Stem Cell Clinic

Stem cell treatment ‘worth it,’ but no cure for Cat Davis – Thu, 12 Sep 2013 PST

Seven months after undergoing a stem cell transplant, Cat Davis sports a short new haircut and a biggrin.

The hairstyle was necessary when all her hair fell out during chemotherapy, but the brilliant smile is her trademark. However, in recent years, she hasnt had much to smileabout.

Four years ago, the 2006 Northwest Christian School graduate was diagnosed with CREST syndrome, a combination of five diseases. The symptoms of CREST are associated with a generalized form of scleroderma, which literally means hard skin. The disease causes the immune system to attack and destroy healthytissue.

Her doctor

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Cat Davis photo

Cat Davis is shown in March after the stem celltransplant. (Full-size photo)(All photos)

Seven months after undergoing a stem cell transplant, Cat Davis sports a short new haircut and a biggrin.

The hairstyle was necessary when all her hair fell out during chemotherapy, but the brilliant smile is her trademark. However, in recent years, she hasnt had much to smileabout.

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Stem cell treatment ‘worth it,’ but no cure for Cat Davis - Thu, 12 Sep 2013 PST

Pluristem shares gain on stem cell therapy patent

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Pluristem shares gain on stem cell therapy patent

Faulty stem cell regulation may contribute to cognitive deficits associated with Down syndrome

Sep. 11, 2013 Michael Clarke and his colleagues were the first to discover that Down syndrome may be linked to faulty stem cell regulation.

The learning and physical disabilities that affect people with Down syndrome may be due at least in part to defective stem cell regulation throughout the body, according to researchers at the Stanford University School of Medicine. The defects in stem cell growth and self-renewal observed by the researchers can be alleviated by reducing the expression of just one gene on chromosome 21, they found.

The finding marks the first time Down syndrome has been linked to stem cells, and addresses some long-standing mysteries about the disorder. Although the gene, called Usp16, is unlikely to be the only contributor to the disease, the finding raises the possibility of an eventual therapy based on reducing its expression.

"There appear to be defects in the stem cells in all the tissues that we tested, including the brain," said Michael Clarke, MD, Stanford's Karel H. and Avice N. Beekhuis Professor in Cancer Biology. The researchers conducted their studies in both mouse and human cells. "We believe Usp16 overexpression is a major contributor to the neurological deficits seen in Down syndrome."

Clarke is the senior author of the research, published Sept. 11 in Nature. Postdoctoral scholar Maddalena Adorno, PhD, is the lead author.

"Conceptually, this study suggests that drug-based strategies to slow the rate of stem cell use could have profound effects on cognitive function, aging and risk for Alzheimer's disease in people with Down syndrome," said co-author Craig Garner, PhD, who is the co-director of Stanford's Center for Research and Treatment of Down Syndrome and a professor of psychiatry and behavioral sciences

Down syndrome, which is caused by an extra copy of chromosome 21, affects about 400,000 people in the United States and 6 million worldwide. It causes both physical and cognitive problems. While many of the physical issues, such as vulnerability to heart problems, can now be treated, no treatments exist for poor cognitive function.

The new study's findings suggest answers to many long-standing mysteries about the condition, including why people with Down syndrome appear to age faster and exhibit early Alzheimer's disease.

"This study is the first to provide a possible explanation for these tendencies," said Garner. The fact that people with Down syndrome have three copies of chromosome 21 and the Usp16 gene "accelerates the rate at which stem cells are used during early development, which likely exhausts stem cell pools and impairs tissue regeneration in adults with Down syndrome. As a result, their brains age faster and are susceptible to early onset neurodegenerative disorders."

The researchers didn't confine their studies to laboratory mice. They also investigated the effect of Usp16 overexpression in human cells. Adorno and colleagues in the laboratory of co-author Samuel Cheshier, MD, assistant professor of neurosurgery, found that the presence of excess Usp16 caused skin cells from unaffected people to grow more slowly. Furthermore, neural progenitor cells (those self-renewing cellular factories responsible for the development and maintenance of many of the cell types in the brain) were less able to form balls of cells called neurospheres -- a laboratory test that reflects the number and robustness of nerve stem cells in a culture. Conversely, reducing Usp16 expression in skin and nerve-progenitor cells from people with Down syndrome allowed the cells, which usually proliferate slowly, to assume normal growth patterns.

