Boning up: McMaster researchers find home of best stem cells for bone marrow transplants

Public release date: 1-Aug-2013 [ | E-mail | Share ]

Contact: Thana Dharmarajah dharmar@mcmaster.ca 905-525-9140 x22196 McMaster University

Hamilton, ON (August 1, 2013) McMaster University researchers have revealed the location of human blood stem cells that may improve bone marrow transplants. The best stem cells are at the ends of the bone.

It is hoped this discovery will lead to lowering the amount of bone marrow needed for a donation while increasing regeneration and lessening rejection in the recipient patients, says principal investigator Mick Bhatia, professor and scientific director of the McMaster Stem Cell and Cancer Research Institute.

In a paper published online today by the journal Cell Stem Cell, his team reports that human stem cells (HSC) residing in the end (trabecular region) of the bones display the highest regenerative ability of the blood and immune system.

"Like the best professional hockey players, our findings indicate blood stem cells are not all equal," said Bhatia. "We now reveal the reason why -- it's not the players themselves, but the effect the arena has on them that makes them the highest scorers."

Bone marrow transplants have been done for more than 50 years and are routine in most hospitals, providing a life saving treatment for cancer and other diseases including leukemia, anemia, and immune disorders.

Bhatia, who also holds a Canada Research Chair in Human Stem Cell Biology, said that cells surrounding the best blood stem cells are critically important, as these "stem cell neighbors" at the end of the bone provide the unique instructions that give these human blood stem cells their superior regenerative abilities.

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The research was funded by the Canadian Institutes of Health Research and Ontario Cancer Research Institute.

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Boning up: McMaster researchers find home of best stem cells for bone marrow transplants

Man pleads guilty in stem cell scheme

Mike Martin needed a medical miracle.

Diagnosed with amyotrophic lateral sclerosis, better known as Lou Gehrig's disease, the Houston man tried to find help in what authorities said was a scheme to illegally harvest and sell stem cells.

On Wednesday, 42-year-old Vincent Dammai of South Carolina pleaded guilty in federal court in Houston for his role in the scheme. Prosecutors said he processed stem cells at the Medical University of South Carolina in Charleston without approval from the Food and Drug Administration or the university.

Martin, the owner of a Houston-based landscaping business, was among the victims of the scam, prosecutors said. Martin was diagnosed in 2009 and died two years later.

He paid $47,000 after hearing of a treatment based on stem cell injections and a cocktail of herbs and vitamins that promised to reverse the terminal illness.

"I told him it was a glorified spa treatment," said Martin's sister, Katie Martin. "But he said, 'No. It's my only hope.' So I shut my mouth."

The charges against Dammai were the result of an FBI and FDA investigation into the manufacture and distribution of stem cells in the treatment of human autoimmune diseases such as Parkinson's.

"Mike needed a medical miracle," Martin said. "They said he'd be able to live and would never even need a wheelchair."

Dammai admitted using university facilities to harvest and process stem cells, for which he was paid more than $161,000.

He was hired in 2006 only to conduct research into kidney cancer and had no formal training in processing stem cells, officials said.

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Efficient model for generating human induced pluripotent stem cells

Aug. 1, 2013 Researchers at the University of California, San Diego School of Medicine report a simple, easily reproducible RNA-based method of generating human induced pluripotent stem cells (iPSCs) in the August 1 edition of Cell Stem Cell. Their approach has broad applicability for the successful production of iPSCs for use in human stem cell studies and eventual cell therapies.

Partially funded by grants from the California Institute for Regenerative Medicine (CIRM) and the National Institutes of Health (NIH), the methods developed by the UC San Diego researchers dramatically improve upon existing DNA-based approaches -- avoiding potential integration problems and providing what appears to be a safer and simpler method for future clinical applications.

The generation of human iPSCs has opened the potential for regenerative medicine therapies based on patient-specific, personalized stem cells. Pluripotent means that these cells have the ability to give rise to any of the body's cell types. The human iPSCs are typically artificially derived from a non-pluripotent adult cell, such as a skin cell. They retain the characteristics of the body's natural pluripotent stem cells, commonly known as embryonic stem cells. Because iPSCs are developed from a patient's own cells, it was first thought that treatment using them would avoid any immunogenic responses. However, depending on methods used to generate such iPSCs, they may pose significant risks that limit their use. For example, using viruses to alter the cell's genome could promote cancer in the host cell.

