Category Archives: Stem Cell Therapy

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Posted on June 15, 2012 at 5:53 PM

Updated Friday, Jun 15 at 7:35 PM

Meg Farris / Eyewitness News Email: mfarris@wwltv.com | Twitter: @megfarriswwl

NEWORLEANS- She was only in kindergarten when doctors gave her family the bad news.

Now she's one of the first in Louisiana to try a new treatment for people who get gravely ill after a bone marrow transplant.

The last three years of Sami Smith's life have been physically and emotionally painful.

"I literally, they try to scare me and they can't, because I've been through the scariest thing that you can," said Smith, 9, of Ponchatoula.

Her mother noticed she was napping more and bruising. Doctors diagnosed AML, a type of leukemia or blood cancer. Had she not gotten to the doctor then, she would not have made it much longer. A Child's Wish sent her to Disney World. The good news, one of her teen sisters Mary Hannah, 13, was a good bone marrow match. The transplant worked and Sami was cancer free.

Then devastating news. Sami got a condition called GvHD (Graft-versus-host disease) where the new marrow launches a painful attack on the recipient's body. It's the leading cause of transplant-related death.

See the article here:
Stem cell treatment offers hope to those sickened after getting bone marrow

"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."

The six patients suffered strokes between six months and five years before they were treated, and all had been left with limb weakness.

The patients were assessed using the National Institutes of Health Stroke Scale which ranked the first five patients with a median score of eight before the treatment and four points three months afterwards.

The sixth patient was treated less than three months ago. Six further patients will be treated as part of this Phase 1 trial.

Professor Muir said he was "intrigued" by the early results.

He added: "We know that if you're involved in a trial you are going to see patients change in behaviour, particularly if you're doing something invasive, so we need to be very cautious indeed in interpreting these results.

"However, that said, it is not something we'd anticipated seeing in this group of patients."

Further trials are needed to establish whether stem cells actually help the brain repair damaged tissue.

Michael Hunt, chief executive officer of the company developing the treatment, ReNeuron, said: "The clinical trial is primarily a safety study and we must therefore treat any of the observed early indications of functional benefit with considerable caution at this stage.

"That said, we remain encouraged by the results seen in the study to date and we look forward to providing further updates."

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Stem cell treatment helps heal stroke victims

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."

See the article here:
Stem cells 'help' stroke patients

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics Inc. (BCLI), a developer of adult stem cell therapeutics targeting Central Nervous System (CNS) neurodegenerative diseases, announced today that Brainstorm Cell Therapeutics Ltd. received the first installment of the 2012 grant from Israels Office of the Chief Scientist (OCS) in the amount of approximately $350,000. The yearly grant for 2012 is $1,100,000 (~4.2 M NIS). The grant is awarded to BrainStorms Research and Development program towards the development of its leading and innovative NurOwn therapy for ALS using autologous adult stem cells.

We are thankful to the OCS for its continued support of our Research and Development program. The non-dilutive capital that we are receiving from the OCS will help move forward our NurOwn technology as a potential new treatment standard for patients with Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS), said Dr. Adrian Harel BrainStorms newly promoted CEO.

BrainStorm is in Phase I/II human clinical trials in Israel with NurOwn, BrainStorms adult stem cell therapy in patients with ALS (often referred to as Lou Gehrig's Disease). The study is conducted at the Hadassah Medical Center and is headed by principal investigator Dimitrios Karussis, M.D., Ph.D., of the Hadassah Medical Center, together with a scientific team from BrainStorm headed by Prof. Eldad Melamed. The initial phase of the study is designed to assess the safety of NurOwn. As previously announced by Brainstorm (see our press release of March 29, 2012) the interim results for the first 12 patients are expected by July 2012.

The OCS grant will enable BrainStorm to continue its clinical program and accelerate its development of new CNS indications, said Chaim Lebovits, President of Brainstorm. I would also like to take this opportunity to congratulate Dr. Adrian Harel on the occasion of his promotion by the Board of Directors as CEO of Brainstorm. Dr. Harel is successfully leading the company, together with the entire wonderful team at Brainstorm, to the next exciting phase of developing our NurOwn product to treat ALS and other neurodegenerative diseases," said Lebovits.

The OCS has supported BrainStorm Cell Therapeutics Ltd. the Israeli Subsidiary since 2007, providing grants of a total of $1.75 million including this grant. The Company is required to pay royalties to the OCS, amounting to 3% - 5% of revenues derived from sales of the products funded with these grants, but only up to the amount equal to 100% of the grants received.

About the Office of the Chief Scientist

The Office of the Chief Scientist [OCS] in the Ministry of Industry, Trade and Labor is charged with execution of government policy for support of industrial R&D. The goal of the OCS is to assist in the development of technology in Israel as a means of fostering economic growth, encouraging technological innovation and entrepreneurship, leveraging Israel's scientific potential, enhancing the knowledge base of industry in Israel, stimulating high value-added R&D and encouraging R&D collaboration both nationally and internationally.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotech company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. Brainstorm, through its wholly owned subsidiary, holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The technology is currently in a Phase I/II clinical trials for ALS.

