BEIJING Theyre paralyzed from diving accidents and car crashes, disabled by Parkinsons, or blind. With few options available at home in America, they search the Internet for experimental treatments and often land on Web sites promoting stem cell treatments in China.

They mortgage their houses and their hometowns hold fundraisers as they scrape together the tens of thousands of dollars needed for travel and the hope for a miracle cure.

A number of these medical tourists claim some success when they return home.

Jim Savage, a Houston quadriplegic, says he can move his right arm. Penny Thomas of Hawaii says her Parkinsons tremors are mostly gone. The parents of 6-year-old Rylea Barlett of Missouri, born with an optical defect, say she can see.

But documentation is mostly lacking, and Western doctors warn that patients are serving as guinea pigs in a country that isnt doing the rigorous lab and human tests that are needed to prove a treatment is safe and effective.

Effectiveness questioned Noting the lack of evidence, three Western doctors undertook their own limited study. It involved seven patients with spinal cord injuries who chose to get fetal brain tissue injections at one hospital in China. The study reported no clinically useful improvements even though most patients believed they were better. Five developed complications such as meningitis.

Experts in the West have theories about why some people think theyve improved when the evidence is thin. Some are often getting intensive physical therapy, along with the mysterious injections; the placebo effect may also be a factor.

John Steeves, a professor at the University of British Columbia who heads an international group that monitors spinal cord treatments, has another theory. Some patients may be influenced by the amount of money they paid and the help they got from those who donated or helped raise money.

Needless to say, when they come back, what are they going to report to their friends and neighbors? That it didnt work? said Steeves. Nobody wants to hear that.

He and other experts have written a booklet advising patients who are considering such treatments.

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Americans seek stem cell treatments in China - Health ...

Spinal Cord Injury Patient Walks After 26 Years in Wheel Chair Thanks To Stem Cells

Chicago, Illinois; August 22, 2012

After 26 years in a wheel chair William Orr is walking. Granted it is with the assistance of a walker, but he is walking. Orr is walking to get his mail, he is walking to rehab from his parked car and he is planning on walking into his 35th high school reunion.

The 52-year-old Aurora man has been a quadriplegic for half his life, since a car hit him while he was riding his bike back in 1986. He suffered a C6-C7 incomplete spinal cord injury and has used a wheel chair since.

In August of 2010, Orr underwent what many believe is a first of its kind stem cell procedure in Naples, Florida, using bone marrow from his hip that doctors believe has regenerated damaged cells in his spinal cord. He had such a good response that a second treatment was performed in July 2012. Subsequently, Orr has gained both motor and sensory improvement, as well as having the majority of his muscle spasms dissipate.

There is a remarkable difference. The results for Mr. Orr and others in the treatment group are truly remarkable and have exceeded our expetations said Michael Calcaterra for Intercellular Sciences. Frankly, this is an area that regeneration was thought not to be possible.

I feel like a new person, said Orr. And its only going to get better. He hopes to someday be walking without the walker. Doctors believe that if his quadriceps strength continues to improve as well as his foot lift, then its a real possibility. In the meantime, hes relishing every new sensation, big or small. Its this amazing work ethic and attitude along with the stem cells, his doctor insists, that will help get this man back on his feet again.

UPDATE:

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Spinal Cord Injuries - Regenocyte

An experiment conducted by a team of Japanese researchers from the Keio University School of Medicine, offers new hope for patients with spinal cord injuries. They managed to obtain motor functional recovery after injecting neural stem / progenitor cells (NS / PCs ) in mice. It was known for some time that transplantation of neural stem / progenitor cells (NS / PCs ) promotes functional recovery in spinal cord injury, but it was not very clear what is the optimal transplantation site. Therefore, researchers made an experiment in which they injected NS / PCs in four groups of mice in several sites : at the lesion epicenter, caudal and rostral sites; the control group received phosphate buffered saline. It should be noted that all mice included in the study received contusivespinal cord injury at the T10 level.

Dr. Masaya Nakamura of the Department of Orthopedic Surgery at the Keio University School of Medicine, emphasizedthat it is critical to determine the optimal site for transplanting NS / PCs designed to treat spinal cord injury.Previous studies conducted by the same team showed that NS / PCs injected intravenously or intrathecally in non injury sites, did not engraft at the lesion site in sufficient numbers; the researchers observed that instead these NS / PCs were trapped in the lungs or kidney. In this way they concluded that the optimal outcome for transplantation of NS / PCs can be obtained by intralesional application. To determine how effective isintralesional injection, researchers conducted another study on laboratory mice with spinal cord injury. They injected NS / PCstaken from transgenic mice for Venus and luciferase fusion protein, a method that allowed the researchers to track the cells after transplantation by bioluminescence imaging ( BLI ).

Dr. Nakamura explained that wild-type mice received a spinal cord injury at T10 and thatlow and high doses of NS / PCs taken from fetal transgenic mice were administered to four groups of mice; the fifth group received phosphate buffered saline. Researchers reported that all four groups of mice had functional motor recovery while mice in the control group did not. The researchers also mentioned that in all four groups, the photon counts from BLI transplant were similar. In other words, the survival of stem cells was uniform when it was transplanted more than acertain threshold number of cells. However, it seems that there is a difference between rostral and caudal (RC ) sites and lesion epicenter (E ) because brain -derived neurotropic factor expression was higher in RC.This may mean that the microenvironments of the E and RC sites are similarly able to support NS/PCs transplanted during the sub-acute phase of SCI, researchers said.

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Stem cell transplantation for treat spinal cord injury offers ...

