Category Archives: Stem Cell Videos

Researchers create early stage sperm cells from induced pluripotent stem cells, raising hopes that infertile men could be fathers.

By Hayley Dunning | August 30, 2012

Men made infertile by cancer treatments could have their fertility restored by creating new sperm from their own skin samples, researchers at the University of Pittsburgh School of Medicine reported last week (August 23) in Cell Reports. While there is the opportunity for men to bank their sperm before undergoing cancer treatment, this doesnt help young, pre-pubescent boys or men who didnt plan that far ahead, lead author Charles Easley told The Telegraph.

There are procedures to store testicular tissue prior to cancer therapy, but men who didnt have the opportunity to save tissue are permanently sterile, and so far there are no cures for their sterility, he said.

Easley and colleagues developed an in vitro culture to generate human induced pluripotent stem cells from adult skin samples, and differentiate the cells into advanced male germ cell lineages, including post-meiotic, spermatid-like cells. The technique mirrors the in vivo process, and produces spermatids similar to human sperm.

This model also gives us a unique opportunity to study the molecular signals that govern the process, allowing us to learn much more about how sperm are made, said Easley. Perhaps one day this will lead to new ways of diagnosing and treating male infertility.

By Sabrina Richards

A small molecule that inhibits a protein important for chromatin organization can cause reversible sterility in male mice.

By Sabrina Richards

Researchers track tumors as they develop, providing more support for the idea that cells with stem-cell-like properties underlie cancer growth and recurrence.

Continued here:
Creating Sperm from Skin

Stem cell-powered implant set to revolutionise orthopaedic surgery

Scientists at the University of Glasgow are working to harness the regenerative power of stem cells to improve orthopaedic implant surgery. They are collaborating with surgeons at Glasgows Southern General Hospital to develop a new type of orthopaedic implant which could be considerably stronger and more long-lived than the current generation of products.

Currently, implants are commonly made from materials such as polyethylene, stainless steel, titanium or ceramic and have a limited lifespan due to loosening, requiring replacement after 15 or 20 years of use. In hip replacement surgery, the head of the thigh bone is removed and replaced with an implant which is held in place by a rod fixed inside the marrow along the length of the bone.

Marrow is a rich source of mesenchymal stem cells, which have the potential to divide, or differentiate, into other types of cells such as skin, muscle or bone which can improve the process of healing. However, stem cells can also differentiate into cells which have no use in therapy. Artificially controlling the final outcome to ensure the desired type of cells are created is very difficult, even under laboratory conditions.

When traditional implants are fixed into bone marrow, the marrows stem cells do not receive messages from the body to differentiate into bone cells, which would help create a stronger bond between the implant and the bone. Instead, they usually differentiate into a buildup of soft tissue which, combined with the natural loss of bone density which occurs as people age, can weaken the bond between the implant and the body.

The team from the University of Glasgows Colleges of Science and Engineering and Medical, Veterinary and Life Sciences have found a reliable method to encourage bone cell growth around a new type of implant. The implant will be made of an advanced implantable polymer known as PEEK-OPTIMA, from Invibio Biomaterial Solutions, which is already commonly used in spinal and other orthopaedic procedures.

Dr Matthew Dalby, of the Universitys Institute of Molecular, Cell and Systems Biology, explained: Last year, we developed a plastic surface which allowed a level of control over stem cell differentiation which was previously impossible. The surface, created at the Universitys James Watt Nanofabrication Centre, is covered in tiny pits 120 nanometres across. When stem cells are placed onto the surface, they grow and spread across the pits in a way which ensures they differentiate into therapeutically useful cells.

By covering the PEEK implant in this surface, we can ensure that the mesenchymal stem cells differentiate into the bone cells. This will help the implant site repair itself much more effectively than has ever been possible before and could well mean that implants will last for the rest of patients life.

Dr Dalby added: People are living longer and longer lives nowadays; long enough, in fact, that were outliving the usefulness of some of our body parts. Our new implant could be the solution to the expensive and painful follow-up surgeries which conventional implants require.

Dr Nikolaj Gadegaard, Senior Lecturer in Biomedical Engineering at the University, explained: One of the main selling points of PEEK is that it is very strong, has excellent stability and is very resistant to wear. However, the inertness of the material is not always suitable for implants that require some interaction with the surrounding tissue. Our nanopatterned surface may allow Invibios PEEK polymer to interact with stem cells and enable an effective integration between the implant and the body for the first time.

