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Newswise (TORONTO, Canada Feb. 12, 2014) Cancer researchers led by stem cell scientist Dr. John Dick have discovered a pre-leukemic stem cell that may be the first step in initiating disease and also the culprit that evades therapy and triggers relapse in patients with acute myeloid leukemia (AML).

The research, published online today in Nature (http://dx.doi.org/10.1038/nature13038) is a significant leap in understanding the steps that a normal cell has to go through as it turns into AML, says Dr. Dick, and sets the stage to advance personalized cancer medicine by potentially identifying individuals who might benefit from targeting the pre-leukemic stem cell. AML is an aggressive blood cancer that the new research shows starts in stem cells in the bone marrow. Dr. Dick, a Senior Scientist at Princess Margaret Cancer Centre, University Health Network (UHN), and Professor in the Department of Molecular Genetics, University of Toronto, pioneered the cancer stem cell field by first identifying leukemia stem cells (1994) and colon cancer stem cells (2007).

"Our discovery lays the groundwork to detect and target the pre-leukemic stem cell and thereby potentially stop the disease at a very early stage when it may be more amenable to treatment," says Dr. Dick, who holds a Canada Research Chair in Stem Cell Biology and is also Director of the Cancer Stem Cell Program at the Ontario Institute for Cancer Research (OICR).

VIDEO: Dr. Dick talks about the research at: http://ow.ly/tyLY8.

"Now we have a potential tool for earlier diagnosis that may allow early intervention before the development of full AML. We can also monitor remission and initiate therapy to target the pre-leukemic stem cell to prevent relapse," he says.

The findings show that in about 25% of AML patients, a mutation in the gene DNMT3a causes pre-leukemic stem cells to develop that function like normal blood stem cells but grow abnormally. These cells survive chemotherapy and can be found in the bone marrow at remission, forming a reservoir of cells that may eventually acquire additional mutations, leading to relapse.

The discovery of pre-leukemic stem cells came out of a large Leukemia Disease Team that Dr. Dick assembled and included oncologists who collected samples for the Princess Margaret Cancer Centre Biobank and genome scientists at the OICR who developed sophisticated targeted sequencing methodology. With this team, it was possible to carry out genomic analysis of more than 100 leukemia genes on many patient samples. The findings also capitalized on data from more than six years of experiments in Dr. Dick's lab involving growing human AML in special mice that do not reject human cells.

"By peering into the black box of how cancer develops during the months and years prior to when it is first diagnosed, we have demonstrated a unique finding. People tend to think relapse after remission means chemotherapy didn't kill all the cancer cells. Our study suggests that in some cases the chemotherapy does, in fact, eradicate AML; what it does not touch are the pre-leukemic stem cells that can trigger another round of AML development and ultimately disease relapse," says Dr. Dick, who anticipates the findings will spawn accelerated drug development to specifically target DNMT3a.

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Cancer Researchers Discover Pre-Leukemic Stem Cell at Root of AML, Relapse

Steve Connor, The Independent Feb 9, 2014, 02.02PM IST

(Pluripotentstem cells)

LONDON: Human skin cells have been turned into stem cells which have the potential to develop into fully-formed embryos, simply by bathing them in weak citric acid for half an hour, a leading scientist has told The Independent on Sunday.

The demonstration that the technique, which was pioneered on mouse cells, also works on human skin cells raises the prospect of new treatments for incurable illnesses, from Parkinson's to heart disease, based on regenerating diseased organs in situ from a patient's own stem cells.

Although there is no intention to create human embryos from skin cells, scientists believe that it could, theoretically, be possible to do so given that entire mouse embryos have already been effectively created from the re-engineered blood cells of laboratory mice.

Creating the mouse embryos was the final proof the scientists needed to demonstrate that the stem cells were "pluripotent", and so capable of developing into any specialised tissue of an adult animal, including the "germ cells" that make sperm and eggs.

Pluripotent stem cells could usher in a new age of medicine based on regenerating diseased organs or tissues with injections of tissue material engineered from a patient's own skin or blood, which would pose few problems in terms of tissue rejection.

However, the technique also has the potential to be misused for cloning babies, although stem cell scientists believe there are formidable technical, legal and ethical obstacles that would make this effectively impossible.

A team of Japanese and American scientists converted human skin cells into stem cells using the same simple approach that had astonished scientists around the world last month when they announced that they had converted blood cells of mice into stem cells by bathing them in a weak solution of citric acid for 30 minutes.

The scientist who instigated the research programme more than a decade ago said that he now has overwhelming evidence that the same technique can be used to create embryonic-like stem cells from human skin cells.

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Manchester UK (PRWEB UK) 10 February 2014

RegenX Content The content posted on RegenX is generated through Dr. Stephen Richardson and a number of other stem cell experts in a collaborative effort between Brickhouse Publications and the University of Manchester. Dr. Richardson's 10 years of experience working with adult stem cells, coupled with the expertise of top-notch scientists, provides website visitors with the most current research information. The website is designed for people of all ages to read and comprehend, making it truly accessible to all.