Last updated: 03/2012

The brain and spinal cord together form the central nervous system (CNS) which is responsible for processing all the information coming from our senses, keeping our organs and reflexes functioning, and directing our movements, thoughts and feelings.

The spinal cord is the critical organ that connects the brain to the rest of the body by conveying electrical impulses along the long nerve fibres that are bundled within it.

The nerves that branch out from the spinal cord to the rest of the body comprise the peripheral nervous system (PNS). These peripheral nerves both receive and convey messages creating a feedback loop that allows us to feel sensation and enable movement.

A nerve cell, or neuron, has a long slender projection, called the axon that acts like a transmission line coming from the control centre of the cell. Even though axons are microscopic in diameter, they may be many feet long. Wrapped around the nerve fibres is a fatty substance called myelin that is similar to insulation on a telephone wire. Myelin is a critical component of the nervous system in that it speeds up the electrical signals and protects the nerves. In addition to neurons, the brain is also home to glial cells which play a critical role in stabilizing the environment, making myelin and supporting and protecting the neurons.

Spinal cord injury (SCI) may occur anywhere from the neck to the lower back. During an initial trauma in which the spinal vertebrae fracture or dislocate, the delicate spinal cord is violently struck. While the cord itself typically remains in one piece, many of the tiny nerve fiber bundles within it are severed. After this initial mechanical injury, inflammation, swelling, and other metabolic processes are triggered, causing further damage and disruption of the nerve fibers. The severity of paralysis experienced by the patient is dependent upon the degree of damage done to the spinal cord. However, even in cases of complete paralysis where the patient has no feeling or movement below the injury, the spinal cord itself is not severed completely, and in fact, there are some axons that remain intact across the injury site. Some of these are thought to have lost their myelin sheaths (their insulation) and therefore do not conduct electrical signals well.

Spinal cord injury affects mostly young adults, about 80% of whom are males. Car accidents are responsible for about 50% of cases. Sporting accidents, serious falls, wounds, and diseases of the spine, such as spina bifida, can also cause permanent injury to the spinal cord. In North America, it is estimated that more than a million individuals live with a disability resulting from some type of spinal cord injury.

Because spinal cord injuries are often the result of terrible accidents which paralyze otherwise fit and mostly healthy young people, they can cause significant and prolonged suffering. Depending on the severity of the injury, rehabilitation may help many people to regain some degree of function.

Unlike the skin, blood, muscle and other organs, for many reasons the CNS does not routinely regenerate after damage hence, the disability caused by spinal cord injury may be permanent and profound. In contrast, the nerves in the PNS tend to regenerate after injury, both because they are intrinsically better programmed to regenerate, and because the cells that myelinate axons in the PNS (called Schwann cells) tend to encourage regeneration.

After spinal cord injuries occur, there is only a small window of opportunity hours, maybe weeks in which therapies may reduce the disability. Restoring the electrical transmission between the brain and spinal cord requires repairing the myelin sheath around the damaged neurons and, in severe cases, the regrowth of severed nerve fibres across the site of injury and into the neural network below the lesion. Scarring and other cellular damage that occurs when the body responds to injury often compounds the difficulties in bridging the lesion site in the aftermath of the injury, and in many cases rehabilitation is the only recourse.

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Spinal Cord Injury - Stem Cell Network

For years we have seen immobilized rats walking after getting an injection of stem cells for their spinal cord injuries. The good thing is that along the way, stem cells have started to be used in studies and experimental therapies to attempt to get SCI patients walking again. While the results for humans have not been nearly as miraculous as for mice, many patients have reported, and some studies have shown, that these early treatments do bring back some sensory ability and improved motor function. Most importantly, a good percentage of patients who have received stem cell transplantsfeel that the treatment has helped not only to improve their quality of life but also that of their caretaker.

Clinical trials and studies using stem cell treatment for spinal cord injuries have been done in Argentina, China, Portugal and are now starting in the United States. The signs are quite positive that within ten to fifteen years, stem cell treatment will be widely available to the general public. The stem cells that being tested in clinical trials today in the west will be approved for medical use for the public in ten years. For patients who dont want to wait for this process, Beike provides an option chosen by over 1000 patients since 2003 making it one of the most established experimental therapies available today.

Stem cell treatment, using Beikes cord mensenchymal stem cells and protocols for spinal cord injuries, is available at various hospitals in China and one in Thailand. Generally, many patients have reported improvements soon after treatment, and continue to notice more improvements for up to 12 months following the stem cell transplants.

Patients who report that they do benefit from the procedure, most always report that those improvements are retained permanently, without regression. Reported improvements differ from patient to patient (depending on the severity of their injury and specifics of their case) - some patients may experience mild increases in sensation, while some regain muscle control and strength where there was little or none before. Many of the patients who see the greatest benefits from the treatment focus heavily on rehabilitation after their stem cell transplant. Like any medical procedure or medicine, there are some patients who report no improvement.

To learn first hand from other patients who have had the treatment, contact us and we will do our best to put you in touch with past patients with similar spinal cord injuries (including those who saw good results and those with no results) who were treated with Beikes stem cell treatment.

Read more here:
Spinal Cord Injury Treatment (Adult Stem Cell Therapy)

When injury occurs to the spinal cord, the connections between the brain and the body are hampered or broken, which results in some level of impairment and a certain degree of paralysis. Symptoms may include movement disability, loss of sensation, impaired control of urination and defecation, cramps, pain and depression.

Conventional treatments for spinal cord injury are focused on prevention of secondary damage and providing rehabilitation.