Methods previously developed to generate integration-free iPSCs were not easily and efficiently reproducible. Therefore, the UC San Diego researchers focused their approach on developing a self-replicating, RNA-based method (one that doesn't integrate into the DNA) with the ability to be retained and degraded in a controlled fashion, and that would only need to be introduced once into the cell.

Using a Venezuelan equine virus (VEE) with structural proteins deleted, but non-structural proteins still present, the scientists added four reprogramming factors (OCT4, KLF4, SOX2 with either c-MYC or GLIS1). They made a single transfection of the VEE replicative form (RF) RNA into newborn or adult human fibroblasts, connective tissue cells that provide a structural framework for many other tissues.

"This resulted in efficient generation of iPSCs with all the hallmarks of stem cells," said principal investigator Steven Dowdy, PhD, professor in the UC San Diego Department of Cellular & Molecular Medicine. "The method is highly reproducible, efficient, non-integrative -- and it works."

Dowdy added that it worked on both young and old human cells. He explained that this is important since -- in order to be used therapeutically in fighting disease or to create disease models for research -- iPSCs will need to be derived from the cells of middle-aged to old adults who are more prone to the diseases scientists are attempting to treat. In addition, reprogramming factors can be easily changed.

Additional contributors to the study include lead scientist Naohisa Yoshioka, Edwige Gros, Hai-Ri Li, Shantanu Kumar, Dekker C. Deacon, Cornelia Maron, Alysson R. Muotri, Neil C. Chi, Xiang-Dong Fu, and Benjamin D. Yu, all from the University of California, San Diego.

The study was supported by CIRM, NIH #U01HL107442, the Department of Defense, and the Howard Hughes Medical Institute.

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BrainStorm Submits Favorable Interim Safety Report for Second Group of Patients in Its Phase IIa Dose-Escalating Trial …

NEW YORK, NY and PETACH TIKVAH, ISRAEL--(Marketwired - Aug 1, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has submitted a favorable safety report to the hospital Helsinki Committee (IRB) for the second group of patients in its ongoing Phase IIa ALS clinical trial at the Hadassah Medical Center in Jerusalem, Israel. The treatment was well tolerated and no serious adverse events were observed. The company will release the preliminary efficacy data at the conclusion of the trial.

In this Phase IIa dose-escalating trial, currently underway at Hadassah under the direction of Principal Investigator Professor Dimitrios Karussis, 12 ALS patients are receiving combined intramuscular (IM) and intrathecal (IT) administration of NurOwn cells, in three cohorts, with increasing doses. The study participants will be monitored for six months following transplantation to evaluate the safety, tolerability and preliminary efficacy of NurOwn.

"This second group of patients received 50% more NurOwn cells than the first group in this trial," explained Professor Karussis. "Given the fact that they were treated both IM and IT, they received significantly more cells than in the previous Phase I study completed in our clinic," he added.

About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe Harbor Statement - Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements.The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov.These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements.The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Submits Favorable Interim Safety Report for Second Group of Patients in Its Phase IIa Dose-Escalating Trial ...

Cancer Immunotherapy Platform Targets Broad Range of Metastatic Cancers

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

California Stem Cell, Inc. (CSC) has announced the completion of an internal study demonstrating that the companys proprietary immunotherapy manufacturing process can be applied to multiple cancer types. Originally developed for late stage metastatic melanoma, the platform tissue culture technology has also been shown to work with tumor tissues from hepatocellular carcinoma, ovarian cancer, glioblastoma multiforme, and other solid tumor cancers.

The unique principle supporting CSCs cancer immunotherapeutic approach is purification of tumor stem cells isolated from a patients own tumor tissue, to use as an antigenic source. While prior companies processes typically took months and often yielded unreliable or unusable materials, CSC has standardized its platform technology for reproducibility, resulting in optimized high cell yields, and efficient and scalable manufacturing.

The companys proprietary stem cell culturing technologies, performed under cGMP conditions, have resulted in a consistent production time of less than 8 weeks, with a 100% success rate in generating lines with potential applicability to a broad range of cancer types.