In order to break down the complex concepts about stem cells and regenerative medicine, the website was designed with many visuals to aid in understanding. For those who learn best through reading text, there are many articles and informational bits. In addition, there are also many short animations, including a spoof news video, to help the general public understand the science behind research.

As far as the different topics are concerned, RegenX presents visitors with a wide range of information, building up from the simple to the complex. Some information simply shares the basics around stem cell and regenerative medicine research, while other pieces delve into more technical details. There are even informational pieces available that discuss the ethics around stem cell research, specifically. There is even a stem cell quiz on the website so readers can take to see where they stand on their understanding of the research and use.

Out in the general public, there is not very much accurate information shared about stem cell and regenerative medicine research. The media does not help as it often mis-portrays the benefits. Most often, the mis-portrayals lie in the legality and morality of the issue. Unfortunately, the misunderstood issues surrounding stem cell research can be huge roadblocks for those trying to advance the science around it.

Educational Outreach In order to address some of the misunderstandings about stem cell research, RegenX provides teacher packs that complement the site. These packets can be used in schools, colleges, and universities, to help educate the public. The classroom activities presented are usually animated or in video format, making it more engaging and easy to understand. In addition to helping students learn, the videos also help classroom teachers who are lacking the information to build some background knowledge. The teacher packets also include debate and discussion topics for students to process the information.

Included in the teacher packets from RegenX are interviews with stem cell research experts. Their information is research-based as they all work at the University of Manchester. In addition to discussing stem cell and regenerative medicine, the experts also share information about the jobs and the research currently conducted at the University. They even talk about their careers and what they needed to do in order to earn the privilege of conducting such research.

Funding The RegenX website is funded with monies from the Biotechnology and Biological Sciences Research Council (BBSRC) and the University of Manchester. Their reason for funding the project was to offer unbiased, scientifically accurate information for people from a variety of backgrounds. Their intended audience is not purely scientists, but also children and adults of all ages from all walks of life.

Staying Updated In order to keep people updated in a fast-changing field, the website has Facebook and Twitter pages to complement it. These social media networks allow RegenX to relay a great deal of updated information in a quick way. They are also able to reach a larger population of readers at any time of the day to keep them posted as well.

Making sure that people are getting the most updated information as quickly as possible is one way to build a community, which was the initial goal of Dr. Stephen Richardson. He wanted to make sure that there was a community of individuals who have slight or intense interest in stem cell and regenerative medicine research. It is also healthy to generate debate around the latest information in the field.

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Ground Breaking New Website REGENX, provides credible and up to date information on Stem Cell research straight from ...

MINNEAPOLIS, Minn. (Ivanhoe Newswire) - Statistics from the Department of Health and Human Services reveal that an average of 18 people dies waiting for organ transplants each day. There are about 2,500 hearts available and a waiting list of about 100,000 patients in need. Now, researchers at the University of Minnesota hope to bridge that gap.

"I couldn't walk, or breathe, or eat," congestive heart failure patient Allan Isaacs told Ivanhoe.

That was life with congestive heart failure for 71-year-old Isaacs, but after a left ventricular assist device was implanted into his chest, Allan's life got moving again.

"(I do)15 minutes on the elliptical and about 30 minutes on the treadmill," Allan said.

The LVAD helps pump oxygen rich blood throughout the body, but Allan's recovery may also have to do with the fact that his treatment may have included injections of his own bone marrow stem cells. Allan's taking part in a leading edge blind study at the University of Minnesota's Medical Center.

"We isolate the stem cells and when they go for surgery we inject those cells on the heart wall," Ganesh Raveendran, MD, MS, Director of the Cardiac Catheterization Laboratory at the University of Minnesota Medical Center, told Ivanhoe.

One-third of the patients receive a placebo, the rest get ten injections of stem cells into their hearts. Muscle tissue is then analyzed to, "see whether these cells have made any meaningful change, whether the cells have transformed into cardiac muscle," Dr. Raveendran explained.

In many cases an LVAD is a bridge to transplant, but researchers and Allan hope this stem cell therapy could eliminate that need.

"Now, I can do whatever I feel like doing," Allan said.

The research team at the University of Minnesota Medical Center hopes to wrap up the study by end of this year and collaborate on a multicenter study involving seven medical centers throughout the nation.

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Heart Stem Cells, LVAD May Avoid Transplants ...

Stem cell therapy - Age reversal1 - Cristal Jan 2014
http://a1stemcells.com/ Cristal, 70 years old. 1 Year after our 1st Age reversal study with stem cells (12 ESC injections in 12 months) For more info: http:/...

By: A1 Stem Cells

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Stem cell therapy - Age reversal1 - Cristal Jan 2014 - Video

Hematopoietic stem cells (HSCs) are the blood cells that give rise to all the other blood cells.

They give rise to the myeloid (monocytes and macrophages, neutrophils, basophils, eosinophils, erythrocytes, megakaryocytes/platelets, dendritic cells), and lymphoid lineages (T-cells, B-cells, NK-cells). The definition of hematopoietic stem cells has changed in the last two decades. The hematopoietic tissue contains cells with long-term and short-term regeneration capacities and committed multipotent, oligopotent, and unipotent progenitors. HSCs constitute 1:10.000 of cells in myeloid tissue.