Background information on this condition

With the advancement of stem cell treatments in China now you have a novel treatment option for Spinal Cord Injury. Stem cell therapy can support the natural regeneration processes of the body by stimulating the repair of damaged tissues. It goes beyond symptomatic treatment and may potentially help you to improve or regain some of the impaired functions.

Cell death occurs when cells are injured. However, these dead cells are surrounded by damaged and healthy cells. Stem cells have the potential to stimulate the healing of these injured cells by the secretion of cytokines, such as nerve growth factor to promote the bodys self-repair mechanisms.

Stem cells are injected by an innovative procedure known as a CT-guided intraspinal injection technique and this is supplemented by further stem cell transplantation via lumbar punctures or IV injections.

We are proud to be the pioneers of the CT-guided intraspinal stem cell transplantation surgical procedure, which is a landmark in the field of stem cell therapy for Spinal Cord Injury. To date, CT-guided intraspinal stem cell transplantation is only available at our hospital in China. CT guidance enables the neurosurgeon to target the stem cells precisely, administering the stem cells inside healthy spinal cord tissue adjacent to the lesion. This technique avoids open surgery of the spine. Thus pain, risks, and healing time are all minimized.

Our doctors understand that a variety of factors may influence decisions regarding your treatment. Our team is dedicated to patient education and collaboration so that you are clearly aware of your condition and treatment options. The hospital offers a wide range of treatments and related services. Therefore we advise you to consult with one of our specialists for personalized treatment information before you arrive to China.

We also encourage you to carefully study our CT Guided Transplantation Method and our stem cell treatment schedule.

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Stem Cell Treatment for Spinal Cord Injury (SCI) with CT Guidance

Stem Cells and Spinal Cord Injury:

Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.

Treatment of spinal cord injuries starts with restraining the spine and controlling inflammation to prevent further damage. The actual treatment can vary widely depending on the location and extent of the injury. In many cases, spinal cord injuries require substantial physical therapy and rehabilitation, especially if the patient's injury interferes with activities of daily life.

After a spinal cord injury, many of the nerve fibers at the injury site lose their insulating layer of myelin. As a result, the fibers are no longer able to properly transmit signals between the brain and the spinal cord contributing to paralysis. Unfortunately, the spinal cord lacks the ability to restore these lost myelin-forming cells after trauma.

Tissue engineering in the spinal cord involves the implantation of scaffold material to guide cell placement and foster cell development. These scaffolds can also be used to deliver stem cells at the site of injury and maximize their regenerative potential.

When the spinal cord is damagedeither accidentally (car accidents, falls) or as the result of a disease (multiple sclerosis, infections, tumors, severe forms of spinal bifida, etc.)it can result in the loss of sensation and mobility and even in complete paralysis.

Spinal Cord Injury and Stem Cell Treatment

Adult stem cell transplants for spinal cord injury repair: current state in preclinical research.

Hernndeza J, Torres-Espna A, Navarro X.

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Spinal Cord Injury Stem Cell Treatment - ASCI - Stem Cell Rejuvenation

The Promise of Stem Cells

Studying stem cells will help us understand how they transform into the dazzling array of specialized cells that make us what we are. Some of the most serious medical conditions, such as cancer and birth defects, are due to problems that occur somewhere in this process. A better understanding of normal cell development will allow us to understand and perhaps correct the errors that cause these medical conditions.

Another potential application of stem cells is making cells and tissues for medical therapies. Today, donated organs and tissues are often used to replace those that are diseased or destroyed. Unfortunately, the number of people needing a transplant far exceeds the number of organs available for transplantation. Pluripotent stem cells offer the possibility of a renewable source of replacement cells and tissues to treat a myriad of diseases, conditions, and disabilities including Parkinson's disease, amyotrophic lateral sclerosis, spinal cord injury, burns, heart disease, diabetes, and arthritis.

Scientists have been able to do experiments with human embryonic stem cells (hESC) since 1998, when a group led by Dr. James Thomson at the University of Wisconsin developed a technique to isolate and grow the cells. Although hESCs are thought to offer potential cures and therapies for many devastating diseases, research using them is still in its basic stages. hESCs are thought to offer potential cures and therapies for many devastating diseases, and we are now seeing the first clinical trials using cells derived from hESCs.

The NIH funded its first basic research study on hESCs in 2002. Since that time, biotechnology companies have built upon those basic foundations to begin developing stem cell-based human therapies. There are currently two active clinical trials using cells derived from human embryonic stem cells, both being conducted by a biotechnology company called ACT. The company has laboratories in Marlborough, Massachusetts and corporate offices in Santa Monica, California. ACT has begun enrolling patients for Phase I (safety and tolerability) clinical trials of two hESC-derived stem cell products:

In January, 2012, the investigators published a preliminary report on the first two patients treated with hESC-derived cells: http://www.ncbi.nlm.nih.gov/pubmed/22281388. A third patient was treated on April 20, 2012.

Late in 2007, scientists reported that they had been able to reprogram adult human skin cells to behave like hESCs. This type of stem cells is known as induced pluripotent stem cells, or iPSCs. Since these first reports, researchers have rapidly improved the techniques to generate iPSCs, creating a powerful new way to "de-differentiate" cells whose developmental fates were thought to be determined. In July 2013, Japans health minister approved the first clinical trial using cells derived from iPSCs. Masayo Takahashiin Kobe, Japan will use the cells to attempt to treat a form of blindness - age-related macular degeneration.

