Monthly Archives: October 2013

Investigators from Chongqing University Target Stem Cells

Posted: October 23, 2013 at 6:43 pm

By a News Reporter-Staff News Editor at Stem Cell Week -- A new study on Stem Cell Research is now available. According to news reporting from Chongqing, People's Republic of China, by NewsRx journalists, research stated, "The purpose of this study was to investigate the influences of nanoscale wear particles derived from titanium/titanium alloy-based implants on integration of bone. Here we report the potential impact of titanium oxide (TiO2) nanoparticles on adhesion, migration, proliferation, and differentiation of mesenchymal stem cells (MSC) from the cellular level to the molecular level in the Wistar rat."

The news correspondents obtained a quote from the research from Chongqing University, "A series of TiO2 nanoparticles (14 nm, 108 nm, and 196 nm) were synthesized and characterized by scanning electron microscopy and transmission electron microscopy, respectively. The TiO2 nanoparticles had negative effects on cell viability, proliferation, and the cell cycle of MSC in a dose-dependent and size-dependent manner. Confocal laser scanning microscopy was used to investigate the effects of particle internalization on adhesion, spreading, and morphology of MSC. The integrity of the cell membrane, cytoskeleton, and vinculin of MSC were negatively influenced by large TiO2 nanoparticles. The Transwell migration assay and a wound healing model suggested that TiO2 nanoparticles had a strong adverse impact on cell migration as particle size increased (P < 0.01)."

According to the news reporters, the research concluded: "Furthermore, alkaline phosphatase, gene expression of osteocalcin (OC) and osteopontin (OPN), and mineralization measurements indicate that the size of the TiO2 nanoparticles negatively affected osteogenic differentiation of MSC."

For more information on this research see: Effects of titanium nanoparticles on adhesion, migration, proliferation, and differentiation of mesenchymal stem cells. International Journal of Nanomedicine, 2013;8():3619-3630. International Journal of Nanomedicine can be contacted at: Dove Medical Press Ltd, PO Box 300-008, Albany, Auckland 0752, New Zealand (see also Stem Cell Research).

Our news journalists report that additional information may be obtained by contacting Y.H. Hou, Chongqing Univ, Coll Bioengn, Minist Educ, Chongqing 400044, People's Republic of China. Additional authors for this research include K.Y. Cai, J.H. Li, X.Y. Chen, M. Lai, Y. Hu, Z. Luo, X.W. Ding and D.W. Xu.

Keywords for this news article include: Asia, Titanium, Chongqing, Light Metals, Stem Cell Research, People's Republic of China

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2013, NewsRx LLC

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Induced pluripotent stem cells reveal differences between humans and great apes

Posted: October 23, 2013 at 6:43 pm

Oct. 23, 2013 Researchers at the Salk Institute for Biological Studies have, for the first time, taken chimpanzee and bonobo skin cells and turned them into induced pluripotent stem cells (iPSCs), a type of cell that has the ability to form any other cell or tissue in the body.

Mouse iPSCs were created in 2006 by Kazutoshi Takahashi and Shinya Yamanaka at Kyoto University in Japan, and human iPSCs soon followed -- -feats which earned Yamanaka the Nobel Prize in Physiology or Medicine last year. Now scientists regularly use iPSCs to model diseases using cells that would be otherwise difficult to obtain from a living person or animal. By adding a combination of four key factors, a skin cell can be made into an iPSC, which can then be coaxed into forming liver, lung and brain cells in a culture dish.

It's now possible to not only model disease using the cells, but also to compare iPSCs from humans to those of our closest living relatives -- -great apes, with which we share a majority of genes -- -for insight into what molecular and cellular features make us human.

"Comparing human, chimpanzee and bonobo cells can give us clues to understand biological processes, such as infection, diseases, brain evolution, adaptation or genetic diversity," says senior research associate Iigo Narvaiza, who led the study with senior staff scientist Carol Marchetto at the Salk Institute in La Jolla. "Until now, the sources for chimpanzee and bonobo cells were limited to postmortem tissue or blood. Now you could generate neurons, for example, from the three different species and compare them to test hypotheses."

In the new study, published online October 23 in the journal Nature, scientists found disparities in the regulation of jumping genes or transposons -- -DNA elements that can copy and paste themselves into spots throughout the genome -- between humans and non-human primate cells. Jumping genes provide a means to rapidly shuffle DNA and might be shaping the evolution of our genomes, the scientists say.