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Stem cells power implants

In past years, these nine little letters, stem cells, have caused much controversy and misunderstanding.

Stem cells are primitive, undifferentiated cells that are able to divide and become specialized cells of the body such as liver cells, muscle cells, blood cells and other cells with specific functions.

Because they have not yet committed to a developmental path that will form a specific tissue or organ, they are considered master cells with great potential. You may have wondered about what they are used for, and if they hold promise for helping you or a family member with serious disease or injury.

Stem cells are interesting and useful to doctors and scientists for several reasons:

Further work includes potential treatment for Type 1 diabetes, arthritis, stroke, Parkinsons disease, heart disease and Alzheimers disease.

There are also cosmetic applications, using the patients own cells for facial and body enhancement, such as the stem cell facelift, and topical skin applications.

The different types of stem cells include:

These come from embryos that are four to five days old, usually left over from fertility treatments and voluntarily donated.

These were thought to have the most potential for scientific use because they had minimal exposure to potential environmental toxins and great potential for use in tissue and organ regeneration. They are able to self-renew and are pluri-potent, meaning they become any type of cell in the future.

Embryonic cells are also the source of great controversy and debate, since many of us believe that life begins at conception and that manipulation of embryonic stem cells is unethical.

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Positively Beautiful: Ever wondered about stem cells?

ScienceDaily (Aug. 30, 2012) The skin, the blood, and the lining of the gut -- adult stem cells replenish them daily. But stem cells really show off their healing powers in planarians, humble flatworms fabled for their ability to rebuild any missing body part. Just how adult stem cells build the right tissues at the right times and places has remained largely unanswered.

Now, in a study published in an upcoming issue of Development, researchers at the Stowers Institute for Medical Research describe a novel system that allowed them to track stem cells in the flatworm Schmidtea mediterranea. The team found that the worms' stem cells, known as neoblasts, march out, multiply, and start rebuilding tissues lost to amputation.

"We were able to demonstrate that fully potent stem cells can mobilize when tissues undergo structural damage," says Howard Hughes Medical Institute and Stowers Investigator Alejandro Snchez Alvarado, Ph.D., who led the study. "And these processes are probably happening to both you and me as we speak, but are very difficult to visualize in organisms like us."

Stem cells hold the potential to provide an unlimited source of specialized cells for regenerative therapy of a wide variety of diseases but delivering human stem cell therapies to the right location in the body remains a major challenge. The ability to follow individual neoblasts opens the door to uncovering the molecular cues that help planarian stem cells navigate to the site of injury and ultimately may allow scientists to provide therapeutic stem cells with guideposts to their correct destination.

"Human counterparts exist for most of the genes that we have found to regulate the activities of planarian stem cells," says Snchez Alvarado. "But human beings have these confounding levels of complexity. Planarians are much simpler making them ideal model systems to study regeneration."

Scientists had first hypothesized in the late 1800s that planarian stem cells, which normally gather near the worms' midlines, can travel toward wounds. The past century produced evidence both for and against the idea. Snchez Alvarado, armed with modern tools, decided to revisit the question.

For the new study, first author Otto C. Guedelhoefer, IV, Ph.D., a former graduate student in Snchez Alvarado's lab, exposed S. mediterranea to radiation, which killed the worms' neoblasts while leaving other types of cells unharmed. The irradiated worms would wither and die within weeks unless Guedelhoefer transplanted some stem cells from another worm. The graft's stem cells sensed the presence of a wound -- the transplant site -- migrated out of the graft, reproduced and rescued their host. Unlike adult stem cells in humans and other mammals, planarian stem cells remain pluripotent in fully mature animals and remain so even as they migrate.

But when Guedelhoefer irradiated only a part of the worm's body, the surviving stem cells could not sense the injury and did not mobilize to fix the damage, which showed that the stem cells normally stay in place. Only when a fair amount of irradiated tissue died did the stem cells migrate to the injured site and start to rebuild. Next, Guedelhoefer irradiated a worm's body part and cut it with a blade. The surviving stem cells arrived at the scene within days.

