Archive for the ‘Gene Therapy Research’ Category

The Ministry of Primary Industries is failing to monitor food labelling requirements relating to genetic engineering and irradiation, the Green Party said today.

"New Zealanders deserve to know when they are eating food that is genetically engineered or irradiated, but the Government isnt making sure that companies label these foods properly," said Green Party genetic engineering spokesperson Steffan Browning.

Official information released to the Green Party by the Ministry of Primary Industries shows that the last systematic monitoring of food labelling compliance was in 2003. Furthermore, it shows the Government does not intend to schedule any systematic monitoring of labelling compliance for irradiated food in the future.

"New Zealanders want to know and deserve to know how their food has been produced and treated, but the Government isnt checking to see that companies are correctly labelling GE or irradiated food," said Mr Browning.

"Companies will know that the Government isnt conducting systematic checks, and could be exploiting this lack of monitoring.

"The Government shouldnt simply trust companies to do the right thing when companies have a clear financial incentive not to label GE or irradiated food.

"Its not good enough that its been a decade since the Government last monitored for GE labelling.

"How can New Zealanders be confident that companies will label foods as GE when the companies know that theyre not going be checked," said Mr Browning.

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MPI 'failing to monitor labelling of GE food'

Rockville, MD (PRWEB) August 08, 2013

Personalized Medicine and Companion Diagnostic Market Q2 2013 - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

The personalized medicine and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics.

Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics will be more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine will reduce the frequency of adverse drug reactions and therefore have a dramatic impact on health economics. Developmental and diagnostic companies will benefit from lower discovery and commercialization costs and more specific market subtypes.

This report describes the current technologies that are propelling the personalized medicine and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures. Forecast projections and future growth rates are provided to give the reader a forthcoming perspective of this growing industry.

To order this report: Personalized Medicine and Companion Diagnostic Market Q2 2013- A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

Contact: Shauna 800.298.5699 Customerservice(at)marketresearch(dot)com

About Kelly Scientific Publications Kelly Scientific Publications specializes in pharmaceutical, biotechnology and medical diagnostic industries. They offer high end reports that focus on emerging markets and key niche industries. Initiated by Deirdre Kelly PhD, they are located in Dublin, Ireland and provide business intelligence, market insights, and competitor analysis. Kelly Scientific Publications clients include business leaders in industry, biotech, pharmaceutical, government departments, and hi-tech organizations.

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Personalized Medicine and Companion Diagnostic Market Q2 2013 - A Strategic Analysis of Industry Trends, Technologies ...

SAN FRANCISCO, Aug. 8, 2013 (GLOBE NEWSWIRE) -- CollabRx, Inc. (CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, today announced the launch of the company's Genetic Variant Annotation(TM) (GVA(TM)) service. The GVA service is a new product and the company's first offering for the clinical laboratory market. CollabRx will provide the GVA service to the molecular diagnostic segment of the clinical laboratory market which includes reference laboratories, hospital laboratories, research institutions, and laboratories within academic medical centers.

The GVA service provides for a fully automated and scalable medical informatics solution that seamlessly pairs the results of genetic sequencing tests with clinically actionable and dynamically updated knowledge that can be used to inform patient treatment planning. Such knowledge includes the clinical impact of specific genetic profiles and associated therapeutic strategies such as drugs and clinical trials. This content leverages the company's semantic integration platform, a proprietary technology that enables CollabRx scientists and physicians to dynamically update the company's knowledge base with the latest medical and scientific data available in the public domain. This knowledge is further contextualized in collaboration with CollabRx's large and growing network of over 75 leading clinical practitioners in the U.S. and Europe.

The GVA service will initially be available in oncology to support the clinical interpretation of tests to elucidate tumor mutation profiles generated on any testing platform, including next generation sequencing devices. The range of tumor genetic aberrations interpreted by the GVA service include single base pair substitutions, nucleotide insertions and deletions, frameshifts, gene fusions, large-scale chromosomal rearrangement, and copy number variation. Planned functional extensions of the GVA service that are under development include the interpretation of similar genetic tests for inherited/developmental delay conditions, prenatal screening, as well as neurological and metabolic diseases.

CollabRx will provide the GVA service using a combination subscription-based and Software as a Service (SaaS) model. The standard deployment can be customized to support customer specific technical integration requirements and knowledge management preferences.

