Category Archives: Stem Cell Research

A judicial technicality may decide the fate of NIH-funded human embryonic stem cell research.

By Sabrina Richards | April 24, 2012

Wikimedia Commons, Avjoska

The legality of federally funding human embryonic stem cell (hESC) research is being questioned in court again, and the decision may rest on a technicality, reported ScienceInsider.

National Institutes of Health guidelines released in 2009 lifted the Bush-era restrictions on hESC research, but were met with a lawsuit by adult stem cell researchers that August. A preliminary injunction by the US District Court in Washington, DC, prevented NIH funding for hESCs in August 2010. Just 2 weeks later, the US Court of Appeals for the District Court stayed the injunction, then overturned it for good in April 20113 months before the appeals court dismissed the lawsuit altogether. Now, the case is once again in appeals court, and current arguments focus on whether this earlier decision is binding.

The plaintiffs argue that the 2009 NIH guidelines contravene the 1996 Dickey-Wicker Amendment, which prohibits federal funding for research that may harm or destroy human embryos. NIH argues that the earlier decision should be binding because the plaintiffs are not presenting new arguments, but the plaintiffs counter that the court has yet to rule on whether the NIH guidelines create demand for new hESC lines, which are derived from embryos.

The plaintiffs also argue that comments from opponents of hESC research should have been considered by the NIH when the guidelines were crafted, but the NIH disputes this, saying that the agency was responding to an order from President Obama asking how, not whether, to fund such research.

The Appeals Court may rule within 4 to 6 months, but some observers expect the case to eventually reach the US Supreme Court.

By Jef Akst

Science adviser John Holdren speaks out about how the Obama Administration is handling the controversial research that rendered avian flu transmissible between ferrets.

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Embryonic Stem Cells in Court Again

Public release date: 25-Apr-2012 [ | E-mail | Share ]

Contact: Kim Irwin kirwin@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Health Sciences

Can one feel too attached? Does one need to let go to mature? Neural stem cells have this problem, too.

As immature cells, neural stem cells must stick together in a protected environment called a niche in order to divide so they can make all of the cells that populate the nervous system. But when it's time to mature, or differentiate, the neural stem cells must stop dividing, detach from their neighbors and migrate to where they are needed to form the circuits necessary for humans to think, feel and interact with the world.

Now, stem cell researchers at UCLA have identified new components of the genetic pathway that controls the adhesive properties and proliferation of neural stem cells and the formation of neurons in early development.

The finding by scientists at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA could be important because errors in this pathway can lead to a variety of birth defects that affect the structure of the nervous system, as well as more subtle changes that impair cognitive and motor functions associated with disorders such as autism.

The results of the four-year study are published April 26, 2012 in the peer-reviewed journal Neuron.

The UCLA team found that a delicate balance of gene expression enables the pool of neural stem and progenitor cells in early development to initially increase and then quickly stop dividing to form neurons at defined times.

"One of the greatest mysteries in developmental biology is what constitutes the switch between stem cell proliferation and differentiation. In our studies of the formation of motor neurons, the cells that are essential for movement, we were able to uncover what controls the early expansion of neural stem and progenitor cells, and more importantly what stops their proliferation when there are enough precursors built up," said Bennett G. Novitch, an assistant professor of neurobiology, a Broad Stem Cell Research Center scientist and senior author of the study. "If the neurons don't form at the proper time, it could lead to deficits in their numbers and to catastrophic, potentially fatal neurological defects."

During the first trimester of development, the neural stem and progenitor cells form a niche, or safe zone, within the nervous system. The neural stem and precursor cells adhere to each other in a way that allows them to expand their numbers and keep from differentiating. A protein called N-cadherin facilitates this adhesion, Novitch said.

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Growing up as a neural stem cell: The importance of clinging together and then letting go

ANN ARBOR The University of Michigans second human embryonic stem cell line has just been placed on the U.S. National Institutes of Healths registry, making the cells available for federally funded research. It is the second of the stem cell lines derived at UM to be placed on the registry.

The line, known as UM11-1PGD, was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. That embryo was created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation, and would therefore have otherwise been discarded when it was donated in 2011.

