Manila, Philippines The Department of Health (DoH) warned yesterday against the proliferation of commercial establishments offering stem cell treatment for medical or aesthetic purposes.

DoH Secretary Enrique T. Ona said the use and effects of stem cell therapy is still being investigated by doctors while the Food and Drugs Administration (FDA) has yet to release the standards and regulations governing the safety of its use. Although this technology holds promise, stem cell therapy is not yet part of standard of care and is considered an investigative procedure for compassionate use. Applications of stem cells for the treatment of malignancies, blood disorders, degenerative diseases (such as Alzheimers Disease), metabolic diseases (e.g. diabetes), and immune cell therapy are still under clinical evaluation and study, Ona said in a statement.

While research has shown that adult stem cells and umbilical cord stem cells are the safest and most ethical, the public is warned that claims of preventive and curative bene ts of stem cell therapy are still on their investigative stage. Thus, the Department of Health (DoH) advises the public to be cautious with stem cell therapies being promoted in the media or through word of mouth, he added.

The DoH noted that there is an increasing demand for the use of stem cells in cancer therapy, endorgan diseases, and regenerative medicine.

But until a conclusive study has been completed, health of cials said the public is strongly advised to avoid stem cell therapies which use the following as sources for stem cells: Embryonic stem cells, aborted fetuses, and geneticallyaltered and animal fresh cells.

The DoH will soon issue guidelines for the use of stem cell therapy and the process of giving license to facilities offering such services, Ona noted. (Jenny F. Manongdo)

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

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

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

Today's new findings show that:

Other recent findings discussed show that:

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

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

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

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

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

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

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

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

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

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

About Neuralstem

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

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

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

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Contact: Karen Robinson karobinson@som.umaryland.edu 410-706-7590 University of Maryland Medical Center

A new method of using adult stem cells as a model for the hereditary condition Gaucher disease could help accelerate the discovery of new, more effective therapies for this and other conditions such as Parkinson's, according to new research from the University of Maryland School of Medicine.

Scientists at the University of Maryland School of Medicine reprogrammed stem cells to develop into cells that are genetically similar to and react to drugs in a similar way as cells from patients with Gaucher disease. The stem cells will allow the scientists to test potential new therapies in a dish, accelerating the process toward drug discovery, according to the paper published online in the journal the Proceedings of the National Academy of Sciences (PNAS) on Oct. 15 (Panicker et.al.).

The study was funded with $1.7 million in grants from the Maryland Stem Cell Research Fund; researchers received a start-up grant for $200,000 in 2007 and a larger, five-year grant for $1.5 million in 2009.

"We have created a model for all three types of Gaucher disease, and used stem cell-based tests to evaluate the effectiveness of therapies," says senior author Ricardo Feldman, Ph.D., associate professor of microbiology and immunology at the University of Maryland School of Medicine, and a research scientist at the University of Maryland Center for Stem Cell Biology and Regenerative Medicine. "We are confident that this will allow us to test more drugs faster, more accurately and more safely, bringing us closer to new treatments for patients suffering from Gaucher disease. Our findings have potential to help patients with other neurodegenerative diseases as well. For example, about 10 percent of Parkinson's disease patients carry mutations in the recessive gene for Gaucher disease, making our research possibly significant for Parkinson's disease as well."

Gaucher disease is the most frequent lipid-storage disease. It affects 1 in 50,000 people in the general population. It is most common in Ashkenazi Jews, affecting 1 in 1,000 among that specific population. The disease occurs in three subtypes Type 1 is the mildest and most common form of the disease, causing symptoms such as enlarged livers and spleens, anemia and bone disease. Type 2 causes very serious brain abnormalities and is usually fatal before the age of two, while Type 3 affects children and adolescents.

The condition is a recessive genetic disorder, meaning that both parents must be carriers for a child to suffer from Gaucher. However, said Dr. Feldman, studies have found that people with only one copy of a mutated Gaucher gene those known as carriers are at an increased risk of developing Parkinson's disease.

"This science is a reflection of the mission of the University of Maryland School of Medicine to take new treatments from bench to bedside, from the laboratory to patients, as quickly as possible," says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. "We are excited to see where this research goes next, bringing new hope to Gaucher patients and their families."

Dr. Feldman and his colleagues used the new reprogramming technology developed by Shinja Yamanaka in Japan, who was recognized with this year's Nobel Prize for Medicine or Physiology. Scientists engineered cells taken from the skin of Gaucher patients, creating human induced pluripotent stem cells, known as hiPSC stem cells that are theoretically capable of forming any type of cell in the body. Scientists differentiated the cells to form white blood cells known as macrophages and neuronal cells.

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University of Maryland School of Medicine scientists develop stem cell model for hereditary disease

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

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

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

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

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

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

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

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

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

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

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Bay Area stem cell researchers see encouraging results

Hisashi Moriguchi presented his work at the New York Stem Cell Foundation meeting this week.

