Researchers at the Salk Institute in La Jolla, California have announced two ground-breaking accomplishments: one is a demonstration of the fact that amyotrophic lateral sclerosis (ALS) can be improved with specific antioxidants, and the second is the creation of a new model of ALS which is based upon human rather than mouse tissue.

Dr. M. Carol Marchetto of the Salk Institute has created the first human ALS laboratory model ever developed, by using human embryonic stem cells. Previously, laboratory experimentation with ALS has typically been conducted with mouse models, which are only rough approximations of human ALS since the disease is caused by genetic mutations that are unique to the human genome and cannot be identically reproduced in the mouse genome. Dr. Marchetto has circumvented the problems associated with the mouse model by creating the new human model, in which she induced a genetic mutation in SOD1 (superoxide dismutase 1), the gene that instructs the body in how to manufacture the enzyme superoxide dismutase, which, among other properties, defends the body from the oxidative and inflammatory cellular damage caused by free radicals, which have long been suspected of playing a key role in motor neuron death. By studying the cellular environment of the motor neurons in this new human model, the researchers made an important discovery with astrocytes (astroglia), which are the star-shaped glial cells in the brain and spinal cord that play a number of key roles, which include providing nutrients to the nervous tissue, repairing brain tissue and supporting endothelial cells, especially in the blood-brain barrier. In a cellular environment in which ALS is present, the researchers discovered that the astrocytes are constantly bombarding the motor neurons with free radicals. The team of scientists then began testing potential drugs for their antioxidant and anti-inflammatory properties, which could possibly protect the motor neurons from the damage caused by the constant stream of free radicals. Although several pharmaceuticals were found to be prime candidates, the naturally occurring antioxidant apocynin, which is present in many plants, was identified for its ability to prevent neuronal death by blocking both the oxidation and the inflammation of the motor neuron cells. Short of figuring out how to get the astrocytes to stop secreting free radicals, the next best approach is simply to block the damage caused by the free radicals.

Until now there has only one drug approved for the treatment of ALS in the United States, namely, riluzole, which at best can only slow the progession of the disease by a month or two and does nothing to reverse the cellular damage caused by the death of the motor neurons. According to Dr. Fred Gage, professor of genetics and the principal investigator of the study, “There is an urgent need for new models of the disease that have the potential to translate into clinical trials and that could, at a minimum, be used to verify drugs and drug targets.”

Many embryonic stem cell experts, including the pioneering embryologist Dr. James Thomson, have emphasized the point that the development of actual cell-based therapies from embryonic stem cells is a long and complex process, and such therapies are still at least a decade away, if not further. Meanwhile, instead of directly seeking cell-based cures, such embryonic stem cell authorities have advocated an approach that focuses on the use of embryonic stem cells for drug testing and development, and this new human model of ALS is an excellent example of precisely such an approach. Although the use of embryonic stem cells even for this purpose does not pacify the embryonic stem cell opponents, who still find the use of embryonic stem cells for drug testing to be unethical, the new ALS model nevertheless does highlight the sobering scientific reality that therapeutic cell-based cures from embryonic stem cells will not be immediately forthcoming, purely for scientific, not political, reasons. Opponents of embryonic stem cells also point out the fact that adult stem cells could just as easily be used to create new laboratory models of diseases, bioengineered from human rather than mouse tissue, while avoiding entirely the controversial ethics of embryonic stem cells as well as the numerous scientific problems and medical dangers that are inherent in embryonic stem cells, such as their ability to form the specific type of tumor known as a carcinoma, among other problems. Furthermore, laboratory models of diseases created from adult stem cells could be used not only for drug testing but also for the development of actual cell-based therapies that directly use the adult stem cells themselves for the treatment of disease and injury. In fact, such cell-based therapies have already been developed from adult stem cells, and are already in clinical use.

