Thirty Percent of Patients Show Improved Functioning after Stem Cell Therapy

Philadelphia, Pa. (May 17, 2012) One of the first long-term studies of stem cell treatment for spinal cord injury shows significant functional and other improvements in three out of ten patients, reports a study in the May issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The results support the safety of mesenchymal stem cells (MSCs) derived from the patient’s own bone marrow, showing “continuous and gradual motor improvement” in at least some patients with disability caused by spinal cord injury. The lead author of the new study was Dr. Sang Ryong Jeon of University of Ulsan College of Medicine, Seoul, South Korea.

Evidence of Improved Function after MSC Treatment for Spinal Cord Injury The researchers performed MSC transplantation in ten patients with permanent motor (movement) deficits or paralysis (paraplegia or quadriplegia) after spinal cord injury. Mesenchymal stem cells are a type of “multipotent” cell that can be cultured from adult bone marrow and induced to develop into many different types of cells.

The cultured MSCs were injected directly into the injured spinal cord and the surrounding (intradural) space. Additional cells were injected after another four and eight weeks. The results were assessed by measuring improvement in the patients’ ability to move their arms and hands and to perform key activities of daily living. Imaging scans and tests of muscle activity were performed as well.

During the first six months after MSC transplantation, six of the ten patients showed improvement in motor power of the arms and hands. Of these, three patients had gradual improvement in the ability to perform daily activitiesfor example, preparing meals and typing on a keyboard.

These three patients also showed significant changes on MRI scans of the spinal cord, including evidence of healing around the injured area of the spine. They also had improvement in electrophysiologic studies of muscle electrical activity.

No Long-Term Safety Problems of MSC Transplant None of the ten patients had any permanent complications related to MSC transplantation. This helps to alleviate concerns that MSC injection could lead to later problems like the development of tumors or calcifications.

Previous studies have shown promising results with MSC transplantation in animals and humans with spinal cord injury. Mesenchymal cells have some important potential advantages for stem cell therapy, as they are a relatively easily accessible source of the patient’s own cells. The ten patients treated by Dr. Jeon and colleagues represent the first attempt at direct spinal injection of MSCs for the treatment of spinal cord injury in humans.

Following up on a previous study reporting initial improvement in six patients, the new paper describes continued improvementincluding meaningful gains in the ability to perform everyday functional tasksin three patients. Dr. Jeon and colleagues note that all three patients with progressive improvement had some “residual neurological function.” They write, “Therefore, MSC treatment is more likely to enhance the remaining neurological function rather than rengeneration.” They call for further studies to understand the mechanism of improvement after MSC treatment and to clarify which patients with spinal cord injury are most likely to benefit.

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Stem Cells for Spinal Cord Injury: Some Patients Have Long-Term Improvement

GAITHERSBURG, MD–(Marketwire -05/16/12)- Cytomedix, Inc. (OTC.BB: CMXI) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, announced that the independent Data Safety Monitoring Board (DSMB) reviewing the safety data from the ongoing RECOVER-Stroke trial has recommended that the Phase 2 trial of ALD-401, a unique and differentiated stem cell population derived from patients’ own bone marrow, can continue as designed. This determination follows a review of the clinical safety data on the first 10 patients that were treated post-acutely for ischemic stroke.

The double-blind, placebo-controlled trial of 100 patients is designed to assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22 when administered between 13 and 19 days post the ischemic event. The primary endpoint of the study is safety and the secondary efficacy endpoint is neural function based on the modified Rankin Scale assessed at three months following treatment.

Currently being conducted at three clinical sites, the trial will now expand up to a total of approximately 15 U.S. clinical sites with this clearance by the DSMB. The study has gained Investigation Review Board (“IRB”) approval from a number of leading healthcare institutions under the guidance of key opinion leaders in the field of ischemic stroke. Additional DSMB reviews are scheduled at 30 and 60 patients per the clinical protocol.