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Faulty stem cell regulation may contribute to cognitive deficits associated with Down syndrome

Scammers offering phoney stem cell therapies to 'treat' incurable diseases

Stem cell therapies have proven to be extremely valuable options for medical treatment, with the potential to treat everything from cancer and diabetes to Parkinsons disease and cardiac illness.

But now, scammers are capitalizing on these scientific discoveries by offering phoney stem cell treatments to patients, claiming they can provide miracle cures for untreatable conditions, the Irish Times reported.

Many vulnerable people with incurable degenerative diseases are paying upwards of $150,000 for treatments that use what are known as mesenchymal stem cells.

While researchers have been experimenting with these types of stem cells to potentially treat conditions such as osteoarthritis and other bone diseases, they have yet to be proven effective. Additionally, the use of mesenchymal stem cells to treat disease is currently against the law, and clinics that offer these treatments operate under the radar or by word of mouth.

Not only are these therapies illegal, but they are potentially dangerous as well. While mesenchymal stem cells have shown promise in regards to bone and tissue health, they havent been successful when it comes to nerve and brain tissues yet some scammers are using them to treat neurological conditions such as Parkinsons and dementia, according to the Irish Times. One company claimed that they could cure more than 100 diseases with these transplantable cells.

Experts estimated that approximately 100,000 people in the United States have utilized these untested therapies.

Click for more from the Irish Times.

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Scammers offering phoney stem cell therapies to 'treat' incurable diseases

MD Stem Cells Begins the Largest Stem Cell Eye Treatment Study to Date

RIDGEFIELD, Conn., Sept. 10, 2013 /PRNewswire/ --For patients with serious eye disease, going blind is a constant fear. The loss of vision experienced from retinal or optic nerve problems may be progressive with devastating impact on a person's ability to live a full life. Treatment with Bone Marrow DerivedStem Cellsmay hold the key to reversing blindness and restoring vision. But the concern has been whether such stem cell treatments have enough published reports and studies to show effectiveness in a convincing way.MD Stem Cellshopes to help provide that evidence.

MD Stem Cells is Collaborator for the new Stem Cell Ophthalmology Treatment Study, abbreviated asSCOTS. Dr. Steven Levy, President of MD Stem Cells, will function as Study Director for the clinical trial expected to continue through August 2017. The Retinal Associates of South Florida is the study Sponsor and Dr. Jeffrey Weiss, retinal surgeon and physician, is the Principle Investigator and provider of the ophthalmic stem cell treatments.

"We are extremely pleased to have helped design and implement this broadly encompassing retinal and optic nerve disease study," Dr. Levy exclaimed. "We believe ours is the largest, most comprehensive registered ophthalmology stem cell study to date. We have taken great care in powering the study and expect to obtain statistically meaningful results. SCOTS is being conducted under an Institutional Review Board whose evaluation was rigorous."

SCOTS is registered with the National Institutes of Health and listed on their website http://www.clinicaltrials.govwith identifierNCT01920867. Patients interested in whether they may participate and healthcare providers may reach Dr. Levy at info@mdstemcells.com or 203-423-9494 Eastern Time USA.

"We hope that the treatment will be shown to improve vision in the vast majority of individuals who are enrolled in SCOTS. Patients considering treatment should understand that this is clinical research and individual responses cannot be predicted," stated Dr. Levy. He added, "Our previous anecdotal experience with eye disease treated with stem cells has been positive. With SCOTS we hope to provide strong evidence of the effectiveness of these treatments to the medical community."

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MD Stem Cells Begins the Largest Stem Cell Eye Treatment Study to Date

Novartis Ties Up With Regenerex

In a bid to expand presence in the cell therapy space, Novartis (NVS) recently announced that it has entered into a global licensing and research collaboration agreement with privately-held biopharmaceutical company, Regenerex.