"Life Technologies, Sengenics, and OncoDNA are early adopters of CollabRx technology and content resources which form the basis of the GVA service," said Gavin Gordon, CollabRx Vice President of Business Development and Strategic Alliances. "With this commercial launch, the company is now in a position to provide the GVA service more broadly beyond these initial customers. For example, in addition to reference laboratories CollabRx is also providing the GVA service in collaboration with multiple academic medical institutions, such as the University of Chicago Medical Center, to support clinical sequencing testing and interpretation initiatives."

About CollabRx

CollabRx, Inc. (CLRX) is a recognized leader in cloud-based expert systems to inform healthcare decision-making. CollabRx uses information technology to aggregate and contextualize the world's knowledge on genomics-based medicine with specific insights from the nation's top cancer experts, starting with the area of greatest need: advanced cancers in patients who have effectively exhausted the standard of care. More information may be obtained at http://www.collabrx.com.

CollabRx Safe Harbor Statement

This press release includes forward-looking statements about CollabRx's anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and CollabRx's plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by CollabRx with the Securities and Exchange Commission. CollabRx undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.

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CollabRx Launches Commercial Service for the Interpretation of Clinical Cancer Sequencing

Doctors removed tissue from Henrietta Lacks' cervix In 1951. Those samples sparked decades of scientific discovery.

STORY HIGHLIGHTS

(CNN) -- In 1951, a doctor at Johns Hopkins Hospital removed two thin slivers of tissue from a dying woman's cervix.

Cells from that biopsy would later multiply wildly and continuously -- a feat never seen until that time -- and become the cornerstone of research for diseases ranging from polio to Parkinson's disease.

The woman's name was Henrietta Lacks. The cells, culled from her cancerous cervical tumor, are called HeLa.

"Her cells were part of research into the genes that cause cancer and those that suppress it; they helped develop drugs for treating herpes, leukemia, influenza, hemophilia, and Parkinson's disease," wrote Rebecca Skloot in her book, "The Immortal Life of Henrietta Lacks."

"They helped with some of the most important advances in medicine: the polio vaccine, chemotherapy, cloning, gene mapping, in vitro fertilization."

HeLa cells are arguably one of the most important contributions to medicine ever made. And they're still the most commonly used cells in research today, Skloot told CNN.

But although the cells have been a boon for the scientific community, they have been a persistent source of pain for the Lacks family.

Henrietta Lacks had no clue her cells would be used for research, and neither did her family. Decades after her death, scientists took tissue samples from other members of the Lacks family and tested them, never disclosing why they were doing it.

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A say in our genetic destiny?

05 - Molecular Genetics II from Human Behavioral Biology 2012 by Robert Sapolsky
Other course materials including a reading list and lecture summaries can be found on my website at http://j.mp/qNtvjE .

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05 - Molecular Genetics II from Human Behavioral Biology 2012 by Robert Sapolsky - Video

#39;Spiritual Genetics #39; by Pastor Apollo C. Quiboloy on Sounds of Worship - SMNI
Sounds of Worship: August 4, 2013 What is Spirit and truth? The Spirit that we talk about here is the spirit of obedience to His Will that makes us connecte...

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'Spiritual Genetics' by Pastor Apollo C. Quiboloy on Sounds of Worship - SMNI - Video

Pastor Chui More Evidence for Epigenetic Controls on Genetics
This is a 7.5-minute sermon from science. A headline on Science Daily sounds almost Biblical: "Gene Mutations Caused by a Father #39;s Lifestyle Can Be Inherited...

By: Christopher Chui

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Pastor Chui More Evidence for Epigenetic Controls on Genetics - Video

Derek Gordon - Applications of Statistical Genetics
Associate Professor Derek Gordon discusses research being done on statistical genetics and its practical applications at the Department of Genetics.

By: Rutgers

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Derek Gordon - Applications of Statistical Genetics - Video

Talking Genetics: Dementias - FTD and Alzheimer #39;s
Genetic counselor Beth McCarty Wood, MS, CGC, explains the role in genetics of FTD and Alzheimer #39;s disease. She also discusses how predictive testing and fam...