Commenting on the clearance to continue the Phase 2 trial, Martin P. Rosendale, Chief Executive Officer, stated, “We are very encouraged by the decision of the DSMB to recommend the continuation of the RECOVER-Stroke trial and look forward to expanding this important trial to additional leading stroke clinical sites across the U.S. The only currently approved treatment options (tissue plasminogen activator (tPA) and mechanical retrievers) must be used within a very short time frame from the onset of the stroke. Consequently, less than 5% of stroke patients receive any approved treatments. ALD-401 is being delivered to patients suffering from the often devastating effects of ischemic stroke approximately two weeks following the stroke.

“Strokes remain one of the leading causes of long-term disability. With the majority of strokes occurring in patients 65 years and older, it is also a major financial burden for our healthcare system. Preclinical research with ALD-401 has shown improvements in motor function, in mitigation of the decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow in the brain. We are hopeful that ALD-401 will continue to demonstrate these regenerative activities in this trial and look forward to advancing its clinical development,” added Mr. Rosendale.

“We are grateful to our early investigators, which include the University of Texas Health Science Center at Houston, Duke University Medical Center, and the Los Angeles Brain and Spine Institute, for their support and guidance through the early enrollment of this trial. We also look forward to working with a number of premier academic and private health leaders as we expand the study. Importantly, we want to recognize the care and thoughtful guidance received from our independent DSMB,” commented James Hinson, M.D., Cytomedix’ Chief Medical Officer. “We just concluded an Investigator’s Meeting and were especially pleased and encouraged to see the underlying enthusiasm for this potential treatment option among leading clinicians in stroke treatment and research.”

About Stroke

According to the American Stroke Association, stroke is a disease that affects the arteries leading to and within the brain. It is the fourth leading cause of death and a leading cause of disability in the United States. A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts. When that happens, part of the brain cannot get the blood and oxygen it needs, so it starts to die. Strokes are typically classified into two major categories: ischemic and hemorrhagic. Approximately 800,000 patients in the United States suffer a stroke each year and approximately 87% of these strokes are ischemic.

About ALD-401

ALD-401 is the population of ALDHbr stem cells produced using Cytomedix’ proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. These adult stem cells express high levels of the enzyme ALDH, and preclinical research suggests that they may promote the repair of ischemic tissue damage. This is tissue damage caused by inadequate blood flow resulting from the obstruction of blood vessels supplying blood to the tissue. Investigators have completed preclinical research showed improvements in motor function, improvements in the slowing of decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow, or perfusion, in the brain.

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Cytomedix Announces Expansion of Phase 2 Study to Treat Post-Acute Ischemic Stroke at Up to 15 U.S. Clinical Sites

Animal stem cell regenerative therapy is the newest service at the Animal Hospital of Tiffin.

“We are the official first site for the therapy in Ohio,” said veterinarian Bob McClung.

The technology uses an adult animal’s stem cells to heal itself.

Veterinarian Mike Brothers performed the surgery Monday on his dog, Tucker, a 2-year-old labrador retriever. It was the second surgery performed at the clinic.

Brothers said his dog’s joint problems are hereditary and he’s had problems since he was a puppy.

“What we’ve been able to do is slow down the arthritis,” Brothers said. The cause of the degeneration will continue, but the fatty tissue removed from the dog can be used for future treatments.

From a piece of fatty tissue of the size removed from Tucker, McClung estimated $3.2 billion stem cells were harvested.

Each injection uses about 90 million cells, so there will be enough of the material for future treatments.

“We have basically 2 billion cells to bank,” he said. “We use cryo-preservation.”

In the freezing process, the cells are gradually cooled to prevent damage and stored in liquid nitrogen at temperatures of minus 80 to minus 90 degrees Fahrenheit.

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Vet undertakes stem cell surgery

Kolkata, May 15:

Stem cell banking companies are looking at aggressive marketing initiatives to move into the mass market segment. Direct marketing to customers and reduction in price tag for storing umbilical cord blood are on the cards.

The umbilical cord blood and cord tissue are one of the richest sources of stem cells and have potential to treat over 75 serious ailments.

The average cost for storing these for a period of 21 years ranges between Rs 75,000 and Rs 90,000 in India.