Such significant improvements in the manufacturing time and success rate are critical when working with late stage cancers that typically have a short window for treatment, said Gabriel Nistor, M.D., CSC Vice President of Research and Development. The improvements allowed us to test our proprietary manufacturing methods on a broader range of devastating cancer types, with encouraging results.

CSC recently submitted a Phase III protocol to the U.S. Food and Drug Administration to explore efficacy of its cancer stem cell-based treatment for recurrent stage III and stage IV melanoma. The company is also completing a Phase I clinical study in liver cancer, and preparing to submit a Phase II clinical study in ovarian cancer.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA-based company focused on the development of stem cell-based therapies for metastatic cancers, spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease).

CSC has proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and cGMP processes.

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Cancer Immunotherapy Platform Targets Broad Range of Metastatic Cancers

Stem Cell Therapy – Amazing Breakthrough in Skin wrinkles treatment – Video

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Stem cell pioneer demands funding billions

The UK lead in stem cell research is being wiped out by a US investment blitz and Britain needs to raise billions of pounds to keep pace, says Sir Chris Evans founding father of the Cambridge medical technology sector.

He delivered his call to arms in an exclusive interview given to Rob Symes at Business Weeklys recent Nerve disruptive technology conference in Cambridge.

Sir Chris said: Britain has done all the hard work to get stem cells from raw research with Reneuron, the company I started 14 years ago, into humans. Now its all about money. Big Government money must come in right now.

The US has gone from a position of stasis with the George Bush clampdown to Obama unleashing investment and now multi institutions across America are doing some fabulous work on the back of billions of dollars of funding. Britain is dealing in tens of millions against Americas billions.

We need billions in the UK and if the Government doesnt recognise it and act fast we will have to go outside the UK and bring it back into the country.

Sir Chris said the progress the UK had made in scientific terms had been impressive. Stem cells have given rise to everything underpinning the whole era of regenerative medicine.

You can forget drugs; you can get a brand new organ preferably taken from yourself and stem cell medicine gives you a cure, not a treatment. Its a bit like a vaccine delivered once it lasts for life.

They give you a new heart or lung and you look after this one. Its really exciting that we are in the clinic with stem cells. When I started Reneuron 14 years ago it was all about research, ideas and conceptualising.

We were nowhere near the human. Now we are injecting stem cells into the human brain. You pray first of all that it is safe and then that it succeeds and we achieved both in the clinic, which is fantastic.

We saw stroke patients who couldnt raise a finger, grasping an object, picking it up and moving it. We have got over so many hurdles - first the research, then regulatory, then the ethics and now its all about money.

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Stem cell pioneer demands funding billions

DOCTORS DIVIDED | Performing 'unproven' stem-cell procedures vs following DOH guidelines

By: Jet Villa, InterAksyon.com July 31, 2013 8:46 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - Filipino physicians are now divided over the controversial stem cell therapy.

Doctors from the Philippine College of Physicians, Philippine Society of General Internal Medicine (PSGIM), Philippine Society of Hematology and Blood Transfusion (PSHBT), and Philippine College of Chest Physicians (PCCP) have lambasted their colleagues from the Philippine Society for Stem Cell Medicine (PSSCM) for performing unproven procedures.

The groups also lamented that PSSCM even charges exorbitant fees when it is the patients who should be paid as these procedures are still under experimental stage.

We are here to inform the public that they may be being deceived now. There are doctors who are making it appear that stem cell therapy is a panacea, the cure for all diseases when, in fact, there are limited indication where it can be used for, said PCP Vice President Dr. Anthony Leachon in a health forum.

In a separate interview, PSSCM spokesman Dr. Leo Olarte admitted that there is still limited use for the therapy but PSSCM members just go by the guidelines of the DOH.

We follow the DOH guidelines and what is allowed by the DOH are autologous stem cells or those you harvest from the patients bone marrow, blood, or fats, he said.

Legal action

But the groups fell short of seeking the head of transplant doctors who are deceiving patients.

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DOCTORS DIVIDED | Performing 'unproven' stem-cell procedures vs following DOH guidelines

New State-Sponsored Stem Cell Study Launches for Alzheimer’s Disease

The war against Alzheimer's disease is getting another round of stem cell research thrown at it. While this involves a public company, the reality is that Alzheimer's is truly a holy grail for any company that can make progress against the degenerative brain disease. StemCells, Inc. (STEM) has formally launched its Alzheimer's disease program under support of the California Institute for Regenerative Medicine.

