Category Archives: Regenerative Medicine

Regenerative medicine, a field that didn't exist 20 years ago and contains techniques seemingly straight out of science fiction, could be the next big thing in Virginia's biotechnology sector.

That's the opinion of Roy Ogle, an expert in the field who works at Old Dominion University as head of its new school of Medical Diagnostic and Translational Sciences.

So what is regenerative medicine? Simply put, it's the process of re-growing human cells to repair damaged tissues and organs.

In a meeting Thursday hosted by the Virginia Biotechnology Association, Ogle and Brian Pollok, principal of Rapidan BioAdvisors, discussed one of the field's newest developments: induced pluripotent stem cells, or iPSCs.

Let's go back to high school biology: Perhaps you remember embryonic stem cells. These cells can differentiate into different types of cells skin, blood, bone, muscle before a baby is born. But their use in scientific research has become controversial and difficult.

So scientists needed a new way to develop stem cells. iPSCs are already formatted cells that are "induced," or returned, to their original state as a stem cell. Then that stem cell can be reprogrammed to become a different type of cell. For example, a researcher can take a red blood cell, turn it into an iPSC, and then turn that into a muscle cell. (Yeah, our jaw dropped at this point, too). So you get most of the benefits of an embryonic stem cell without the controversy.

What's that mean for the business community?

"Ten or 20 years from now, we could have a way to do cell replacements and make a new spinal cord or new and healthy muscles," Ogle said. "But right now, there are genetic discoveries and methods of development with a giant potential that a small company can sell to (pharmaceutical giants such as) Roche or Sanofi-Aventis."

Ogle said this sort of intermediate work after invention but before the science is proven enough for big pharma to get involved is the perfect space for startups, especially those affiliated with research universities. He said small companies are best placed to do this work and sell the results to big companies because a startup is better suited to tolerate the risk and uncertainty.

"While we think about the long-term development as scientists, there are applications right now where we could serve society and make a lot of money," he said.

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Regenerative medicine could be 'next big thing' for Va. biotech

The Yomiuri Shimbun/Asia News Network Friday, Oct 05, 2012

The K supercomputer, which once held the world's fastest computing speed, may be used to shorten the time needed in regenerative medicine from several months, or even years, to several hours, according to the Riken Center of Developmental Biology and other institutions.

Researchers aim to create organs from human embryonic stem cells (ES cells) or induced pluripotent stem cells (iPS cells), but the length of time normally needed to accomplish this task is a problem.

The institutions hope to put regenerative medicine into practical use as soon as possible using iPS cells, a Japanese technology, and other cells, and this is where the supercomputer will come in.

Yoshiki Sasai, group director at the Riken Center, and other researchers are planning to use the K supercomputer to determine the best method to create organs from these cells.

The researchers successfully developed an optic cup, a basic part of the eye, from ES cells for the first time in the world. While it takes about six months to transform ES cells into an optic cup, the researchers spent about three years to find how to do this through trial and error.

Currently, it takes several years to complete basic experiments to transform ES cells or iPS cells into target organs, and in many cases the experiments fail to achieve their purpose.

Plans are under way to use the K supercomputer to develop new medicines, work out disaster prevention measures and conduct research on cosmic evolution and for other purposes.

Sasai and the other researchers, therefore, decided the supercomputer, which performs 10 quadrillion (or one kei in Japanese) calculations per second, would be ideal in completing basic experiments in a fraction of the time it now takes.

If the K supercomputer calculates mathematized data on divisions, growth and internal changes of iPS cells to which protein or certain kinds of genes are added, it will become possible to create target organs more effectively, according to the researchers.

Continued here:
K computer may be used in regenerative medicine

The Yomiuri Shimbun/Asia News Network Friday, Oct 05, 2012

The K supercomputer, which once held the world's fastest computing speed, may be used to shorten the time needed in regenerative medicine from several months, or even years, to several hours, according to the Riken Center of Developmental Biology and other institutions.

Researchers aim to create organs from human embryonic stem cells (ES cells) or induced pluripotent stem cells (iPS cells), but the length of time normally needed to accomplish this task is a problem.

The institutions hope to put regenerative medicine into practical use as soon as possible using iPS cells, a Japanese technology, and other cells, and this is where the supercomputer will come in.