According to Chennai-based Life Cell, high price points and lack of proper marketing have limited the penetration of cord blood banking in India. Affordability is the key factor in India.

Only when the prices come down will we see more customers opting for the service. We are working on it (bringing down prices), Mr Mayur Abhaya Srisrimal, Executive Director Life Cell, told Business Line.

Stem cell bankers have already rolled out easy finance options such as EMIs to make the services attractive. CordLife, for instance, offers EMI facility for 12-24 months.

This has helped boost our sales. We have been acquiring 350-400 clients each month, said Managing Director, Mr Meghnath Roy Chowdhury.

Finance, however, is not the only stumbling block. Cord blood bankers have, so far, been depending largely on hospital network for signing up clients. Bangalore-based Ms Deepa Shankar, who is expecting and is due for delivery in June, recently opted for Life Cell services through the hospital.

It’s not a sustainable approach. We need to get into direct marketing for pushing up volumes growth, Mr Srisrimal points out. To strike a cord with the would-be mothers, the company has roped in Lisa Ray as brand ambassador. Ms Ray was cured of multiple myeloma courtesy stem cell therapy.

Continued here:
Stem cell banking firms to deploy marketing initiatives to boost sales

CARLSBAD, Calif.–(BUSINESS WIRE)–

International Stem Cell Corporation (OTCBB: ISCO.OB – News) (www.internationalstemcell.com) today announced that several of its leading scientists will present experimental results from three of ISCOs pre-clinical therapeutic programs.

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinsons disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinsons.

Secondly, the differentiation of hpSC and embryonic stem cells into cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases, says Dr. Ruslan Semechkin, Vice President of Research and Development.

The presentations will take place at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

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International Stem Cell Corporation Scientists to Present Pre-Clinical Research Results at American Society of Gene …

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Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

Multiple myeloma is a form of cancer where the plasma cells in the bone marrow grow out of control, causing damage to bones as well as predisposing patients to anemia, infection and kidney failure. A medical procedure called autologous hematopoietic stem cell transplantation, commonly known as a stem cell transplant, is frequently an important treatment option for many patients.

Unfortunately, multiple myeloma continues to progress even after a transplant. A study published today in the New England Journal of Medicine offers promising news about a new long-term therapy, lenalidomide, that can be used after transplantation to slow down the progression of the disease.

Thomas Shea, MD, Director of the Bone Marrow and Stem Cell Transplant Program and Associate Director for Outreach Programs at UNC Lineberger and Don Gabriel, MD, Professor of Medicine in the division of hematology/oncology, were both co-authors on the clinical trial, which measured the effect of maintenance lenalidomide therapy on disease-free progression after transplant.

The phase 3 study demonstrated that maintenance therapy with lenalidomide, an oral drug that can be taken for many months or even years, is associated with significant improvement in outcomes for patients with newly diagnosed myeloma who have undergone a transplant. The probability of surviving free of disease progression (the primary end point) for three years was 59 percent in the lenalidomide group, as compared with 35 percent in the placebo group.

“The results of this trial will change our treatment of multiple myeloma patients,” said Dr. Shea.

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Lenalidomide delays progression of multiple myeloma after stem cell transplant

By Cathy C. Yamsuan Philippine Daily Inquirer

Former President Joseph Erap Estrada had always maintained that giving generously to friends and forgiving opponents are the secrets to staying young.

But time has a way of catching up with even the most formidable leading men.

Since he entered national politics 25 years ago, Estrada has struggled with the attributes of old ageweight gain, a painful knee here, a cataract there.

He needed some kind of elixir of youth to put to right what nature has put asunder. And to get back on his feet in time to serve the people, he said which has no age limit.

So he did it, and is very open about it. What is it?

At the prodding of friends, the 75-year-old Estrada flew to Frankfurt, Germany, last month to undergo fresh cell therapy (also known as stem cell treatment), an innovative albeit controversial procedure where fresh cells from donor animals are injected into the human body to treat diseases or reverse the aging process.

