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Category Archives: Stem Cell Therapy

QF honours stem cell researchers

Research on preventing breast cancer recurrence, using organ regeneration to combat obesity-related diseases, and enabling vascular repair for patients suffering from cardiovascular disease has received awards at the ongoing Qatar International Conference on Stem Cell Science and Policy 2012. The award ceremony hosted by Qatar Foundation for Education, Science and Community Development at Qatar National Convention Centre recognised two professional researchers and one student researcher for excellence in stem cell research, with the research exhibited through poster presentations during the conference. Leaders from QF and top figures in the stem cell science and ethics field congratulated the award recipients. Dr Abdelali Haoudi, vice president for research at QF, said: We are truly impressed with the research presented this year in poster presentations, as well as in the oral presentations and panel discussions taking place throughout the conference. He added: Through this conference, we hope to drive further exploration in this field that will lead to even greater progress in applying stem cell science to prevent and treat diseases afflicting communities both in Qatar and around the world. The three posters were selected for recognition by a review committee, comprised of academics, researchers and scientists, including Nobel Laureates and international experts. Pegah Ghiabi, a researcher at the Stem Cell & Microenvironment Laboratory at Weill Cornell Medical College in Qatar, received an award for her poster presentation on research into therapy to inhibit the cancer stem cell population to prevent the recurrence of breast cancer. Research by Lara Bou-Khzam of the McGill University Health Centre Research Institute in Montreal, Canada, also received recognition. The poster focused on her stem cell research towards vascular repair for patients suffering from cardiovascular disease, one of the worlds leading causes of mortality. The final award was presented to Dr Heba al-Siddiqui for her research at the Harvard Stem Cell Institute on preventing chronic obesity-related diseases through tissue engineering and organ regeneration. Dr al-Siddiqui is a trainee in the Qatar Science Leadership Programme, a QF initiative aimed at equipping rising Qatari generations for leading roles in the countrys scientific and research endeavours. The Qatar International Conference on Stem Cell Science and Policy, organised through a partnership between QF and the James A. Baker III Institute of Public Policy at Rice University, will conclude today. The four-day conference, which featured expert panels and presentations on the latest opportunities and challenges in stem cell research, was attended by top figures in the fields of science, ethics and policy of stem cell research from across the Middle East region and around the world.

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individuals own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.

The prospect of using a persons own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach, said Norbert Riedel, Ph.D., Baxters chief science and innovation officer. The goals of this phase III trial are aligned with Baxters overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.

The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.

After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http://www.renewstudy.com or http://www.clinicaltrials.gov.

This trial is being initiated based on the phase II data, which indicated that injections of patients own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

The phase II trial provided evidence that this strategy, leveraging the bodys own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options, said Douglas Losordo, MD, vice president of new therapeutic development at Baxter.

CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.

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Stem-cell therapy takes off in Texas

Celltex hosts the largest stem-cell bank in the United States.

TYLER RUDICK

With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company.

The US Food and Drug Administration (FDA) has not approved any such stem-cell treatment for routine clinical use, although it does sanction them for patients enrolled in registered clinical trials. Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.

There are certainly plenty of people eager to have the treatments. Texas governor Rick Perry, for instance, has had stem-cell injections to treat a back complaint1, and has supported legislation to help create banks to store patients' harvested stem cells.

One company that has benefited from this buoyant climate is Celltex Therapeutics, which multiplies and banks stem cells derived from people's abdominal fat, according to chairman and chief executive David Eller. Its facility in Sugar Land, just outside Houston, opened in December 2011 and houses the largest stem-cell bank in the United States.

Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections.

Celltex says that although it processes and banks cells, it does not carry out stem-cell injections. It declined to answer Nature's questions about whether its cells have been used in patients. But there is evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases.