Although a major advantage of Dr. Marchetto’s new ALS model was the fact that it was conducted on human cells, rather than in mice, she and her colleagues are now planning to test apocynin and other chemicals in mouse models of ALS to see whether or not there is any real benefit that can be measured in mouse survival.

Neuralstem has licensed the patent rights for three inventions from the Cleveland Clinic, all of which utilize spinal cord injection technology, and which Neuralstem will use in clinical trials for ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease). All three inventions were developed by Dr. Nicholas Boulis, currently at Emory University but formerly of the Cleveland Clinic. Neuralstem plans to file its IND (Investigational New Drug) application with the FDA before the end of this year, with trials scheduled to commence in early 2009.

According to Neuralstem President and CEO, Dr. Richard Garr, “We are very pleased to have licensed-in these important delivery technology rights. As we get ready to move into our expected human trial for ALS, we are focused on the optimal way to deliver our cell therapeutics to enhance the safety and efficacy of the treatments. Transplanting our cells directly into the spinal cord is a challenging but necessary part of trying to treat diseases of the spinal cord, not only in ALS but in other spinal cord injuries and diseases. The technology today will help us meet those goals.”

Specifically, the three inventions consist of devices which are known as a “stabilized platform and microelectrode recording guidance validation”, a “floating cannula for spinal cord therapeutic injection”, and a “spinal platform and methods for delivering a therapeutic agent to a spinal cord target”. According to its website, “Neuralstem, Inc. is a biotherapeutics company utilizing its patented Human Neural Stem Cell technology to create cures for diseases of the CNS (central nervous sysem). The Company’s technology allows for the isolation of CNS stem cells from tissue, the expansion in vitro of each cell up to a billion-billion times (60 doublings), and the controlled differentiation of the cells into mature, physiologically relevant human neurons and glia.”

In addition to ALS, ischemic paraplegia, traumatic spinal cord injury, and Parkinson’s disease are also among Neuralstem’s primary areas of focus.

Mesenchymal stem cells (MSCs) have already proven to offer a viable therapy in the treatment of spinal cord injuries, of which approximately 11,000 new cases occur each year in the United States alone. Worldwide, traumatic accidents involving the spinal cord constitute some of the most debilitating of injuries. Now, the Indian company Stempeutics Research, in collaboration with Manipal Hospital in Bangalore, has conducted a pilot study utilizing newly developed techniques for the administration of MSCs to patients in India, which has one of the highest rates of spinal cord injuries of any country in the world, with approximately 20,000 new cases reported each year.

According to Dr. Sujay Rao, a consulting neurosurgeon at St. Philomena’s Hospital in Bangalore, it is important to deliver the stem cells as close as possible to the physical site of injury. Injecting the MSCs via intra-arterial or intra-spinal routes, with the assisted guidance of CT (computed tomography) imaging, will maximize the efficacy of the stem cells in treating the injury. The MSCs used in the pilot study are derived from adult bone marrow and are able to differentiate into oligodendrocytes, which play a key role in the production of myelin and are an important component in the neurological system.

In the past, permanent paralysis and loss of sensation below the site of injury have usually been the result of spinal cord damage, accompanied also by loss of bladder and bowel control. As a result of this pilot study, however, a number of patients have already shown improvement from the newly developed delivery techniques. One quadriplegic patient has regained upper limb movement as well as bladder control and is now able to stand with support. Similarly, a patient who had been paraplegic is now able to walk with support and has regained bladder as well as bowel control.

A private company dedicated to the research and clinical applications of stem cells, Stempeutics currently has facilities in India and Malaysia.

On April 10, 2008, the U.S. Food and Drug Administration (FDA) convened a panel of experts to examine the safety concerns associated with the use of embryonic stem cells in human clinical trials, in response to applications that were submitted by three companies, namely, Geron, Advanced Cell Technology, and Novocell. Consequently, the FDA issued a strong cautionary statement on the dangers of embryonic stem cells, although the three companies continued with their plans to commence clinical trials in the summer of 2008.

