Stem-cell company in crisis

PROFESSOR MIODRAG STOJKOVIC/SCIENCE PHOTO LIBRARY

Advanced Cell Technology is running the only US trials of embryonic-stem-cell therapies.

Advanced Cell Technology (ACT), a biotechnology company based in Marlborough, Massachusetts, has long flirted with fame and bankruptcy.

The company is running the only US Food and Drug Administration (FDA)-approved clinical trials of embryonic stem (ES)-cell therapies. Later this month, ACT plans to report preliminary results from three trials to test the safety of its treatment for two different forms of vision loss. If all goes well, it could be the first clinical demonstration of the safety and perhaps also the therapeutic potential of ES cells.

Yet a series of financial missteps could cost ACT the opportunity to see that potential become reality. On 22 January, the firm announced that its chief executive, Gary Rabin, was stepping down. The news came a month after ACT which had US$5.5 million in cash on-hand as of 30 September 2013 announced that it would pay $4 million to settle a Securities and Exchange Commission (SEC) charge alleging that the company had illegally sold billions of shares of stock.

Thats a big hit for any biotechnology company, says Gregory Bonfiglio, a venture capitalist with Proteus Venture Partners in Portola Valley, California. This is a very painful time for them.

ACT is accustomed to the pain: it has been running on fumes for years and has repeatedly skirted bankruptcy. The company announced this week that it aims to begin the next round of its clinical trials in the second half of 2014. But its last quarterly statement, which covered the period ending 30 September, revealed that the company had only enough funds to last into the second half of 2014. ACT spokesman David Schull says that the firm is exploring all financing options and plans to expand its clinical operations to accommodate the upcoming trials.

That financing may have to carry ACT through additional legal charges. The settlement with the Securities and Exchange Commission was just one of a string of cases ACT has handled over the past few years as it dealt with the legacy left by the fundraising schemes of its previous chief executive, William Caldwell. One such case is still pending, and the SEC has launched a separate investigation of Rabin for distributing stock without reporting it to the SEC in a timely fashion.

More recently, on 2 January, the Wisconsin Alumni Research Foundation (WARF) sued ACT for breach of contract. WARF, which handles patents and licensing for the University of Wisconsin, holds a number of key ES-cell patents, and ACT struck a licensing deal with the foundation in 2007. The case has been sealed, and lawyers representing WARF did not respond immediately to requests for comment.

ACT may soon have company in the clinic. The London Project to Cure Blindness has been developing an ES cellderived therapy to treat age-related macular degeneration, a leading form of vision loss in people aged 50 and older.

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Stem-cell company in crisis

Pluristem stem cell treatment for muscle injury meets main goal

TEL AVIV (Reuters) - Pluristem Therapeutics Inc said results from its early/mid-stage clinical trial indicated its placenta-derived stem cells for the treatment of muscle injury were safe and provided evidence the cells might be effective in treating orthopedic injuries.

"Patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group," Israel-based Pluristem said in a statement on Tuesday.

The trial was conducted at the Orthopedic Clinic of the Charite University Medical School under the auspices of the Paul-Ehrlich-Institute, Germany's health authority.

"This was a very important study not only for Pluristem but for the cell therapy industry in general," Pluristem chief executive Zami Aberman said. "Based on these results, we intend to move forward with implementing our strategy towards using PLX cells in orthopedic indications and muscle trauma."

The injured muscle studied was the gluteus medius muscle in the buttock. Total hip replacement surgery via the standard transgluteal approach necessitates injury of the gluteus medius muscle, and post-operative healing is crucial for joint stability and function.

"The study showed that PLX-PAD cells were safe and well tolerated," the statement said.

The primary efficacy endpoint of the study was the change in maximal voluntary isometric contraction force of the gluteal muscle six months after surgery.

Efficacy was shown in two groups treated with the cells, with one group receiving a 150 million cell dose displaying a 500 percent improvement over the placebo group. Patients treated with a 300 million cell dose showed a 300 percent improvement over the placebo.