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Talking Genetics: Dementias - FTD and Alzheimer's - Video

Peter Gariaev on Linguistic Wave Genetics
This exclusive interview with Dr. Peter Gariaev took place on July 29th, 2013. I apologize for the poor sound quality of this interview, but want to encourage you to sit through its entirety,...

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Peter Gariaev on Linguistic Wave Genetics - Video

Regulatory genomics and epigenomics of complex disease genetics - Luke Ward, MIT
On Thursday, 18 July 2013, the NHGRI #39;s Division of Genomic Medicine presented "Current uses of and future directions for the GWAS Catalog", a webinar highlig...

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Regulatory genomics and epigenomics of complex disease genetics - Luke Ward, MIT - Video

Hereford Genetics; The next decade...where are you going? Dr Rob Banks
Director of the UNE Animal Genetics Breeding Unit Dr Rob Banks speaks on Hereford Genetics; The next decade...where are you going at the Herefords Australi...

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Hereford Genetics; The next decade...where are you going? Dr Rob Banks - Video

#39;Spiritual Genetics #39; by Pastor Apollo C. Quiboloy on Powerline - SMNI
Powerline: August 6, 2013 What is Spirit and truth? The Spirit that we talk about here is the spirit of obedience to His Will that makes us connected to the...

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'Spiritual Genetics' by Pastor Apollo C. Quiboloy on Powerline - SMNI - Video

Public release date: 7-Aug-2013 [ | E-mail | Share ]

Contact: Tracey DePellegrin Connelly tracey.depellegrin@thegsajournals.org 412-760-5391 Genetics Society of America

BETHESDA, MD -- The first study to sequence and analyze the entire genome of a HeLa cell line, along with access to its sequence data, has been published today (Wednesday, August 7) in its final version, by G3: Genes|Genomes|Genetics, an open-access, scientific journal of the Genetics Society of America.

The article, "The Genomic and Transcriptomic Landscape of a HeLa Cell Line," by Landry et al., was authored by scientists at the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany, and was published in an early online version March 11, 2013.

Genomic data from the HeLa cell line are also being released with the final version of the paper as a result of discussions between leaders of the National Institutes of Health (NIH) and relatives of Henrietta Lacks, from whose cervical tumor the original HeLa cell line was derived prior to her death in 1951. The genomic data will now be available to scientists via the NCBI's Database of Genotypes and Phenotypes (dbGaP).

In direct response to the concerns of the Lacks family that the privacy of their genetic information might be affected by the availability of the HeLa genome sequence data published in G3, the EMBL scientists voluntarily removed the HeLa cell line sequence data from public access, and offered to work with the family towards a mutually acceptable solution. NIH Director Francis S. Collins, M.D., Ph.D., and NIH Deputy Director for Science, Outreach, and Policy Kathy L. Hudson, Ph.D., met several times with representatives of the Lacks family, and came to a mutual understanding to allow biomedical researchers controlled access to the data. Dr. Collins and Dr. Hudson describe their discussions with the Lacks family in a Comment published in this week's edition of the journal Nature.

Since their isolation in 1951, HeLa cells have been the most widely used human cell line in research. They have become a valuable resource for biologists, enabling momentous scientific breakthroughs including the development of the polio vaccine the Nobel Prize winning studies defining the role of telomerase in aging, and research on the causative role of human papillomavirus (HPV) in some types of cervical cancer. The latter discovery spurred the development of an HPV vaccine to prevent certain types of cervical cancer from occurring. In fact, Ms. Lacks' death was caused by cervical cancer.

The advent of genomics and rapid sequencing techniques has seen HeLa cells used in numerous large-scale studies of gene function and expression. Yet, "these studies using HeLa cells had to rely on information from the 'reference' sequence produced by the Human Genome Project, even though there was evidence that the genomes of HeLa cell lines were probably quite different," said Lars Steinmetz, Ph.D., who led the G3 study.

Dr. Steinmetz and his team found the genome of the HeLa cell line that they sequenced differs dramatically from a normal human genome sequence. These differences include widespread sequence variation, extra copies of genes, and massive, complex rearrangements.

Because the dataset now will be available to the scientific community, researchers will be able to account for these differences when designing and interpreting experiments using this HeLa cell line. The genomic particularities of HeLa cells relate to their origin from an aggressive cancer and subsequent cultivation in laboratories for decades, both of which cause considerable genomic alterations.