Fresh cell therapy operates under the principle of like heals like.

The fresh cells from a donor animals organ are infused into the human counterpart.

Substances in the donors blood are supposed to reactivate the human bodys immune system and defense mechanism, a reaction that would eventually rebuild and revitalize aging tissues.

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

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Increasing Investment in Stem Cell Technology and Promising Research Outcomes Drives the Stem Cell Research Market …

Editor’s Choice Main Category: Ear, Nose and Throat Also Included In: Radiology / Nuclear Medicine;Cancer / Oncology;Stem Cell Research Article Date: 11 May 2012 – 10:00 PDT

Current Article Ratings:

The researchers note this finding could enhance the quality of life of 500,000 individuals with head and neck cancer each year worldwide.

The team found that the stem cells needed for regenerating the parotid gland (the largest pair of salivary glands) were primarily located in the major ducts of the gland. According to the researchers, these cells could be easily avoided during radiotherapy or given a minimal radiation dose.

Dr. Peter van Luijk, a research associate at the University Medical Center Groningen, The Netherlands, explained:

Findings from the study were presented at the 31st conference of the European Society for Radiotherapy and Oncology (ESTRO31).

Dry mouth syndrome is a condition in which there is not enough saliva in the mouth. The condition can occur when the parotid gland stops functioning properly after radiation damage.

Symptoms of dry mouth syndrome include difficulty sleeping, eating, tooth decay or loss, and bad breath. These symptoms lead to poorer quality of life and difficulty working, as well as social isolation.

The majority of treatments to treat the condition and its consequences are insufficient and can cost hundreds or even thousands of Euros per patient each year.

Dr. van Luijk said:

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Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

By Denise Mann HealthDay Reporter

THURSDAY, May 10 (HealthDay News) — A new treatment that involves spinning bone marrow stem cells to enhance their healing potential may help people with advanced heart failure feel and function better, a small study suggests.

Researchers developed the treatment by culturing a patient’s own bone marrow for 12 days. This process helped increase the amount of immune cells and stem cells that can differentiate into several different cell types, including heart cells. Those cells were then injected into heart muscle. The study was funded by treatment manufacturer Aastrom Biosciences.

According to the findings, this treatment was safe, helped repair the damaged heart muscle and reversed some heart failure symptoms, when compared to a placebo injection. The findings were to be presented Thursday at the Society for Cardiovascular Angiography and Interventions annual meeting, in Las Vegas.

The U.S. National Heart, Lung, and Blood Institute reports that about 5.8 million people in the United States have heart failure, a condition that occurs when the heart can no longer pump enough blood to meet the body’s needs. Symptoms include shortness of breath, fatigue and swelling in the ankles, feet, legs and abdomen. There is no cure; treatment typically includes a cocktail of medications aimed at reducing symptoms and improving quality of life.

“A number of people with heart failure have slowly progressing disease despite medication and/or device therapy. If we could have a therapy for this group that would slow the progression of heart failure, it would be economic and change the disease process tremendously,” said study author Dr. Timothy Henry, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis. The treatment would not be used for people who need a heart transplant.

Calling it the next generation of stem cell therapy, Henry said the treatment process helps enhance the potency of existing stem cells. “It gives a more functional product,” and when injected these stem cells may promote the growth of new blood vessels, he added.

Further study is ongoing, and if the results are positive a product could be available within two years to treat inadequate blood supply to the legs, and soon thereafter for heart failure, he said. According to Henry, six or seven new products that enhance bone marrow stem cells are being developed. “Ask your doctor if you are a candidate for any of the clinical trials,” Henry advised.

The new study included 22 participants with advanced heart failure and an enlarged heart whose current medication regimen was no longer effective. They either received an injection of the stem cell therapy treatment into their heart muscles or a placebo shot. After 12 months, there were no complications and no difference in side effects among those who received the stem cells and the control group. That said, individuals who received the novel stem cell therapy did have a lower number of major heart-related events and were more likely to see improvements in their ability to walk without growing breathless. Those who received the stem cell treatment also showed marked improvements in their ejection fraction, which is a measure of how much blood leaves the heart with each pump.