Working in the lab of Salk's Fred Gage, the Vi and John Adler Chair for Research on Age-Related Neurodegenerative Disease, Narvaiza, Marchetto and their colleagues identified genes that are differentially expressed between iPSCs from humans and both chimpanzees and bonobos.

To the group's surprise, two of those genes code for proteins that restrict a jumping gene called long interspersed element-1or L1, for short. Compared with non-human primate cells, human iPSCs expressed higher levels of these restrictors, called APOBEC3B and PIWIL2. "We weren't expecting that," Marchetto says. "Those genes caught our eyes, so they were the first targets we focused on."

L1 and a handful of other jumping genes are abundant throughout our genomes. Where these bits of DNA insert themselves is hard to predict, and they can produce variable effects. For example, they might completely disrupt genes, modulate them, or cause them to be processed into entirely new proteins.

Using L1 tagged with a fluorescent marker, the group observed higher numbers of fluorescent iPSCs from non-human primates compared with humans. In separate experiments, they produced iPSCs with too much or too little APOBEC3B and PIWIL2, finding -- -as expected -- -that an excess of the two proteins dampened the mobility and reduced the appearance of newly inserted DNA in the non-human primate cells.

These results suggested that L1 elements insert themselves less often throughout our genomes. Indeed, looking at genomes of humans and chimpanzees that had already been sequenced, the researchers found that the primates had more copies of L1 sequences than did humans.

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Stem Cell Research Radio Broadcast Glenbrook South 2013 John, Alex – Video

Posted: October 23, 2013 at 5:41 am


Stem Cell Research Radio Broadcast Glenbrook South 2013 John, Alex

By: John Donaubauer

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Life Stem Genetics is Pleased to Announce That It Has Completed the First $500,000 Private Placement of the Recently …

Posted: October 22, 2013 at 11:40 pm

LOS ANGELES--(BUSINESS WIRE)--

Life Stem Genetics (LIFS) is pleased to announce that it has completed and received the first $500,000 of the recently announced $1mm Private Placement. Our company is very happy to receive the first half of our recent private placement and hopes to close the additional $500,000 in the coming weeks.

The money will be used to attract additional affiliate offices country wide and to invest in various areas of research and development in moving our company's plans forward.

About Life Stem Genetics

Life Stem Genetics (LSG) is a progressive health care company that focuses on healing with a patients own Stem Cells. Stem Cells for years have been known to heal a variety of ailments successfully and now it is being offered as an efficient and painless way to treat many different illnesses ranging from orthopedic injuries, neurological disorders such as Parkinsons and Alzheimers, Cancer, Plastic Surgery, Age Management, Arthritis, Diabetes, Cardiology, COPD, MS, Urology, and many more. Stem Cell Therapy and LSGs proprietary techniques have experienced some of the best results in the industry, helping to repair or re-program damaged or diseased tissues and organs.

LSGs stem cell specialist has performed thousands of stem cell treatments, including the top names in PGA golf, NFL football, NBA basketball, and Major League Baseball. LSG will offer their proprietary treatments through a series of affiliate doctors, and medical clinics, with 60 affiliated clinics so far.

LSGs mission is to create a solid comprehensive approach to the treatment and maintenance of diseases and to break free from the medical insurance world by tapping into an affordable private-pay sector delivering exceptional healthcare free from the medical insurance maze.

http://www.lifestemgenetics.com/

This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995 that are not historical facts. These statements can be identified by the use of forward-looking terminology such as "believe," "expect," "may, could, estimates, "will," "should," "project," "plan," "seek," "intend," or "anticipate" or the negative thereof or comparable terminology, and include discussions of strategy, and statements about industry trends and the Company's future performance, operations, and products. Such statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the results expressed or implied by such statements. Such risks and uncertainties include, without limitation, market acceptance of the Company's stem cell therapy treatment program; the Company's compliance with applicable statutes and regulations: the Company's reliance on third-party contractors to provide suitable treatment facilities; the Company's ability to expand its network of participating clinics and doctors; the Company's ability to develop an effective marketing strategy; the Company's ability to control and reduce advertising and marketing costs; the Company's ability to develop and increase awareness of its brand; the Company's ability to protect its trademarks; and the success of the Company's marketing focus to patients, doctors and clinics. For a discussion of these and other risks and uncertainties see "Risk Factors" and Description of Business in the Company's public filings with the SEC. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.