Bone marrow contains blood-forming stem cells (hematopoietic stem cells) that have been used for decades to treat blood cancers and other blood disorders. Umbilical cord blood is another source of hematopoietic stem cells that is being used in treatment. You can see a list of diseases that may currently be treated with hematopoietic stem cells at the website of the National Marrow Donor Program. You may also search for clinical trials testing "bone marrow stem cells" or "umbilical cord blood" on the ClinicalTrials.gov website.

A biotechnology company called Neuralstem (corporate headquarters in Rockville, Maryland) is conducting a clinical trial testing the use of human spinal cord stem cells to treat Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrigs Disease. The company obtained FDA approval to conduct a Phase I trial (safety and tolerability study) and began enrolling patients in January 2010. Twelve participants have received lumbar transplants, and in March 2012, the second participant received an injection in the cervial region. Details about this trial are listed on the ClinicalTrials.gov website.

Osiris Therapeutics (Columbia, Maryland) is conducting three different Phase 2 clinical trials with a product from adult mesenchymal cells (called Prochymal). The three trials are for:

See the article here:
Stem Cells and Diseases [Stem Cell Information]

CIRM funds a variety of research projects focused on finding a treatment for people with spinal cord injury. These projects range from basic work understanding how nerve cells are damaged in these injuries to projects trying move therapies into clinical trials.

If you want to learn more about CIRM funding decisions or make a comment directly to our board, join us at a public meeting. You can find agendas for upcoming public meetings on our meetings page.

Learn more about stem cell research: Stem Cell Basics Primer | Stem Cell Videos | What We Fund

Find clinical trials: CIRM does not track stem cell clinical trials. If you or a family member is interested in participating in a clinical trial, please see the national trial database to find a trial near you: clinicaltrials.gov

About 250,000 people in the U.S. live with spinal cord injuries. Half of those are quadriplegic, with the paralysis impacting all four limbs to some extent. For those individuals the lifetime cost of managing their condition is estimated to be between $2 million and $3 million.

Spinal cord injury became the first condition targeted in a human clinical trial using cells made from embryonic stem cells. That trial, begun by Geron in 2010 and based on the findings of a team CIRM currently funds, was later cancelled by Geron for financial reasons. By the time of the cancellation five patients around the country had been enrolled in the study, including two at Stanford, who entered the trial during a period when CIRM funded Geron. Those patients continue to be followed to learn as much as possible about this approach.

Californias stem cell agency retains many grants for research to move potential spinal cord injury therapies forward (the full list is below). Much of this work focuses on trying to determine which type of nerve cell is the best one to transplant, and deciding which type of stem cell is the best starting point for making those cells. Other research is trying to see if these transplanted cells become part of the existing nerve system, helping create new pathways that can transmit nerve signals to muscles. The researchers are also looking at ways to try and improve the ability of these transplanted cells to become part of the nerve system.

One obstacle that some teams are trying to overcome is the tendency of the scar at the site of injury to block the growth of these transplanted cells. One group is trying to overcome that by combining stem cells with synthetic scaffolds that can be placed at the site of injury, to help the cells bridge the scar and restore signals. In animal models this combination has resulted in an increase in mobility compared to stem cell grafts alone.

Progress and Promise toward a stem cell-based therapy for spinal cord injury

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Spinal Cord Injury Fact Sheet | California's Stem Cell Agency

ROCKVILLE, Md., Dec. 10, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that Jonathon Glass, MD, Director of the Emory ALS Center, presented new data from the Phase I trial of Neuralstem's human spinal cord stem cells, NSI-566, in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at the International Symposium on ALS/MND in Chicago, sponsored by the Motor Neurone Disease Association. In a Thursday presentation, "RESULTS OF PHASE 1 TRIAL OF SPINAL CORD TRANSPLANTATION OF NEURAL PROGENITOR CELLS IN ALS (THE NEURALSTEM, INC. TRIAL)," Dr. Glass revealed that researchers were able to establish the long-term survival of Neuralstem's transplanted spinal cord stem cells in autopsied patients, through a technology called DNA fingerprinting. Dr. Glass, who is the principal site investigator of the trial at Emory, also announced that the study team has received a grant from the National Institutes of Health (NIH) to cover a majority of the cost of an upcoming Phase II trial.

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"We are quite pleased by our ability to perform all of the surgeries planned for the Phase I trial without evidence of significant surgical or medical complications, including those patients who received both lumbar and cervical transplantations," said Dr. Glass. "We can also report that we found evidence of cell survival in all of the patients who came to autopsy, including our first patient who died 30 months after transplantation.

This is very positive news, supporting our plan to accelerate this study by increasing the dose of stem cells delivered to the cervical spinal cord in the hopes of delaying respiratory failure and prolonging life. The next phase of the study has been partially funded by a generous grant from the National Institutes of Health, and we will begin once the FDA approves our new protocol," Dr. Glass concluded.

"This is a major finding," said Karl Johe, Ph.D., Neuralstem Chairman of the Board and Chief Scientific Officer. "There is currently no way to confirm the survival of the cells in patients while they are alive. Levels of functional recovery, or a slowdown in the progression of the disease in various patients, have given us reason to believe the cells have survived. Now, cell survival has been demonstrated by definitive evidence.

Among the six patients autopsied (five died of ALS disease progression and one, of unrelated heart failure), the survival period, from stem cell transplantation to death, ranged from 196 921 days. Five of these patients had discontinued all immune suppression medications for 57 638 days prior to death, but showed the stem cell DNA content in the range of 0.67% - 5.4% of total DNA in some spots of cord treated with the stem cells. There was no correlation of DNA content to survival period without immune suppression medication. These data, therefore, suggest that long-term immuno suppression of patients is not required for long-term survival of our cells, which points towards the feasibility of needing only transient immune suppression in future ALS trials," Dr. Johe concluded.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently treated the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD).Additional indications could include chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).