In addition to the publicity surrounding Perry's treatment, a woman named Debbie Bertrand has been blogging about her experiences during a five-injection treatment with cells prepared at Celltex. Her blog (http://debbiebertrand.blogspot.com) hosts photographs of herself alongside Jones; Jennifer Novak, a Celltex nurse; Jeong Chan Ra, chief executive of RNL Bio; and her doctor, Jamshid Lotfi, a neurologist who works for the United Neurology clinic in Houston. Another photo is captioned: My cells are being processed in here for my next infusion!!! A third shows Bertrand, Lotfi and a physician called Matthew Daneshmand, who is, according to the caption, injecting Bertrand's stem cells into an intravenous drip, ready for the infusion. Nature has been unable to contact Bertrand.

Lotfi says that he has administered cells processed by Celltex to more than 20 people. Five or six including Bertrand have multiple sclerosis and four or five have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat containing roughly 100,000 mesenchymal stem cells from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection.

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MissionIR News – Seeking Alpha Publishes Article Featuring VistaGen Therapeutics

VistaGen Therapeutics' versatile stem cell technology platform to potentially revolutionize drug testing

Atlanta, GA (PRWEB) February 27, 2012

MissionIR would like to highlight VistaGen Therapeutics, Inc. (OTCBB: VSTA). VistaGen Therapeutics is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants ("drug rescue variants") of promising drug candidates that have been discontinued during preclinical development ("put on the shelf") due to safety concerns.

Today, Seeking Alpha published the following article featuring VistaGen Therapeutics: http://seekingalpha.com/article/394361

The article titled “VistaGen Therapeutics: A Hidden Stem Cell Opportunity” reviews the largely overlooked application of stem cells in the early stage testing of drug candidates. Using advanced stem cell technology, VistaGen has produced functional human cardiac cells that can be used early on in the drug development process to test for cardiotoxicity. Cardiotoxicity has been a factor in over 30% of drug withdrawals, and addressing it is seen as a major market. The use of real human heart cells in pre-clinical testing offers important advantages over traditional testing methods, such as animal testing.

First of all, it can be performed at the earliest stages of development, reducing the risks of developing the wrong drug. It's also more accurate, since traditional testing involving animals can fail to detect potential risks in humans. And it's far easier than the large number of patients and lengthy testing required in human trials. By identifying cardiotoxicity issues early in the process, drug developers can take steps to rescue the drug candidate, developing variants that are both functional and safe. Given that stem cells, including non-embryonic stem cells, can be pointed in many different directions, their potential to transform drug development has no clear limit.

VistaGen sees itself as essentially transforming drug development by bring human biology to the front end of the process, attacking cardiotoxicity issues early in the cost curve, and removing much of the risk and uncertainty typically involved in bringing new drugs to market. Perhaps more importantly, it lessens the chance that patients will be asked to play the role of unsuspecting guinea pig, taking drugs that may cause them far more harm than good.

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MissionIR News - Seeking Alpha Publishes Article Featuring VistaGen Therapeutics

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Bad breath used as stem cell tool

27 February 2012 Last updated at 00:06 ET

Hydrogen sulphide, the gas famed for generating the stench in stink bombs, flatulence and bad breath, has been harnessed by stem cell researchers in Japan.

Their study, in the Journal of Breath Research, investigated using it to help convert stem cells from human teeth into liver cells.

The scientists claimed the gas increased the purity of the stem cells.

Small amounts of hydrogen sulphide are made by the body.

It is also produced by bacteria and is toxic in large quantities.

Therapy

A group in China has already reported using the gas to enhance the survival of mesenchymal stem cells taken from the bone marrow of rats.

Researchers at the Nippon Dental University were investigating stem cells from dental pulp - the bit in the middle of the tooth.

They said using the gas increased the proportion of stem cells which were converted to liver cells when used alongside other chemicals. The idea is that liver cells produced from stem cells could be used to repair the organ if it was damaged.

Dr Ken Yaegaki, from Nippon Dental University in Japan, said: "High purity means there are less 'wrong cells' that are being differentiated to other tissues, or remaining as stem cells."