Excerpt from:
BrainStorm Receives 1.3 Million NIS Grant from Israel’s Office of the Chief Scientist

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).

Read more from the original source:
ReNeuron Group plc - PISCES Trial Interim Data

Public release date: 12-Jun-2012 [ | E-mail | Share ]

Contact: Jia Liu liujia@genomics.cn BGI Shenzhen

Chalfont St. Giles, UK, and Shenzhen, China 12 June, 2012 GE Healthcare, the healthcare business of GE (NYSE: GE), and BGI, the world's largest genomics organization, jointly announced today 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 and 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 cells 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. "

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About GE Healthcare

GE Healthcare provides transformational 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 (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at http://www.gehealthcare.com.

About BGI

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BGI, GE Healthcare team up on pioneering stem cell science projects

CARLSBAD, Calif., June 12, 2012 /PRNewswire/ -- Life Technologies Corporation (LIFE) today announced a partnership with Cellular Dynamics International (CDI), the world's largest producer of human cells derived from induced pluripotent stem (iPS) cells, to commercialize a set of three new products optimized to consistently develop and grow human iPS cells for both research and bioproduction.

The partnership marries CDI's leadership in human iPS cell development with Life Technologies' expertise in stem cell research tool manufacturing and global distribution network to make these novel technologies accessible to researchers around the world. Life Technologies' commercialization of Essential 8 Medium, Vitronectin (VTN-N), and Episomal iPSC Reprogramming Vectors addresses several challenges associated with developing relevant cells for use in a wide range of studies, from basic and translational research to drug discovery efforts. The effectiveness of these products is the focus of recent validation studies published in the journals Nature Methods and PLoS One.

"The launch of these new stem cell culture products furthers CDI founder and stem cell pioneer Jamie Thomson's vision to enable scientists worldwide to easily access the power of iPSC technology, thus driving breakthroughs in human health," noted Bob Palay, CDI Chief Executive Officer.

To eliminate the variability introduced by a mouse cell feeder layer previously used during the culture of human iPS cells, researchers have adopted "feeder-free" media. However, existing feeder-free culture media contain more than 20 interactive ingredients, many of which, such as bovine serum albumin (BSA) and lipids, are highly uncharacterized and vary significantly from lot-to-lot.This leads to variability in iPS cell growth and differentiation and impedes the progress of disease studies and potential clinical applications.

Essential 8 Medium, manufactured in a Life Technologies current Good Manufacturing Practices (cGMP) facility, overcomes this barrier. In addition, BSA and other undesirable components have been removed from the media, thus reducing the number of ingredients to just eight well-characterized elements required to support efficient growth, eliminate variability, and enable large-scale production of human iPS cells.

"Essential 8 has far fewer variables, it's more straight-forward and a lot more reproducible," said Emile Nuwaysir, Ph.D., Chief Operating Officer and Vice President of Cellular Dynamics International. "If the goal is to make a billion cardiomyocytes a day, every day, you want to make sure they're all the same. That's virtually impossible using mouse embryonic fibroblasts and it's very difficult using the more complex, feeder-free media that were available before Essential 8."

Optimized for use with Essential 8 Medium, Vitronectin (VTN-N) is a defined, human protein-based substrate that further eliminates variability during iPS cell culture unlike most existing feeder-free media that requires the use of an undefined matrix derived from mouse tumor cells for cell attachment and growth. The combination of Essential 8 Medium and Vitronectin (VTN-N) provides a defined, culture system free of non-human components for robust, cost-effective and scalable iPS cell culture.

Life Technologies is also introducing the Episomal iPSC Reprogramming Vectors, which leverages non-viral, non-integrating technology to deliver six genes to initiate the reprogramming of human somatic cells, such as blood and skin cells, to iPS cells. A non-viral approach offers a key advantage: human-derived iPS cells have more relevance for patient-specific, disease research. Traditional viral-based methods, such as lentivirus or retrovirus, require integration into the host genome for replication and can disrupt the genome of the reprogrammed cells.

"The ability to reproducibly establish andculture iPS cells using defined reagent systems is key for the advancement of stem cell research, disease modeling and drug discovery," said Chris Armstrong Ph.D, General Manager and Vice President of Primary and Stem Cell Systems at Life Technologies. "The commercialization of these exciting new products serves that purpose and underscores our commitment to provide the most innovative and relevant workflow tools to our customers."

All three products were developed at the University of Wisconsin by Dr. James Thomson, whose lab pioneered embryonic stem cell research and much of the technology surrounding stem cell culturing conditions, in vitro differentiation and iPS cell generation.

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Life Technologies and Cellular Dynamics International Partner for Global Commercialization of Novel Stem Cell ...