Yesterday, however, the company Geron received an oral notification from the FDA of a delay in the approval process that is required before clinical trials may begin. Based in Menlo Park, California, Geron had planned to begin human clinical trials for the treatment of acute spinal cord injuries in which they would test their proprietary compound made with human embryonic stem cells. Geron is now awaiting a formal letter of explanation from the federal regulators at the FDA.

According to Thomas B. Okarma, Geron’s CEO, “We are disappointed with this action given the interactions we had with the FDA over 3 years leading to the filing”, which consisted of an application that was 21,000 pages in length. According to Ren Benjamin, an analyst with the investment bank Rodman & Renshaw, Wall Street is not surprised by the FDA’s action which analysts regard merely as causing a temporary delay in, rather than a final end to, the clinical trial plans.

The panel of experts that was convened by the FDA in their April 10th meeting stressed the importance of stringent safety measures in embryonic stem cell trials. According to Dr. Steven Bauer, Acting Chief of the FDA’s Office of Cellular, Tissue and Gene Therapies, a branch of the Center for Biologics Evaluation and Research (CBER), the agency is likely to require “particularly strong” evidence to substantiate claims of embryonic stem cell safety and efficacy. Assuming that the clinical trials will be allowed to begin, the FDA may also require longer trials than those that are required for the approval of conventional drugs.

It is a well-established fact that embryonic stem cells cause the formation of a specific type of cancerous tumor known as a teratoma; indeed, such a feature of embryonic stem cells constitutes their defining trait. An embryonic stem cell is a cell which, by definition, forms a teratoma, and this remains the universal laboratory test by which embryonic stem cells are identified throughout the world. This test is the global scientific standard of measurement: if a cell forms a teratoma, then it is recognized as being an embryonic stem cell; if a cell does not form a teratoma, then it is recognized as being just an ordinary adult stem cell or some other type of cell. Adult stem cells, by stark contrast to embryonic stem cells, carry no such risk for the formation of teratomas. These facts are well known and well understood throughout the scientific community, and always have been, although they are not often reported to the general public by the media.

Ever since 1999, when an 18-year-old patient named Jesse Gelsinger died four days after receiving experimental gene therapy in a clinical trial, FDA regulators have been particularly sensitive to potential risks that may be associated with clinical trials, and justifiably so. Any further undesirable medical conditions that may result from clinical trials would not only constitute personal tragedies for the individuals involved, but such consequences would also constitute severe policy setbacks for the entire FDA approval process as a whole. Currently, with human embryonic stem cells, the dangers are already well documented and no successes to date have ever been reported or published. Thus far, human embryonic stem cells have never been used to treat any human disease or injury, precisely because human embryonic stem cells have proven to be so highly problematic in the laboratory. By dramatic contrast, however, adult stem cells are already being used in numerous clinics around the world to treat a wide variety of diseases and injuries, efficaciously and in most cases without any side effects.

Dispite the cautionary delay by the FDA, Geron, as well as Advanced Cell Technology and Novocell, are still planning to be able to begin human clinical trials with their proprietary embryonic stem cell compounds.

Three biotech companies are currently preparing for their upcoming clinical trials that will test the therapeutic value of their proprietary embryonic stem cell products. In the midst of such preparation, the U.S. FDA (Food and Drug Administration) convened a panel of experts yesterday to examine the safety concerns associated with such proposed therapies, not the least of which is the risk of cancer.

It is a well-established fact that embryonic stem cells cause the formation of a specific type of cancerous tumor known as a teratoma; indeed, such a feature of embryonic stem cells constitutes their defining trait. An embryonic stem cell is a cell which, by definition, forms a teratoma, and this remains the universal laboratory test by which embryonic stem cells are identified throughout the world. This test is the global scientific standard of measurement: if a cell forms a teratoma, then it is recognized as being an embryonic stem cell; if a cell does not form a teratoma, then it is recognized as being just an ordinary adult stem cell or some other type of cell. Adult stem cells, by stark contrast to embryonic stem cells, carry no such risk for the formation of teratomas. These facts are well known and well understood throughout the scientific community, and always have been, although they are not often reported to the general public by the media.