HSCs are a heterogeneous population. Three classes of stem cells exist, distinguished by their ratio of lymphoid to myeloid progeny (L/M) in blood. Myeloid-biased (My-bi) HSC have low L/M ratio (>0, <3), whereas lymphoid-biased (Ly-bi) HSC show a large ratio (>10). The third category consists of the balanced (Bala) HSC for which 3 L/M 10. Only the myeloid-biased and -balanced HSCs have durable self-renewal properties. In addition, serial transplantation experiments have shown that each subtype preferentially re-creates its blood cell type distribution, suggesting an inherited epigenetic program for each subtype.

HSC studies through most of the past half century and have led to a much deeper understanding. More recent advances have resulted in the use of HSC transplants in the treatment of cancers and other immune system disorders.[1]

HSCs are found in the bone marrow of adults, with large quantities in the pelvis, femur, and sternum. They are also found in umbilical cord blood and, in small numbers, in peripheral blood.[citation needed]

Stem and progenitor cells can be taken from the pelvis, at the iliac crest, using a needle and syringe.[citation needed] The cells can be removed a liquid (to perform a smear to look at the cell morphology) or they can be removed via a core biopsy (to maintain the architecture or relationship of the cells to each other and to the bone).[citation needed]

In order to harvest stem cells from the circulating peripheral, blood donors are injected with a cytokine, such as granulocyte-colony stimulating factor (G-CSF), that induce cells to leave the bone marrow and circulate in the blood vessels.[citation needed]

In mammalian embryology, the first definitive HSCs are detected in the AGM (Aorta-gonad-mesonephros), and then massively expanded in the Fetal Liver prior to colonising the bone marrow before birth.[2]

As stem cells, HSC are defined by their ability to replenish all blood cell types (Multipotency) and their ability to self-renew.

It is known that a small number of HSCs can expand to generate a very large number of daughter HSCs. This phenomenon is used in bone marrow transplantation, when a small number of HSCs reconstitute the hematopoietic system. This process indicates that, subsequent to bone marrow transplantation, symmetrical cell divisions into two daughter HSCs must occur.

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Hematopoietic stem cell - Wikipedia, the free encyclopedia

Provided by: Wayland Baptist University

PLAINVIEW In honor of Lana Watson, Wayland Baptist University is hosting a bone marrow drive on Monday from 4 to 6 p.m. in Pete's Place, the student lounge in the basement of the McClung University Center, in conjunction with Covenant Health Plainview.

Other screening locations are the hospital lab at 2601 Dimmitt Road from 7 to 9 a.m., the South Plains College nursing lab at 1920 W. 24 from 10 a.m. to 12 p.m., and the First Baptist Church parlor at 205 W. 8th from 1 to 3 p.m.

Lana is the wife of Rodney Watson, Director of the Llano Estacado Museum and a deacon at First Baptist Church. Lana is currently in Dallas undergoing a transplant procedure of her own stem cells and waiting while the search for a bone marrow donor continues.

According to Laurie Hall, Coordinator of Health Services at Wayland, donors should be between the ages of 18-44. People over the age of 44 can be screened, but there is a $100 registration fee. Contact Be the Match at http://www.bethematch.orgfor more information.

No needles are involved in the screening process as donor information is collected through a mouth swab and registration process.

Through a similar drive last year, former Wayland student Scott Langford was identified as a match for a transplant patient. Langford donated his bone marrow to save a life.

Everyone interested in donating bone marrow is encouraged to undergo the screening process.

Excerpt from:
Wayland Baptist hosting bone marrow drive

Already, scientists in laboratories across the world have begun dipping mature cells in acid, hoping to see whether this simple intervention really can trigger a transformation into stem cells, as reported by a team of Boston and Japanese researchers last week.

At the Harvard Stem Cell Institute, a number of scientists have already embarked on the experiment, which theyre informally calling stem cell ceviche, comparing it to the Latin American method of cooking seafood in lime and lemon juice. At meetings with other experts and even in casual conversation, stem cell scientists say they are exchanging surprise, doubt, and wonder about the discovery, reported in two papers in the journal Nature.

The range of responses varies widely. But most scientists seem to be surprised and skeptical about the technique, though also impressed by the rigorous testing that experts in the field did on the cells. It appears that no one knows quite what to think.

Paul Knoepfler, an associate professor in the department of cell biology and human anatomy at the University of California, Davis, has been blogging extensively about the discovery and polled his readers about what they think. In an unscientific poll that has drawn about 400 responses, hes found that scientists are pretty evenly split on whether they are leaning toward believing in the technique or not. Interestingly, he found people responding to the poll from Japan are far more likely to be convinced it is true.

