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Category Archives: Cell Therapy

ReNeuron Group plc – PISCES Trial Interim Data

Posted: June 14, 2012 at 6:10 pm

ReNeuron Group (Berlin: RQE.BE - news) plc

(the "Company")

Interim data from clinical trial of ReNeuron's stem cell therapy for stroke to be presented at leading scientific conference

Data show no safety concerns and evidence of sustained reductions in neurological impairment and spasticity

Guildford, UK, 14 June 2012: ReNeuron Group plc (the "Company") (LSE: RENE.L) is pleased to announce the presentation of interim data from the PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, 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 primary aim of the study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.

To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.

No cell-related adverse events or adverse immune-related responses were reported in any of the patients treated to date. A number of the patients experienced minor procedure-related adverse events such as asymptomatic bleeds or superficial scalp infections at the implantation wound site.

Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Neurological deficits were measured using the National Institutes of Health Stroke Scale (NIHSS), a higher score representing a worse deficit. Patients are required to have a NIHSS score of at least 6 to participate in the study. The pre-treatment median score for the first five patients was 8 (range 6 to 10) and the three month post-treatment median score was 4 (range 3 to 9).

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ReNeuron Group plc - PISCES Trial Interim Data

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Stem cells ‘help’ stroke patients

Posted: June 14, 2012 at 6:10 pm

14 June 2012 Last updated at 07:25 ET By Eleanor Bradford BBC Scotland Health Correspondent

The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.

Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.

After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.

Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.

It is the world's first trial of a neural stem cell therapy for stroke.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.

He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

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Stem cell stroke trial promising

Posted: June 14, 2012 at 6:10 pm

14 June 2012 Last updated at 10:45 ET By Pallab Ghosh Science correspondent, BBC News

Doctors in Scotland have said five stroke patients involved in an experimental stem cell treatment have shown signs of slight improvement.

They have stressed that it is too soon to tell whether the improvement is due to the therapy.

The medical team has talked about the first results of the treatment at a conference in Japan.

The procedure is controversial as brain cells from a foetus were originally used to create the stem cells.

A team, from Glasgow's Southern General Hospital, has been injecting the stem cells into the brains of stroke patients.

The trial began in November 2010. The participants are all men over the age of 60 who have been severely disabled by a stroke and have shown no sign of improvement for at least a year.

We hope to tease out over the next 18 months whether the improvement is due to the treatment

The doctors hope that the treatment will repair their damaged brain tissue and restore some of their movement and ability to speak.

The trail is at an early stage, and doctors are primarily looking to see that the treatment is safe. But they have found that five of the six patients treated so far have shown some slight signs of improvement.

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International Stem Cell Corporation Scientists Create New Protein-Based Stem Cell Technology

Posted: June 14, 2012 at 12:18 pm

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (ISCO) http://www.internationalstemcell.com announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs." TTFs are designed to pass into stem cells and direct the stem cells to change into specific cell types that can be both therapeutically-useful and can be used as revenue-generating research products.

In contrast to more traditional cell therapy methods this technology does not require the use of viruses or chemicals, and has the potential to produce safe therapeutic cells from stem cells. In addition, the TTF proteins are naturally eliminated by the cells when no longer required, a characteristic that further improves safety. The Company intends that this technology, once perfected, will first be used to create revenue-generating research products for sale through Lifeline Cell Technologys international distribution channels to the academic, biotechnology and pharmaceutical markets for cellular proteins, including the quickly growing markets for the study of stem cell biology and drug testing.

According to Jeffrey Janus, Lifeline Cell Technologys CEO, These proteins can be sold into the market for cellular proteins which exceeds $700 million and represents an excellent opportunity for LCT to grow sales. Since the technology also has broad application in research and therapy, it should provide ISCO with future out-licensing opportunities to the biotechnology and pharmaceutical industries.

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). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, 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 or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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Scientists see new hope for restoring vision with stem cell help

Posted: June 13, 2012 at 9:18 pm

This is a human ES cell-derived optic cup generated in our self-organization culture (culture day 26). Bright green, neural retina; off green, pigment epithelium; blue, nuclei; red, active myosin (strong in the inner surface of pigment epithelium). Credit: Nakano et al. Cell Stem Cell Volume 10 Issue 6

Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye that allows us to see, according to a study published by Cell Press in the 5th anniversary issue of the journal Cell Stem Cell. Transplantation of this 3D tissue in the future could help patients with visual impairments see clearly.

"This is an important milestone for a new generation of regenerative medicine," says senior study author Yoshiki Sasai of the RIKEN Center for Developmental Biology. "Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery."

During development, light-sensitive tissue lining the back of the eye, called the retina, forms from a structure known as the optic cup. In the new study, this structure spontaneously emerged from human embryonic stem cells (hESCs)cells derived from human embryos that are capable of developing into a variety of tissuesthanks to the cell culture methods optimized by Sasai and his team.