The three companies under current scrutinization, namely, Geron, Advanced Cell Technology, and Novocell, are in the process of planning their imminent clinical trials to test embryonic stem cells in the treatment of, respectively, acute spinal cord injury, visual impairment, and diabetes. Following the announcement by the FDA, yesterday’s discussion among a panel of experts focused on the many unanswered questions that are associated with the as yet unproven safety and efficacy of embryonic stem cells.

Ever since 1999, when an 18-year-old patient named Jesse Gelsinger died four days after receiving experimental gene therapy in a clinical trial, FDA regulators have been particularly sensitive to potential risks that may be associated with clinical trials, and justifiably so. Any further undesirable medical conditions that may result from clinical trials would not only constitute personal tragedies for the individuals involved, but such consequences would also constitute severe policy setbacks for the entire FDA approval process as a whole. Currently, with human embryonic stem cells, the dangers are already well documented and no successes to date have ever been reported or published. Thus far, human embryonic stem cells have never been used to treat any human disease or injury, precisely because human embryonic stem cells have proven to be so highly problematic in the laboratory. By dramatic contrast, however, adult stem cells are already being used in numerous clinics around the world to treat a wide variety of diseases and injuries, efficaciously and in most cases without any side effects.

According to the authors of this review, “Scientists know that undifferentiated stem cells can form a benign mass known as a teratoma when injected into animals, and they fear that a safety incident in the first round of clinical trials could devastate the already-troubled field. The cell therapies under development use differentiated cells, but the possibility remains that some undifferentiated cells may be left in the mix.” While teratomas are technically classified as “benign”, in the sense that they do not metastasize, they do have a malignant counterpart known as a teratocarcinoma, which may also form from embryonic stem cells. It should also be noted that a person can die from either of these tumorous forms, including the so-called “benign” teratoma.

The committee convened by the FDA plans to release a formal guidance statement, formulated at yesterday’s meeting. Meanwhile, however, the 3 companies under consideration remain undaunted, with Geron in particular insisting that they will proceed with plans for clinical trials with embryonic stem cells that will commence in the summer of this year.

With the first Australian trial of a new adult stem cell treatment, the hope of improved movement for those with spinal cord injuries has been given a new boost.

In order to coordinate national and international research and apply it to patients, the new dedicated spinal cord laboratory at Melbourne’s St. Vincent’s Hospital. The facility is the first of it’s kind in Australia and will be the location where the trial is conducted.

With no cure in sight and the cost of care at an estimated $1.2 billion, Australia sees a new spinal cord injury every single day.

“This is a major unmet medical need,” said Dr. George Owen, head of Step Ahead Australia, (formerly the Spinal Cord Society of Australia).

After diving into a shallow pool 13 years ago, Dr. Owen’s son Sam became a quadriplegic. Sam is now 26 years old.

New leads into the treatment and possible cure for spinal cord injury may be developed during the trial where scientists will work with a spinal cord

A 38-year old woman has been treated for spinal cord injuries using stem cell therapy. K G Hospital treated and cured a heart patient with stem cell therapy previous to the woman’s treatment as well.

On Friday, Dr. G. Bhaktavasalam, Chairman, K G Hospital, told reporters that after a road accident, the woman suffered paralysis below the neck and lost movement in her limbs due to spinal cord injury.

With a fracture of the neck bone, she was diagnosed with a

On Wednesday, a Japanese researcher proposed a system that could help reduce the time and money needed for treating patients with regenerative medicine in the future. A new type of stem cell, which is produced from a donor’s ordinary skin cells, would be banked much like umbilical cord blood is today.

Shinya Yamanaka of Kyoto University said that instead of tailor-made treatments for individual patients, the proposed system would be more practical.