On Thursday, Knoepfler made his own opinion known. Its a harsh critique, starting with his view that the method is illogical and defies common sense. It ends with questions about why the researchers would only now be trying the technique on human cells, since they seemed to have proved it to themselves for several years now. The biggest mystery may be why, if simple stress can trigger cells to return to a stem cell-like state, it doesnt happen more often in the body. Why dont people just have lots of cancers and tumors in the acidic environment of their stomach, for example?

There are also basic questions about whether these truly are the same as spore-like cells that Dr. Charles Vacanti, an anesthesiologist at Brigham and Womens Hospital who led the new work, described in a highly controversial 2001 paper. Many scientists doubted the existence of those cells, and Vacanti has said he thinks the new stem cells, which are called STAP cells, are the same.

Obviously, it has to be reproduced. Thats the caveat, said Dr. Kenneth Chien, a professor in the department of cell and molecular biology and medicine at the Karolinska Institute in Stockholm. I still think its shocking. And it makes me wonder if its true or not, its so shocking.

Right now, we seem to have arrived at an unusual spot in scienceno one knows quite what to believe. People have quite informed gut reactions, but still seem to lack solid evidence to show the technique does or doesnt hold up. Its exciting and nerve wracking, but even those with doubts dont seem ready to dismiss it outright. This is how science works: people turn to the experiments to smash or solidify their doubts. Many are scurrying to recreate those in their laboratories, which should bring some clarity to the situation.

One reason the finding is so unusual is that it pretty much blind-sided the scientific community. Often, researchers are aware of discoveries that will be published in their fields through informal channels. They attend the same meetings, they present early versions of their results, or they know who is generally working on what area of research. In this case, people were surprised. Thats in part because one of the scientists pushing the work was far from an insider. Vacanti is an anesthesiologist, not a stem cell scientist.

Notably, even though the team of researchers was partially based in Boston, where there are many leaders in the stem cell field, they turned to world experts in Japan to vet the cells.

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The debate over new stem cell technique begins - Boston.com

MediVet Stem Cell Therapy For Pets
MediVet is the company that created the technology to use stem cell therapy to treat pets with arthritis and hip dysplasia.

By: Newman Veterinary Centers

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MediVet Stem Cell Therapy For Pets - Video

CLEVELAND, OH Whod have ever thought something as unappealing as body fat could be useful much less lifesaving, right?

I think this will revolutionize medicine if it works, says Dr. Mark Foglietti of the Stem Cell Center of Ohio.

It turns out, fat is highly regenerative and rich in stem cells, Warren Buffett rich, having 2,500 times more stem cells than bone marrow.

And these are Mesenchymal stem cells. Mesenchymal meaning theyre able to change into whatever type of tissue theyre attracted to.

So doctors in Cleveland are trying an experimental procedure on Multiple Sclerosis patient Kym Sellers, She was saying Dad, if I could only just get the use of my hands. If I can just use my hands, I can comb my hair. I can feed myself.

Doctors liposuction fat from Sellers, take the stem cells and mix in a biological potpourri called Stromal Vascular Fraction or SVF. The cells are supposed to act like a rescue squad responding to an emergency (they find damage to the body and repair it).

Dr. Foglietti happily tells his patient, We have 7ccs. We have 39 million stem cells! The SVF is then reintroduced into Kyms body intravenously.

You just want to pray that this is something that will improve your quality of life, says Kym Sellers.

Although the procedure only takes a few hours, itll be months until Kym or the doctors can determine if it was successful. If it is, itll be used to treat everything from asthma to A.L.S. For now though, Kym waits and prays.

Just praying for the best, she says.

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Experimental procedure uses stem cells made from body fat

US researchers offer diabetes cure hope

Friday, February 07, 2014

A diabetes cure could be in sight after scientists transformed ordinary skin cells into pancreatic cells producing insulin.

By John von Radowitz

At the end of the process they created immature precursors to pancreatic beta cells, the bodys insulin factory.

When these cells were injected into mice genetically engineered to mimic symptoms of diabetes, the animals blood sugar levels returned to normal.

The US research is a major step forward in the hunt for a stem cell solution to Type 1 diabetes, caused by the bodys own immune system attacking and destroying insulin-making beta cells.

Type 1 diabetes is distinct from the much more common Type 2 version of the disease.

Type 1 diabetes usually strikes in childhood and dooms sufferers to a lifetime of self-administered insulin injections, without which their blood sugar would reach lethal levels.

Earlier attempts at using stem cells to replenish lost pancreatic beta cells have been largely disappointing.

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US researchers offer diabetes cure hope

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Newswise NEW YORK, NY (February 6, 2014) In most cases of amyotrophic lateral sclerosis (ALS), or Lou Gehrigs disease, a toxin released by cells that normally nurture neurons in the brain and spinal cord can trigger loss of the nerve cells affected in the disease, Columbia researchers reported today in the online edition of the journal Neuron.

The toxin is produced by star-shaped cells called astrocytes and kills nearby motor neurons. In ALS, the death of motor neurons causes a loss of control over muscles required for movement, breathing, and swallowing. Paralysis and death usually occur within 3 years of the appearance of first symptoms.