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From mature cells to embryonic-like stem cells

Posted: October 22, 2013 at 3:43 pm

BERKELEY Bioengineers at the University of California, Berkeley, have shown that physical cues can replace certain chemicals when nudging mature cells back to a pluripotent stage, capable of becoming any cell type in the body.

The researchers grew fibroblasts cells taken from human skin and mouse ears on surfaces with parallel grooves measuring 10 micrometers wide and 3 micrometers high. After two weeks of culture in a special cocktail used to reprogram mature cells, the researchers found a four-fold increase in the number of cells that reverted back to an embryonic-like state compared with cells grown on a flat surface. Growing cells in scaffolds of nanofibers aligned in parallel had similar effects.

The study, published online Sunday (Oct. 20) in the journal Nature Materials, could significantly enhance the process of reprogramming adult cells into embryonic-like stem cells that can differentiate, or develop, into any type of tissue that makes up our bodies.

The 2012 Nobel Prize in Physiology or Medicine was awarded to scientists who discovered that it was possible to reprogram cells using biochemical compounds and proteins that regulate gene expression. These induced pluripotent stem cells have since become a research mainstay in regenerative medicine, disease modeling and drug screening.

"Our study demonstrates for the first time that the physical features of biomaterials can replace some of these biochemical factors and regulate the memory of a cell's identity," said study principal investigator Song Li, UC Berkeley professor of bioengineering. "We show that biophysical signals can be converted into intracellular chemical signals that coax cells to change."

The current process for reprogramming cells relies on a formula that uses a virus to introduce gene-altering proteins into mature cells. Certain chemical compounds, including valproic acid, that can dramatically affect global DNA structure and expression are also used to boost the efficiency of the reprogramming process.

"The concern with current methods is the low efficiency at which cells actually reprogram and the unpredictable long-term effects of certain imposed genetic or chemical manipulations," said study lead author Timothy Downing, who did this research as a graduate student in the UC Berkeley-UC San Francisco Joint Graduate Program in Bioengineering. "For instance, valproic acid is a potent chemical that drastically alters the cell's epigenetic state and can cause unintended changes inside the cell. Given this, many people have been looking at different ways to improve various aspects of the reprogramming process."

Previous studies have shown that physical and mechanical forces can influence cell fate, but the effect on epigenetic state and cell reprogramming had not been clear.

The new study found that culturing cells on micro-grooved biomaterials improved the quality and consistency of the reprogramming process, and was just as effective as valproic acid.

"Cells elongate, for example, as they migrate throughout the body," said Downing, who is now a research scientist in Li's lab. "In the case of topography, where we control the elongation of a cell by controlling the physical microenvironment, we are able to more closely mimic what a cell would experience in its native physiological environment. In this regard, these physical cues are less invasive and artificial to the cell and therefore less likely to cause unintended side effects."

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Predicting the fate of stem cells

Posted: October 22, 2013 at 3:43 pm

PUBLIC RELEASE DATE:

22-Oct-2013

Contact: Erin Vollick Comm.ibbme@utoronto.ca 416-946-8019 University of Toronto

University of Toronto researchers have developed a method that can rapidly screen human stem cells and better control what they will turn into. The technology could have potential use in regenerative medicine and drug development. Findings are published in this week's issue of the journal Nature Methods.

"The work allows for a better understanding of how to turn stem cells into clinically useful cell types more efficiently," according to Emanuel Nazareth, a PhD student at the Institute of Biomaterials & Biomedical Engineering (IBBME) at the University of Toronto. The research comes out of the lab of Professor Peter Zandstra, Canada Research Chair in Bioengineering at U of T.

The researchers used human pluripotent stem cells (hPSC), cells which have the potential to differentiate and eventually become any type of cell in the body. But the key to getting stem cells to grow into specific types of cells, such as skin cells or heart tissue, is to grow them in the right environment in culture, and there have been challenges in getting those environments (which vary for different types of stem cells) just right, Nazareth said.

The researchers developed a high-throughput platform, which uses robotics and automation to test many compounds or drugs at once, with controllable environments to screen hPSCs in. With it, they can control the size of the stem cell colony, the density of cells, and other parameters in order to better study characteristics of the cells as they differentiate or turn into other cell types. Studies were done using stem cells in micro-environments optimized for screening and observing how they behaved when chemical changes were introduced.