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Neuralstem Investigator Presents New ALS NSI-566 Data at International Symposium on ALS/MND

BANGKOK, Oct 18 - A Siriraj Hospital medical team today announced its successful isolation of stem cells from amniotic fluid which they said will contribute to treatments of many chronic diseases.

Dr Udom Kachintorn, dean of the Siriraj medical school, said further research will be conducted on the use of stem cells to treat various illnesses including Alzheimers, osteoarthritis, diabetes and spinal cord pain. These chronic ailments are related to deteriorating stem cells in a human body.

A preliminary lab test has been done with animals but it will take some time before the medical team starts testing on human beings, he said.

Dr Udom said stem cells normally spread all over a person's body but they are abundant and pure in an infant's umbilical cord and placenta.

Dr Tassanee Permthai, chief of the stem cell research project, said stem cells from the placenta of a four-month-old baby can be transplanted in a patient like fully-developed stem cells.

Once transplanted in a patients body, the stem cells evolve into cells in different parts of the body, she explained, adding that the transplantation of stem cells can also prevent tumours.

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Pattaya Mail

ScienceDaily (Oct. 15, 2012) New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today.

The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons -- essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

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The above story is reprinted from materials provided by Society for Neuroscience (SfN), via AlphaGalileo.

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Realizing the potential of stem cell therapy: Studies report progress in developing treatments for diseases and injuries

ROCKVILLE, Md., Oct. 15, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that data on Neuralstem's NSI-566 spinal cord-derived neural stem cell line in a rat model of ischemic stroke was presented in a poster, "Histopathological Assessment of Adult Ischemic Rat Brains after 4 Weeks of Intracerebral Transplantation of NSI-566RSC Cell Line," at The Society for Neurosciences Annual Meeting (http://www.sfn.org/AM2012/). This study was conducted independently in the laboratory of Dr. Cesar Borlongan, who is the director at the Center of Excellence for Aging and Brain Repair at the University of South Florida College of Medicine. Post-mortem histology was conducted in collaboration with Neuralstem. Rats that suffered ischemic stroke by middle cerebral artery occlusion, were transplanted 7 days post-stroke with increasing doses of NSI-566 into the stroke area. The animals were followed for safety and behavioral response for 56 days post-transplantation. Researchers reported Saturday that there was significant improvement in both motor and neurological tests in the stem cell-treated rats. There were significant dose-dependent differences in the behavioral improvement across treatment groups at post-transplantation periods, with the highest dose showing the most significant improvement in both motor and neurological tests. Similarly, there were significant differences in the behavioral performance among treatment groups at post-transplantation periods, with the most significant improvement in both motor and neurological tests seen at day 56 post-transplantation.

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"This study was designed to evaluate the potential therapeutic value of intracerbral dosing of human neural stem cells (NSI-566, supplied by Neuralstem) in an animal model of adult ischemic stroke," said Cesar V. Borlongan, Ph.D., University of South Florida College of Medicine, and the lead study author. "The results are very clear. The recovery of motor and neurological tests demonstrated by high-dose transplanted stroke animals was significantly better throughout the 56-day study period compared to vehicle-infused stroke animals, or low-dosed animals. In addition, there was stable improvement in the high-dose animals, and they showed a trend of better improvement over time."

A separate poster, "Survival and Differentiation of Human Neural Stem Cells (NSI-566RSC) After Grafting into Ischemia-Injured Porcine Brain," was also presented on Saturday. This study was independently carried out by Dr. Martin Marsala and his colleagues. Dr. Marsala is a professor and the head of the Neuroregeneration Laboratory at University of California San Diego and also a member of the Sanford Consortium for Regenerative Medicine. In this study, the same stem cells were transplanted into the brains of pigs that received an ischemic stroke on one side of the brain. 8-9 weeks after the ischemic event, which models chronic stroke in humans, feasibility and safety of escalating cell doses and injections were assessed. Body temperature, behavior, muscle tone and coordination, sensory function, food consumption, defecation, and micturition were monitored at least twice daily for the first 7 days, and once weekly thereafter, until termination. Up to 12 million cells in 25 cell injection deposits via 5 cannula penetrations were shown to be safe, which closely mimics the intended clinical route and method of delivery in future human clinical trials. At 6 weeks post-transplantation, there were no complications from the cell transplantation method or the cells. All animals recovered and showed progressive improvement with no distinction. All treated animals showed effective engraftment and neuronal maturation with extensive axonal projections. These data support the application of NSI-566RSC cell line to be transplanted into a chronic stage of previously ischemia-injured brain for treatment of motor deficits resulting from stroke.

"Our study was designed to evaluate the potential value of Neuralstem's cells in a chronic model of ischemic stroke and in a species that allowed for the use of human scale transplantation tools and dosing," said Martin Marsala, MD, at the University of California at San Diego Medical School, and the lead study author of the porcine study. "We have demonstrated clearly that both the route of administration and the cells are safe and well tolerated and that the cells survived and differentiated into mature neurons in the host brain tissue."

"We have demonstrated safety and efficacy of NSI-566RSC in a subacute model of ischemic stroke in rats and feasibility and safety in a chronic model of ischemic stroke in mini-pigs," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "Together, these two studies demonstrate strong proof of principle data that our NSI-566 cells are ready to go into humans to treat paralysis in stroke patients."