The report follows the researchers previous study, which found similar results in mice with a rare, genetic form of the disease, as well as in a separate study from another group that used astrocytes derived from patient neural progenitor cells. The current study shows that the toxins are also present in astrocytes taken directly from ALS patients.

I think this is probably the best evidence we can get that what we see in mouse models of the disease is also happening in human patients, said the studys senior author, Serge Przedborski, MD, PhD, the Page and William Black Professor of Neurology (in Pathology and Cell Biology), Vice Chair for Research in the Department of Neurology, and co-director of Columbias Motor Neuron Center.

The findings also are significant because they apply to the most common form of ALS, which affects about 90 percent of patients. Scientists do not know why ALS develops in these patients; the other 10 percent of patients carry one of 27 genes known to cause the disease.

Now that we know that the toxin is common to most patients, it gives us an impetus to track down this factor and learn how it kills the motor neurons, Dr. Przedborski said. Its identification has the potential to reveal new ways to slow down or stop the destruction of the motor neurons.

In the study, Dr. Przedborski and study co-authors Diane Re, PhD, and Virginia Le Verche, PhD, associate research scientists, removed astrocytes from the brain and spinal cords of six ALS patients shortly after death and placed the cells in petri dishes next to healthy motor neurons. Because motor neurons cannot be removed from human subjects, they had been generated from human embryonic stem cells in the Project A.L.S./Jenifer Estess Laboratory for Stem Cell Research, also at CUMC.

Within two weeks, many of the motor neurons had shrunk and their cell membranes had disintegrated; about half of the motor neurons in the dish had died. Astrocytes removed from people who died from causes other than ALS had no effect on the motor neurons. Nor did other types of cells taken from ALS patients.

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Toxin from Brain Cells Triggers Neuron Loss in Human ALS Model

New details about how motor neurons die in ALS have been uncovered by a new cell-culture system that combines spinal cord or brain cells from ALS patients with human motor neurons. The culture system shows that patient astrocytes (shown here with a blue-stained nucleus) release a toxin that kills motor neurons via a recently discovered process described as a controlled cellular explosion. Image: Diane Re.

NEW YORK, NY (February 6, 2014) In most cases of amyotrophic lateral sclerosis (ALS), or Lou Gehrigs disease, a toxin released by cells that normally nurture neurons in the brain and spinal cord can trigger loss of the nerve cells affected in the disease, Columbia researchers reported today in the online edition of the journal Neuron.

The toxin is produced by star-shaped cells called astrocytes and kills nearby motor neurons. In ALS, the death of motor neurons causes a loss of control over muscles required for movement, breathing, and swallowing. Paralysis and death usually occur within 3 years of the appearance of first symptoms.

The report follows the researchers previous study, which found similar results in mice with a rare, genetic form of the disease, as well as in a separate study from another group that used astrocytes derived from patient neural progenitor cells. The current study shows that the toxins are also present in astrocytes taken directly from ALS patients.

I think this is probably the best evidence we can get that what we see in mouse models of the disease is also happening in human patients, said the studys senior author, Serge Przedborski, MD, PhD, the Page and William Black Professor of Neurology (in Pathology and Cell Biology), Vice Chair for Research in the department of Neurology, and co-director of Columbias Motor Neuron Center.

The findings also are significant because they apply to the most common form of ALS, which affects about 90 percent of patients. Scientists do not know why ALS develops in these patients; the other 10 percent of patients carry one of 27 genes known to cause the disease.

Now that we know that the toxin is common to most patients, it gives us an impetus to track down this factor and learn how it kills the motor neurons, Dr. Przedborski said. Its identification has the potential to reveal new ways to slow down or stop the destruction of the motor neurons.

In the study, Dr. Przedborski and study co-authors Diane Re, PhD, and Virginia Le Verche, PhD, associate research scientists, removed astrocytes from the brain and spinal cords of six ALS patients shortly after death and placed the cells in petri dishes next to healthy motor neurons. Because motor neurons cannot be removed from human subjects, they had been generated from human embryonic stem cells in the Project A.L.S./Jenifer Estess Laboratory for Stem Cell Research, also at CUMC.

Within two weeks, many of the motor neurons had shrunk and their cell membranes had disintegrated; about half of the motor neurons in the dish had died. Astrocytes removed from people who died from causes other than ALS had no effect on the motor neurons. Nor did other types of cells taken from ALS patients.

Astrocytes from ALS patients release a toxin that kills human motor neurons. Left: a disintegrating motor neuron on top of human astrocytes (blue). Right: a healthy motor neuron on top of astrocytes from people unaffected by ALS. Image: Diane Re.