In November of 2007, without using human embryos or cloning technology, Yamanaka led one of two teams which were able to transform ordinary human skin cells into cells that look and act like embryonic stem cells.

Ethical debates have swarmed stem cell research for years, but Yamanaka’s Japanese based team, along with another team from the United States quited many by reporting their research last year.

Even though researchers say it will take years before such medicine can be used to treat people, new hopes for regenerative medicine have been kindled by the new type of cell called the induced pluripotent stem cell (iPS cell).

“It may be a good idea to make an iPS cell bank,” Yamanaka told a news conference.

“By making such a bank, we can cut down the cost of treatment and also we can shorten the period which is required for the generation of iPS cells,” he said.

“In reality, tailor-made medicine using iPS cells is not so ideal.”

The way to treating people with injuries as well as diseases like diabetes, Alzheimer’s, and heart disease may be paved with iPS cells. Scientists expect them to improve disease research considerably.

However, cells may be needed within 10 days to treat a spinal cord injury and Yamanaka said it takes about three months to transform a patient’s skin cells into iPS cells. The lag in time is the reason for the banking proposal.

Before iPS cells can be used to treat humans, more testing is needed. Although he expects iPS cells to be clinically useful within ten years, it could be longer before iPS cells are used to treat some of the more challenging diseases said Yamanaka.

Stem cell research, particularly the type involving embryos, has been a hot topic responsible for a high amount of writing, discussion, and media attention as of late.

With the power to repair and even replace damaged tissue and cells, stem cells, although very meager in looks, are the most remarkable building blocks in our bodies.

Stem cells which have been derived from sources which include blood, bone marrow, fat, umbilical cord blood, nerves, adult tissue, and even the pulp of baby teeth have amassed data; proving their success in the treatment of numerous conditions and diseases.

These cells are often called “adult stem cells”. Heart damage, Parkinson’s Disease, spinal cord injury, autism, diabetes are among the nearly 80 conditions which have been successfully treated using these adult cells.

In fact, since the active ingredient in the bone marrow is stem cells, thousands of lives have been saved by adult stem cells in the form of bone marrow transplants for leukemia and other illnesses alone.

A stem cell can make any number of cells with more specialized functions, or make a copy of itself. The cell starts as an unspecified cell and changes when it divides.

For example, depending on what the body needs, white bloods cells, red blood cells, or other kinds can be created from just one type of stem cell in the human blood.

To this day, not one single human patient has ever been cured or successfully treated with embryonic stem cells, thus, it is a wonder why there is so much hype surrounding embryonic stem cell research. Especially given the fact that adult stem cells have produced such gleaming results thus far. and will undoubtedly continue to do so well into the future.

Embryonic stem cell are not only ineffective, but dangerous. In animal tests, subjects have experienced immune system rejection, formed lethal tumors, and displayed genetic instability.

At the expense of advancing adult stem cell research, why does the media, culture, and society continually support embryonic stem cell research? The scientific validity of adult stem cell being vastly superior to embryonic cells is undeniable.

The answer is green.

Money, and extremely large amounts of it are floating around embryonic stem cell research. The ongoing attempts to obtain our tax dollars for this purpose, the billions that are already invested privately, even the basic cost of donated eggs for embryonic research; all this money has been wasted thus far at the expense of advancing and producing more treatments that save human lives.

However, the current querulous embryonic stem cell debate may soon be at an end thanks to the recent announcements by Japan’s Shinya Yamanaka and James A. Thomson at the University of Wisconsin. The two scientists made two separate discoveries involving skin cells. They were able to produce embryonic stem cell equivalents without the use of an embryo.

Why continue research on such a controversial issue when such an important breakthrough has been made? Embryonic stem cell research should be a non-issue at this point.