An analysis of the gluteal muscle indicated an increase in muscle volume in those patients treated with PLX-PAD cells versus the placebo group.

(Reporting by Tova Cohen)

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Pluristem stem cell treatment for muscle injury meets main goal

Scientists Find That Estrogen Promotes Blood-Forming Stem Cell Function

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Newswise DALLAS Jan. 22, 2014 Scientists have known for years that stem cells in male and female sexual organs are regulated differently by their respective hormones. In a surprising discovery, researchers at the Childrens Medical Center Research Institute at UTSouthwestern (CRI) and Baylor College of Medicine have found that stem cells in the blood-forming system which is similar in both sexes also are regulated differently by hormones, with estrogen proving to be an especially prolific promoter of stem cell self-renewal.

The research, published in Nature, raises several intriguing possibilities for further investigation that might lead to improved treatments for blood cancers and increased safety and effectiveness of chemotherapy.

Before the finding, blood-forming stem cells were thought to be regulated similarly in both males and females, according to the papers senior author, Dr. Sean Morrison, Director of CRI, Professor of Pediatrics, and the Mary McDermott Cook Chair in Pediatric Genetics at UTSouthwestern Medical Center.

However, while working in Dr. Morrisons laboratory as postdoctoral fellows, Dr. Daisuke Nakada, the first and co-corresponding author of the study, and Dr. Hideyuki Oguro discovered that blood-forming stem cells divide more frequently in females than in males due to higher estrogen levels. The research, conducted using mice, demonstrated that the activity of blood-forming stem cells was regulated by systemic hormonal signals in addition to being regulated by local changes within the blood-forming system.

This discovery explains how red blood cell production is augmented during pregnancy, said Dr. Morrison. In female mice, estrogen increases the proliferation of blood-forming stem cells in preparation for pregnancy. Elevated estrogen levels that are sustained during pregnancy induce stem cell mobilization and red cell production in the spleen, which serves as a reserve site for additional red blood cell production.

The study involved treating male and female mice over a period of several days with amounts of estrogen needed to achieve a level consistent with pregnancy. When an estrogen receptor that is present within blood-forming stem cells was deleted from those cells, they were no longer able to respond to estrogen, nor were they able to increase red blood cell production. The results demonstrate that estrogen acts directly on the stem cells to increase their proliferation and the number of red blood cells they generate.

If estrogen has the same effect on stem cells in humans as in mice, then this effect raises a number of possibilities that could change the way we treat people with diseases of blood cell-formation, said Dr. Morrison. Can we promote regeneration in the blood-forming system by administering estrogen? Can we reduce the toxicity of chemotherapy to the blood-forming system by taking into account estrogen levels in female patients? Does estrogen promote the growth of some blood cancers? There are numerous clinical opportunities to pursue.

Research support for Dr. Morrison came from the Cancer Prevention and Research Institute of Texas (CPRIT); the National Heart, Lung, and Blood Institute; the Howard Hughes Medical Institute; and donors to Childrens Medical Center Foundation. Dr. Nakada is now a CPRIT Scholar and Assistant Professor of Molecular and Human Genetics at Baylor College of Medicine. The research was initiated in the Life Sciences Institute at the University of Michigan and completed at Baylor College of Medicine and CRI.

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Scientists Find That Estrogen Promotes Blood-Forming Stem Cell Function

Teen battling rare disease

A YOUNG FOOTBALLER continues to seek help in his fight against a rare blood disease.

Joshua Sobers-Henry and his immediate family are asking for financial assistance as the teenaged goalkeeper looks to head to the United States later this week for stem cell treatment in his battle with aplastic anaemia.

News of Sobers-Henrys rare condition broke on the Barbados Soccer Academys Facebook page as his family and club members continue to appeal to the public for blood donations and monetary assistance.

He has an appointment for Monday in Washington at the National Institute of Health (NIH) in Bethesda, Maryland, where he starts stem-cell treatment for six months so we need as much help as we can get, explained Sobers-Henrys mother Carolann in an interview with MIDWEEKSPORT yesterday.