It carries the gene defect responsible for Charcot-Marie-Tooth disease, a hereditary neurological disorder characterized by a slowly progressive degeneration of the muscles in the foot, lower leg and hand. CMT, as it is known, is one of the most common inherited neurological disorders, affecting one in 2,500 people in the United States. People with CMT usually begin to experience symptoms in adolescence or early adulthood.

The embryo used to create the cell line was never frozen, but rather was transported from another IVF laboratory in the state of Michigan to the UM in a special container. This may mean that these stem cells will have unique characteristics and utilities in understanding CMT disease progression or screening therapies in comparison to other human embryonic stem cells.

We are proud to provide this cell line to the scientific community, in hopes that it may aid the search for new treatments and even a cure for CMT, says Gary Smith, Ph.D., who derived the line and also is co-director of the UM Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute. Once again, the acceptance of these cells to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines.

UM is one of only four institutions including two other universities and one private company to have disease-specific stem cell lines listed in the national registry. UM has several other disease-specific hESClines submitted to NIH and awaiting approval, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

Stem cell lines that carry genetic traits linked to specific diseases are a model system to investigate what causes these diseases and come up with treatments, says Sue OShea, professor of cell and developmental biology at the UM Medical School, and co-director of the Consortium for Stem Cell Therapies.

Each line is the culmination of years of preparation and cooperation between UM and Genesis Genetics, a Michigan-based genetic diagnostic company. This work was made possible by Michigan voters November 2008 approval of a state constitutional amendment permitting scientists to derive embryonic stem cell lines using surplus embryos from fertility clinics or embryos with genetic abnormalities and not suitable for implantation.

The amendment also made possible an unusual collaboration that has blossomed between the University of Michigan and molecular research scientists at Genesis Genetics, a company that has grown in only eight years to become the leading global provider of pre-implantation genetic diagnosis (PGD) testing. PGDis a testing method used to identify days-old embryos carrying the genetic mutations responsible for serious inherited diseases. During a PGD test, a single cell is removed from an eight-celled embryo. The other seven cells continue to multiply and on the fifth day form a cluster of roughly 100 cells known as a blastocyst.

Genesis Genetics performs nearly 7,500 PGD tests annually. Under the arrangement between the company and UM, patients with embryos that test positive for a genetic disease now have the option of donating those embryos to UM if they have decided not to use them for reproductive purposes and the embryos would otherwise be discarded.

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Second UM Stem Cell Line Now Available To Help Cure Nerve Condition

Public release date: 25-Apr-2012 [ | E-mail | Share ]

Contact: Kara Gavin kegavin@umich.edu 734-764-2220 University of Michigan Health System

The University of Michigan's second human embryonic stem cell line has just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research. It is the second of the stem cell lines derived at U-M to be placed on the registry.

The line, known as UM11-1PGD, was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. That embryo was created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation, and would therefore have otherwise been discarded when it was donated in 2011.

It carries the gene defect responsible for Charcot-Marie-Tooth disease, a hereditary neurological disorder characterized by a slowly progressive degeneration of the muscles in the foot, lower leg and hand. CMT, as it is known, is one of the most common inherited neurological disorders, affecting one in 2,500 people in the United States. People with CMT usually begin to experience symptoms in adolescence or early adulthood.

The embryo used to create the cell line was never frozen, but rather was transported from another IVF laboratory in the state of Michigan to the U-M in a special container. This may mean that these stem cells will have unique characteristics and utilities in understanding CMT disease progression or screening therapies in comparison to other human embryonic stem cells.

"We are proud to provide this cell line to the scientific community, in hopes that it may aid the search for new treatments and even a cure for CMT," says Gary Smith, Ph.D., who derived the line and also is co-director of the U-M Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute. "Once again, the acceptance of these cells to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines."

U-M is one of only four institutions including two other universities and one private company to have disease-specific stem cell lines listed in the national registry. U-M has several other disease-specific hESC lines submitted to NIH and awaiting approval, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

"Stem cell lines that carry genetic traits linked to specific diseases are a model system to investigate what causes these diseases and come up with treatments," says Sue O'Shea, Ph.D., professor of Cell and Developmental Biology at the U-M Medical School, and co-director of the Consortium for Stem Cell Therapies.