The hESC-derived cells formed the correct 3D shape and the two layers of the optic cup, including a layer containing a large number of light-responsive cells called photoreceptors. Because retinal degeneration primarily results from damage to these cells, the hESC-derived tissue could be ideal transplantation material.

Beyond the clinical implications, the study will likely accelerate the acquisition of knowledge in the field of developmental biology. For instance, the hESC-derived optic cup is much larger than the optic cup that Sasai and collaborators previously derived from mouse embryonic stem cells, suggesting that these cells contain innate species-specific instructions for building this eye structure. "This study opens the door to understanding human-specific aspects of eye development that researchers were not able to investigate before," Sasai says.

The anniversary issue containing Sasai's study will be given to each delegate attending the 2012 ISSCR meeting in Yokohama, Japan. To highlight the ISSCR meeting and showcase the strong advances made by Japanese scientists in the stem cell field, the issue will also feature two other papers from Japanese authors, including the research groups of Akira Onishi and Jun Yamashita. In addition, the issue contains a series of reviews and perspectives from worldwide leaders in stem cell research.

More information: Nakano et al.: "Self-Formation of Optic Cups and Storable Stratified Neural Retina from Human ESCs." DOI 10.1016/j.stem.2012.05.009

Journal reference: Cell Stem Cell

Provided by Cell Press

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BGI, GE Healthcare Team Up On Pioneering Stem Cell Science Projects

Posted: June 13, 2012 at 11:11 am

GE Healthcare, the healthcare business of GE, and BGI, the worlds largest genomics organization, jointly announced recently a pioneering multi-year research collaboration in stem cell science. The objective of the collaboration is to help advance the potential global utility of stem cell-derived assays for use in drug discovery and toxicity testing by exploring the underlying genetic variation between ethnically diverse human stem cell lines. The collaboration was announced at a signing ceremony attended by Dr Amr Abid, General Manager Cell Technologies, GE Healthcare Life Sciences and Lin Fang, Vice President of BGI, Ye Yin, Deputy President of BGI, and Yutao Du, Deputy President of BGI.

The collaborating parties are initially undertaking two ground-breaking projects. Firstly, BGI is performing genome sequencing and epigenetic analysis on cardiomyocytes and hepatocytes supplied by GE Healthcare Life Sciences. The aim is to map out the genetic variation across an ethnically diverse range of stem cell lines and to examine the changes that occur during differentiation into specific cell types in order to increase the understanding of cell models used in drug development research. Secondly, GE Healthcare is providing BGI with an IN Cell Analyzer 2000 system, a research tool for high content cellular imaging analysis. Training on the IN Cell Analyzer will be provided to BGI, enabling it to investigate gene function ! for a library of previously sequenced cell types by overexpressing or blocking the activity of single genes and observing the effect in selected populations of cells.

Dr Amr Abid, General Manager Cell Technologies, GE Healthcare Life Sciences, said, As the pharmaceutical industry seeks to reduce the cost of drug development and to bring more effective, safer drugs to market, the availability of more biologically relevant and predictive cell models is becoming increasingly important. Our long term vision is to help this process by developing a broad range of Cytiva stem-cell derived assays, to include cell types from a wide diversity of ethnic backgrounds. This is a big challenge a! nd we are delighted to be working with such a prestigious institute as the BGI, with its significant resources and world-class capabilities in genomics and epigenomics. By working together, we will advance our understanding of different stem cell lines, which in turn may in the future help in the global drive to develop new, safer and more effective medicines.

Yutao Du, Deputy President of BGI, said, The importance of high-throughput sequencing has been increasing rapidly in the areas of healthcare, agriculture, environment, and others. Genetic variation analysis of functional cells derived from embryonic stem ce! lls may provide a promising cell model resource for drug development and cell therapy. We are grateful for this opportunity to join hands with an outstanding healthcare organization to push the boundaries of understanding in the field of stem cells.

About GE Healthcare GE Healthcare provides tr ansformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. Our healthymagination vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company. Worldwide, GE Healthcare employees are ! committed to serving healthcare professionals and their patients in more than 100 countries. For more information, visit http://www.gehealthcare.com.

About BGI BGI was founded in Beijing, China on September 9th, 1999 with the mission of being a premier scientific partner to the global research community. The goal of BGI is to make leading-edge genomic science highly accessible through its investment in infrastructure that leverages the best avail! able technology, economies of scale, and expert bioinformatics resourc es. BGI, and its affiliates, BGI Americas, based in Cambridge, MA and BGI Europe, based in Copenhagen. Denmark, have established partnerships and collaborations with leading academic and government research institutions as well as global biotechnology and pharmaceutical companies, supporting a variety of disease, agricultural, environmental, and related applications.