To perform the experiments, Guedelhoefer adapted worm surgery and x-ray methods created sixty to ninety years ago. "Going back to the old literature was essential and saved me tons of time," says Guedelhoefer, currently a postdoctoral fellow at the University of California, Santa Barbara. He was able to reproduce and quantify results obtained in 1949 by F. Dubois, a French scientist, who first developed the techniques for partially irradiating planarians with x-rays.

But Guedelhoefer went further. He pinpointed the locations of stem cells and studied how far they dispersed using RNA whole-mount in situ hybridization (WISH), specifically adapted to planarians in Snchez Alvarado's lab. Using WISH, he observed both original stem cells and their progeny by tagging specific pieces of mRNA . The technique allowed him to determine that pluripotent stem cells can travel and produce different types of progeny at the same time.

Originally posted here:
Moving toward regeneration

Public release date: 28-Aug-2012 [ | E-mail | Share ]

Contact: Leslie Orr Leslie_Orr@urmc.rochester.edu University of Rochester Medical Center

University of Rochester Medical Center scientists believe they are the first to identify genes that underlie the growth of primitive leukemia stem cells, and then to use the new genetic signature to identify currently available drugs that selectively target the rogue cells.

Although it is too early to attach significance to the drug candidates, two possible matches popped up: A drug in development for breast cancer (not approved by the Food and Drug Administration), and another experimental agent that, coincidentally, had been identified earlier by a URMC laboratory as an agent that targets leukemia cells.

The research not only provides a better understanding of the basic biology of leukemia it uncovered genes not previously known to be associated with the disease -- but demonstrates a powerful strategy for drug discovery, said senior investigator Craig T. Jordan, Ph.D., the Philip and Marilyn Wehrheim professor of Medicine at URMC and the James P. Wilmot Cancer Center.

First author John Ashton, PhD, led the study, which was published this month in the journal Cell Stem Cell.

"Our work is both basic and translational, and is an example of a terrific collaboration," Jordan said. "We were able to use the latest technology to expand very strong basic laboratory concepts and conduct an intriguing analysis that may yield new insights for treatments of leukemia."

Jordan studies leukemia stem cells, which, unlike normal cells, renew uncontrollably and are believed to be the first cells at the root of malignancy. He collaborated with Hartmut (Hucky) Land, Ph.D. and Helene McMurray, Ph.D., investigators in the Biomedical Genetics Dept at URMC, who study the principle that cancer evolves from a unique, interactive network of genes that are governed by a distinct set of rules.

In 2008 Land's laboratory published a paper in Nature reporting on a pool of approximately 100 genes that cooperate to promote colon cancer. The Land laboratory coined the term CRG for "cooperation response genes," to emphasize the special synergy controlling this pool of genes. Land is the Robert and Dorothy Markin Professor and Chair of the Department of Biomedical Genetics at URMC, and co-director of the Wilmot Cancer Center.

The identification of CRGs broadened the view of cancer, Jordan said. Historically, scientists would study the intricacies of one or two individual pathways in a vast network of alterations. With the advent of CRGs, however, researchers now have a better picture of the sub-populations of genes that dole out instructions to primitive cancer cells, like controls on a circuit board. Depending on whether CRGs are turned off or on, patterns change and cancer either progresses or stops, Land's research showed.

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URMC researchers connect new genetic signature to leukemia

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08.29.12 -- Human Melanoma Stem Cells Identified

