Category Archives: Stem Cell Treatment


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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Efficient model for generating human induced pluripotent stem cells

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 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

Stem cell discovery: Astrocytes could repair stroke brain damage

Featured Article Academic Journal Main Category: Stroke Also Included In: Neurology / Neuroscience;Stem Cell Research Article Date: 29 Jul 2013 - 0:00 PDT

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Stem cell researchers have discovered that astrocytes may prove useful against stroke and other brain disorders.

Astrocytes - neural cells that form the blood-brain barrier and so control what can and cannot enter the brain from the blood supply - have previously been overlooked in this area of stroke research.

A collaborative study published in Nature Communications suggests that astrocytes can do far more than simply support nerve cells (neurons).

Wenbin Deng, senior author of the study and associate professor of biochemistry and molecular medicine at UC Davis in California, told Medical News Today:

"This exciting research uncovers the brain-protective powers of stem cell-derived astrocytes.

Astrocytes may help to limit the spread of damage after an ischemic brain stroke in patients, and may also help to regenerate and repair damaged brain cells.

Both of these actions may lead to better functional recovery in patients."

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Stem cell discovery: Astrocytes could repair stroke brain damage

De Leon: Medical Tourism and the Future of Stem Cell Therapy (Part 3)

THE International Society for Stem Cell Research (ISSCR), an independent, non-profit organization has been established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application. Members are admitted on the basis of their professional credentials as scientists or clinicians working in the field of stem cell research. Over the years, ISSCR has raised its concerns regarding stem cell therapies that are being offered worldwide before being scientifically and clinically proven safe and effective. The Catholic Church, supports stem cell research, with an introduction for a book on the subject by no less than now Pope Emeritus Benedict XVI.

Associated press has reported that Benedict XVI wrote the introduction for "The Healing Cell: How the Greatest Revolution in Medical History Is Changing Your Life" co-authored by Dr. Robin Smith, Msgr. Tomasz Trafny, and Max Gomez. The Catholic Church supports using adult stem cells in scientific research, especially when it will benefit society. However, The Church has consistently opposed research on embryonic stem cells.

Stem cell therapies are just about all new and experimental. ISSCR contends that most medical discoveries are based on years of research performed at universities and companies, requiring a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people. The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely limited. The best defined and most extensively used is blood stem cell transplantation to treat diseases and conditions of the blood and immune system, or to restore the blood system after treatments for specific cancers. Some bone, skin and corneal diseases or injuries can be treated with grafting of tissue that depends upon stem cells from these organs. These therapies are also generally accepted as safe and effective by the medical community. The ISSCR is cautioning the public to be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated. Snake oil salesmen associated with those clinics are preying on the hopes of desperate patients/potential victims trying to make people believe that such treatment are effective in curing diseases in the absence of strong scientific evidence. If your doctor does not have a compelling reason to believe that your disease can be treated effectively with a therapy that is being offered and is not supported by a compelling evidence in scientific literature and that it hasnt been the basis of sound clinical trials is not open to the light of day and replicated in independent clinics -- then there is reason to be skeptical of these potential therapies and that you should be very cautious in engaging these clinics.

There has been enormous amount of excitement that stem cell treatments offer. It is important to realize that those opportunities are in the future. There are no established and proven stem cell treatments that work yet for some of the incurable diseases today (e.g. spinal injury, or Alzheimers); what works today that we can be sure about is bone transplantation. Therapies based on stem cells are still new and there is a so much that has yet to be discovered and tapped. Furthermore, side effects and long-term safety must be determined, since transplanted cells may remain for many years in patients bodies. Therefore, careful monitoring and extended follow-up of patients who receive stem cell treatments is extremely important. Patients intending to undergo stem cell treatment need to be sure that there is good scientific evidence that the treatment is safe and effective, and that your rights as a patient are being respected. Ask for evidential support pertaining to pre-clinical studies that have been published and reviewed by other experts in the field, and is approved by the Bureau of Food and Drugs administration. Other warning signs offered by ISSCR (www.isscr.org) that each patient should be cautious about include:

1. Claims based on patient testimonials. Patients want to believe so much that a treatment is helping them that they can convince themselves that it has. (Placebo effect) They may even have experienced some recovery unrelated to the treatment. Unless there has been carefully evaluated clinical research it is very difficult to know what is a true effect of the treatment and what you can expect.

2. Multiple diseases treated with the same cells. Unless the diseases are related, such as all being diseases of the blood, different diseases, such as Parkinsons disease and heart disease, would be expected to have very different treatments. Also, you want to be treated by a doctor that is a specialist in your disease.

3. The source of the cells or how the treatment will be done is not clearly documented.

This should be clearly explained to you in a treatment consent form. In addition, there should be a protocol that outlines the treatment in detail to the medical practitioner. The protocol is the operating manual for the procedure. While it may not be made available to you automatically, you should be able to request this. For a clinical trial or experimental treatment, protocols should have been reviewed for scientific merit by independent experts and approved by an ethics committee to ensure that the rights and well-being of the participants will be respected. Ask who has approved this protocol and when the approval expires.

4. Claims there is no risk. There is always risk involved with treatment. Information about the possible risks should be available from preclinical or earlier clinical research.

5. High cost of treatment or hidden costs. It is not customary for someone to pay to be in a clinical trial (other than perhaps travel and other personal expenses). Consider whether you should pay for a treatment that is unproven. Furthermore, ask about the costs of emergency medical care if something goes wrong, particularly if you are outside your own country.

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De Leon: Medical Tourism and the Future of Stem Cell Therapy (Part 3)