It was found that two specific proteins within stem cells, Oct4 and Sox2, can be used to track the four major early cell fate types that stem cells can turn into, allowing four screens to be performed at once.

"One of the most frustrating challenges is that we have different research protocols for different cell types. But as it turns out, very often those protocols don't work across many different cell lines," Nazareth said.

The work also provides a way to study differences across cell lines that can be used to predict certain genetic information, such as abnormal chromosomes. What's more, these predictions can be done in a fraction of the time compared to other existing techniques, and for a substantially lower cost compared to other testing and screening methods.

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New Technology Investment in Age-Old Question Regenerative Medicine

Posted: October 22, 2013 at 3:43 pm

New Technology Investment in Age-Old Question: Regenerative Medicine

October 1, 2013 (www.investorideas.com newswire) Regenerative medicine is a field involving the study of stem cells to regenerate or regrow cells and even entire body parts in humans, reestablishing normal function. Successes in regenerative medicine could help the entire medical field advance as previously chronic and incurable conditions may be reversible. Some estimates claim that as many as 1 in 3 Americans would be helped by regenerative medicine therapies.

Stem cells function as "master cells," which have the ability to become any other type of cell. Natural stem cells can be found in human cord blood and embryos. Stem cells can also be created through a "reprogramming" process, using blood and skin cells to create induced pluripotent stem cells (iPS). Recently, scientists at the Spanish National Cancer Research Center in Madrid were able to replicate human stem cells in mice, opening a new avenue for regenerative medicine. These cells may possess more plasticity and may be better able to differentiate into many more types of adult human cells than traditional iPS cells.

According to a recent article in Forbes, regenerative medicine could take 20 to 25 years to truly come to fruition. However, some regenerative medicine therapies are being used today, such as implementing stem cell therapies to repair knee joint damage. Many small cap companies operate in the field, helping to fuel progress in regenerative medicine.

Osiris Therapeutics, Inc. (Nasdaq:OSIR), based in Columbia, MD, manufactures mesenchymal stem cells (MSCs), which are typically created from bone marrow donations. The rapidly-grown MSCs can then be frozen for future patient use. Because MSCs are "attracted" to the damaged or diseased area, the cells can be introduced into a patient? body through injection or intravenous methods. Osiris markets Prochymal, which was approved in Canada in May 2012. It is currently undergoing Phase III clinical trials in the US for acute graft versus host disease and Crohn? disease. OSIR closed September 30th at 16.64, up 0.15, with a market cap of 550.31 million. Its 52-week trading range is 6.55 - 27.40.

Rockville, MD-based Neuralstem, Inc. (NYSE:CUR) uses their patented technology to produce neural stem cells based on the human brain and spinal cord. They currently have three FDA-approved trials: a Phase II trial on their NSI-566 therapy for treatment of amyotrophic lateral sclerosis (ALS), a Phase I trial for the same therapy for chronic spinal cord injury and a Phase Ib trial of their NSI-189 therapy to treat major depressive disorder (MDD). By using stem cells derived from site-specific areas of the body, these cells may already be suited for the type of treatment they are expected to provide. CUR closed September 30th at 2.71, down 0.10, with a market cap of 192.74 million. Its 52-week trading range is 0.88 - 3.02.

One important element of stem cell research is the ability to preserve and store the cells until needed. BioLife Solutions, Inc. (OTCMKTS:BLFS), based in Bothell, WA, creates cGMP-grade bio-preservation media for blood, organs and cells, including stem cells. BioLife recently signed an agreement with SAVSU Technologies, Inc to market SAVSU? thermal packaging products. Temperature stability is a significant piece of the biologistics - the logistics of transporting cells and tissues - puzzle. BLFS closed September 30th at 0.795, no change for the day, with a market cap of 58.13 million. Its 52-week trading range is 0.13 - 0.88.

Health care investors interested in new opportunities in interesting sectors may wish to seek out small caps in the regenerative medicine arena. Although it may be some time before comprehensive regenerative medicine therapies are available on a widespread scale, these cutting-edge companies are making scientific advances that could become quite important. With breakthroughs in stem cell research and creation occurring frequently, investment in these new health technologies may well provide future growth.