Yoshiki Sasai, group director at the Riken Center, and other researchers are planning to use the K supercomputer to determine the best method to create organs from these cells.

The researchers successfully developed an optic cup, a basic part of the eye, from ES cells for the first time in the world. While it takes about six months to transform ES cells into an optic cup, the researchers spent about three years to find how to do this through trial and error.

Currently, it takes several years to complete basic experiments to transform ES cells or iPS cells into target organs, and in many cases the experiments fail to achieve their purpose.

Plans are under way to use the K supercomputer to develop new medicines, work out disaster prevention measures and conduct research on cosmic evolution and for other purposes.

Sasai and the other researchers, therefore, decided the supercomputer, which performs 10 quadrillion (or one kei in Japanese) calculations per second, would be ideal in completing basic experiments in a fraction of the time it now takes.

If the K supercomputer calculates mathematized data on divisions, growth and internal changes of iPS cells to which protein or certain kinds of genes are added, it will become possible to create target organs more effectively, according to the researchers.

Read more here:
K computer may be used in regenerative medicine

The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.


Before you right this post off as the stuff of conspiracy theories, fear-mongering, and 'alternative world views' consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.


Here's the underlying premise as succinctly described by author Ben Goldacre:

"Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.

When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."

Authors M. Todwin and J. Abramson summarize it thusly:

"Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge."

Here is a great list of very recent resources that may convince you of the merits of this concern:

• What doctors don't know about the drugs they prescribe (2012: TED video)
• The drugs don't work: a modern medical scandal (2012: The Guardian)
• Clinical Trial Data as a Public Good (2012: JAMA [subscription req'd])
• Registering Clinical Trial Results. The Next Step (2010: JAMA [subscription req'd])
• The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience (2012: Plos Medicine)

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The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.


Before you right this post off as the stuff of conspiracy theories, fear-mongering, and 'alternative world views' consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.


Here's the underlying premise as succinctly described by author Ben Goldacre:

"Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.

When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."

Authors M. Todwin and J. Abramson summarize it thusly:

"Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge."

Here is a great list of very recent resources that may convince you of the merits of this concern:

• What doctors don't know about the drugs they prescribe (2012: TED video)
• The drugs don't work: a modern medical scandal (2012: The Guardian)
• Clinical Trial Data as a Public Good (2012: JAMA [subscription req'd])
• Registering Clinical Trial Results. The Next Step (2010: JAMA [subscription req'd])
• The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience (2012: Plos Medicine)

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

GAITHERSBURG, MD--(Marketwire - Sep 19, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that Martin P. Rosendale, Chief Executive Officer of Cytomedix, will present a corporate update at BIOX; Noble Financial Capital Markets' Life Sciences Exposition to be held at the University of Connecticut, Stamford Campus on September, 24-25, 2012.Mr. Rosendale's presentation will take place on Monday, September 24th at 8:00 a.m. Eastern time.

In addition to the corporate presentation, Mr. Rosendale will be a participant on the panel presentation titled "Advancements in Cell Therapy & Regenerative Medicine," on September 24th at 11:45 a.m.

Following the event, a high-definition video webcast of the Company's presentation and a copy of the presentation materials will be available on the Company's web site at http://www.cytomedix.com, or through the Noble Financial websites: http://www.noblefcm.com, or http://www.nobleresearch.com/BioExposition.htm. Microsoft SilverLight viewer (a free download from the presentation link) is required to participate. The webcast will be archived on Cytomedix's website for 90 days following the event.

About Noble Financial Noble Financial Capital Markets was established in 1984 and is an equity research driven, full-service, investment banking boutique focused on life sciences, technology and media, emerging growth, companies. The company has offices in New York, Boston, New Jersey, Los Angeles, and Boca Raton, FL. In addition to non-deal road shows and sector-specific conferences throughout the year, Noble Financial hosts its large format annual equity conference in January in South Florida featuring 150 presenting companies from across North America and total attendance of close to 600. For more information: http://www.noblefcm.com.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally.Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells.A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts,the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix to Present at BIOX; Noble Financial Capital Markets' Life Sciences Exposition

Public release date: 18-Sep-2012 [ | E-mail | Share ]

Contact: Andy Hoang ahoang@salk.edu 619-861-5811 Salk Institute

LA JOLLA, CA---- Salk scientists have identified a unique molecular signature in induced pluripotent stem cells (iPSCs), "reprogrammed" cells that show great promise in regenerative medicine thanks to their ability to generate a range of body tissues.