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Access to HeLa cell genome data restored following agreement

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Why Is Myriad Genetics Still Filing Patent Suits for Breast-Cancer Tests?

SEATTLE, WA--(Marketwired - Aug 8, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company, announced today that BUYINS.NET, http://www.buyins.net, a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has initiated coverage on Atossa Genetics after releasing the latest short sale data through August 6, 2013. The total aggregate number of shares shorted since December 2012 is approximately 3.3 million shares. Approximately 23.99% of daily trading volume is short selling. The SqueezeTrigger price for all ATOS shares shorted is $6.99.A short squeeze is expected when ATOS closes above its $6.99 SqueezeTrigger price.

Click here to view Report: http://www.buyins.com/reports/atos8-7-13.pdf

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Click here for Friction Factor: http://www.buyins.com/images2/atosff8-7-13.jpg

Click here for detailed explanation: http://www.buyins.com/brochure.pdf

Friction Factor calculates if a fair market is being made in the shares of ATOS. 38% of the previous 39 trading days have been positive or bullish-biased and 62% have been negative or bearish-biased.

Regulation SHO requires bona-fide market-making activities to include making purchases and sales in roughly comparable amounts. The Commission has stated that bona-fide market-making DOES NOT include activity that is related to speculative selling strategies or investment purposes of the broker-dealer and is disproportionate to the usual market making patterns or practices of the broker-dealer in that security. Likewise, where a market-maker posts continually at or near the best offer, but does not also post at or near the best bid, the market-maker's activities would not generally qualify as bona-fide market-making. Moreover, a market-maker that continually executes short sales away from its posted quotes would generally not be considered to be engaging in bona-fide market-making.

BUYINS.NET monitors ATOS market-makers daily for compliance with Fair Market-Making Requirements.

About BUYINS.NETBUYINS.NET, http://www.buyins.net, monitors trading in all US stocks in real time and maintains massive databases of short sale and naked short sale time and sales data, short squeeze SqueezeTrigger prices, market-maker price movements, shareholder data, statistical data on earnings, sector correlation, seasonality, hedge fund trading strategies and comparable valuations. Reports include:

REGULATORY & COMPLIANCE NEWS

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BUYINS.NET Issues Atossa Genetics SqueezeTrigger Report

LOS ANGELES, Aug. 8, 2013 (GLOBE NEWSWIRE) -- Response Genetics, Inc. (RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced its consolidated financial results and business progress for the second quarter ended June 30, 2013.

Total revenue for the second quarter ended June 30, 2013 was $5.3 million compared to $3.8 million for the quarter ended June 30, 2012. The Company's pharmaceutical client revenue increased by 121% and the Company's ResponseDX(R) revenue increased 10% relative to the quarter ended June 30, 2012. The Company's pharmaceutical client revenue, which is characteristically inconsistent, decreased 10% from the first quarter of 2013. This decrease was primarily related to a timing delay on one large pharma project which subsequently restarted late in the second quarter. The Company's ResponseDX(R) revenues were relatively consistent with the prior quarter.

The Company also increased its gross margin to 49% for the quarter ending June 30, 2013 compared to 37% for the second quarter of 2012. Gross margin decreased by 6% relative to the quarter ended March 31, 2013 which was primarily related to the pharma project delay discussed above. Gross margin is calculated as gross profit as a percentage of net revenue.

Excluding cost of revenue, total operating expenses for the second quarter were $3.9 million, compared to $4.1 million for the same period last year and were relatively consistent with the quarter ended March 31, 2013.

Cash and cash equivalents at June 30, 2013, were $5.9 million, compared to $9.0 million at December 31, 2012.

"We believe our financials speak for themselves. Our pharma segment continued to be strong and our Dx revenues continued to grow year-over-year while we concurrently increased our gross margin from 37% just a year ago to over 49% for the quarter," said Thomas Bologna, the Company's Chairman & Chief Executive Officer.