And even then it all depends on how the body reacts to the treatment because if it doesnt [respond positively] then we have to look at doing a bone marrow transplant.

Aplastic Anaemia is an extremely rare blood disorder in which the bodys bone marrow doesnt make enough new blood cells and if left untreated, has a high risk of death.

At present, Sobers-Henry receives blood transfusions at the Queen Elizabeth Hospital, but his blood type AB positive is not as common as others and isnt always available.

But those transfusions are just temporary as he needs to start stem cell treatment as soon as possible if he is to successfully overcome the disease.

The situation unfolded last November when Sobers-Henry inexplicably started to get regular headaches after playing for both Coleridge and Parry and the St Lucy constituency side.

At first it was thought to be just the flu, but later tests showed positive for the rare blood disorder after his eyes, tongue and finger tips all turned white one day.

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Teen battling rare disease

Stem Cell Treatment – Stem Cell Therapy – Stem Cell …

Stem Cell Therapy

Stem cell treatment and stem cell therapy may be considered controversial and are, perhaps, viewed as akin to science fiction by some people. However, stem cell treatments have been used regularly in veterinary practice since 2003 for the repair of bone and tissue damage, and have a wealth of research highlighting their efficacy in both humans and other animals. Stem cells are found in plentiful supply in embryonic tissue, but are also found in adult tissues. These cells have the ability to self-renew, giving rise to countless generations of new cells with varying abilities to differentiate into specific cell types. By introducing stem cells into an area of damage or pathology, the body can be encouraged to repair and renew regardless of how old the trauma is. Stem cells also show application for inhibiting the death of cells (apoptosis) through disease, making them candidates for use in treating degenerative illnesses such as Lou Gehrigs disease, Multiple Sclerosis, Parkinsons disease and Alzheimers.

Stem cells from embryos are considered more flexible in terms of their ability to become either new liver cells, new neurons, new skin cells, and so on, whereas adult stem cells tend to be more restricted to the tissue type from which they were taken. New research is showing that this might not necessarily have to remain the case however, with the plasticity of adult stem cells now under investigation. Stem cell use carries little risk of the resulting tissues being rejected, it appears safe, efficient, and almost endless in its possibilities for application.

Potential Stem Cell Treatments

Conditions such as cardiovascular disease, diabetes, spinal cord injury, and cancer, among others, are considered possible candidates for stem cell treatment. Cures for some of these diseases could be closer than previously thought with clinical trials already showing impressive results where stem cells have been used in cases thought intractable. The rapid rate of progression in research and clinical use means that some of the controversial issues, such as the use of embryos as a source of stem cells, have been overcome, with governments around the globe subtly altering their legal policies in order to accommodate new scientific advances. In the US, Bill Clinton was the first president to have to consider the legal issues surrounding stem cells, and subsequent presidents have been forced to readdress the issues time and again in line with medical discoveries. Worldwide, governments have remained generally cautious over the use of this technology but are gradually improving funding access, whilst keeping an eye on the ethics of stem cell treatment, in order to explore the tremendous benefits that appear possible. The credibility of research remains a concern, with some stem cell studies discredited by ethics committees after initial general acceptance of their veracity.

Stem cells may be garnered from living adult donors and, indeed, already are in the case of bone marrow transplants. More usually they are taken from discarded embryos leftover after IVF treatment, or from the placenta after birth. Previously the removal of stem cells resulted in the destruction of these embryos, but now it is possible for scientists to remove the stem cells without this occurring. This development negates some of the criticism faced by the technology from religious groups and ethical bodies over the sanctity of life and the attribution of sentience and autonomy to embryos, gametes, and the foetus. Clearly, some debate remains about these issues in relation to stem cell research, but recent improvements in methodology may remove the need for these considerations completely. Clinicians have demonstrated the possibility of taking adult stem cells and seemingly teaching them to become cells of a different type to their site of removal, effectively returning them to a similar state to that of the embryonic stem cell. Whilst stem cells from embryos remain more reliable and more economical to work with, the use of adult tissue-derived stem cells could revolutionize the research in this field.