In this week's Proceedings of the National Academy of Sciences, the Salk scientists and their collaborators at University of California, San Diego, report that there is a consistent, signature difference between embryonic and induced pluripotent stem cells. The findings could help overcome hurdles to using the induced stem cells in regenerative medicine.

"We believe that iPSCs hold a great potential for the treatment of human patients," says Juan Carlos Izpisua Belmonte, a professor in Salk's Gene Expression Laboratory and the senior author on the paper. "Yet we must thoroughly understand the molecular mechanisms governing their safety profile in order to be confident of their function in the human body. With the discovery of these small, yet apparent, epigenetic differences, we believe that we are now one step closer to that goal."

Embryonic stem cells (ESCs) are known for their "pluripotency," the ability to differentiate into nearly any cell in the body. Because of this ability, it has long been thought that ESCs would be ideal to customize for therapeutic uses. However, when ESCs mature into specific cell types, and are then transplanted into a patient, they may elicit immune responses, potentially causing the patient to reject the cells.

In 2006, scientists discovered how to revert mature cells, which had already differentiated into particular cell types, such as skin cells or hair cells, back into a pluripotent state. These "induced pluripotent stem cells" (iPSCs), which could be developed from the patient's own cells, would theoretically carry no risk of immune rejection.

However, scientists found that iPSCs had molecular differences from embryonic stem cells. Specifically, there were epigenetic changes, chemical modifications in DNA that might alter genetic activity. At certain points in the iPSC's genome, scientists could see the presence of different patterns of methyl groups when compared to the genomes of ESCs. It seemed these changes occurred randomly.

Izpisua Belmonte and his colleagues wanted to understand more about these differences. Were they truly random, or was there a discernable pattern?

Unlike previous studies, which had primarily analyzed iPSCs derived from only one mature type of cells (mainly connective tissue cells called fibroblasts), the Salk and UCSD researchers examined iPSCs derived from six different mature cell types to see if there were any commonalities. They discovered that while there were hundreds of unpredictable changes, there were some that remained consistent across the cell types: the same nine genes were associated with these common changes in all iPSCs.

Read more from the original source:
Discovery of reprogramming signature may help further stem cell-based regenerative medicine research

GAITHERSBURG, MD--(Marketwire - Sep 19, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that Martin P. Rosendale, Chief Executive Officer of Cytomedix, will present a corporate update at BIOX; Noble Financial Capital Markets' Life Sciences Exposition to be held at the University of Connecticut, Stamford Campus on September, 24-25, 2012.Mr. Rosendale's presentation will take place on Monday, September 24th at 8:00 a.m. Eastern time.

In addition to the corporate presentation, Mr. Rosendale will be a participant on the panel presentation titled "Advancements in Cell Therapy & Regenerative Medicine," on September 24th at 11:45 a.m.

Following the event, a high-definition video webcast of the Company's presentation and a copy of the presentation materials will be available on the Company's web site at http://www.cytomedix.com, or through the Noble Financial websites: http://www.noblefcm.com, or http://www.nobleresearch.com/BioExposition.htm. Microsoft SilverLight viewer (a free download from the presentation link) is required to participate. The webcast will be archived on Cytomedix's website for 90 days following the event.

About Noble Financial Noble Financial Capital Markets was established in 1984 and is an equity research driven, full-service, investment banking boutique focused on life sciences, technology and media, emerging growth, companies. The company has offices in New York, Boston, New Jersey, Los Angeles, and Boca Raton, FL. In addition to non-deal road shows and sector-specific conferences throughout the year, Noble Financial hosts its large format annual equity conference in January in South Florida featuring 150 presenting companies from across North America and total attendance of close to 600. For more information: http://www.noblefcm.com.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally.Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells.A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts,the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix to Present at BIOX; Noble Financial Capital Markets' Life Sciences Exposition