Mr. Bologna added, "We view 2012 as the year of our turnaround and 2013 as the year we work our top line. As we continue to aggressively build a marketing department and restructure and grow our sales organization, we expect to deliver meaningful top-line growth in our Dx business in the second half of 2013. During the last six months of the year, we expect to begin implementing several new marketing initiatives which are well underway including, but not limited to, introducing a completely new web-based portal to enhance the customer experience and a pathology partnering program that we believe will be the best in our space. Additionally, we plan on introducing several new assays as well as updating our messaging and branding. We believe the further strengthening of our sales and marketing organizations, combined with enhanced technological infrastructure, and a constant focus on operational efficiencies which were the hallmarks of our 2012 turnaround, will drive our strategic and financial performance."

The Company's net loss for the second quarter ended June 30, 2013 decreased to $1.3 million, or $(0.04) per share, compared to a net loss of $2.7 million, or $(0.11) per share, for the quarter ended June 30, 2012 and a net loss of $0.8 million, or $(0.03) per share, for the quarter ended March 31, 2013.

Total revenues for the six months ended June 30, 2013 were $10.9 million compared to $7.8 million for the six months ended June 30, 2012. The increase is largely a result of an increase in Dx revenues of $0.5 million to $6.3 million for the six months ended June 30, 2013 and an increase in pharmaceutical client revenue of $2.6 million to $4.6 million for the six months ended June 30, 2013.

The Company's net loss for the six months ended June 30, 2013 was $2.1 million, compared with a net loss of $5.9 million for the six months ended June 30, 2012.

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Response Genetics, Inc. Announces Second Quarter 2013 Financial Results

MRI-Guided Gene Therapy for Brain Cancer at UC San Diego Health System
Neurosurgeons at UC San Diego Moores Cancer Center are among the first in the world to utilize real-time MRI guidance for delivery of gene therapy as a poten...

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MRI-Guided Gene Therapy for Brain Cancer at UC San Diego Health System - Video

Featured Article Main Category: MRI / PET / Ultrasound Also Included In: Cancer / Oncology Article Date: 08 Aug 2013 - 0:00 PDT

Current ratings for: Brain cancer: groundbreaking MRI-guided gene therapy

Neurosurgeons from the University of California, San Diego (UCSD) have conducted the first real-time MRI-guided gene therapy for patients with brain cancer, advancing the clinical trial of new cancer drug, Toca 511.

The new treatment, carried out by neurosurgeons at the UCSD School of Medicine and the UCSD Moores Cancer Center, uses real-time magnetic resonance imaging (MRI) as a way of guiding the delivery of the new gene therapy directly into brain tumors.

MRI navigational technology, called Clearpoint, enables the neurosurgeons to inject Toca 511 (vocimagene amiretrorepvec) directly into a brain tumor.

Clearpoint provides visual confirmation that the correct amount of Toca 511 is injected into the tumor, and it ensures physicians are able to make adjustments to optimize the location of drug delivery.

Clark Chen, chief of stereotactic and radiosurgery and vice chairman of neurosurgery at UCSD Health System, says this new method may be preferable to chemotherapy.

"With chemotherapy," Chen says. "Just about every human cell is exposed to the drug's potential side-effects. By using the direct injection approach, we believe we can limit the presence of the active drug to just the brain tumor and nowhere else in the body." he adds:

See a fuller, exclusive interview given by Clark Chen to Medical News Today.

Toca 511 is a new investigational gene therapy that works as a retrovirus to selectively replicate in cancer cells, such as glioblastomas (brain tumors). Toca 511 creates an enzyme that changes an anti-fungal drug called flucytosine (5-FC), into an anti-cancer drug called 5-fluorouracil (5-FU).

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Brain cancer: groundbreaking MRI-guided gene therapy

WASHINGTON--(BUSINESS WIRE)--

The applications of gene therapy and genetic engineering are broad: everything from pet fish that glow red to increased crop yields worldwide to cures for many of the diseases that plague humankind. But realizing them always starts with solving the same basic scientific questionhow to "transfect" a cell by inserting foreign DNA into it. Many methods already exist for doing this, but they tend to be clumsy and destructive, not allowing researchers to precisely control how and when they insert the DNA or requiring them to burn through large numbers of cells before they can get it into one.

A team of scientists in South Korea have now developed the most precise method ever used to insert DNA into cells. The method combines two high-tech laboratory techniques and allows the researchers to precisely poke holes on the surface of a single cell with a high-powered "femtosecond" laser and then gently tug a piece of DNA through it using "optical tweezers," which draw on the electromagnetic field of another laser. The teams approach, which is a breakthrough in precision and control at the single-cell level, was published today in the Optical Societys (OSA) open-access journal Biomedical Optics Express.