As well as stem cell use in pathology and disease, there are also applications in personal aesthetics such as the regeneration of hair follicles and an end to baldness through stem cell treatment. Stem cells are also considered useful in regenerating the skin after injury, without the scarring usually associated with repair. There are reports of paralyzed patients becoming mobile after years in a wheelchair through the use of stem cells injected into the spinal cord, and the rapid disappearance of tumors in brain tissue after stem cells were injected.

Stem cell treatment provides an exciting possibility to change the face of modern medicine, alleviating pain and suffering, and improving the prognosis for millions withe diseases previously thought incurable.

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Stem Cell Treatment – Stem Cell Therapy – Stem Cell ...

Stem Cell Therapies for Celiac Disease and IBD Now Offered in the United States

Tampa, FL (PRWEB) January 21, 2014

Regenerative Medicine Solutions (RMS), a global provider of stem cell treatments for degenerative diseases, is now offering Regenerative ColoTherapy (RCT), a proprietary stem cell treatment for people suffering with celiac and inflammatory bowel disease (IBD). Crohns disease and ulcerative colitis (UC) are two of the most notable conditions that fall under the IBD umbrella, affecting millions of people across the United States and the world.

It is estimated that there are 1.4 million cases of Crohns and colitis in the United States, which roughly translates to the population size of Philadelphia. Although Crohns, colitis, and celiac disease are very different conditions, affecting different areas of the intestines, treatment options are similar and mainly consist of diet modification, anti-inflammatories, and immunosuppressants.

In severe cases, sufferers use the restroom over 20 times a day and may require surgery to remove part of their intestine or colon. As you can imagine, symptoms of these disorders take a heavy toll on sufferers quality of life. Andrew, a 26-year-old RMS patient that suffers from ulcerative colitis underwent the Regenerative ColoTherapy.

For three years, I suffered from diarrhea, bleeding, painful stomach cramping, and being completely drained of energy, Andrew said. 90 days following the RCT procedure, I noticed considerable improvements in my symptoms. My bowel movements went from upwards of 20 times a day to less than five. This procedure was invaluable and in my opinion the best option for treating this disease.

As stem cells have the ability to differentiate into many different types of tissues and have been found to be immunomodulatory and anti-inflammatory in nature, their intrinsic healing capacity is highly beneficial for sufferers of celiac disease and IBD. RMS has harnessed the natural properties of stem cells in the form of Regenerative ColoTherapy, a unique stem cell treatment that utilizes stem cells from a patients own body for the regeneration and repair of damaged tissues in the intestines and colon.

Regenerative ColoTherapy treatments are being performed RMSs headquarters in Tampa, FL where it also operates its subsidiary company Lung Institute. To learn more about RCT or to schedule a free consultation call today at 1-855-469-5864.

About Regenerative Medicine Solutions

Regenerative Medicine Solutions (RMS) is a leading global provider of stem cell treatments for the treatment of an array of debilitating medical conditions. Notably, RMS performs Regenerative ColoTherapy an innovative treatment for people with celiac disease and IBD. For more information, visit MyRegenMed.com or call us today at 1-855-469-5864.

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Stem Cell Therapies for Celiac Disease and IBD Now Offered in the United States

Pluristem Gains Most in 17 Months on Stem-Cell Study

Pluristem Therapeutics Inc. (PSTI), the Israeli developer of stem-cell therapies, rose the most in more than 17 months after an experimental treatment showed promise in a study of 20 patients with muscle injuries.

The stock surged 22 percent to 16.18 shekels ($4.63) at 11:04 a.m. in Tel Aviv. Earlier it gained as much as 27 percent, the biggest increase since Aug. 6, 2012. The shares fell 15 percent yesterday ahead of the study results.

The early-stage clinical trial assessing Pluristems placental-expanded, or PLX-PAD, cells in people who had a buttock muscle injured during hip-replacement surgery found the treatment was safe, the company said in a statement today. Patients getting the injection also fared better in a muscle-contraction exercise six months later.