A cure for spinal cord injury? Diabetes? Macular degeneration? Hope or just hype? There are now some clinical trials using embryonic stem cells to treat serious diseases for which no other good therapy is currently available. But this is just the beginning of a major medical megatrend that will blossom forth in the coming years. Embryonic stem cells are present after a fertilized egg divides for two or three days. They have the seemingly miraculous ability to turn into any of the tissue types in the bodywhether brain neurons, beating heart cells, bone, or pancreatic islet cells. It is important to understand just where these cells come from. Those used in science are the byproduct of in vitro fertilization (IVF), cells taken from the often left over embryos that are otherwise discarded. In 1998, scientists under the leadership of Dr James Thomson at the University of Wisconsin, learned how to take some of the cells from these about to be discarded embryos and put them into a cell culture basically a fluid in which the cells can grow to produce more cells. These cells in turn can then be directed to grow into heart or lung or pancreas or other types of cells by the addition of various additives to the fluid in which they are growing. So it is from these discards that embryonic stem cells are available to us. Just to be clear. The blastocyst or embryo with its 32 or so cells is not grown in the culture dish. Rather, individual cells are removed and allowed to divide and grow. These are the so called embryonic stem cells. But no embryo is growing, just individual cells. It is true that much can be done with adult stem cells as discussed last time but science so far suggests that embryonic stem cells hold promise for much more benefit. It will probably be embryonic stem cells (or perhaps induced pluipotent stem cells see the first in this series) that pave the way for replacing the islet cells of the pancreas with new insulin producing cells to cure diabetes or replace the damaged cells in the brain that are key to Parkinsons disease. Some strongly feel that it is wrong to use cells from embryos. It is important to remember that these are fertilized eggs that were prepared for couples that could not conceive and so had eggs and sperm placed into a dish with special fluids. Experience has shown that success is better if the doctor implants a few embryos into the womans uterus rather than just one. But the doctor may have more than enough embryos and the extras will be discarded if the woman becomes pregnant. I look at it this way. Since the embryos will be destroyed anyway, why not use them for creating stem cells that perhaps many people with diverse diseases might benefit from. It is not dissimilar to transplanting the organs of a person who has died in a car accident rather than burying them in the grave. And the embryo, made up of just a few cells, is disrupted so each cell grows independently. Now the cells can be stimulated to become heart cells, liver cells or whatever and might be useful in treating a disease. It will take some years but there will certainly be major advances down the road in how we can repair, restore or replace damaged tissues or organs. The pace at which we benefit from stem cell therapy will be influenced by factors including cultural attitudes which in turn lead to legislative decisions and legal challanges. The issues revolving around federal funding via the NIH for research on embryonic stem cells reached the federal courts two summers ago and were further addressed by an appellate court in April of 2011. Cohen and Adashi, writing in the New England Journal of Medicine in May, 2011, gave a clear account of the debate in the courts. They concluded with It is difficult to overestimate the vast potential of stem-cell research. We believe we cannot afford to allow ongoing legal ambiguities to compromise this line of scientific pursuit. Quite the contrary, now is the time to pick up the pace with an eye toward realizing the hoped-for translational benefits. With statutory relief deemed unlikely to be provided before the 2012 elections, it appears all but inevitable that the matter of funding of human ESC research will have to be settled in a court of law. Of course that never happened and stem cell research is not high on the publics set of concerns for this years elections but the makeup of the coming Congress after the election could be relevant down the road. Here is an example of how stem cells could be used: islet cells on demand One day, and I believe it will occur within five to ten years, stem cells will be able to be mass grown into islet cells. They will be ready when the patient needs them. Just give them by vein and they will home into where they need to go. And if they are created from the process called nuclear transfer or adult cells reprogrammed from the patient by genes (iPSC) or proteins (piPSC) that I described previously, they probably will not be rejected because they will be developed to not provoke the immune system. But still, whatever process destroyed their own islet cells years before will probably still be