AP/Press Association

From the beginning, it seemed too good to be true. Days after Kyoto University biologist Shinya Yamanaka won a Nobel prize for his 2006 discovery of induced pluripotent stem (iPS) cells (see 'Cell rewind wins medicine Nobel'), Hisashi Moriguchi a visiting researcher at the University of Tokyo claimed to have modified that technology to treat a person with terminal heart failure. Eight months after surgical treatment in February, said a front-page splash in the Japanese newspaper Yomiuri Shimbun yesterday, the patient was healthy.

But after being alerted to the story by Nature, Harvard Medical School and Massachusetts General Hospital (MGH), where Moriguchi claimed to have done the work, denied that the procedure had taken place. No clinical trials related to Dr Moriguchi's work have been approved by institutional review boards at either Harvard University or MGH, wrote David Cameron, a spokesman for Harvard Medical School in Boston, Massachusetts. The work he is reporting was not done at MGH, says Ryan Donovan, a public-affairs official at MGH, also in Boston.

A video clip posted online by the Nippon News Network and subsequently removed showed Moriguchi presenting his research at the New York Stem Cell Foundation meeting this week.

If true, Moriguchis feat would have catapulted iPS cells into use in a wide range of clinical situations, years ahead of most specialists' predictions. I hope this therapy is realized in Japan as soon as possible, the head of a Tokyo-based organization devoted to helping children with heart problems told Yomiuri Shimbun.

But there were reasons to be suspicious. Moriguchi said he had invented a method to reprogram cells using just two chemicals: microRNA-145 inhibitor and TGF- ligand1. But Hiromitsu Nakauchi, a stem-cell researcher at the University of Tokyo, says that he has never heard of success with that method. He adds that he had also never heard of Moriguchi before this week.

Moriguchi also said that the cells could be differentiated into cardiac cells using a 'supercooling' method that he had invented. Thats another weird thing, says Nakauchi.

The article in which Moriguchi presented his two-chemical method, published in a book1 describing advances in stem-cell research, includes paragraphs copied almost verbatim from other papers. The section headed 2.3 Western blotting, for example, is identical to a passage from a 2007 paper by Yamanaka2. Section 2.1.1, in which Moriguchi describes human liver biopsies, matches the number of patients and timing of specimen extractions described in an earlier article3, although the name of the institution has been changed.

When contacted by Nature, Moriguchi stood by his publication. We are all doing similar things so it makes sense that wed use similar words, he says. He did admit to using other papers as reference.

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Stem-cell transplant claims debunked

ST. LOUIS Local cancer patients who need bone marrow transplants could soon have the option of sleeping in their own beds instead of staying in the hospital for weeks or months.

The region's first outpatient bone marrow transplant center is set to open later this month at St. Louis University Hospital.

Bone marrow transplants are most commonly used for certain patients with cancers of the blood including leukemia and lymphoma. Stem cells from bone marrow harvested from the patient or a donor are transplanted into the patient's bloodstream to replace diseased cells. Patients require chemotherapy before the transplant to kill the cancer cells, and antibiotics, blood transfusions and daily monitoring afterward.

Historically, patients were hospitalized up to two months or longer because side effects from the transplant can be life-threatening. In an effort to reduce costs of the transplant, which can reach several hundred thousand dollars, several U.S. cancer centers in the last 20 years pursued an outpatient option.

Since then, research published in the journal Nature has shown that infection rates and outcomes do not vary significantly if they are treated as inpatients or outpatients.

"We have patients who really don't need to be (in the hospital), they're as bored as can be," said Fran Poglajen, administrative director of nursing for hematology/oncology at SLU.

Stronger patients at low risk of transplant rejection will now have the option of going home each night, as long as they have a caregiver available 24 hours a day. If they develop a fever or other complications, they need to be admitted to the hospital.

The outpatient treatments can last two to 10 hours and are given each day for about a month.

The $3 million center at SLU Hospital includes 16 rooms in about 10,000 square feet. It was built on the site of the operating rooms of the former Bethesda Hospital. About 10 new jobs were created with the opening, and within a few years about 100 patients a year are expected to receive transplants there.

"Bone marrow transplant really has revolutionized treatment of malignant blood diseases," said Dr. Friedrich Schuening, SLU's director of hematology and oncology. Schuening ran the inpatient/outpatient bone marrow transplant center at Vanderbilt University before coming to St. Louis last year.

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SLU to open outpatient bone marrow transplant center

Kyodo / Reuters

Kyoto University Professor Shinya Yamanaka (left) and John Gurdon of the Gurdon Institute in Cambridge, England, at a symposium on induced pluripotent stem cells in Tokyo in April 2008

In a testament to the revolutionary potential of the field of regenerative medicine, in which scientists are able to create and replace any cells that are at fault in disease, the Nobel Prize committee on Monday awarded the 2012 Nobel in Physiology or Medicine to two researchers whose discoveries have made such cellular alchemy possible.

The prize went to John B. Gurdon of the University of Cambridge in England, who was among the first to clone an animal, a frog, in 1962, and to Shinya Yamanaka of Kyoto University in Japan who in 2006 discovered the four genes necessary to reprogram an adult cell back to an embryonic state.