Each line is the culmination of years of preparation and cooperation between U-M and Genesis Genetics, a Michigan-based genetic diagnostic company. This work was made possible by Michigan voters' November 2008 approval of a state constitutional amendment permitting scientists to derive embryonic stem cell lines using surplus embryos from fertility clinics or embryos with genetic abnormalities and not suitable for implantation.

Read more from the original source:
New embryonic stem cell line will aid research on nerve condition

MOBILE, Alabama -- At the end of this past season with the Oakland Raiders, an aching Rolando McClain gave an assignment to his agent: Find out more about stem cell therapies for injuries, like other athletes are trying.

Ive been having two seasons of nagging pain in my knee, the former University of Alabama standout said.

Not long afterward, McClain was on his way to Gulf Shores.

There, radiologist Jason R. Williams performed liposuction on McClain and then injected stem cells from the linebackers own fat cells into his knee and into the area of a high ankle sprain.

It feels a lot better, McClain said in an interview last week, adding that hes working out four days a week with the Raiders, running, lifting weights, doing squats and even sprinting with hardly any pain at all.

About three months ago, Williams, 38, began the new procedure in which he injects patients -- two of them being McClain and former University of Alabama receiver Marquis Maze -- with their own stem cells in an effort to repair damaged joints and muscles.

This is going to be the future of medicine, said Williams, who owns Precision StemCell, which includes a diagnostic and interventional radiology practice in Gulf Shores.

Stem cells, sometimes called the bodys master cells, are precursor cells that develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use.

Their promise in medicine, according to many scientists and doctors, is that the cells have the potential to help and regenerate other cells.

While Williams treatments are considered investigational, he said, they meet FDA guidelines since the stem cells are collected from a patients fat tissue and administered back to that patient during the same procedure.

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Former Alabama football players get stem cell injections from Gulf Shores doctor

When pitching in the Dominican Republic, C.J. Nitkowski said he felt he was back to his normal self on the mound

STORY HIGHLIGHTS

For the full story on C.J. Nitkowski's risky medical procedure and baseball comeback, watch CNN Presents, Sunday night at 8ET.

Alpharetta, Georgia (CNN) -- At 39 years old, Christopher John Nitkowski really has no business trying to pitch in the major leagues. In the harsh reality of professional sports, he's a has-been.

Just don't tell him that.

The former first-round draft pick last pitched for the Washington Nationals in 2005 after a 10-season career spent mostly as a left-handed reliever.

"You go as long as you can," he told CNN. "I had a good friend tell me, 'Man, just make them tear the uniform off of you. You can do whatever you're gonna do for the rest of your life. You can't play baseball forever.'"

A doctor injects C.J. Nitkowski's stem cells into his injured shoulder

In the middle of the 2011 baseball season Nitkowski announced in a first-person article for Sports Illustrated that he would try a comeback. After his brief major league appearance in 2005, he pitched subsequent years for one team in Japan and three in South Korea.

This time, he wrote, he would agree to a risky medical experiment that would involve injecting his own stem cells into his injured pitching shoulder, which he hurt in an initial comeback attempt last spring.

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Pitcher hopes stem cell procedure will get him one last season

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

International Stem Cell Corporation (ISCO.OB), http://www.internationalstemcell.com, today announced that several of its senior scientists, led by Dr. Ruslan Semechkin Vice President Research and Development, will present the results of their most recent experiments on the therapeutic use of human parthenogenetic stem cells (hpSCs) in Parkinsons disease at the 64th Annual Meeting of American Academy of Neurology in New Orleans (April 21 to 28 2012).

The data presented at the conference represents progress made in ISCOs Parkinsons disease program, the successful use of functional dopaminergic neurons and the results of pre-clinical studies in rodents.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.

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

Forward-looking Statements

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

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ISCO Scientists to Present Results of Recent Stem Cell Research on Parkinson’s Disease at Annual Meeting of American ...

Republican Michigan legislators who are trying to force the University of Michigan to provide details on embryonic stem-cell research have a big hurdle to overcome: Gov. Rick Snyder.

Snyder, also a Republican, remains convinced that the Legislature cannot force U-M or other universities to answer questions about stem cells included in budget bills, his spokeswoman told the Free Press.