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Medical Center Researchers Create Human ALS Model That May Lead to New Therapies

RANCHO CORDOVA, Calif., LOS ANGELES and NEW DELHI, India, Feb. 3, 2014 (GLOBE NEWSWIRE) -- ThermoGenesis Corp. (Nasdaq:KOOL) a cellular therapy medical device company and TotipotentRX Corporation, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular and orthopedic disease, announced the TotiPotentRX cellular therapy clinical team in partnership with Fortis Healthcare, Gurgaon (New Delhi) has achieved its 20 th pediatric bone marrow transplant (BMT). This haploidentical BMT was performed from a mother as a donor for a 10 year old child suffering from combined immunodeficiency due to a DOCK-8 gene mutation. The Fortis Centre has so far performed 15 allogenetic BMT including five haploidentical and one double unrelated cord blood transplants, and 5 autologous transplants. This transplant was completed on February 1, 2014 at the Pediatric Hematology and Bone Marrow Transplant department led by Dr. Satya Yadav, M.D., Head of the Department for Pediatric Hematology and Bone Marrow Transplant, and with scientific and laboratory support by the TotipotentRX's cell therapy GMP laboratory facility. This 20 th transplant is a significant milestone in the pursuit of developing the new FMRI BMT program into one of the leading stem cell transplant centers in Asia.

TotipotentRX provides laboratory services and scientific support to Fortis' cutting edge program at FMRI, some of which employs a proprietary approach to the transplant using the ThermoGenesis AutoXpress AXP and MarrowXpress MXP platforms when the processing of the donor's mobilized peripheral blood or bone marrow is required. These technologies allow for a proprietary transplant approach that increases pediatric patient access to this life saving treatment by enabling the following types of transplants that might otherwise not be an option for the patient:

Dr. Yadav remarked, "this 20 th transplant is a significant milestone for our patients, our research hospital and our transplant team.Achieving 15 allogenetic and 5 autologous transplants in the first half year of our program is remarkable for any leading academic institution.Our goal is to have the most advanced pediatric bone marrow transplant program in India, whilst taking a global leadership role in advanced therapy like the haploidentical transplant approach.We look forward to continuing our cutting edge program with TotipotentRX as a scientific collaborator."

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TotipotentRX And ThermoGenesis Achieve Bone Marrow Stem ...

By William T. Koustas

The litigation between Regenerative Sciences, LLC (Regenerative) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority to regulate certain autologous stem cells procedures. The D.C. Circuit affirmed the lower courts decision granting summary judgment to the government, dismissing Regeneratives counterclaims, and permanently enjoining Regeneratives operations.

Regenerative is a Colorado company that owns a medical technique known as the Regenexx Procedure, a non-surgical procedure by which physicians take bone marrow and blood samples from a patient, culture the stem cells, mix the cultured cells with doxycycline, and inject the stem cell mixture back into the same patient in order to treat joint, muscle, tendon, or bone pain. The Regenexx Procedure is exclusively licensed for use by a Colorado clinic where its inventors practice.

Our prior blog posts on this case provide more background (see here andhere for example), but in essence, FDAs litigation stance was that the stem cell mixture used in the Regenexx Procedure was a drug under the Federal Food, Drug, and Cosmetic Act (FDCA), thus imposing current Good Manufacturing Practices (cGMP) and labeling requirements applicable to all drugs. On the other side, Regenerative argued that FDA had no authority over the Regenexx Procedure because it involved the practice of medicine, which is outside of FDAs purview, and because the stem cell mixture was not introduced or delivered for introduction into interstate commerce.

The D.C. Circuit upheld the district courts decision, frequently relying on long-standing principles of food and drug law. The court first found that the stem cell mixture met the definition of drug contained in the FDCA as it was an article derived mainly from human tissue intended to treat orthopedic diseases and to affect musculoskeletal function. Slip Op. at 6. In addition, and perhaps of more consequence, the court disagreed with Regeneratives argument that FDA was interfering with the practice of medicine by preventing physicians from performing autologous stem cell procedures. The D.C. Circuit described this argument as wide of the mark, clarifying that FDA was seeking to regulate the stem cell mixture and not the procedure itself. Id. at 7.

The court also rejected Regeneratives argument that FDA lacked jurisdiction over the stem cell mixture given that the Regenexx Procedure is performed entirely within the State of Colorado. Unsurprisingly, the court restated the well-known principle that the interstate commerce requirement of the FDCA is satisfied if a component of a product is shipped in interstate commerce prior to its administration to a patient. Id. at 9. The court also seemed to agree with FDAs position that the interstate commerce requirement could be satisfied simply because the stem cell mixture would undoubtedly have effects on interstate markets for orthopedic care . . . . Id. at 8.

The D.C. Circuit also dismissed Regeneratives argument that the stem cell mixture was a human cell, tissue, or cellular and tissue-based product (HCT/P), and thus exempt from manufacturing and labeling requirements. The court found that the stem cell mixture was likely more than minimally manipulated [b]ecause [Regenerative] concede[d] that culturing [stem cells] affects their characteristics and offer[ed] no evidence that those effects constitute only minimal manipulation, they fail to carry that burden as a matter of law. Id. at 12.

After summarily rejecting Regeneratives arguments, the D.C. Circuit ruled that the stem cell mixture was adulterated and misbranded. The court found that the stem cell mixture was adulterated because it was not manufactured in conformance with cGMP requirements, and that they were misbranded because the information on the label on the syringe that contains the stem cell mixture did not include adequate directions for use or bear the Rx only symbol. Id. at 14-15.