Neuralstem has recently completed a Phase I trial testing the safety of NSI-566 in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has been approved to initiate a human clinical trial in ischemic stroke in China, through its subsidiary, Suzhou Neuralstem.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently treated the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.

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Significant Recovery Of Motor And Neurological Functions In Ischemic Stroke Rats With Neuralstem NSI-566 Cells

NEWARK, Calif., Oct. 12, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the issuance of U.S. Patent Number 8,283,164 titled "Liver engrafting cells, assays, and uses thereof." The patent broadly covers purified populations of human liver cells, including the Company's human liver engrafting cells (hLEC). hLEC cells were first isolated by Company researchers in the late 1990s, and Company scientists have repeatedly demonstrated the cells' engraftment and robust bioactivity in vivo and that they are expandable. While the Company's hLEC cells are purified from donated adult livers not suitable for transplant, the newly issued '164 patent importantly claims cells independent of tissue source. Therefore, the '164 patent has potential relevance to those deriving liver cells from iPS or ESC platforms. The term of the '164 patent extends into 2022.

"This new patent extends our IP protection around hLEC cells and should be of interest to those searching for an expandable human liver cell," said Martin McGlynn, President and Chief Executive Officer of StemCells, Inc. "Because the liver is such a key organ, finding an expandable, reliable and well-characterized liver cell population is an important step forward in both medical research and drug development. For example, liver disease afflicts some 25 million Americans and transplantation of an expandable liver cell could potentially address many of the shortcomings of whole liver transplantation. Moreover, the right liver cells could make profound contributions to drug screening and toxicity testing."

In October 2011, StemCells formed a wholly-owned subsidiary to focus on both the therapeutic and research tool applications of its hLEC technologies and to serve as an investment vehicle for those interested in a "pure play" liver cell company. The '164 patent is one of several patents issued to the Company on a worldwide basis claiming expandable liver cells, including U.S. Patent Nos. 7,811,818 and 7,211,404, Japan Patent No. 4445876, Australian Patent No. 2002315392, and European Patent No. 1406998. Patent prosecution in the family is ongoing on a worldwide basis, including China application 02816528.4.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. The Company recently reported results from a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children. The trial results showed preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and a Phase I/II clinical trial in dry age-related macular degeneration in the United States. In addition, the Company is pursuing preclinical studies of its HuCNS-SC cells in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect of enforcing the Company's intellectual property against infringers, the potential breadth and length of patent protection in the United States or in any other geography; and the likelihood that any of the Company's intellectual property will be found to be valid and enforceable. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the Company's ability to obtain the increased capital resources needed to continue its current operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals and for continued patent prosecution efforts; uncertainty regarding the validity and enforceability of the Company's existing patents; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and in its subsequent reports on Form 10-Q and Form 8-K.

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StemCells, Inc. Awarded Broad U.S. Patent Covering Expandable Liver Cells

SAN FRANCISCO (KGO) -- Bay Area stem cell researchers are reporting early, encouraging results from two clinical trials. The first, involves patients, paralyzed with spinal cord injuries and a treatment that could offer new hope for their future.

Nearly 20 years after the football injury that left him paralyzed, Roman Reed still holds onto the hope that he will someday walk again.

"One hundred percent, without a doubt. I've been wrong about the date, but not the fact I will walk again," said Reed.

Reed now runs a foundation to promote stem cell research and has been closely watching a clinical trial being conducted by Bay Area based Stem Cells Inc. Its goal is to use stem cell therapy to restore motor function in patients with spinal cord injuries.

"We're on the road on to being able to cure paralysis, it's so important, and stem cells are the way to do it," said Reed.

Stephen Huhn, M.D., Ph.D., from Stem Cells Inc., says the test procedure began a two hour surgery to clear a path to the spinal cord. Researchers then injected the cells directly into the damaged area.

"So the first three patients in the trial were designed to enroll patients who had the worst of the worst injuries. In other words, complete loss of sensory function and complete loss of motor function below the level of injury," said Huhn.

The phase one trials are all about establishing safety, but six months out, the researchers began measuring some intriguing improvements in two of those three patients. Both reported feeling in areas below the areas of their injuries.

The company cautions that the data is very preliminary, but they say researchers were able to measure the improved sensory response using several testing methods, including electrical stimulation, and response to heat -- which are considered more accurate than the patient's own self-reporting.

"You can't fake that. When we saw that data, that's when we became very excited," said Martin McGlynn, the CEO of Stems Cells Inc.

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Bay Area stem cell researchers see encouraging results

Public release date: 11-Oct-2012 [ | E-mail | Share ]

Contact: David McKeon dmckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (October 11, 2012) For the second day, The New York Stem Cell Foundation (NYSCF) Seventh Annual Translational Stem Cell Research Conference hosts the world's most preeminent stem cell scientists to present their findings on how advances in stem cell science lead to better treatments and cures for disease and injury. The conference is held at The Rockefeller University in Manhattan on October 10-11.

Today, in disease-specific sessions, scientists will share their latest finds in moving stem cell research to treatments in the following areas: cancer and blood disease; diabetes and autoimmunity; heart and muscles; neurodegeneration and spinal cord injury.

In Cancer and Blood Disease, Elaine Fuchs, PhD, The Rockefeller University, will share findings on identification of skin cancer stem cells, which have implications in understanding other cancers as well as stem cells. Joanne Kurtzberg, MD, Duke University, will discuss her work developing therapies for disease with autologous cord blood transplants. Ravi Majeti, PhD, Stanford University, will describe his recent insights into acute myeloid leukemia and how stem cell technologies can lead to new cancer treatments.