These are remarkable results that signal advances in the cell-therapy industry, Jason Kolbert, an analyst with Maxim Group LLC in New York, said at a press conference organized by Pluristem in Tel Aviv.

The study results suggest the stem-cell therapy could help treat a broader range of muscle and tendon injuries, according to the Haifa-based company. We intend to move forward with implementing our strategy towards using PLX cells in orthopedic indications and muscle trauma, Chief Executive Officer Zami Aberman said in the statement.

The results come after the U.S. Food and Drug Administration in June placed one of Pluristems most advanced studies on hold after a patient suffered an allergic reaction. The hold was lifted in September.

To contact the reporter on this story: David Wainer in Tel Aviv at dwainer3@bloomberg.net

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Pluristem Gains Most in 17 Months on Stem-Cell Study

Inhaled Stem Cells Might Replace Lost Neurons

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Intranasal stem cell therapy may one day treat brain disorders

Image: Jim Kopp

Many diseases of the central nervous system involve the death of neuronsso, theoretically, the replacement of dead cells should improve symptoms of degenerative disorders such as Parkinson's, Huntington's, amyotrophic lateral sclerosis (ALS) and Alzheimer's, as well as stroke and brain tumors. Stem cell therapy may do just that even though evidence of its effectiveness is mixed.

In any cell transplant procedure, the host organin this case, the brainmay reject its new additions. Further, it is unclear whether grafted cells can truly integrate into complex neural circuitry. Finally, current procedures require invasive surgical implantation, which can be expensive and risky. The surgery can cause neural inflammation, and the implanted cells may quickly die.

Intranasal administration may address at least some of these issues. Most important, it eliminates the need for surgery. Further, some research suggests that stem cells delivered intranasally are smartthey do not spread through the brain indiscriminately but instead target damaged cells.

Although it is difficult to predict when medical practice will adopt stem cell therapy for the brain, animal studies have produced some promising results. In a rat model of Parkinson's, for example, treatment with intranasal stem cells appeared to improve motor function and slow the neurological deterioration associated with the disease.

2014 Scientific American, a Division of Nature America, Inc.

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Inhaled Stem Cells Might Replace Lost Neurons

SmartChoice® Adult Stem Cell Procedures – Incredible pain relief in just one treatment – Video

SmartChoice Adult Stem Cell Procedures - Incredible pain relief in just one treatment
Patient Testimonial: Donna was a patient with severe knee and back pain. After just one treatment at SmartChoice, her life has significantly improved. Learn...

By: Hardesh Garg

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SmartChoice® Adult Stem Cell Procedures - Incredible pain relief in just one treatment - Video

New Development in Stem Cell Treatment

Physicians and researchers have used Hematopoietic Stem Cell Therapgy for more than 50 years to treat many diseases according to the National Institutes of Health. You ask, "What is Hematopoietic Stem Cell? The National Institutes of Health states it is a stem cell that is isolated from the blood or bone marrow and it can renew itself. Cells have long term and short term replicating ability. The classic source of these cells is through bone marrow. I recall a friend of mine dying at a young age, while waiting for a bone marrow transplant. It is sad to hear of those unable to find a donor while they wait for a transplant.

Have you ever asked, "Where do you find stem cells?" Well, they can come from several places such as bone marrow, the bloodstream, or the umbilical cord after it has been detached from the baby. Stem cells for transplant can come from your own body or from a donor's body. If they come from your body, they are generally taken and frozen before chemotherapy and radiation. This type of transplant is called autologous transplant. Then after chemotherapy and radiation treatment they are put back in your body to increase the number of good cells. If the transplant is from a donor, there must be testing to be sure of a perfect match.

Stem Cell Studies

Did you know there may be a stem cell treatment for the cure of baldness? If the clinical trials are successful, women can benefit from this as well as men. This new approach could increase the hair follicles. It would require fewer hair cells to grow in a lab culture, then the multiplied cells would be transplanted back into the bald or thinning hair area. Sounds like a plan to me.

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