What is magical is that all this happens for one cell, said Yong-Gu Lee, an associate professor in the School of Mechatronics at the Gwangju Institute of Science and Technology in South Korea and one of the researchers who carried out the study. "Until today, gene transfection has been performed on a large quantity of agglomerate cells and the outcome has been observed as a statistical average and no observations have been made on individual cells."

Common techniques to force DNA into cells can be clumsy or even violent, Lee said. For instance, researchers often use so-called gene guns to fire particles coated with strands of DNA known as plasmids at large populations of cells. Alternatively, scientists may puncture the membranes of individual cells with lasers, place the cells in a plasmid soup, and let the genes diffuse into the perforated cells on their own. While either method can transfect some fraction of a population, researchers cannot control whether any individual cell will incorporate the desired genes, and large numbers of cells may be damaged or destroyed in the process.

In the new study, the researchers sought to safely transfect an individual cell. To manipulate the foreign DNA, the scientists used optical tweezers, which essentially tweaks a laser beam whose electromagnetic field can grab hold of and transport a plasmid-coated particle. The researchers first moved the particle to the surface of the cell membrane. Guided by the trapped particle, they then created a tiny pore in the cell membrane using an ultra-short laser pulse from a femtosecond laser. While another laser beam detected the exact location of the cell membrane, they pushed the particle through the pore with the tweezers. Using this technique, the scientists were able to ease a microparticle right up to the pore in the membrane and drop it into the cell, like a golfer sinking an easy putt.

To determine whether their method had succeeded, the researchers inserted plasmids carrying a gene that codes for a green fluorescent protein. Once inside the cell, the gene became active and the cells machinery began producing the protein. The researchers could then detect the green glow using a fluorescence microscope. They found that approximately one in six of the cells they studied became transfected. This rate is lower than that recorded for some other methods, but those are less precise and involve many cells at a time.

Lee hopes the work will allow other researchers to investigate the effects of transfection on individual cells, not just large populations. With the new technique, you can put one gene into one cell, another gene into another cell, and none into a third, he said. So you can study exactly how it works.

Paper: "Single-cell optoporation and transfection using femtosecond laser and optical tweezers," M. Waleed et al., Biomedical Optics Express, Vol. 4, Issue 9, pp. 1533-1547 (2013).

EDITORS NOTE: Images are available to members of the media upon request. Contact Angela Stark, astark@osa.org.

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New High-Tech Laser Method Allows DNA to be Inserted ‘Gently’ into Living Cells

Technique offers greater control of essential gene therapy and genetic engineering method.

The applications of gene therapy and genetic engineering are broad: everything from pet fish that glow red to increased crop yields worldwide to cures for many of the diseases that plague humankind.

But realising them always starts with solving the same basic scientific questionhow to "transfect" a cell by inserting foreign DNA into it. Many methods already exist for doing this, but they tend to be clumsy and destructive, not allowing researchers to precisely control how and when they insert the DNA or requiring them to burn through large numbers of cells before they can get it into one.

A team of scientists in South Korea have now developed the most precise method ever used to insert DNA into cells. The method combines two high-tech laboratory techniques and allows the researchers to precisely poke holes on the surface of a single cell with a high-powered "femtosecond" laser and then gently tug a piece of DNA through it using "optical tweezers," which draw on the electromagnetic field of another laser. The team's approach, which is a breakthrough in precision and control at the single-cell level, was published in the Optical Society's (OSA) open-access journal Biomedical Optics Express.

"What is magical is that all this happens for one cell," said Yong-Gu Lee, an associate professor in the School of Mechatronics at the Gwangju Institute of Science and Technology in South Korea and one of the researchers who carried out the study. "Until today, gene transfection has been performed on a large quantity of agglomerate cells and the outcome has been observed as a statistical average and no observations have been made on individual cells."

IMAGE: Image 2: Optical manipulation of plasmid-coated particles and insertion into the cell through a small pore punctured by a short-pulsed laser is shown. Plasmids produce a green fluorescent protein once... Click here for more information.