Sir John Gurdon, who is now a professor at an institute that bears his name, earned the ridicule of many colleagues back in the 1960s when he set out on a series of experiments to show that the development of cells could be reversed. At the time, biologists knew that all cells in an embryo had the potential to become any cell in the body, but they believed that once a developmental path was set for each cell toward becoming part of the brain, or a nerve or muscle it could not be returned to its embryonic state. The thinking was that as a cell developed, it would either shed or silence the genes it no longer used, so that it would be impossible for a cell from an adult animal, for example, to return to its embryonic state and make other cells.

(MORE: Stem Cell Miracle? New Therapies May Cure Chronic Conditions Like Alzheimers)

Working with frogs, Gurdon proved his critics wrong, showing that some reprogramming could occur. Gurdon took the DNA from a mature frogs gut cell and inserted it into an egg cell. The resulting egg, when fertilized, developed into a normal tadpole, a strong indication that the genes of the gut cell were amenable to reprogramming; they had the ability to function as more than just an intestinal cell, and could give rise to any of the cells needed to create an entirely new frog.

Just as Gurdon was facing his critics in England, a young boy was born in Osaka, Japan, who would eventually take Gurdons finding to unthinkable extremes. Initially, Shinya Yamanaka would follow his fathers wishes and become an orthopedic surgeon, but he found himself ill-suited to the surgeons life. Intrigued more by the behind-the-scenes biological processes that make the body work, he found himself drawn to basic research, and began his career by trying to find a way to lower cholesterol production. That work also wasnt successful, but it drew him to the challenge of understanding what makes cells divide, proliferate and develop in specific ways.

In 2006, while at Kyoto University, Yamanaka stunned scientists by announcing he had successfully achieved what Gurdon had with the frog cells, but without using eggs at all. Yamanaka mixed four genes in with skin cells from adult mice and turned those cells back to an embryo-like state, essentially erasing their development and turning back their clock. The four genes reactivated other genes that are prolific in the early embryo, and turned off those that directed the cells to behave like skin.

(MORE: Ovary Stem Cells Can Produce New Human Eggs)

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Stem Cell Scientists Awarded Nobel Prize in Physiology and Medicine

Two scientists who discovered the developmental clock could be turned back in mature cells, transforming them into immature cells with the ability to become any tissue in the body pluripotent stem cells are being honored with the Nobel Prize in Physiology or Medicine.

The Nobel Prize honoring Sir John B. Gurdon and Shinya Yamanaka was announced today (Oct. 8) by the Royal Swedish Academy of Sciences.

Th duo's work revealed what scientists had thought impossible. Just after conception, an embryo contains immature cells that can give rise to any cell type such as nerve, muscle and liver cells in the adult organism; these are called pluripotent stem cells, and scientists believed once these stem cells become specialized to carry out a specific body task there was no turning back.

Gurdon, now at the Gurdon Institute in Cambridge, England, found this wasn't the case when in 1962 he replaced the nucleus of a frog's egg cell with the nucleus taken from a mature intestinal cell from a tadpole. And voila, the altered frog egg developed into a tadpole, suggesting the mature nucleus held the instructions needed to become all cells in the frog, as if it were a young unspecialized cell. In fact, later experiments using nuclear transfer have produced cloned mammals. [5 Amazing Stem Cell Discoveries]

Then in 2006, Yamanaka, who was born in 1962 when Gurdon reported his discovery and is now at Kyoto University, genetically reprogrammed mature skin cells in mice to become immature cells able to become any cell in the adult mice, which he named induced pluripotent stem cells (iPS). Scientists can now derive such induced pluripotent stem cells from adult nerve, heart and liver cells, allowing new ways to study diseases.

When Yamanaka received the call from Stockholm about his award, he was doing housework, according to an interview with the Nobel Prize website. "It is a tremendous honor to me," Yamanaka said during that interview.

As for his hopes for mankind with regard to stem cells, he said, "My goal, all my life, is to bring this technology, stem cell technology, to the bedside, to patients, to clinics." He added that the first clinical trials of iPS cells will begin next year.

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Stem Cell Discoveries Snag Nobel Prize in Medicine

Shinya Yamanaka of Japan and John Gurdon of Britain won the Nobel Prize for work in cell programming, a frontier that has nourished dreams of replacement tissue for people crippled by disease.

The two scientists found that adult cells can be transformed back to an infant state called stem cells, the key ingredient in the vision of regenerative medicine.

"Their findings have revolutionised our understanding of how cells and organisms develop," the Nobel jury declared on Monday. "By reprogramming human cells, scientists have created new opportunities to study diseases and develop methods for diagnosis and therapy."

Among those who acclaimed the award were Britain's Royal Society, Ian Wilmut, "father" of Dolly the cloned sheep, and a leading ethicist, who said it eased a storm about the use of embryonic cells.

Stem cells are precursor cells which differentiate into the various organs of the body.

They have stirred huge excitement, with hopes that they can be coaxed into growing into replacement tissue for victims of Alzheimer's, Parkinson's and other diseases.

