry Report (Updated)