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.

Since stem cell treatment cannot be administered in the United States due to federal restrictions, many U.S. citizens are traveling abroad to get this form of treatment.

Health officials call the procedures, which have been proven safe in many cases, risky and experimental. Despite the criticism, it seems the scientific evidence has trumped any attempt at diminishing the very real therapeutic potential of stem cells. Patients are traveling to countries in Central America and India and spending thousands of dollars to undergo stem cell treatment procedures.

Brian Sheridan, who is the supervisor for the Center for Spinal Cord Injury at the Rehabilitation Institute of Michigan in Detroit said that, “there are always risks.”

“You can end up with an adverse event. That’s the nature of some of these experimental procedures.”

With the hope of regaining her ability to walk, Jeni Rummelt is currently in Europe receiving her 6th stem cell treatment. The 32-year-old was paralyzed from the waist down following a car accident.

“(These abilities) would have never come back without the stem cells,” said Rummelt, who spent $25,000 on the first procedure and $7,000 for each subsequent therapy. “It’s a slow progress. You know it’s not going to happen overnight, but it’s worth it.”

Since the destruction of human embryos is required for embryonic stem cell research, many individuals say this type of research is unethical.

However, it is now possible to transform adult stem cells which are derived from the skin, into the equivalent of embryonic stem cells. This new discovery should quiet many critics, especially with further advancements of the technology already on the way.

“I can understand their motivation, their desperation but it’s not something I can recommend if the treatments have not been proven to be safe and effective,” said Mervin Yoder, an Indiana-based doctor who is president of the International Society for Hematology and Stem Cells.

Critical information has been unveiled that could lead to novel therapies for repairing previously irreversible nerve damage in the injured spinal cord. Key elements in the in the body’s reaction to spinal cord injury have been discovered in this seminal study which has been published in this week’s Proceedings of the National Academy of Science.

Why the adult nervous system is unable to repair itself following spinal injury is still unknown. This is unlike a skin wound for example, where the repair process is well documented.

Even following severe injuries, repair and regeneration is common place in non-mammals and the developing brain. The role of stem cells and their potential to develop into different cell types has been suspected to play a major role in the rejuvenation of these cases.

“Because of their regenerative role, it is crucial to understand the movements of stem cells following brain or spinal cord injury,” says Dr. Philip Horner, co-lead investigator and neuroscientist at the University of Washington. “We know that stem cells are present within the spinal cord, but it was not known why they could not function to repair the damage. Surprisingly, we discovered that they actually migrate away from the lesion and the question became why – what signal is telling the stem cells to move.”

The migratory pattern of stem cells following injury is controlled by a key molecule called netrin-1. This was discovered after scientists tested numerous proteins. Guiding nerve cells to their proper targets, netrin-1 acts as a repulsive or attractive signal in the developing nervous system. Preventing stem cells from replenishing nerve cells, scientists found that netrin-1 specifically repels stem cells away from the injury site in the adult spinal cord.

“When we block netrin-1 function, the adult stem cells remain at the injury site,” says Dr. Tim Kennedy, co-lead investigator and neuroscientist at the Montreal Neurological Institute of McGill University. “This is a critical first step towards understanding the molecular events needed to repair the injured spinal cord and provides us with new targets for potential therapies.”

The National Institutes of Health and the Craig H. Nielsen Foundation funded the study.

Researchers from the University of California, San Diego (UCSD) School of Medicine are reporting that six weeks after receiving grafts of human spinal stem cells (hSSCs), paralyzed rats regained almost normal ambulatory function. The animals were paralyzed due to loss of blood flow. The study has been published in the June 29, 2007 edition of Neuroscience. UC San Diego professor of anesthesiology Dr. Martin Marsala, M.D. led the study.

“We demonstrated that when damage has occurred due to a loss of blood flow to the spine’s neural cells, by grafting human neural stem cells directly into the spinal cord we can achieve a progressive recovery of motor function,” said Marsala.

“This could some day prove to be an effective treatment for patients suffering from the same kind of ischemia-induced paralysis.”

Marsala hopes to be prepared to carry out human clinical trials by next year. The current focus is on using animal models to establish effectiveness and safety of the human stem cell therapy.

For those individuals who undergo aortic cross-clamping, 20 to 40 percent of patients experience spinal cord ischemia as a consequence of the surgical procedure. It is a serious complication and causes paraplegia. During the procedure to correct a potentially lethal aneurysm, blood flow from the heart must be temporarily blocked with a clamp as the surgeon works on the aorta. Even though the spinal cord remains intact, loss of muscle control or irreparable rigidity and spasticity of the lower limbs can occur due to the lack of blood flow that results in the death of spinal inhibitory neurons which are specialized spinal cord neurons. After only 30 minutes, the neurons become susceptible to death.

“The important difference between spinal cord ischemia and spinal cord trauma, such as might occur in a diving or car accident, is that in the ischemia model, no mechanical damage has occurred to the spinal cord,” said Marsala.

“The spinal cord and brain motor centers are still partially connected, but there has been a selective loss of inhibitory neurons in the spinal cord. Since these cells are necessary for coordinated motor activity, our research aims to replace these lost neurons by grafting new spinal stem cells, which repopulates the pool of degenerated neurons.”

Human spinal stem cells were injected into nine rats 21 days after spinal cord ischemia was induced. There were a total of 16 rats used in the study and the seven non-stem cell rats were injected with a placebo medium containing no stem cells. Every seven days the motor function was recorded and in the rats that received stem cells, a progressive recovery of ambulatory functions was observed.

In all lower extremity joints, three of the nine rats injected with hSSC’s improved their mobility, but most compelling was that another three actually returned to walking after six weeks. According to Marsala, in all nine rats, the majority of transplanted human spinal stem cells survived and became mature neurons. In the spinal area, all the animals had a constant presence of transplanted cells and compared to the control group the hSSC’s rats all achieved significantly better motor scores. Similar results were achieved during a second study which was conducted over three-months.

“Other human stem cell transplants in the spinal cord have focused on repairing the myelin-forming cells,” said co-author Karl Johe, a researcher at Neuralstem, the company that manufactures the hSSCs used in the study. “In this study, we succeeded at reconstructing the neural circuitry, which had not been done before.”

The researchers believe that the therapy may eventually be confirmed to be even more successful in human patients, who would be able to receive physical therapy once treated.

Saying that the goal is to offer a significant gain in functional mobility of the patient’s legs Johe added that, “physical therapy may accelerate integration of the grafted stem cells and enhance their therapeutic benefit.”

Marsala has a history working with human neuronal stem cells. A previous work also using rat models was published in the October 2004 issue of the European Journal of Neurosciences. 40 to 50 percent of the animals tested in that study had significant improvement in motor function. The progress was measured by recording improved muscle tone and the suppression of spastic movements. In the spinal cords of the rats that received transplanted neuronal cells, a post-mortem study showed an increase in the expression of inhibitory neurotransmitters and a robust maturation of neurons.

Spinal drug treatments using implanted pumps or continuous systemic drugs make up the current and somewhat effective standard treatment for debilitating muscle spasticity. These treatments are susceptible to eventual drug tolerance which lessens their efficacy, and are also accompanied by side effects.

“These research findings could offer great hope to people with spinal ischemic injury who suffer from resulting spasticity and rigidity,” said Marsala.