Gurdon, 79, said he was grateful but also surprised by the honour, since his main research was done a half-century ago.

In 1962, he discovered that the DNA code in the nucleus of an adult frog cell held all the information to develop into every kind of cell.

This meant that an adult cell could in essence be reprogrammed.

His landmark discovery was initially met with scepticism, as the journey from immature to specialised cell was previously deemed irreversible.

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Stem cell pioneers win Nobel for medicine

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 contract and a Phase 2 option from the National Cancer Institute (NCI) valued up to $1,683,503. The SBIR Contract funds the development of CLT-009, a first-in-class, human allogeneic Megakaryocyte Progenitor Cell therapy for the treatment of thrombocytopenia in cancer patients and allows the Company to conduct studies to enable an Investigational New Drug (IND) Application to be filed with the FDA in the next two years.

Thrombocytopenia is characterized as a significant reduction in the concentration of circulating platelets. Platelets are crucial in the process of coagulation to stop bleeding, and thrombocytopenia can increase the risk of severe bleeding in patients. It is becoming an increasingly common problem among oncology patients and a significant dose-limiting toxicity, especially in the treatment of hematological malignancies. Chemotherapy and radiation therapy are the most common causes of thrombocytopenia because the platelet-producing cells, megakaryocytes, and their precursors are highly sensitive to myelosuppressive cytotoxics and ionizing radiation. Thrombocytopenia typically occurs during the initial cycles of high-dose chemotherapy and radiation therapy, usually 614 days after administration. According to Datamonitor, the estimated incidence of cancer patients who suffer from significant chemotherapy-induced thrombocytopenia worldwide was approximately 200,000 in 2008.

Occurrence of severe thrombocytopenia may require dose reductions for chemotherapy regimens which can impact subsequent disease control and survival, especially in the treatment of hematological malignancies such as acute leukemia and high-risk myelodysplastic syndrome. Current treatment options include platelet transfusions which are costly and labor intensive and are associated with risks such as contamination and transmission of viral and bacterial infections. Recombinant human interleukin-11 is the only approved agent for chemotherapy induced thrombocytopenia but its use is limited and has only modest efficacy and significant side effects. CLT-009, a human Megakaryocyte Progenitor Cell product, would be an alternative treatment option, providing the critical megakayocyte progenitor cellular support to rapidly produce platelets in vivo and shorten the duration of severe thrombocytopenia following chemotherapy treatment.

We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. This contract allows us to not only leverage our experience in developing cellular therapies but also provides us with the ability to bring CLT-009 closer to the clinic. Our unique product portfolio, which now includes CLT-009, along with our CLT-008 myeloid progenitor cell product and our therapeutic antibodies targeting cancer stem cells, demonstrates our continued commitment to developing novel products for the benefit of cancer patients.

In addition to this SBIR contract, Cellerant has previously received grants from the National Institute of Health (NIH) in 2008 2010 to conduct research studies in platelet recovery which it has successfully completed. In its previous studies, Cellerant demonstrated that megakaryocyte progenitor cells were able to produce human platelets in preclinical models with in vivo functionality similar to that of normal human platelets.

This program is funded with Federal funds from the National Institute of Health, Department of Health and Human Services, under Contract No.HHSN261201200076C.

About CLT-009

CLT-009 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Megakaryocyte Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional platelets in vivo. Cellerant is developing CLT-009 as an effective treatment for chemotherapy and radiation-induced thrombocytopenia in cancer patients.

About Cellerant Therapeutics

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Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

WEDNESDAY, Oct. 3 (HealthDay News) -- People who undergo the transplantation of stem cells taken from bone marrow, circulating blood or umbilical cord blood are more likely to develop risk factors for heart disease, such as high blood pressure, diabetes and high cholesterol, a new study contends.

Researchers from the American Society of Hematology noted that patients who were treated with chemotherapy or radiation before such a transplant -- called a "hematopoietic cell transplant," or HCT -- had a significantly higher risk for heart disease later in life.

"While we know that heart disease is a real concern for long-term HCT survivors, small sample sizes and a lack of long-term follow-up in previous studies have only allowed us to look at a small piece of the puzzle of how this chronic condition develops in these patients," the study's first author, Dr. Saro Armenian, medical director of the Pediatric Survivorship Clinic in the Childhood Cancer Survivorship Program at City of Hope in Duarte, Calif., said in a society news release.

"Our study sought to better determine the specific factors before and after transplant that can lead to heart disease in a large group of transplant recipients," Armenian explained.

In conducting the study, the researchers examined the medical records of nearly 1,900 hematopoietic cell transplant recipients to identify factors that could affect their development of risk factors for heart disease. The transplants occurred between 1995 and 2004, and the patients survived for at least one year after the treatment.

The investigators considered the patients' exposure to chemotherapy or radiation before the transplant, the type of hematopoietic cell transplant and whether they were treated for a serious transplant complication known as graft-versus-host disease.

Using the U.S. National Health and Nutrition Examination Survey, the researchers also projected heart disease risk factor rates for the general population.