functional. So these new cells may be destroyed over time as well, unless some new technology or drugs are developed to prevent this cell destruction by the body. But in the meantime, just come back for a new infusion whenever needed. Sort of like going to the gas station to refill the tank! Islet cells injected into the vein seem to know to go to the liver and live there and do their work. Bone marrow stem cells when injected by vein go to the bone marrow, take up residence and repopulate the marrow of the patient with leukemia who just got very aggressive treatments to eliminate all of his own marrow cells (and hopefully all of the leukemia cells as well.) But would all stem cells know where to go? Or what to do? Would they go to the heart after a heart attack or do they need to be infused directly into the coronary arteries or injected into the heart muscle itself? And stem cells or stem cells prompted to develop into brain cells will they need to be injected directly into those areas of the brain damaged by Parkinsons or Alzheimers diseases? These are but a few of the issues to be resolved with careful research. Here are just a few studies in progress, some in animals, some in humans and many in laboratory settings: iPS cells have been created for multiple different diseases by taking cells from affected patients such as diabetes type I, Lou Gehrigs disease (amyotrophic lateral sclerosis), Gauchers disease and muscular dystrophy. It is hoped that these cells will help explain the disease processes and their origination. In addition, they might prove useful in growing large numbers of mature cells that could in turn be used for drug screening and drug toxicity evaluations. And in this regard, iPSCs and piPSCs matured into cardiac cells are already being used by pharmaceutical companies to test new drugs for side effects. We all know that if we have a tooth pulled, thats it a tooth wont grow back. But an intriguing study has taken the cells of the progenitors of the molars from mouse embryos and grown them in culture for a few days. Meanwhile, a molar or two from multiple adult mice were extracted. Then the stem cells were implanted into that space and within two months the mice had new teeth with normal structure and strength, demonstrating that stem cells in the proper setting can lead to the re-growth of an organ or tissue. Think about the potential in humans to get a real new tooth rather than a prosthetic tooth or a bridge when a diseased or damaged tooth must be extracted. One of the most exciting studies to get underway was a phase 1 trial of stem cells in patients with spinal cord damage. The Geron Company began this FDA-approved trial in late 2010. They took human embryonic stem cells and from them derived oligodendrocyte progenitor cells; in other words, nerve cells. These were injected next to the spinal cord at the level of very recent injury. In extensive animal experiments, these cells were found able to cause the damaged spinal cord cells to remylinate (basically reapply an insulator as with the covering of an electric wire) and to create some type of nerve growth stimulation with remarkable restoration of some or all function. The rats began to move much more normally within just a week or so of the injection. Then came the human trial. It was Phase 1 meaning that it was all about studying if the injected cells would cause any toxicity. It is a good guess that they would not but because they were be used initially in low dosage (relative to what was used in the rats to obtain responses) so it is unlikely any functional improvement would occur. That would be the test in later trials (Phase 2 and 3) with higher cell numbers provided this Phase 1 study proceeded successfully. As it turned out, Geron Corporation ended the study after enrolling just four patients citing lack of adequate funding to continue. This left Advanced Cell Technology, Inc. as the only other American company conducting a study of embryonic stem cells for macular degeneration and for macular dystrophy in the eyes. They use embryonic stem cells to produce retinal epithelial pigment cells to be injected behind the retina in affected patients. Results will be forthcoming. Another very early Phase I study, this one using adult stem cells, is just beginning in Israel for amyotrophic lateral sclerosis (ALS). The patients own bone marrow stem cells will be treated in the laboratory with a proprietary process by BrainStorm Cell Therapeutics and then placed back into patients. So far 12 of 24 patients have been treated with no apparent adverse effects. The final results will be of real interest. As I said at the beginning, there is still much to be learned before stem cells will become routinely utilized for patient care but progress is real and the opportunities are exciting for a major transformation of medical care in the coming years. Here, as with genomics, we see the value and the importance of innovation. Scientists with good ideas taking the steps needed to bring new and until recently almost undreamed of possibilities to transform healthcare clearly a medical megatrend in the making.