“This study tells us that injecting stem cells into the heart muscle of a patient with chronic heart failure may be beneficial,” says Dr. Sandeep Jauhar, director of the congestive heart failure program at Long Island Jewish Medical Center in New Hyde Park, N.Y. Typically, these individuals are treated with multiple medications, put on a low-salt diet and encouraged to get some exercise.

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Stem Cell Study Shows Promising Results Against Heart Failure

ROCKVILLE, Md., May 8, 2012 /PRNewswire/ –Neuralstem, Inc. (CUR) announced that the Federal Drug Administration (FDA) has approved the return of three patients from earlier cohorts in its ongoing Phase I safety trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells (HSSC’s). These patients will be permitted to return to the trial for second treatments as the next cohort of patients, provided they meet inclusion requirements at the scheduled time. They will be the first to receive stem cell transplantation along the length of the spinal cord.

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

The first twelve patients in the trial, which is taking place at Emory University Hospital in Atlanta, Georgia, received stem cell transplants in the lumbar (lower back) region of the spinal cord only. Thelast cohort of three, completed in April, received transplants in the cervical (upper back) region of the spinal cord, where stem cell transplantation could help support breathing, a key function that is lost as ALS progresses. The next cohort of three patients is designed to receive 10 HSSC injections in the lumbar region and 5 in the cervical, for a total of 15 injections along the length of the spinal cord. In the case of the returning patients, who have already received 10 lumbar injections, they will receive five cervical injections. These patients are between 15-17 months out from their first dosing and appear to have tolerated the first procedure well.

Additionally, Neuralstem has submitted a trial amendment to the FDA to increase both the number of patients treated as well as the dose in future cohorts. The amendment would also expand the trial to include certain efficacy endpoints. The trial was initially designed as a safety trial to treat 18 patients.

“The return of these patients to the trial for second treatments is a continuing validation of the trial’s safety. Typically, Phase I trials do not bring study subjects back, as that could increase their exposure to potentially harmful treatments,” said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. “Treating these patients who have already received injections in one part of their spine allows us to both increase the overall dosage for each patient as well as transplant them in regions of the spine where they have not been treated,” Dr. Johe continued. “Thisnext cohort of patients will be the first in the world to receive stem cell transplants in both cervical and lumbar regions of their spinal cord. With cervical injections of the lumbar patients, for example, we could also potentially support their breathing function, which is vital for preserving quality of life.”

“Patients 10-12, who might return to the trial, were among those studied in a paper examining the first safety data from the trial, published online in STEM CELLS last month,” 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. “As the paper showed, we believe that the cells and the route of administration are safe. It is a further validation of the safety profile to be able to bring patients back for additional dosing several months past the period which was reported on in the journal.” Dr. Feldman is also principal investigator (PI) of the ALS trial and an unpaid Neuralstem consultant.

The FDA-approved amendment to the protocol requires approval of the Emory Institutional Review Board before it can be implemented.

About the Study

The ongoing Phase I study is designed to assess the safety of Neuralstem’s spinal cord stem cells (HSSC’s) and transplantation technique in up to 18 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease).

The first twelve patients were all transplanted in the lumbar (lower back) region of the spine. Of these, the initial six (Cohort A) were all non-ambulatory with permanent paralysis. The first patient was treated on January 20, 2010. Successive surgeries have followed at the rate of one every one-to-two months. The first three patients (Cohort A1) were each treated with five unilateral HSSC injections in L2-L4 lumbar segments, while the next three patients (Cohort A2) received ten bilateral injections (5 on each side) in the same region. The next six patients (Cohort B and C) were all ambulatory. Of these, the first three (Cohort B) received five unilateral injections in the L2-L4 region. The last three patients (Cohort C) in this study group received ten bilateral injections in the same region.

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Neuralstem Updates ALS Stem Cell Trial Progress

Public release date: 8-May-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (May. 8, 2012) Two studies appearing in a recent issue of Cell Transplantation (20:11-12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, evaluate stem cells derived from dental tissues for characteristics that may make them therapeutically useful and appropriate for transplantation purposes.