Dieter Egli, PhD, The New York Stem Cell Foundation (NYSCF), will open the session on Diabetes and Autoimmunity by detailing his group's development of stem cell-derived models of pancreatic beta cells for the study of diabetes. Yuval Dor, PhD, Hebrew University, Israel, will discuss experiments with pancreatic beta cells with the goal to understand the regenerative potential of these cells. Matthias von Herrath, MD, Novo Nordisk, will delve into another aspect of Type 1 diabetes, the problem of autoimmunity. He will close the session by sharing insights into the need for an immune modulated therapy to diabetes.

Before the afternoon sessions, Shahin Rafii, MD, Weill Medical College of Cornell University will deliver the first of two keynote addresses of the conference. He will describe his recent successes in deriving vascular cells from amniotic cells.

In the afternoon session on Heart and Muscle Diseases, Amy Wagers, PhD, Harvard University, will focus on advances in treatments and explain how studies into the mechanisms of tissue stem cell renewal may have relevant therapeutic implications. Gordon Keller, PhD, McEwen Centre for Regenerative Medicine, Canada, will describe modeling cardiac cell development from human pluripotent cells for use in toxicology and electrophysiology studies. Helen Blau, PhD, Stanford University, will describe her research to improve stem cell culture in the direction of stem cell fate and for drug screens.

In Neurodegeneration and Spinal Cord Injury, Paola Arlotta, PhD, Harvard University and a NYSCF-Robertson Stem Cell Investigator, will address the application of stem cells to understanding and possibly treating these debilitating diseases and conditions, and will describe investigations to direct reprogramming of neurons into different neuronal lineages. Lorenz Studer, MD, Memorial Sloan-Kettering Cancer Center, will discuss the potential stem cell technology holds in the treatment of Parkinson's disease. Despite past failures in the replacement of lost dopamine neurons, Dr. Studer will describe his novel protocols for the generation of these neurons for eventual use in clinical trials.

Rudolf Jaenisch, MD, The Whitehead Institute, will deliver the second keynote address of the day. Building on Shinya Yamanaka's paradigm-changing work in induced pluripotent stem (iPS) cell reprogramming, Dr. Jaenisch will discuss new methods to counter the generally low successful output of these cells. He will also summarize how targeted genome editing may help unleash the potential of iPS cells and embryonic stem cells for both the study of and therapy for disease.

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Scientists discuss stem cell discoveries at New York Stem Cell Foundation Conference

Kyoto University Professor Shinya Yamanaka talks with Japan's Prime Minister Yoshihiko Nada by a mobile phone during a news conference in Kyoto, western Japan, in this photo taken by Kyodo October 8, 2012.

By Tan Ee Lyn Reuters Wednesday, Oct 10, 2012

HONG KONG - The Internet is full of advertisements touting stem cell cures for just about any disease -- from diabetes, multiple sclerosis, arthritis, eye problems, Alzheimer's and Parkinson's to spinal cord injuries -- in countries such as China, Mexico, India, Turkey and Russia.

Yamanaka, who shared the Nobel Prize for Medicine on Monday with John Gurdon of the Gurdon Institute in Cambridge, Britain, called for caution.

"This type of practice is an enormous problem, it is a threat. Many so-called stem cell therapies are being conducted without any data using animals, preclinical safety checks," said Yamanaka of Kyoto University in Japan.

"Patients should understand that if there are no preclinical data in the efficiency and safety of the procedure that he or she is undergoing ... it could be very dangerous," he told Reuters in a telephone interview.

Yamanaka and Gurdon shared the Nobel Prize for the discovery that adult cells can be transformed back into embryo-like stem cells that may one day regrow tissue in damaged brains, hearts or other organs.

"I hope patients and lay people can understand there are two kinds of stem cell therapies. One is what we are trying to establish. It is solely based on scientific data. We have been conducting preclinical work, experiments with animals, like rats and monkeys," Yamanaka said.

"Only when we confirm the safety and effectiveness of stem cell therapies with animals will we initiate clinical trials using a small number of patients."

Yamanaka, who calls the master stem cells he created "induced pluripotent stem cells" (iPS), hopes to see the first clinical trials soon.

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Nobel laureate Yamanaka warns of rogue "stemcell therapies"

The techniques pioneered by the winners of this years Nobel Prize in medicine, John B. Gurdon and Shinya Yamanaka, have already allowed scientists to generate stem cells and clone animals.

But it is the potential these discoveries hold that truly boggles the mind. If stem cells the primitive cells that develop into tissue like skin, blood, nerves, muscle and bone can be harnessed, the belief is they can be used as a repair kit for the body.

In theory, a few skin cells could be harvested to rebuild a spinal cord damaged by trauma, to replace brain cells destroyed by dementia, to rebuild heart muscle damaged by a heart attack or to grow a new limb ravaged by diabetes. It is the stuff of science fiction, so close we can taste it.

But these dreams of miracle cures must be tempered with a strong dose of realism.

Despite billions of dollars in investment in research, from government agencies and biotech companies, there is little evidence that stem cell therapies work.

Yes, some hearing has been restored in gerbils and there have been modest improvements in paralyzed lab rats using stem cell treatments, but these are baby steps. In humans, the gains have been far more modest.