Common techniques to force DNA into cells can be clumsy or even violent, Lee said. For instance, researchers often use so-called "gene guns" to fire particles coated with strands of DNA known as plasmids at large populations of cells. Alternatively, scientists may puncture the membranes of individual cells with lasers, place the cells in a plasmid soup, and let the genes diffuse into the perforated cells on their own. While either method can transfect some fraction of a population, researchers cannot control whether any individual cell will incorporate the desired genes, and large numbers of cells may be damaged or destroyed in the process.

In the new study, the researchers sought to safely transfect an individual cell. To manipulate the foreign DNA, the scientists used optical tweezers, which essentially tweaks a laser beam whose electromagnetic field can grab hold of and transport a plasmid-coated particle. The researchers first moved the particle to the surface of the cell membrane. Guided by the trapped particle, they then created a tiny pore in the cell membrane using an ultra-short laser pulse from a femtosecond laser. While another laser beam detected the exact location of the cell membrane, they pushed the particle through the pore with the tweezers. Using this technique, the scientists were able to ease a microparticle right up to the pore in the membrane and drop it into the cell, like a golfer sinking an easy putt.

To determine whether their method had succeeded, the researchers inserted plasmids carrying a gene that codes for a green fluorescent protein. Once inside the cell, the gene became active and the cell's machinery began producing the protein. The researchers could then detect the green glow using a fluorescence microscope. They found that approximately one in six of the cells they studied became transfected. This rate is lower than that recorded for some other methods, but those are less precise and involve many cells at a time.

Lee hopes the work will allow other researchers to investigate the effects of transfection on individual cells, not just large populations. With the new technique, "you can put one gene into one cell, another gene into another cell, and none into a third," he said. "So you can study exactly how it works."

Excerpt from:
Laser improves gene therapy control

6 weeks post-op Adipose Stem Cell Therapy
"Dugan" 6 weeks post-op Adipose Stem Cell Therapy. Visit Kindred-caninesinmotion.org.

By: Joyce Gerardi

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Whoifwhat: Stem Cell Therapy- Knees, Hip, Back, etc.!
It works: Now in St. Louis, New York Phily: coming to your town soon ! Using stem cells from belly fat ( got any) platelets to mark area an injection is ...

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MANILA - Foreign doctors are now required to secure a permit to perform stem cell therapy in the country or face criminal liability.

The Professional Regulation Commission (PRC)s Board of Medicine (BOM) made the announcement yesterday, explaining that the requirement is part of government efforts to regulate the practice of stem cell therapy in the country to ensure the safety of patients.

In a statement, the BOM said foreign physicians who intend to practice stem cell therapy here must obtain special temporary permit from the PRC to avoid being charged with medical malpractice.

Even local doctors who have aided foreign physicians illegal practice of stem cell therapy shall be also held criminally liable, the BOM added.

To secure the special temporary permit, a foreign doctor must submit proof of education and actual practice in the field of stem cell therapy and current license authenticated by the Philippine embassy and the embassy in the country of origin.

The board said physicians should have acquired the necessary education, supervised training and extensive clinical experience prior to performing the treatment. It noted that the argument that stem cell therapy falls under the general practice of medicine since it only involves injection of stem cell solution is erroneous.

As professionals, physicians should be able to conduct self-assessment and self-evaluation regarding what they can and what they should not do, they added.

The BOM also noted that stem cell therapy should be practiced only in hospitals and clinics licensed by the Department of Heath for assurance that these medical facilities have the necessary manpower and equipment to prevent risks and hazards to patients.

The board also warned patients desiring to undergo stem cell therapy abroad to first verify the status of clinics and hospitals as well as practitioners from regulatory authorities.

Earlier, the Food and Drug Administration and the Philippine Medical Association (PMA) reported receiving numerous complaints of foreign doctors performing stem cell therapy in hotels and other non-medical facilities. The PMA said foreign doctors injected patients with animal-based stem cells at P1 million per shot, but these foreigners are not even licensed to practice medicine in the country.

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Foreign doctors need permit for stem cell therapy

SAN DIEGO, Calif., Aug. 6, 2013 /PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today announced that it has entered into an agreement with Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Cardium's Excellagen pharmaceutically-formulated gel as a delivery agent for Orbsen's proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers. The research is being conducted by the Regenerative Medicine Institute (REMEDI), at the National University of Ireland Galway (NUIG), a world-class biomedical research centre focused on mesenchymal stromal cell (MSC) research. The research initiative is funded by REDDSTAR, a European Union Framework 7 (EU FP7) research collaboration focused on treating diabetes and its complications with a defined MSC therapy and enlisting academic and industry partners throughout Europe in the program (www.reddstar.eu).