BGI has established a proven track record of excellence, delivering results with high efficiency and accuracy for innovative, high-profile research which has generated over 170 publications in top-tier journals such as Nature and Science. These accomplishments include sequencing one percent of the human genome for the International Human Genome Project, contributing 10 percent to the International Human HapMap Project, carrying out research to combat SARS and German de! adly E. coli, playing a key role in the Sino-British Chicken Genome Project, and completing the sequence of the rice genome, the silkworm genome, the first Asian diploid genome, the potato genome, and, most recently, 1,000 genomes and human gut metagenome. For more information, visit http://www.genomics.cn.

SOURCE: GE Healthcare Life Sciences

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Abunda to try stem cell therapy for mom

Posted: June 13, 2012 at 8:16 am

MANILA, Philippines -- "The Buzz" host Boy Abunda is going to Europe this weekend with his mother, who is suffering from dementia and Alzeimers disease.

In an interview with ABS-CBN News on Tuesday afternoon, Abunda said he will bring his mother to Germany to try stem cell therapy.

"Ako ay pupunta sa Europe hindi para magbakasyon. Dadalhin ko po ang aking ina para magpagamot sa Germany. Ito po 'yung fresh stem cell therapy. Maganda 'yung dini-diretso na dahil napag-uusapan ito," Abunda said.

While Abunda is in Germany, Kris Aquino will take his place on ABS-CBN's entertainment talk show "The Buzz."

In the interview, Abunda also said he's proud of Aquino, who's now open to doing extreme adventures, while continuing to be a good mother to her two sons.

"Ang daming nagbago kay Kris. May mga bagay na hindi ko inakala na gagawin ni Kris like 'yung diving, zipline at marami pang iba. Natutuwa ako that she has become more open to many things. She has become more adventurous. She has retained being the doting mother that she is pero mas malalim ang halakhak niya ngayon sa buhay. She's just so joyful. Natutuwa ako habang pinapanood ko ang kanyang adventure sa 'KrisTV,'" Abunda said.

Abunda said he's also hoping to do a new project with Aquino.

"I'm hoping na someday ay muli kaming magtagpo sa isang palabas dahil marami ang humihiling na kami ay magsama sa isang palabas. Sigurado ako sa puso ko na kami ay gagawa at gagawa dahil magkadugtong ang aming pusod," he said.

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Heart disease and stem-cell treatments: caught in a clinical stampede

Posted: June 12, 2012 at 11:16 am

A few years ago, concerns over these heart trials were voiced by a Norwegian professor, Harald Arnesen. He concluded in 2007 that they are not convincing and that one German team had achieved striking results only because the control group in its trial had done particularly badly. Prof Arnesen called for a moratorium on this kind of stem-cell therapy.

That still did not deter the clinicians. This January, another trial funded by the EU was announced the largest of all, with 3,000 heart-attack patients recruited from across Europe.

The idea behind the trials is straightforward. During a heart attack, a clogged blood vessel starves heart muscle of oxygen. Up to a billion heart muscle cells, called cardiomyocytes, can be damaged, and the body responds by replacing them with relatively inflexible scar tissue, which can lead to fatal heart failure. So why not implant stem cells that can grow into cardiomyocytes?

Stem cells, of course, come in many kinds: the embryonic variety have the potential to turn into all 200 cell types in the body. Adult stem cells, harvested from the patient, have a more limited repertoire: bone marrow stem cells generate blood cells, for example. So to claim, as was done in 2001, these bone marrow stem cells could turn into heart muscle was both surprising and exciting.

Analysis shows that, at best, the amount of blood pumped during a contraction of one heart chamber rose by 5 per cent after treatment. In a patient where heart efficiency has fallen to 30 per cent of normal, that could be significant but it is relatively meagre, none the less. And it turns out that this level of improvement results whatever the cells injected into the damaged muscle even if they have no prospect of forming cardiomyoctes.

Even the believers in the technique now agree that implanted cells exert a paracrine action, triggering a helpful inflammatory response or secreting chemicals that boost blood vessel formation. But were still waiting for convincing evidence that a patients lost heart muscle cells can be replaced.

Embryonic stem cells offer one route to that goal, though it is difficult to turn them into the right cell type reliably, and there are other risks, such as uncontrolled growths. Another option has come from work by Prof Richard Lee at the Harvard Stem Cell Institute, who has found that some adult stem cells can recruit other stem cells already in the heart to become cardiomyocytes.

Meanwhile, other fields of medicine that have seen more systematic research on stem cells are making real progress in using them for example, to treat Parkinsons, diabetes and macular degeneration. The lesson here is that, ultimately, it takes careful experiments, not belief, to make that huge leap from the laboratory to the hospital.