Although the court upheld the permanent injunction, it did so only after analyzing whether there was a reasonable likelihood of further violations in the future. Id. at 18. While the court determined that such likelihood existed in this case, this suggests that a violation of the FDCA, in and of itself, does not automatically necessitate injunctive relief but must be considered based on the facts of each case.

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D.C. circuit rules FDA can regulate autologous stem cells

The Stem Cell Experts
The McGowan Institute for Regenerative Medicine is a program of the University of Pittsburgh and UPMC. The Institute specializes in discovering the potential...

By: Fernanda Torres

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The Stem Cell Experts - Video

Current ratings for: Stem cells cultivated without using human or animal cells

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Previously, stem cells have been cultivated using animal proteins or by growing them from other human cells. Both methods come with associated problems. But, according to a study published in the journal Applied Materials & Interfaces, researchers have now identified a new method for cultivating stem cells.

Stem cells are a kind of cell that are able to divide or self-renew indefinitely. This allows the stem cell to generate into a range of different cell types for the organ that they originate from, or they may even be able to regenerate the whole organ.

Because of this, scientists are interested in using stem cells in a range of medical treatments, to replenish damaged tissue in the brain or skin, or as a treatment for diseases of the blood.

In adults, these stem cells have been found in tissues such as the brain, bone marrow, blood, blood vessels, skeletal muscles, skin and liver. Adult stem cells only become "activated" and start dividing and generating new cells when their host tissue becomes damaged by disease or injury.

A more potent kind of stem cell is found in human embryos - this type has the unique ability to grow into any kind of cell in the human body. But using these cells in scientific research is controversial - and illegal in some countries - as harvesting them requires the destruction of a fertilized human egg (a "blastocyst") that has not had the chance to develop into a baby.

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Stem cells cultivated without using human or animal cells

PUBLIC RELEASE DATE:

5-Feb-2014

Contact: Connie Hughes Connie.Hughes@wolterskluwer.com 646-674-6348 Wolters Kluwer Health

Philadelphia, Pa. (February 4, 2014) - Patients with massive burns causing complete loss of the facial skin pose a difficult challenge for reconstructive surgeons. Now a group of surgeons in China have developed an innovative technique for creating a one-piece skin flap large enough to perform full-face resurfacing, reports The Journal of Craniofacial Surgery, published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

Dr. QingFeng Li and colleagues of Shanghai Jiao Tong University School of Medicine describe their approach to creating "monoblock" flaps for use in extensive face skin resurfacing. In their successful experience with five severely disfigured patients, the full-face tissue flap "provides universally matched skin and near-normal facial contour."

New Technique Grows One-Piece Skin Flaps for Full-Face Resurfacing

Complete destruction of the facial skin and underlying (subcutaneous) tissues presents "the most challenging dilemma" in facial reconstructive surgery. Multiple skin flaps and grafts are needed to provide complete coverage, creating a "patchwork" appearance. Standard skin grafts are also too bulky to provide good reconstruction of the delicate features and expressive movement of the normal facial skin.

To meet these challenges, Dr. Li and colleagues have developed a new technique for creating a single, large skin flap appropriate for use in full-face resurfacing. Their approach starts with "prefabrication" of a flap of the patient's own skin, harvested from another part of the body. The skin flap, along with its carefully preserved blood supply, is allowed to grow for some weeks in a "pocket" created under the patient's skin of the patient's upper chest.

Tissue expandersballoon-like devices gradually filled with saline solutionare used to enlarge the skin flap over time. While skin expansion is a standard technique for creation of skin flaps, Dr. Li and his team used an "overexpansion" approach to create very large flaps of relatively thin skinideal for use in the facial area. In some cases, when the skin flap was growing too thin, stem cells derived from the patients' own bone marrow were used as an aid to tissue expansion.

Using this technique, Dr. Li and colleagues were able to create very large skin flapsup to 30 30 cmfor use in full-face resurfacing. In the new article, they describe their use of their prefabrication/overexpansion technique in five patients with complete loss of the facial skin, caused by flame or chemical burns. All patients had previously undergone facial reconstruction, but were left with severe deformity and limited facial movement.

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Innovative technique creates large skin flaps for full-face resurfacing

PUBLIC RELEASE DATE:

6-Feb-2014

Contact: Anne Holden anne.holden@gladstone.ucsf.edu 415-734-2534 Gladstone Institutes

SAN FRANCISCO, CAFebruary 6, 2014A cure for type 1 diabetes has long eluded even the top experts. Not because they do not know what must be donebut because the tools did not exist to do it. But now scientists at the Gladstone Institutes, harnessing the power of regenerative medicine, have developed a technique in animal models that could replenish the very cells destroyed by the disease. The team's findings, published online today in the journal Cell Stem Cell, are an important step towards freeing an entire generation of patients from the life-long injections that characterize this devastating disease.