The About Small Cap blog covers breaking news on small cap stocks from around the world, delving deep into pressing issues both large and small that affect small caps. For example, we recently covered groundbreaking news about artificial heart technology in the small cap world. We write about things like natural gas drilling and interviews with notable personalities across a wide variety of industries, like Elemer Piros in the biotech sector.

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ACT’s Dr. Robert Lanza to Deliver Keynote Lecture at the World Conference on Regenerative Medicine

Posted: October 22, 2013 at 3:43 pm

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB:ACTC), a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering a Keynote lecture at the World Conference on Regenerative Medicine being held in Leipzig, Germany October 23-25th. The Conference is considered one of the world's largest and most influential events in stem cells and regenerative medicine, and provides a platform that brings scientists with an academic, clinical and industrial background together. Dr. Lanzas Lecture, entitled ES and iPS Cells Moving into the Clinic, will take place at 9:00 a.m. at the Congress Center Leipzig.

The World Conference will, as in past years, encompass a broad range of topics in regenerative medicine from biomaterials to biomarkers as well as regulation and stem cell technologies. The organizers expect more than 1,000 attendees and hundreds of papers with ground-breaking scientific insights and new results. Furthermore, the conference will host a large exhibition where international researchers and biotechnology companies can demonstrate the reach of current technologys translation and the implementation of research in products. In addition to Dr. Lanzas Keynote Lecture, the Conference will include presentations on cell and immunotherapy, stem cells, cell and tissue engineering, biomaterials and tissue interaction, models of regeneration, molecular mechanisms of regeneration, diagnostic and imaging of regeneration, and regulatory affairs.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, the relevance and applicability of clinical trials in animals to studying the effect of products in humans, future growth in animal and human research and development programs, potential new applications of and expanded indications covering our technology, the effects of donorless sources of stem cells on potency and the risk of communicable diseases in the manufacturing context, the existence and size of potential or existing market opportunities for the company, the effect of the companys products on the medical needs and quality of life of pets, and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for and limited sources of future capital, failures or delays in obtaining regulatory approval of products, risks inherent in the development and commercialization of potential products, reliance on new and unproven technology in the development of products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the Quarterly Report on Form 10-Q for the three months ended June 30, 2013. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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International Stem Cell and Regenerative Medicine Community Convenes in Banff, Alberta

Posted: October 22, 2013 at 3:43 pm

OTTAWA, ONTARIO and TORONTO, ONTARIO--(Marketwired - Oct 21, 2013) - Stem cell and regenerative medicine experts from around the world will physically and virtually come together in Banff, Alberta, when Canada's premier stem cell research event - the Till & McCulloch Meetings (T&MM) - takes place October 23-25, 2013.

"Canada and Europe chose the same dates to host their most significant regenerative medicine events and we're utilizing technology to bring the two conferences together," explains Drew Lyall, Executive Director of the Stem Cell Network. "While our European colleagues won't get to enjoy the beauty of Alberta, they will benefit from hearing some thrilling science, produced in Canada."

A novel technology discovered in Dr. Peter Zandstra's lab, which has the potential to improve the viability and success of cord blood stem cell transplantation, will be featured during a live broadcast to the World Conference on Regenerative Medicine in Leipzig, Germany, on October 24 at 8:45 a.m. Dr. Zandstra (University of Toronto and CSO with the Centre for Commercialization of Regenerative Medicine) has received the 2013 Till & McCulloch Award for having published the year's most influential peer-reviewed article by a stem cell researcher in Canada.

Other highlights include the following:

October 23 at 12:20 p.m.

The conference will premiere and showcase a series of short, animated videos about basic concepts in stem cell research narrated by world-renowned stem cell scientists. The videos are produced by Ben Paylor, a PhD candidate in experimental medicine at the University of British Columbia, and Mike Long, a post-doctoral fellow at the University of Toronto, who engaged award-winning animator David Murowsky and Emmy-nominated composer James Wallace to create the signature animations and music featured in the videos. The three videos are targeted at youth of high school age or older. More details about the videos and the award can be found here: http://bit.ly/15GBOsw.

October 23 at 2:10 p.m.

An afternoon plenary session will focus on current research in cell therapy. The session will include presentations by Dr. Duncan Stewart (Ottawa Hospital Research Institute) on lessons learned in bringing cell therapies to the clinic. He will focus on his recently launched stem cell clinical trial for the treatment of acute heart attack, as well as offer overviews of Canada's strategy for stem cell research going forward and the emerging regenerative medicine technologies market.