The study found that high blood pressure, diabetes and high cholesterol were more common among long-term survivors of the blood-forming stem cell transplants.

The risk for developing diabetes was 1.5 times higher for hematopoietic cell transplant survivors who underwent total body radiation. Their risk for high cholesterol was 1.4 times higher. The researchers noted this was true regardless of the type of blood-forming stem cell transplant the patient received.

Although it's unclear why total body radiation increased these patients' risk for diabetes and high cholesterol, previous studies have shown that abdominal radiation may contribute to insulin resistance and an increase in belly fat among cancer patients.

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Stem Cell Transplant May Spur Heart Disease Risk: Study

And rightly so: stem-cell scientists have derived many types of cells from stem-cell precursors, but have in the past struggled with sex cells. The research by a team at Kyoto University provides a powerful model into mammalian development and infertility, but it is still a long way off from being used in human therapy.

Despite this fact, it did not stop the headlines in some of today's press screaming that infertile women could one day become pregnant by creating eggs from stem cells.

Evelyn Telfer, a reproductive biologist at the University of Edinburgh, told me this study has no clinical application to humans whatsoever because the tissue used in this study were all foetal and not adult cells.

Mitinori Saitou led a team using foetal mouse tissue from embryos or skin cells to create stem cells. Those stem cells were then genetically reprogrammed to become germ cells egg precursor cells.

These were then given a cocktail of "factors" to support their growth into mature eggs. The eggs were fertilised by IVF in the lab and then implanted into surrogate mice. Three baby mice were born and grew into fertile adults.

The fact that artificially manufactured eggs have gone on to produce healthy mice which are fertile is absolutely astounding and a great step forward for science. The results are published in the journal, Science.

But there are huge differences between human and mouse cells, not to mention the medical and ethical issues surrounding human ovarian tissue to culture cells.

Further clinical trials would be necessary using adult mouse cells first before we can start projecting that we can manufacture babies, and scientists need to learn so much more about how women form eggs.

So while this is major contribution to the field of reproductive biology, the study is not a ready-made cure for women with fertility problems.

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Stem cells: of mice and women?

Hopes of a cure for infertility in humans were raised Friday after Japanese stem cell researchers announced they had created viable eggs using normal cells from adult mice.

The breakthrough raises the possibility that women who are unable to produce eggs naturally could have them created in a test tube from their own cells and then planted back into their body.

A team at Kyoto University harvested stem cells from mice and altered a number of genes to create cells very similar to the primordial germ cells that generate sperm in men and oocytes -- or eggs -- in women.

They then nurtured these with cells that would become ovaries and transplanted the mixture into living mice, where the cells matured into fully-grown oocytes.

They extracted the matured oocytes, fertilised them in vitro -- in a test tube -- and implanted them into surrogate mother mice.

The resulting mice pups were born healthy and were even able to reproduce once they matured.

Writing in the US journal Science, which published the findings, research leader professor Michinori Saito said the work provided a promising basis for hope in reproductive medicine.

"Our system serves as a robust foundation to investigate and further reconstitute female germline development in vitro, not only in mice, but also in other mammals, including humans," he said.

Saito cautioned that this was not a ready-made cure for people with fertility problems, adding that a lot of work remained.

"This achievement is expected to help us understand further the egg-producing mechanism and contribute to clarifying the causes of infertility," he told reporters.

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Fertility hope in stem cell eggs

4 October 2012 Last updated at 18:31 ET By James Gallagher Health and science reporter, BBC News

Stem cells made from skin have become "grandparents" after generations of life were created in experiments by scientists in Japan.

The cells were used to create eggs, which were fertilised to produce baby mice. These later had their own babies.

If the technique could be adapted for people, it could help infertile couples have children and even allow women to overcome the menopause.

But experts say many scientific and ethical hurdles must be overcome.

Stem cells are able to become any other type of cell in the body from blood to bone, nerves to skin.

Last year the team at Kyoto University managed to make viable sperm from stem cells. Now they have performed a similar feat with eggs.

They used stem cells from two sources: those collected from an embryo and skin-like cells which were reprogrammed into becoming stem cells.

I just thought wow! The science is quite brilliant

The first step, reported in the journal Science, was to turn the stem cells into early versions of eggs.

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Skin cells become 'grandparents'

NEWARK, Calif., Oct. 4, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the first patient in its Phase I/II clinical trial in dry age-related macular degeneration (AMD) has been enrolled and transplanted. The trial is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) as a treatment for dry AMD, and the patient was transplanted with the cells yesterday at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas, one of the leading independent vision research centers in the United States. AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss and blindness in people over 55 years of age.

"This trial signifies an exciting extension of our on-going clinical research with neural stem cells from disorders of the brain and spinal cord to now include the eye," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Studies in the relevant animal model demonstrate that the Company's neural stem cells preserve vision in animals that would otherwise go blind and support the therapeutic potential of the cells to halt retinal degeneration. Unlike others in the field, we are looking to intervene early in the course of the disease with the goal of preserving visual function before it is lost."