Induced pluripotent stem cells from immature dental pulp stem cells

A Brazilian and American team of researchers used human immature dental pulp stem cells (IDPSCs) as an alternative source for creating induced pluripotent stem cells (iPSCs), stem cells that can be derived from several kinds of adult tissues. According to the study authors, production of iPSCs “opens new opportunities for increased understanding of human genetic diseases and embryogenesis” and will likely have a “great impact on future drug screening and toxicology tests.”

The authors note, however, that the reprogramming methodology for making iPSCs is relatively new and “needs refining” in terms of technique, efficiency and cell type choice.

The researchers report that they easily, and in a short time frame, programmed human immature dental pulp stem cells into iPSCs with the hallmarks of pluripotent stem cells.

“Human IDPSCs can be easily derived from dental pulp extracted from adult or ‘baby teeth’ during routine dental visits,” said study lead author Dr. Patricia C.B. Beltrao-Braga of the highly ranked National Institute of Science and Technology in Stem and Cell Therapy in Ribeirao Preto, Brazil. “hIDPSCs are immunologically privileged and can be used in the absence of any immune suppression protocol and have valuable cell therapy applications, including reconstruction of large cranial defects.”

Contact: Dr. Patricia C.B. Beltrao-Braga, National Institute of Science and Technology in Stem Cell and Cell Therapy, 2051 Tenente Catao Roxo St. Ribeirao Preto, Brazil. Tel. 55 (11) 3091-7690 Email patriciacbbbraga@usp.br

Citation: Beltro-Braga, P. C. B.; Pignatari, G. C.; Maiorka, P. C.; Oliveira, N. A. J.; Lizier, N. F.; Wenceslau, C. V.; Miglino, M. A.; Muotri, A. R.; Kerkis, I. Feeder-free derivation of induced pluripotent stem cells from human immature dental pulp stem cells. Cell Transplant. 20(11-12):1707-1719;2011.

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2 Cell Transplantation studies impact dental stem cell research for therapeutic purposes

UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.

In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.

“We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance,” said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. “Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system.”

To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.

Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:

a human/rhesus macaque TRIM5 isoform, which disrupts HIV from uncoating in the cytoplasm a CCR5 short hairpin RNA (shRNA), which prevents certain strains of HIV from attaching to target cells a TAR decoy, which stops HIV genes from being expressed inside of the cell by soaking up a critical protein needed for HIV gene expression These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.

The results were successful on all counts.

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Novel stem cell transplantation holds promise for HIV prevention

MONTRAL, April 30, 2012 /CNW/ – Canada’s most coveted stem cell prize will be awarded to a Stem Cell Network researcher who has used drug screening to find a potential new treatment for a deadly form of cancer.

Dr. Aaron Schimmer, associate professor in the University of Toronto’s Department of Medical Biophysics and a clinician-scientist in the Princess Margaret Cancer Program/Ontario Cancer Institute at University Health Network, has received the 2012 Till & McCulloch Award, presented each year by the Stem Cell Network in recognition of the year’s most influential peer-reviewed article by a researcher in Canada. Dr. Schimmer will accept the award and present a lecture entitled “Novel therapeutic strategies to target leukemia stem cells” as part of the Till and McCulloch Meetings in Montral at 2 p.m. this afternoon.

In an advance interview, Dr. Schimmer described his findings and their potential as a new drug therapy in the treatment of leukemia.

“When you treat patients with leukemia, you can kill off 99 per cent of their leukemic cells with just about anything, and yet, 80 per cent or more of patients relapse,” Schimmer explained. “When we examined this in a really objective way, the question was not how to kill off those bulk cells – we already knew how to do that – but are we really missing a critical component of what we should be targeting?”

Dr. Schimmer and his team eventually found that cutting off the energy production capacity of bulk leukemia cells and leukemia stem cells was a way of treating the disease, and that the compound tigecyclinean FDA-approved antibiotic sometimes used to treat skin and abdominal infectionswas up to the task.