Without the slightest bit of knowledge as to what is possible, probable, or even feasible, politicians will ask us to allocate billions for stem cell research. We were told that embryonic stem cells were the only answer for treating diabetes, MS, blindness, Parkinson’s, spinal cord injury, and heart disease. But the truth is that embryonic stem cells have failed in every single category. Successful treatments do exist for these conditions, but they are all derived from adult stem cells, which are non-controversial, and non-embryonic.

With what could be considered the most important medical advancement in history coming to fruition as we debate on ethics, it is sad that we don’t receive non-selective, factual, and accurate news. With all the important breakthroughs that are taking place, it is amazing that the public is being kept in the dark.

Stunning the entire research community last week, revered embryonic scientific stem cell leader Ian Wilmut (cloner of Dolly the sheep) made an announcement in support of adult stem cells over embryonic. His decision was based on solid scientific principal as opposed to religious or moral preference. Professor Wilmut has always maintained that there is a better way to accomplish the objective without destroying the embryo; in fact, he has never believed embryonic research to be unethical.

Despite the resistance of governments to fund embryonic stem cell research in the U.S. and England, the rest of the world has been conducting unrestricted research for more than ten years using embryos. Despite the joint efforts of Germany, India, Korea, Russia, and China who invested billions in research, not even one successful treatment was produced. This fact was made painfully obvious by neurologist Dr. Carlos Lima earlier this year when he was addressing the House of Lords in England.

Miracle Stem Cell Heart Repair, a breakthrough book by author/researcher Christian Wilde makes the case for adult stem cells in perhaps the most succinct manner possible.

As the author explains; “If you take the moral, political and ethical concerns off the table, the scientific issues alone confronting ESC research (according to many scientists) are in themselves, daunting. Before an ESC can be safely injected into a human being it must be proven safe in an animal study. In cases to date, animal subjects have experienced dangerous tumor growth and rejection by the body.”

He believes the public deserves balanced non-selective and un-biased reporting on both forms of stem cell research.

With a one to seven year life expectancy and 50% not making the five-year mark, heart failure is currently claiming the lives of 22 million victims world wide. Using a minimally invasive procedure using their own thigh muscle stem cells only once, patients have successfully transitioned within the FDA trials from near death to recovery. Documentation of these “no option” heart patient’s stories can be found in Miracle Stem Cell Heart Repair.

Why, asks Wilde, should it be headline world news that someday an embryonic stem cell might possibly heal a mouse heart but nowhere is there a headline that proclaims hundreds of actual living breathing people, (not mice) have already had their damaged hearts repaired with adult stem cells? Is this a case of selective reporting?

As many as five previous heart attacks were sustained by several of the patients whose stories were documented in the book.

“75% of your heart is not functioning, frankly I don’t know how you are even alive,” said one patient’s own physician.

The same patient was walking one mile and then two miles a day after six weeks and continues to do well two years after surgery following the one-time stem cell treatment with the patient’s own adult cells at the Arizona Heart Institute. The Myoheart heart failure study has now been opened to 450 more patients as treatment moves toward approval since the FDA was satisfied with the safety and clinical success of the trial’s first phase.

More than 72 diseases which included type I and II diabetes, several cancers, MS, Parkinson’s, traumatic brain injury, and blindness are currently treatable with adult stem cells. Corneal blindness is being cured at a rate of eight patients per month in Cincinnati and more than four hundred and fifty blind patients in India have been cured to date. Type II diabetes is being treated with a high rate of success inBrazil and Argentina using adult stem cells, and in similar fashion, a one-time injection of bone marrow stem cells to the pancreas as kept a type I diabetes patient in London insulin free for three years.

Following a single procedure in which stem cells from their own nasal olfactory cavity were harvested and injected into the areas of spinal lesion, one hundred five quadriplegic and paraplegic patients are beginning to walk (some with braces). Half of Dr. Lima’s patients are United States natives.

With these successes there is wonder in how anyone can argue for embryonic stem cells any more. But regardless, the debate continues. Before long, the cures will be mainstream and there won’t be a place or use for embryonic cells any longer. Perhaps that is what it will take to finally end the debate.