"We remain consistent with the language on the stem-cell issue that we used last year where we took the position that the boilerplate language that was included in the current year's budget is unenforceable and unconstitutional if sought to be enforced," Snyder spokeswoman Geralyn Lasher said in a Friday e-mail. "Our legal counsel wrote a letter to legislative leadership to that effect, and it remains our view at this time as well."

U-M is glad to have Snyder's support, spokesman Rick Fitzgerald said Friday.

"It's encouraging that the governor is being consistent," Fitzgerald said. "We continue to work with the legislators in the appropriations process. We have a lot of time to address this and other issues."

Snyder's reluctance is likely to be a major weapon for U-M as it fights the Republicans on the issue.

The full House appropriations committee and full Senate appropriations committee each have now passed a higher education budget bill. The bills, which move on to the full state House and Senate, both include language tying performance funding to answering questions about embryonic stem-cell research.

U-M is eligible for about $5 million in performance funding.

It's unclear when the House and Senate will vote on the higher education budget.

U-M's share is about $270 million.

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Snyder supports U-M on Republicans' stem-cell research challenge

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

International Stem Cell Corporation (OTCBB: ISCO.OB - News) (www.internationalstemcell.com) today announced it has appointed MZ Group as its investor relations advisor. MZ will assist International Stem Cell with investor relations consulting, corporate communications and investor and shareholder outreach. ISCO also announced the promotion of Dr. Simon Craw to the position of Executive Vice President with responsibility for Business Development and Investor Relations.

MZ is an excellent investor relations partner for several reasons," said Dr. Andrey Semechkin, Ph.D., Chief Executive Officer of International Stem Cell. With our recent financing and steady progress in our Lifeline Skin Care and Cell Technology businesses, we have a tremendous opportunity to introduce our company to a wide variety of investors. MZ has access to a large pool of potential investors who may be interested in an emerging life sciences company such as ours.

We also look forward to steadily expanding our corporate communications efforts with the media and the life sciences industry to further solidify our corporate brands. With this in mind I have promoted Dr. Craw to a new position of EVP, to be responsible for Business Development and oversee our Investor Relations program in addition to his existing responsibly for our Stem Cell banking program. As part of his new role Dr. Craw will work closely with our VP of Research and Development and maintain his involvement in the development of our technologies.

We see a terrific opportunity to help management achieve their goals and objectives," said Ted Haberfield, Managing Partner of MZ Group North America. With advanced R&D and manufacturing facilities located in California and Maryland and its patented parthenogenetic stem cell technology to treat human degenerative diseases, the Company is in the advanced stages of developing multiple groundbreaking commercial applications. We believe investors will be extremely excited to learn more about International Stem Cell Corporation.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.

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

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International Stem Cell Corporation Appoints MZ Group as its Investor Relations Firm

NEW YORK, April 18, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Cell Surface Markers 2012: US, Europe, Japan Forecasts by Test, Market Segment and Country

http://www.reportlinker.com/p0365379/Cell-Surface-Markers-2012-US-Europe-Japan-Forecasts-by-Test-Market-Segment-and-Country.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

The use of surface marker identification and classification of cells is spreading beyond lymphocytes to the identification of monocytes, macrophages, myeloid stem cells, and tumor cells. A synergistic combination of the hybridoma technology with flow cytometry is further expanding the applications of both technologies. During the next ten years, the main trend in cell surface marker analysis will be further simplification of the sample preparation and the analysis itself.

This report presents a detailed overview of the CD4, CD8 and CD34 Cell Surface Marker testing in the US, Europe (France, Germany, Italy, Spain, UK) and Japan, including clinical significance and current laboratory practice, as well as 5- and 10-year test volume forecasts by country and market segment.

The report examines market applications of monoclonal antibodies, IT, DNA probes, biochips/microarrays, and other technologies; reviews features and operating characteristics of automated analyzers; profiles leading suppliers and recent market entrants developing innovative technologies and products; and identifies alternative market penetration strategies and entry barriers/risks.

Contains 120 pages and 15 tables

Table of Contents

I. Introduction

II. Worldwide Market and Technology Overview

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Cell Surface Markers 2012: US, Europe, Japan Forecasts by Test, Market Segment and Country