“Tigecycline appeared to work by essentially shutting down the energy supply of the leukemia cells and stem cells,” said Dr. Schimmer. “Essentially it is like producing a selective power outage in leukemia cells but not normal cells.”

By focusing on FDA-approved drugs, Dr. Schimmer was able to produce results that were quickly translated into clinical trials. Less than two years passed between his initial findings and the commencement of a phase-one clinical triala process that can otherwise take three or four times that long.

“It is incredibly impressive how much progress Dr. Schimmer has made in such a short period of time by using these stem cell screening techniques,” said Stem Cell Network Scientific Director Michael Rudnicki. “By identifying drugs which are already approved for human therapies and testing their efficacy in treating diseases such as leukemia, Dr. Schimmer has shaved years off of the clinical trial process. It is likely that his discovery will improve the outcomes for many patients in the near future.”

In 2005, the Stem Cell Network established the Till & McCulloch Award in honour of Canadians Drs. James Till and Ernest McCulloch, whose pioneering work established the field of stem cell research. The Award had been granted at the Stem Cell Network’s Annual Scientific Meeting, but became part of the Till & McCulloch Meetings this year.

The previous winner was Timothy Caulfield, who was recognized for his global leadership in the field of stem cell ethics.

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Dr. Aaron Schimmer Receives the Till and McCulloch Award – Award Lecture to be Presented Today on Drug Screening with …

South San Francisco, CA (Marketwire) – VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, has secured a new United States patent covering the company’s proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, (U.S. Patent 11/445,733), titled “Toxicity Typing Using Liver Stem Cells,” cover all mammalian liver stem cells — rat and mouse cells, for example, in addition to human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS).

H. Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Scientific Officer, said, “This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. The specific sets of genes that are affected become a profile of that drug.”

VistaGen’s new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity. Using sophisticated “pattern matching” database tools, drug developers can analyze these related profiles to determine “gene expression signatures” that are common and predictive of drugs that produce specific types of toxicity.

“Without this database capability, a drug’s single gene expression profile could not be interpreted,” Dr. Snodgrass added. “The ability to use liver stem cells to differentiate drug-dependent gene expression profiles, and to compare those profiles of drugs known to induce toxic liver effects, provides a powerful tool for predicting liver toxicity of new drug candidates, including drug rescue variants.”

Shawn K. Singh, VistaGen’s Chief Executive Officer, stated, “Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube platform. This new liver toxicity typing patent further solidifies our growing IP portfolio, and supports the continuing development of LiverSafe 3D, our human liver cell-based bioassay system, which complements our CardioSafe 3D human heart cell-based bioassay system for heart toxicity.”

About VistaGen Therapeutics VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen’s small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson’s disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen’s Facebook page at http://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward Looking Statements The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen’s ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen’s stem cell technology-based Human Clinical Trial in a Test Tube platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen’s research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

SOURCE: VistaGen Therapeutics, Inc.

Originally posted here:
VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used To Test Drug Candidates For Liver Toxicity

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MissionIR News – VistaGen Therapeutics Awarded U.S. Stem Cell Technology Patent Covering Methods Used to Test Drug …

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Calcutta News.Net Friday 27th April, 2012 (IANS)

The Directorate General of Health Services has established a stem cell division to evaluate proposals concerning stem cell research, Health and Family Welfare Minister Ghulam Nabi Azad said here Friday.

Speaking in the Lok Sabha, Azad said the stem cell division was established within the Biological Division in Central Drugs Standard Control Organisation for the internal evaluation of all proposals, including stem cell concerning with clinical trial and marketing authorisation.

“Till recently, there was no mechanism in place to take note of the cases violating these guidelines or take action against the agencies found violating these guidelines,” said Azad.

The Indian Council of Medical Research and the Department of Biotechnology have jointly formulated guidelines for stem cell research and therapy to help experts and scientists working in the field conduct research responsibly and ethically sensitive manner.

However, in view of the recent development in the field, the guidelines will be revised this year.

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Stem cell division to evaluate clinical trials