Alzheimer's disease has no cure and all drug efforts to date have only delayed or slowed the progression of the disease. Most drug studies have ended before even making it to the formal U.S. Food and Drug Administration (FDA) application process because the efficacy has been so limited. The Alzheimer's Association indicates that roughly 5.4 million Americans have the disease, and the situation will worsen as our population continues to age. The annual cost is projected to be from $150 billion to $200 billion per year in the United States alone to treat the patients with Alzheimer's disease.

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Why today's study launch matters is that its stated goal is to file an Investigational New Drug (IND) application with the FDA within four years. It will evaluate StemCells' proprietary HuCNS-SC product candidate as a potential therapeutic in the treatment of Alzheimer's.

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As a part of the arrangement, the California Institute for Regenerative Medicine is providing close to $19.3 million to StemCells via a forgivable loan. This will help to fund preclinical development and IND-enabling activities. StemCells already hasreceived an initial $3.8 million disbursement from the institute to begin the study.

Again, there are currently no cures and no approved drugs that effectively or universally prevent or rapidly alter the progression of Alzheimer's disease. StemCells is signaling that cell-based therapies have a better potential than the biologic efforts of pharmaceutical R&D to date by acting on several relevant biological targets.

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StemCells is targeting the healthy and self-renewing cells that can halt or slow disease progression rather than targeting a single mechanism in an effort to preserve or restore cognitive function. StemCells will evaluate its HuCNS-SC cells in collaboration with researchers at the University of California, Irvine.

Whether StemCells will get a true financial boost from this effort remains up in the air. Investors who have chased stem cell projects have made and lost fortunes on this sector over the past 15 years or so. StemCells closed at $1.59 on Monday, against a 52-week range of $1.40 to $2.67, and its market capitalization was roughly $62 million.

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New State-Sponsored Stem Cell Study Launches for Alzheimer’s Disease

Stem cell treatment no panacea, docs say

By Jeannette I. Andrade Philippine Daily Inquirer

Researcher Shruti Dave (right) and assistant Chetan Patel work on stem cell cultures at the Transplantation Biology Research Centre at The Institute of Kidney Disease and Research Centre (IKDRC), Civil Hospital campus in Ahmedabad on February 6, 2013. The Philippine College of Physicians wants the Food and Drug Administration to more strictly regulate the use of stem cell therapy, which was being wrongfully projected as a cure-all. AFP FILE PHOTO

MANILA, PhilippinesThe Philippine College of Physicians (PCP) wants the Food and Drug Administration (FDA) to more strictly regulate the use of stem cell therapy, which was being wrongfully projected as a cure-all.

At a press conference in Quezon City on Tuesday, PCP vice president Dr. Anthony Leachon said the use of stem cell therapy to treat almost all medical conditions was becoming rampant even though the treatment has been tested and approved only for some blood and bone marrow cancers and primary immune deficiencies. This poses serious safety issues, he warned.

Leachon said the use of the treatment to cure other diseases or even slow down aging has not been scientifically proven in clinical studies.

He said current government regulations were centered on the proficiency of the medical practitioners and not on the treatments use and efficacy.

While the therapy has been clinically tested to be beneficial in the treatment of cancers in the blood and bone marrow as well as primary immune deficiencies through stem cell transplants from a persons own body (autologous) or from a donor (allogeneic), it has not been proven effective to cure other health conditions.

Leachon said stem cell therapy has been wrongfully projected as a cure for all kinds of illness including diseases of the heart, lungs, skin, and the kidneys; neurologic, rheumatologic and gastrointestinal conditions; as well as diabetes mellitus, hypertension, autism, the human immunodeficiency virus or Acquired Immunodeficiency Syndrome (HIV/AIDS), and even aging.

Stressing that simple diseases can be treated simply without resorting to stem cell therapy, he added: Preventive health is always preferable to depending on quick fixes.

The president of the Philippine Society of General Internal Medicine (PSGIM), Dr. Antonio Dans, clarified that the PCP is not against stem cell therapy per se but about its effective use in the treatment of health conditions other than blood-related illnesses.

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Stem cell treatment no panacea, docs say