We can treat some forms of cancer, like leukemia and multiple myeloma, with stem cell transplants. But this is simply a refinement of an earlier technique, bone marrow transplant. And to perform such a transplant, the immune system must, for all intents and purposes, be destroyed a punishing regime with a significant mortality rate.

It is a far cry from the notion of an injection of magic stem cells that allow people to walk again or restore their memories.

The International Society for Stem Cell Research says that while there are hundreds of conditions that can purportedly be treated with stem cells, the treatments that have actually been shown to be beneficial are extremely limited. Aside from the cancer treatments mentioned above, some bone, skin and corneal conditions have been treated by grafting stem cells, growing them in the lab and transplanting them.

But in all these cases, the stem cells are tissue-specific, meaning the cells are carrying out a function they were designed to do. This is very different from the notion that undifferentiated stem cells can be used to treat a broad range of conditions.(And we wont delve into potential problems, such as rejection and the concern that stem cells could grow out of control and cause cancerous tumours.)

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Stem cell therapy a miracle cure? Not quite yet

ROCKVILLE, Md., Oct. 9, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE Amex: CUR) announced that Eva Feldman, MD, PhD, principal investigator of the Phase I trial to test Neuralstem's NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), updated data on the trial at the American Neurological Association annual meeting in Boston, MA, yesterday. (http://www.aneuroa.org/i4a/pages/index.cfm?pageid=3311). Dr. Feldman, who is President of the American Neurological Association, presented interim results on all 18 procedures in 15 patients, including the last three patients from earlier cohorts who received second procedures. The trial will conclude six months after the last patient was treated, which was in August.

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"This has been a very successful trial so far," said Dr. Feldman, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "With the transplantation of these neural stem cells, we are exploring a paradigm shift in the treatment of ALS. We have demonstrated that intraspinal transplantation is feasible and well-tolerated. Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in one subgroup of patients. We are anxious to move to future trial phases to examine therapeutic efficacy." Dr. Feldman is an unpaid consultant to Neuralstem.

"The purpose of this trial was to assess the safety of both the intraspinal transplantation procedure, the first in the world, and of the cells themselves, " said Karl Johe, PhD, Chairman of the Board and Chief Scientific Officer of Neuralstem, Inc. "All assessments show both to be safe. Additionally, we believe we are seeing evidence of a treatment effect in some patients over a sustained period of time. We need now to move forward to more advanced, larger trials to increase the dosage and more effectively look at possible efficacy."

About the Trial

The Phase I trial to assess the safety of Neuralstem's NSI-566 spinal cord neural stem cells and intraspinal transplantation method in ALS patients commenced in January 2010, and consisted of 18 treatments in 15 patients. The trial was designed to follow a risk escalation paradigm. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.

The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously-treated patients to this cohort. Consequently, the last cohort of three patients received injections in the cervical region in addition to the lumbar injections they had received earlier. All injections delivered 100,000 cells, for a dosing range of up to 1.5 million cells. The last patient was treated in August, 2012. The entire trial concludes six months after the final surgery.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently treated the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.

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Dr. Eva Feldman, Principal Investigator, Updates Interim Data On Completed Neuralstem ALS Phase I Trial

STOCKHOLM: Scientists from Britain and Japan shared the Nobel Prize in Medicine on Monday for the discovery that adult cells can be reprogrammer back into stem cells which can turn into any kind of tissue and may one day repair damaged organs. John Gurdon, 79, of the Gurdon Institute in Cambridge, Britain and Shinya Yamanaka, 50, of Kyoto University in Japan, discovered ways to create tissue that would act like embryonic cells, without the need to harvest embryos. They share the $1.2 million prize equally. These groundbreaking discoveries have completely changed our view of the development and specialization of cells, the Nobel Assembly at Stockholms Karolinska Institute said in a statement. The big hope for stem cells is that they can be used to replace damaged tissues in everything from spinal cord injuries to Parkinsons disease. All of the tissue in the body starts as stem cells, before developing into mature skin, blood, nerves, muscle and bone. Scientists once thought it was impossible to turn adult tissue back into stem cells, which meant that new stem cells could only be created by harvesting embryos. But Yamanaka and Gurdon showed that development can be reversed, turning adult cells back into cells that behave like embryos. With induced pluripotency stem cells, or iPS cells, ordinary skin or blood cells from adults are transformed back into stem cells which doctors hope will be able to repair damaged organs without being rejected by the immune system. There are concerns, however, that iPS cells could grow out of control and develop into tumors. The eventual aim is to provide replacement cells of all kinds, Gurdons Institute explains on its website. We would like to be able to find a way of obtaining spare heart or brain cells from skin or blood cells. The important point is that the replacement cells need to be from the same individual, to avoid problems of rejection and hence of the need for immunosuppression. Gurdon discovered in 1962 that the specialization of cells could be reversed. In what the prize committee called a classic experiment, he replaced the immature cell nucleus in an egg cell of a frog with the nucleus from a mature intestinal cell. This modified egg cell developed into a normal tadpole, proving that the mature cell still had all the information needed to develop all cells in the frog. More than 40 years later, in 2006, Yamanaka discovered how intact mature cells in mice could be reprogrammer to become stem cells by adding just a few genes. Thanks to these two scientists, we know now that development is not strictly a one-way street, said Thomas Perlmann, Nobel Committee member and professor of Molecular Development Biology at the Karolinska Institute. There is lot of promise and excitement, and difficult disorders such as neurodegenerative disorders, like perhaps Alzheimers and, more likely, Parkinsons disease, are very interesting targets.

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Japan, UK scientists win Nobel for stem cell breakthroughs