"The regenerative medicine market is poised to experience explosive growth in the near future, based on the increasing number of clinical trials, deals, IPOs [initial public offerings] and partnerships happening globally," says Michael May, CEO of the Centre for Commercialization of Regenerative Medicine (CCRM). "Canada's leadership in the field of regenerative medicine is already well known, and it is with events and collaborations like the Till & McCulloch Meetings that we will continue to build a strong infrastructure for future growth in Canada. The fact that this year's conference has engaged 39 industry sponsors - more than twice the number that participated last time - is an indication of just how far we've progressed in a short time."

The Till & McCulloch Meetings, formerly the Stem Cell Network's Annual Scientific Meeting, was renamed in 2012 to acknowledge its expanded focus to include the broader field of regenerative medicine and the business focus of commercializing stem cell- and biomaterials-based products and therapies. In addition to excellent science originating from Canada, Japan, China, Israel, Europe and the United States, the conference will feature industry networking meetings and international efforts to share resources to accelerate progress in commercializing new discoveries.

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No evidence to support stem cell therapy for pediatric optic nerve hypoplasia

Posted: October 22, 2013 at 3:40 pm

Oct. 22, 2013 A study performed at Children's Hospital Los Angeles found no evidence that stem cell therapy improves vision for children with optic nerve hypoplasia (ONH). Their results are reported in the Journal of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS).

ONH, an underdevelopment of optic nerves that occurs during fetal development, may appear either as an isolated abnormality or as part of a group of disorders characterized by brain anomalies, developmental delay, and endocrine abnormalities. ONH is a leading cause of blindness in children in North America and Europe and is the only cause of childhood blindness that shows increasing prevalence. No treatments have been shown to improve vision in these children.

With no viable treatment options available to improve vision, ophthalmologists are becoming aware that families with children affected by ONH are travelling to China seeking stem cell therapy, despite lack of approval in the United States and Europe or evidence from controlled trials. The American Association for Pediatric Ophthalmology and Strabismus has also expressed its concern about these procedures. In response to this situation, pediatric neuro-ophthalmologist Mark Borchert, MD, Director of both the Eye Birth Defects and Eye Technology Institutes in The Vision Center at Children's Hospital Los Angeles, realized that a controlled trial of sufficient size was needed to evaluate whether stem cell therapy is effective at improving optic nerve function in children with ONH. He agreed to conduct an independent study when asked by Beike Biotech, a company based in Shenzhen, China, that offers treatment for ONH using donor umbilical cord stem cells injected into the cerebral spinal fluid.

Beike Biotech agreed to identify 10 children with bilateral ONH (ages 7-17 years) who had volunteered to travel to China for stem cell therapy and who agreed to participate in the study; Children's Hospital was to find case matched controls from their clinic. However, only two case-controlled pairs were evaluated because Beike Biotech was only able to recruit two patients. Treatments consisted of six infusions over a 16-day period of umbilical cord-derived mesenchymal stem cells and daily infusions of growth factors. Visual acuity, optic nerve size, and sensitivity to light were to be evaluated one month before stem cell therapy and three and nine months after treatment.

No therapeutic effect was found in the two case-control pairs that were enrolled. "The results of this study show that children greater than 7 years of age with ONH may have spontaneous improvement in vision from one examination to the next. This improvement occurs equally in children regardless of whether or not they received treatment. Other aspects of the eye examination included pupil responses to light and optic nerve size; these did not change following treatment. The results of this research do not support the use of stem cells in the treatment of ONH at this time," says lead author Cassandra Fink, MPH, program administrator at The Vision Center, Children's Hospital Los Angeles.

Confounding the trial was that subjects received additional alternative therapies (acupuncture, functional electrical stimulation, and exercise) while receiving stem cell treatments, which was contrary to the trial protocol. The investigators could not determine the effect of these additional therapies.

"This study underscores the importance of scientifically testing these procedures to validate them and also to ensure their safety. Parents of afflicted children should be aware that the science behind the use of stem cell technology is unclear. This study takes a step toward testing this technology and finds no beneficial effect," says William V. Good, MD, Senior Associate Editor, Journal of AAPOS and Clinical Professor of Ophthalmology and Senior Scientist at the Smith-Kettlewell Eye Research Institute.

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