One of the concerns with dental pulp as a source of stem cells is the number that can be harvested.

However, the study did not say how many cells were actually produced.

Prof Chris Mason, a specialist in regenerative medicine at University College London, said: "It would be interesting to see how hydrogen sulphide works with other cells types."

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Ovarian Stem Cells Produce Eggs in Method That May Aid Fertility Therapy

By Ryan Flinn - Mon Feb 27 05:00:01 GMT 2012

Stem cells taken from human ovaries were used to produce early-stage eggs by scientists in Boston who may have created a new method to help infertile women.

Females have a fixed number of eggs from birth that are depleted by the time of menopause. The finding, published today in the journal Nature Medicine, challenges the belief that their ovaries can’t make more. The research was led by Jonathan Tilly, the director of Massachusetts General Hospital’s Vincent Center for Reproductive Biology.

Tilly reported in 2004 that ovarian stem cells in mice create new eggs, or oocytes, in a way similar to how stem cells in male testes produce sperm throughout a man’s life. His latest work, if reproduced, would suggest the same is true for human ovaries, potentially pointing at new ways to aid fertility by delaying when the ovaries stop functioning.

“The 50-year-old belief in our field wasn’t actually based on data proving it was impossible, or not ongoing,” Tilly said in a telephone interview. “It was simply an assumption made because there was no evidence indicating otherwise. We have human cells that can produce new oocytes.”

In the study, healthy ovaries were obtained from consenting patients undergoing sex reassignment surgery. The researchers were able to identify ovarian stem cells because they express a rare protein that’s only seen in reproductive cells.

The stem cells from the ovaries were injected into human ovarian tissue that was then grafted under the skin of mice, which provided the blood supply that enabled growth. Within two weeks, early stage human follicles with oocytes had formed.

7-Million Eggs

A female is most endowed with oocytes, or eggs, as a fetus, when she has about 7 million. That number that drops to 1 million by birth, and around 300,000 by puberty. By menopause, the number is zero. Since the 1950’s, scientists thought that ovarian stem cells capable of producing new eggs are only active during fetal development.

“This paper essentially opens the door to the ability to control oocyte development in human ovaries,” Tilly said.

About 10 percent of women of child-bearing age in the U.S., or 6.1 million, have difficulty getting pregnant or staying pregnant, according to the Centers for Disease Control and Prevention. Most cases of female infertility are caused by problems with ovulation, hormone imbalance or age.

The study by Tilley and his colleagues offers “a new model system for understanding the human egg cell,” said David F. Albertini, director of the Center for Reproductive Services and professor in the department of molecular and integrative physiology at Kansas University, in a telephone interview.

‘Practical Applications”

Still, “there’s a long way to go before this has real practical applications. I’ve spent 35 years of my life studying egg cells and this is a cell that is at least as complicated as a neuron in the brain, if not more,” Albertini said.

The work needs to be reproduced and expanded by other scientists “to make it into something that will make us confident the cells are safe to use and we could actually use them to repopulate an egg-depleted ovary,” he said.

Tilly’s team is exploring the development of an ovarian stem-cell bank that can be cryogenically frozen and thawed without damage, unlike human eggs, he said. The researchers are also working to identify hormones and other growth factors for accelerating production of eggs from human ovarian stem cells and ways to improve in-vitro fertilization.

“The problem we face with IVF is we don’t have many eggs to work with,” he said. “These cells are renewable. If we are successful -- and it’s a big if -- in generating functioning eggs from these cells, we can generate as many eggs as we need to on a per patient basis.”

Tilly is also collaborating with researchers at the University of Edinburgh in the U.K. to determine whether the oocytes can be developed into fully mature human eggs for fertilizing. The U.S bans creating or fertilizing embryos for experimental purposes, he said.

A company Tilly co-founded, Boston-based OvaScience Inc., has licensed the technology for potential commercial applications.

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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