Type 1 diabetes, which usually manifests during childhood, is caused by the destruction of -cells, a type of cell that normally resides in the pancreas and produces a hormone called insulin. Without insulin, the body's organs have difficulty absorbing sugars, such as glucose, from the blood. Once a death sentence, the disease can now be managed with regular glucose monitoring and insulin injections. A more permanent solution, however, would be to replace the missing -cells. But these cells are hard to come by, so researchers have looked towards stem cell technology as a way to make them.

"The power of regenerative medicine is that it can potentially provide an unlimited source of functional, insulin-producing -cells that can then be transplanted into the patient," said Dr. Ding, who is also a professor at the University of California, San Francisco (UCSF), with which Gladstone is affiliated. "But previous attempts to produce large quantities of healthy -cellsand to develop a workable delivery systemhave not been entirely successful. So we took a somewhat different approach."

One of the major challenges to generating large quantities of -cells is that these cells have limited regenerative ability; once they mature it's difficult to make more. So the team decided to go one step backwards in the life cycle of the cell.

The team first collected skin cells, called fibroblasts, from laboratory mice. Then, by treating the fibroblasts with a unique 'cocktail' of molecules and reprogramming factors, they transformed the cells into endoderm-like cells. Endoderm cells are a type of cell found in the early embryo, and which eventually mature into the body's major organsincluding the pancreas.

"Using another chemical cocktail, we then transformed these endoderm-like cells into cells that mimicked early pancreas-like cells, which we called PPLC's," said Gladstone Postdoctoral Scholar Ke Li, PhD, the paper's lead author. "Our initial goal was to see whether we could coax these PPLC's to mature into cells that, like -cells, respond to the correct chemical signals andmost importantlysecrete insulin. And our initial experiments, performed in a petri dish, revealed that they did."

The research team then wanted to see whether the same would occur in live animal models. So they transplanted PPLC's into mice modified to have hyperglycemia (high glucose levels), a key indicator of diabetes.

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Scientists reprogram skin cells into insulin-producing pancreas cells

La Jolla, CAA study led by researchers at the Salk Institute for Biological Studies, has catapulted the field of regenerative medicine significantly forward, proving in principle that a human genetic disease can be cured using a combination of gene therapy and induced pluripotent stem (iPS) cell technology. The study, published in the May 31, 2009 early online edition of Nature, is a major milestone on the path from the laboratory to the clinic.

"It's been ten years since human stem cells were first cultured in a Petri dish," says the study's leader Juan-Carlos Izpisa Belmonte, Ph.D., a professor in the Gene Expression Laboratory and director of the Center of Regenerative Medicine in Barcelona (CMRB), Spain. "The hope in the field has always been that we'll be able to correct a disease genetically and then make iPS cells that differentiate into the type of tissue where the disease is manifested and bring it to clinic."

Genetically-corrected fibroblasts from Fanconi anemia patients (shown in green at the top) are reprogrammed to generate induced pluripotent stem cells, which, in turn, can be differentiated into disease-free hematopoietic progenitors, capable of producing blood cells in vitro (bottom: Erythroid colonies.)

Image: Courtesy of Dr. Juan-Carlos Belmonte, Salk Institute for Biological Studies.

Although several studies have demonstrated the efficacy of the approach in mice, its feasibility in humans had not been established. The Salk study offers the first proof that this technology can work in human cells.

Belmonte's team, working with Salk colleague Inder Verma, Ph.D., a professor in the Laboratory of Genetics, and colleagues at the CMRB, and the CIEMAT in Madrid, Spain, decided to focus on Fanconi anemia (FA), a genetic disorder responsible for a series of hematological abnormalities that impair the body's ability to fight infection, deliver oxygen, and clot blood. Caused by mutations in one of 13 Fanconi anemia (FA) genes, the disease often leads to bone marrow failure, leukemia, and other cancers. Even after receiving bone marrow transplants to correct the hematological problems, patients remain at high risk of developing cancer and other serious health conditions.

After taking hair or skin cells from patients with Fanconi anemia, the investigators corrected the defective gene in the patients' cells using gene therapy techniques pioneered in Verma's laboratory. They then successfully reprogrammed the repaired cells into induced pluripotent stem (iPS) cells using a combination of transcription factors, OCT4, SOX2, KLF4 and cMYC. The resulting FA-iPS cells were indistinguishable from human embryonic stem cells and iPS cells generated from healthy donors.

Since bone marrow failure as a result of the progressive decline in the numbers of functional hematopoietic stem cells is the most prominent feature of Fanconi anemia, the researchers then tested whether patient-specific iPS cells could be used as a source for transplantable hematopoietic stem cells. They found that FA-iPS cells readily differentiated into hematopoietic progenitor cells primed to differentiate into healthy blood cells.

"We haven't cured a human being, but we have cured a cell," Belmonte explains. "In theory we could transplant it into a human and cure the disease."

Although hurdles still loom before that theory can become practice-in particular, preventing the reprogrammed cells from inducing tumors-in coming months Belmonte and Verma will be exploring ways to overcome that and other obstacles. In April 2009, they received a $6.6 million from the California Institute Regenerative Medicine (CIRM) to pursue research aimed at translating basic science into clinical cures.

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Genetic Re-disposition: Combined stem cell-gene therapy ...