David G. Birch, Ph.D., Chief Scientific and Executive Officer of the RFSW and Director of the Rose-Silverthorne Retinal Degenerations Laboratory and principal investigator of the study, added, "We are excited to be working with StemCells on this ground breaking clinical trial. There currently are no effective treatments for dry AMD, which is the most common form of the disease, and there is a clear need to explore novel therapeutic approaches."

In February 2012, the Company published preclinical data that demonstrated HuCNS-SC cells protect host photoreceptors and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease which has been used extensively to evaluate potential cell therapies. Moreover, the number of cone photoreceptors, which are responsible for central vision, remained constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed in the study. In humans, degeneration of the cone photoreceptors accounts for the unique pattern of vision loss in dry AMD. The data was published in the international peer-reviewed European Journal of Neuroscience.

About Age-Related Macular Degeneration

Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. AMD is a degenerative retinal disease that typically strikes adults in their 50s or early 60s, and progresses painlessly, gradually destroying central vision. According to the RFSW website, there are approximately 1.75 million Americans age 40 years and older with some form of age-related macular degeneration, and the disease continues to be the number one cause of irreversible vision loss among senior citizens in the United States with more than seven million at risk of developing AMD.

About the Trial

The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial will be an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina in the most affected eye. Patients' vision will be evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations will be performed at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study. Patients interested in participating in the clinical trial should contact the site at (214) 363-3911.

About HuCNS-SC Cells

StemCells' proprietary product candidate, HuCNS-SC cells, is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells. The Company's preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS, and to date has demonstrated human safety data from completed and ongoing clinical studies.

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StemCells, Inc. Announces First Transplant of Neural Stem Cells Into Patient in Clinical Trial for Dry Age-Related ...

LOS ANGELES--(BUSINESS WIRE)--

The producers of the longest running television health series American Health Journal, Windsor Broadcast Productions, are launching Innovations in Medicine, a new series to air on PBS SoCal. Produced by Windsor Broadcast Productions, the series will feature new developments, technology, procedures, and products in healthcare. The company is currently in production of its first six segments for the premiere 30-minute episode.

"Audiences have been demanding for this type of programming for years," said Executive Producer Roland Perez. "We regularly receive great feedback from stories we've produced on new medical equipment in beta testing that's not even FDA approved. People want to know whats going to be available to them."

With Innovations in Medicine Windsor will offer the first weekly show devoted to revealing compelling healthcare information previously available only from trade shows, healthcare insiders, medical journals and research newsletters.

Segments featured in the premiere episode include the glucose sensor company Dexcom and AVIIR Labs which focuses on advancing cardiovascular disease risk assessment, monitoring and an international stem cell story. The first episode of Innovations in Medicine is slated to premiere on SoCal PBS in November of 2012.

About Windsor Broadcast Productions

Founded in 1976, Windsor Broadcast Productions is located in Palm Desert, California. In 1988, they launched the nationwide syndicated program The American Health Journal which now reaches over 30 million homes. The American Health Journal has received over 92 national and international awards. The show is sponsored by Toshiba America and HF Healthcare.

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Windsor Broadcast Productions Launches New 30 Minute Series “Innovations in Medicine”

HOUSTON, Oct. 1, 2012 /PRNewswire/ --The Houston Stem Cell Summit will host an extraordinary lineup of keynote speakers who represent the most accomplished stem cell scientists, clinicians and entrepreneurs in the United States. Joining these distinguished speakers will be Governor of Texas, Rick Perry, consistent champion of adult stem cell therapies.

(Logo: http://photos.prnewswire.com/prnh/20120831/NY66463LOGO )

The Houston Stem Cell Summit will be held October 26 27 in its namesake city and will highlight the latest therapeutic research regarding the use of adult stem and progenitor cell therapies. The Summit will also provide a forum for entrepreneurs to discuss their latest efforts to commercialize stem cell therapies, and to debate and discuss FDA and other legal and regulatory issues impacting stem cell research and commercialization.

Opening Keynote Address October 26, 2012 Arnold I. Caplan, PhD, Professor of Biology and Professor of General Medical Sciences (Oncology) Case Western Reserve University

Dr. Caplan has helped shape the direction and focus of adult stem cell research and commercialization. Virtually every adult stem cell company and literally tens of thousands of research papers are based on Dr. Caplan's original and ground breaking research. Professor Caplan is considered to be the "father" of the mesenchymal stem cell and first described this progenitor cell in his landmark paper; "Mesenchymal stem cells", Journal of Orthopaedic Research 1991;9(5):641-650. Since that foundational study, Dr. Caplan has published over 360 manuscripts and articles in peer reviewed journals. Dr. Caplan has been Chief Scientific Officer at OrthoCyte Corporation since 2010. In addition, Dr. Caplan co-founded Cell Targeting Inc. and has served as President of Skeletech, Inc. as its founder. He is the recipient of several honors and awards from the orthopedic research community. Dr. Caplan holds a Ph. D. from Johns Hopkins University Medical School and a B.S. in chemistry from the Illinois Institute of Technology.