(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)

Cardium's FDA-cleared Excellagen is an aseptically-manufactured, quaternary fibrillar Type I bovine collagen homogenate that is configured into a staggered array of three-dimensional, triple helical, telopeptide-deleted, tropocollagen molecules. This linear array forms a flowable, biocompatible and bioactive structural matrix that promotes chemotaxis, cellular adhesion, migration and proliferation to stimulate tissue formation. The Excellagen homogenate represents a new product delivery platform that allows for the potential development of a portfolio of advanced tissue regeneration therapeutic opportunities that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media.

About Excellagen

Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen's FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen's unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.

There have been important, positive findings reported by physicians using Excellagen as part of Cardium's physician sampling, patient outreach and market "seeding" programs. In several case studies, physicians reported a rapid onset of the growth of granulation tissue in a wide array of wounds, including non-healing diabetic foot ulcers (consistent with the results of Cardium's Matrix clinical study), as well as pressure ulcers, venous ulcers and Mohs surgical wounds. In certain cases, rapid granulation tissue growth and wound closure have been achieved with Excellagen following unsuccessful treatment with other advanced wound care approaches. From a dermatology perspective, a previously unexplored vertical market, remarkable healing responses have been observed following Mohs surgery for patients diagnosed with squamous and basal cell carcinomas, including deep surgical wounds extending to the periosteum (a membrane that lines the outer surface of bones). Additionally, because of the easy-use and platelet activating capacity, physicians have been employing Excellagen in severe non-healing wounds at near-amputation status, in combination with autologous platelet-rich plasma therapy and collagen sheet products. These case studies and positive physician feedback provide additional support of Excellagen's potential utility as an important new tool to help promote the wound healing process. Excellagen case studies are available at http://www.excellagen.com/surgical-wounds.html.

About Orbsen Therapeutics

Orbsen Therapeutics Ltd. is a privately-held company founded in 2006 as a spin out from Ireland's Regenerative Medicine Institute (REMEDI) in NUI Galway. As part of the PurStem EU FP7 program, Orbsen developed proprietary technologies (ORB1) that enable the prospective purification of highly defined and therapeutic stromal cells from several human tissues, including marrow, adipose tissue and umbilical cord. ORB1 stromal cells can be purified from several species including equine and murine tissues, enabling the development of defined equine MSC therapies for the first time. These novel aspects of the ORB1 technology place Orbsen at the leading edge of research, development and regulatory compliance of MSC therapies. The therapeutic ORB1 cells can be purified from a single human donor, expanded and frozen to generate many doses of high-margin, allogeneic ("off-the-shelf") therapeutic products for indications with unmet need. Orbsen's proprietary ORB1 MSC therapy is being developed for several indications, including inflammatory disease of the lungs and liver, diabetes, cardiovascular disorders, joint disease, kidney injury, tissue graft rejection and wound repair. For more information, please visit http://www.orbsentherapeutics.com/.

About The Regenerative Medicine Institute at NUI, Galway

The Regenerative Medicine Institute (REMEDI) is a world-class biomedical research centre focusing on gene therapy and stem cell research. REMEDI is a partnership involving scientists, clinicians, and engineers in academic centres and in industry. Researchers at REMEDI work together to combine the technologies of gene therapy and adult stem cell therapy with the aim of regeneration and repair of tissues. The unique feature of the research carried out at REMEDI is the novel integration of both therapies in a complementary research and development programme. Based in the National University of Ireland, Galway, REMEDI was established in 2003 through a Science Foundation Ireland (SFI) Centre for Science Engineering and Technology (CSET) award, and industry funding. The institute is located at the National Centre for Biomedical Engineering Science and incorporates the National Cell and Gene Vector Laboratory, a GMP grade vector and cell production facility. More information is available at http://www.nuigalway.ie/remedi/about-us.

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Cardium Reports On New Excellagen-Based Stromal Cell Research For Wound Healing With Orbsen Therapeutics Under ...