Roger Highfield is director of external affairs at the Science Museum Group

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Experimental Stem Cell Treatment Tested for Type 1 Diabetes

Posted: June 12, 2012 at 2:15 am

In Early Study, Procedure Helps Teens Halt Insulin Injections

June 11, 2012 (Philadelphia) -- In an early study, an experimental stem cell procedure helped 15 teens with type 1 diabetes stay off of insulin injections for about 1.5 years, on average.

The study was very small, and the procedure is not ready for widespread use. "We now have a unique approach with some positive findings, but it's still early. We need to better understand the biology behind the treatment and follow patients for long-term side effects," Robert E. Ratner, MD, chief scientific and medical officer of the American Diabetes Association, tells WebMD.

This is the latest of several stem cell studies to show promising results for the treatment of type 1 diabetes, Ratner notes.

In the new study, 15 of 28 teens with type 1 diabetes who got an experimental treatment using their own stem cells went into remission and did not need insulin injections for an average of about 1.5 years.

The "cocktail treatment" combines stem cell therapy with drugs that suppress the body's immune system. In type 1 diabetes, the immune system attacks and destroys insulin-producing cells within the pancreas.

The experimental treatment is called autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT). It aims to kill the destructive immune system cells and replace them with immature stem cells not programmed to destroy insulin-producing cells.

First, patients are given drugs to stimulate production of blood stem cells. The blood stem cells are then removed from the body and frozen. Then, patients are hospitalized and given drugs to kill the destructive immune system cells. The harvested blood stem cells are then put back into the patient.

Eight teens who took part in the study have remained insulin-free for two years, on average. One patient has gone without insulin injections for 3.5 years.

"All our patients considered the [treatment] to be worthwhile and beneficial, though some patients experienced side effects," study head Weiqiong Gu, MD, of Ruijin Hospital in Shanghai, tells WebMD.

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Bioluminescence imaging lights up stem cell therapy for hair growth

Posted: June 12, 2012 at 2:15 am

Public release date: 11-Jun-2012 [ | E-mail | Share ]

Contact: Susan Martonik smartonik@snm.org 703-652-6773 Society of Nuclear Medicine

Miami Beach, Fla.Finding a way to restore hair growth after substantial hair loss is something of an obsession worldwide. Investigators at the Society of Nuclear Medicine's 2012 Annual Meeting presented how stem cell research for the development of new hair follicles can be monitored with an optical imaging technique that uses bioluminescence, the same process that allows fireflies to light up.

There is a host of treatments available for hair loss, including creams and drugs, but these have not shown to be very effective for hair growth. Hair stem cells signal the actual regeneration of hair follicles and natural hair. A molecular imaging technique called bioluminescence is used to display processes at the cellular level. Bioluminescent signal is generated in specific chemical substances called substrates. These signals are easily recognized with very sensitive optical imaging systems that can see what is happening in the smallest placesin this case in hair stem cells.

"Hair regeneration using hair stem cells is a promising therapeutic option emerging for hair loss, and molecular imaging can speed up the development of this therapy," saysByeong-Cheol Ahn, M.D., Ph.D., professor and director of the department of nuclear medicine at Kyungpook National University School of Medicine and Hospital in Daegu, South Korea. "This study is the first study of hair follicle regeneration using an in vivo molecular imaging technique."

The current research involves grafting hair stem cells in animal models to investigate if they can grow and proliferate as normal cells do. The progress of hair stem cell therapy is non-invasivelytracked with bioluminescentreporter genes in specialized substrates. There are several bioluminescent reporter genes originating fromnot only fireflies, but also beetles, glowworms and other bioluminescent organisms. The strategy of using bioluminescent reporter genesis ideal for stem cell research, because bioluminescence works only in living cells.

In this study, researchers used bioluminescence imaging usingfirefly luciferase coupled with D-luciferin to monitor the engraftment of hair follicle stem cellscalled newborn fibroblastsin mice to track their viability and development into hair folliclesover time. Bioluminescence imaging was performed five times over the course of 21 days after transplantation of the stem cells.

Results of the study showed successful bioluminescence imaging forhair regeneration with hair stem cell transplantation, and new hair follicles were apparent on the surface of skin samples under microscope. More studies will have to be conducted before clinical trials could be initiated to verify whether this therapy would work for human hair regeneration.

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Scientific Paper 74: Jung Eun Kim, Byeong-Cheol Ahn, Ho Won Lee, Mi-hye Hwang, Sang-Woo Lee and Jaetae Lee, Nuclear Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea; Seng Hyun Shin and Young Kwan Sung, Immunology, Kyungpook National University School of Medicine, Daegu, Republic of Korea, "In vivo monitoring of survival and proliferation of hair stem cells in hair follicle regeneration animal model," SNM's 59th Annual Meeting, June 9, 2012, Miami Beach, Fla.

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