Summit Keynote Address October 26, 2012 Texas Governor Rick Perry

Governor Perry is the 47th and current Governor of Texas. Governor Perry has long championed the role of medical technologies in building the future of not only Texas, but also the United States. In many ways, his strong advocacy on behalf of research and advanced medical technologies is one of his strongest and as yet underappreciated legacies. In addition to his service to the state of Texas, Governor Perry has also served as Chairman of the Republican Governors Association in 2008 and again in 2011. Despite a rigorous schedule, particularly in the teeth of this election season, Governor Perry has graciously made time to speak and encourage the researchers, patients, companies and physicians who form the fabric and future of the stem cell therapy community.

Texas Medical Center Keynote Address, October 27, 2012 James T. Willerson, MD

Over the course of his career, Dr. James T. Willerson has served as a medical, scientific and administrative leader for each of the major institutions that are the foundation of the Texas Medical Center. Dr. Willerson is currently President and Medical Director, Director of Cardiology Research, and Co-Director of the Cullen Cardiovascular Research Laboratories at Texas Heart Institute (THI). Dr. Willerson was appointed President-Elect of THI in 2004 and became President and Medical Director in 2008. He is also an adjunct professor of Medicine at Baylor College of Medicine and at The University of Texas MD Anderson Cancer Center. He is the former chief of Cardiology at St. Luke's Episcopal Hospital and the former chief of Medical Services at Memorial Hermann Hospital.

Dr. Willerson has served as a visiting professor and invited lecturer at more than 170 institutions.

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Houston Stem Cell Summit Announces Extraordinary Lineup of Keynote Speakers

ScienceDaily (Oct. 1, 2012) A novel therapy in the early stages of development at Virginia Commonwealth University Massey Cancer Center shows promise in providing lasting protection against the progression of multiple myeloma following a stem cell transplant by making the cancer cells easier targets for the immune system.

Outlined in the British Journal of Hematology, the Phase II clinical trial was led by Amir Toor, M.D., hematologist-oncologist in the Bone Marrow Transplant Program and research member of the Developmental Therapeutics program at VCU Massey Cancer Center. The multi-phased therapy first treats patients with a combination of the drugs azacitidine and lenalidomide. Azacitidine forces the cancer cells to express proteins called cancer testis antigens (CTA) that immune system cells called T-cell lymphocytes recognize as foreign. The lenalidomide then boosts the production of T-cell lymphocytes. Using a process called autologous lymphocyte infusion (ALI), the T-cell lymphocytes are then extracted from the patient and given back to them after they undergo a stem cell transplant to restore the stem cells' normal function. Now able to recognize the cancer cells as foreign, the T-cell lymphocytes can potentially protect against a recurrence of multiple myeloma following the stem cell transplant.

"Every cell in the body expresses proteins on their surface that immune system cells scan like a barcode in order to determine whether the cells are normal or if they are foreign. Because multiple myeloma cells are spawned from bone marrow, immune system cells cannot distinguish them from normal healthy cells," says Toor. "Azacitidine essentially changes the barcode on the multiple myeloma cells, causing the immune system cells to attack them," says Toor.

The goal of the trial was to determine whether it was safe, and even possible, to administer the two drugs in combination with an ALI. In total, 14 patients successfully completed the investigational drug therapy. Thirteen of the participants successfully completed the investigational therapy and underwent a stem cell transplant. Four patients had a complete response, meaning no trace of multiple myeloma was detected, and five patients had a very good partial response in which the level of abnormal proteins in their blood decreased by 90 percent.

In order to determine whether the azacitidine caused an increased expression of CTA in the multiple myeloma cells, Toor collaborated with Masoud Manjili, D.V.M., Ph.D., assistant professor of microbiology and immunology at VCU Massey, to conduct laboratory analyses on bone marrow biopsies taken from trial participants before and after treatments. Each patient tested showed an over-expression of multiple CTA, indicating the treatment was successful at forcing the cancer cells to produce these "targets" for the immune system.

"We designed this therapy in a way that could be replicated, fairly inexpensively, at any facility equipped to perform a stem cell transplant," says Toor. "We plan to continue to explore the possibilities of immunotherapies in multiple myeloma patients in search for more effective therapies for this very hard-to-treat disease."

In addition to Manjili, Toor collaborated with John McCarty, M.D., director of the Bone Marrow Transplant Program at VCU Massey, and Harold Chung, M.D., William Clark, M.D., Catherine Roberts, Ph.D., and Allison Hazlett, also all from Massey's Bone Marrow Transplant Program; Kyle Payne, Maciej Kmieciak, Ph.D., from Massey and the Department of Microbiology and Immunology at VCU School of Medicine; Roy Sabo, Ph.D., from VCU Department of Biostatistics and the Developmental Therapeutics program at Massey; and David Williams, M.D., Ph.D., from the Department of Pathology at VCU School of Medicine, co-director of the Tissue and Data Acquisition and Analysis Core and research member of the Developmental Therapeutics program at Massey.