Stephen C Schimpff, MD is an internist, professor of medicine and public policy, former CEO of the University of Maryland Medical Center and is chair of the advisory committee for Sanovas, Inc. and senior advisor to Sage Growth Partners. He is the author of The Future of Medicine Megatrends in Healthcare and The Future of Health Care Delivery- Why It Must Change and How It Will Affect You from which this post is partially adapted.

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Medical Megatrends Stem Cells – Part III

A colony of human embryonic stem cells. [Credit: Wikimedia Commons]Stem cells are a miraculous cellular material that can be used to repair nerve damage, or even grow brand new organs. Researchers from John Hopkins Hospital may have discovered a new way to create stem cells using your very own blood cells. This newly developed method could actually revert adult red blood cells back into stem cells as though they came from a 6-day-old embryo.

Technically, scientists have developed reverted blood cells back into stem cells before by using viruses to deliver state-reverting genes. Such a process, however, can have disastrous side effects, like mutated genes or cancers.

The new process developed by the John Hopkins, as published in PLoS One, circumvents the risky need for viruses by using plasmids, rings of DNA that, according to Johns Hopkins, "replicate briefly inside cells and then degrade." To ready the blood cells for the plasmids implantation, the scientists treated them with an electrical pulse to make their surface more porous.

Once the plasmids attach themselves to the blood cells they insert four additional genes into the cell. These additional genes cause the blood cells to revert into a more primitive state called induced-pluripotent stem cells (iPS). The researchers left some of these iPS cells to grow on their own in a petri dish, and left others to cultivate with some irradiated bone-marrow cells.

In the end, the scientists discovered that the dish with bone-marrow cells produced the superior crop of iPS cells within 7 to 14 days. The John Hopkins researchers also say that they have had success in creating stem cells with blood cells from adult bone marrow and circulating blood.

The research sounds promising, to say the least. The availability of stem cells, which can become to whatever kind of cells you need, could one day lead to all new types of therapies. The team is continuing its studies into the science by testing the quality of its newly formed iPS cells and their ability to convert into other cell types.

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John Hopkins Researchers Make Stem Cells From Blood Cells

IRVING, Texas, Aug. 27, 2012 /PRNewswire/ -- RBC Life Sciences, Inc. (RBCL) announced today that the Company's stem cell supplement, Stem-Kine, has been approved for importation and sale in Taiwan. Stem-Kine is marketed in Taiwan under the name SK Plus.

(Photo: http://photos.prnewswire.com/prnh/20120827/DA62543)

"Stem cells are early stage cells, formed primarily in bone marrow that can develop into any type of cell -- heart, brain, or other tissues. Stem cells circulate with the blood, congregating in diseased or damaged tissues, where they replace the injured cells with healthy new cells.

"Stem cells form the body's internal repair and rejuvenation system. Physicians consistently report that a greater number of the body's own adult stem cells results in more effective repair.

"Young people have higher levels of stem cells, and usually recover more quickly from injuries or illness. Beginning in our twenties, our stem cell levels begin a constant decline. However, we can increase our stem cell levels with exercise and healthy nutrition.

"Stem-Kine was developed as optimum nourishment to bone marrow, enabling it to produce more stem cells. In two published studies, Stem-Kine was shown to result in an increase of 50% to 100% in the subject's level of circulating stem cells over a prolonged period of time," stated Clinton Howard, CEO of RBC Life Sciences.

About RBC Life Sciences

Through wholly owned subsidiaries, RBC Life Sciences develops, markets and distributes high-quality nutritional supplements and personal care products under its RBC Life brand to a growing population of consumers seeking wellness and a healthy lifestyle. Through its wholly owned subsidiary, MPM Medical, the Company also develops and markets to health care professionals in the United States proprietary prescription and nonprescription products for advanced wound care and pain management. All products are tested for quality assurance in-house, and by outside independent laboratories, to comply with regulations in the U.S. and in more than thirty countries in which the products are distributed. For more information, visit the company's website at http://www.rbclifesciences.com.

The statements above, other than statements of historical fact, may be forward-looking. Actual events will be dependent upon a number of factors and risks including, but not limited to, changes in plans by the Company's management, delays or problems in production, changes in the regulatory process, changes in market trends, and a number of other factors and risks described from time to time in the Company's filings with the Securities and Exchange Commission.

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Stem Cell Supplement Approved In Taiwan

ROCKVILLE, Md., Aug. 27, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced the completion of the Phase I trial of its NSI-566 spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), with the eighteenth patient treated. This patient, the third to return to the trial for an additional set of injections, is also the last in the Phase I portion of the trial as it is currently designed, which is scheduled to conclude six months after this final surgery.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"We are delighted to have completed Phase I in this groundbreaking trial, the first approved by the FDA to test neural stem cells in patients with ALS," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer.

"There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections, and the first cohort of patients to receive both," said Jonathan D. Glass, MD, Director of the Emory ALS Center. "This has required incredible effort from the Emory medical and support team and I wish to express my thanks to all of them, as well as to acknowledge the generosity and courage of the patients and their families."

"We have found the procedure to be extremely safe," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "In some patients, it appears that the disease is no longer progressing, but it is too early to know if the result from that small number of patients is meaningful." Dr. Feldman is the principal investigator (PI) of the trial and an unpaid consultant to Neuralstem.

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 has been underway since January 2010. The trial was designed to enroll up to 18 patients, the last of which was just treated. 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. The last cohort of threereceived injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The entire 18-patient 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 is 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.

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Neuralstem Completes Phase I ALS Stem Cell Trial