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Immune system harnessed to improve stem cell transplant outcomes

By Sharmistha Banerjee - September 25, 2012 | Tickers: NBS, OSIR, PSTI | 0 Comments

Sharmistha is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited.

Far-reaching accomplishments in the biotechnology sector meet its most ambitious expectations, stem cell therapy. The birth of this new industry has boosted the enthusiasm and energy of investors and has brought unprecedented capability and optimistic predictions. New developments in regenerative medicine are bringing about exciting, novel approaches to create therapies for hard to treat diseases. The biotechnology industry has been soaring in 2012 as companies both large and small have shown impressive growth.

The cell therapy space has seen relatively small companies making strides in the right direction with increased government support. Osiris Therapeutics (NASDAQ: OSIR) a leading stem cell company is currently the only company with an approved cell therapy. The approval is more of a first step in a long walk for Osiris. Reuters reported that shares of Osiris Therapeutics rose 15% on May 30, 2012, after U.S. health regulators said the stem cell technology company's wound treatment was eligible for reimbursement when used in hospitals in out-patient settings or in ambulances. The company carries over a $300 million market capitalization and trades at $9.50 per share, primarily on the strength of a recent Canadian approval for its stem cell drug for graft-versus-host disease. Osiris Therapeutics has a 1-year low of $4.12 and a 1-year high of $14.46. The company has a market cap of $311.3 million and a price-to-earnings ratio of 90.98. Investors are impressed and optimistic with Osiris progress in cell-based therapies. They currently have a $9.75 target price on the stock. Despite having to negotiate a more challenging regulation process the company has continued to show investors strong gains in 2012.With a current ratio of 8.51 and debt equity of (0.00%) the company boasts of a financially secure position in the market.

Pluristem Therapeutics (NASDAQ: PSTI) a small firm with a market cap of less than $180 million has been concentrating on its placenta-based cell therapies, is considered one of the more advanced in the cell therapy arena, and unlike OSIR, its lead candidates treat diseases that could potentially return significant revenue. The upside for PSTI is lower costs, quicker healing time, ease of administration, and most importantly, it can grow vessels and provide the possibility of a cure, which has led to optimism surrounding the stock. Shares of Pluristem Therapeutics are up over 3.98% and most likely headed higher in the days ahead. It has traded higher by 85% during the last three months and is now valued at $200 million. Pluristem may actually beat OSIR in the race to become the first U.S. approved cell therapy with its bone marrow therapy, in which it has recently applied for approval. Pluristem is a company that I think is showing great promise. From the stock's action in the last several months, it is clear investors recognize that Pluristem's unique platform technology has the potential for tremendous value in a lucrative range of medical markets both the very large and the very small. The company wins both ways. Its clinical segment is creating candidates with large revenue potential, with analysts projecting peak sales of $700 million for AMR-001, which treats patients following acute myocardial infarction. The company is reasonably well funded with around $42 million in cash and cash equivalents.

NeoStem (NYSEMKT: NBS) is by far the leader in regards to the manufacturing business, and no other company comes close. In addition, its stock has returned the most over in the last three months, with a 100% gain. NeoStem stocks looks promising as a biotechnology investment. First, the company is focusing on several promising areas of new stem cell treatment development. Second, its contract manufacturing business brings in revenues to offset some of its drug development expenditures. Third, the contract manufacturing business could earn substantial royalties if any of the products on which it works with customers proves to be a commercial success. NeoStem's manufacturing segment which is also known as PCT, is well positioned to return larger gains over the next 24 months with several late stage candidates under development. a $110 million company that has increased in value by 70% during the last three months, In addition to the PCT business, NeoStem's most promising therapy is aimed at preventing major cardiac problems following acute myocardial infarction (AMI), an area that is potentially a multibillion-dollar business. NeoStem's therapy is meeting endpoints never before reached,

The three companies discussed above are showing much potential for growth and each present a significant upward shift in the current stock prices while contributing greatly to the advances of cell therapy.

Osiris is the closest to generating substantial revenue by already having two approvals, and is currently testing its therapy on other diseases, thereby leaving open the possibility of future gains. Pluristem has candidates to treat diseases in potentially large markets, and is expanding with its manufacturing facility. Although Stem Cells is in the early phases of development, it still has a very innovating therapy that, if proven effective, could advance the space even further. NeoStem possesses all the benefits of an innovating technology, a diversified pipeline, and is a candidate with significant revenue potential.

At this point, it appears that the entire space is moving forward and has lifted observers' expectations by making rapid progress. It makes sense that these three stocks would trade with such considerable gains, as investors can now identify the benefits of cell therapies. And as more approvals occur, it could be a space that trades considerably higher regardless of the market's indecisiveness. With the sector growing and maturing, investing in biotech stocks seems a promising choice in future.

SharmisthaB has no positions in the stocks mentioned above. The Motley Fool has no positions in the stocks mentioned above. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.If you have questions about this post or the Fools blog network, click here for information.

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Stem Cell Therapy—Breakthrough in Health Paradigm