As per the agreement, Novartis will gain access to Regenerexs proprietary stem cell based therapy platform Facilitating Cell Therapy (FCRx) which is being evaluated for kidney transplantation.

The stem cell based therapy aims to induce stable immunological tolerance in kidney transplantation. Additionally, FCRx can also be evaluated for the treatment of serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies.

The addition of FCRx will expand Novartis existing cell therapy portfolio which already has two cell therapy platforms - HSC835 and CTL019. Both are being evaluated for hematological malignancies.

While HSC835 is being evaluated in patients with high-risk hematological malignancies in a phase I study, CTL019 is being developed in a phase II study for the treatment of acute lymphoblastic leukemia and chronic lymphocytic leukemia.

We note that apart from stem cell therapy based treatments, Novartis also markets a drug - Glivec, which is approved for the treatment of ALL and chronic myeloid leukemia.

We remind investors that other companies which are developing cell based therapies include Celgene Corporation (CELG) and Israel-based Pluristem Therapeutics Inc. (PSTI).

While Celgene is carrying out research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases, Pluristem develops placenta-based cell therapies using the companys proprietary PluriX therapy.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals (JAZZ) looks well placed with a Zacks Rank #2 (Buy).

Read the Full Research Report on NVS

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Novartis Ties Up With Regenerex

Vitro Biopharma Expands its Product Lines While Targeting New Stem Cell Markets

Golden, Colorado - (ACCESSWIRE - September 10, 2013) - Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced expansion of its current product lines and product development in additional market segments including drug discovery & development together with select opportunities within regenerative medicine market sectors. Vitro's present products target markets within stem cell and cancer research. We provide basic research tools including cell lines, cell culture media and assays of cellular function. We have recently added cancer-associated fibroblast cell lines and novel cell culture media formulations broadening our product offerings for research. Cancer-associated fibroblasts (CAFs) are non-tumor cells within cancerous tumors that promote tumor growth and metastasis.

Also, new evidence, including research using Vitro Biopharma's cell lines, suggest that CAFs mediate immunoprotection of tumor cells and are thus new therapeutic targets for aggressive forms of cancer including pancreatic cancer. We have recently added two new CAF cell lines to our catalog that are derived from ovarian and endometrial cancers. Our specialized culture media for primary cell growth compliments our new products by allowing our customers to derive more cells in a shorter time period accelerating the rate of research using our CAFs.

A recent publication involving a specific type of cancer-associated fibroblast (stellate cell) showed that these cells specifically suppress immune responses to pancreatic cancer cells. New cancer therapies may involve inactivation of this immunosuppressive effect of pancreatic stellate cells.

One of Vitro Biopharma's products was used in this research study that was recently published in Cancer Research (Vol. 73(10): 3007-3018, 2013).

Additional newly launched cell culture media products bolster Vitro Biopharma's offerings for broader use in stem cell research, MSC differentiation and maintenance of quiescence that is more typical of native stem cell niches. Dr. Jim Musick, Vitro Biopharma's President & CEO, said, "We are pleased to offer expanded products for research including CAFs and additional cell culture media formulations. We are also developing further extensions of our existing products to target markets in drug discovery and development.

These products are cell-based assay systems that authentically represent human skeletal-muscular cellular systems for use in drug discovery and development. Our initial products target applications in new treatments of osteoporosis, a significant medical problem with considerable opportunity for new drugs with enhanced efficacy and reduced side-effects. Our novel stem cell-based assays are well suited for interface with various analytical bio-informatic systems to optimize high throughput modern drug discovery focused on specific biological targets resulting in increased drug efficacy with reduced side-effects and toxicity.

We also maintain active development of products for use in regenerative medicine including media and novel pluripotent stem cell lines derived from adult tissues." Pete Shuster, a Vitro Biopharma Director, said these are a great addition to Neuromics' Cell Based Assay Solutions. The demand for cells has exceeded expectations and the feedback from customers has been positive. Our stem and primary cell offerings are our fastest growing segment. CAFs will help fuel this growth. These cells move us closer to having novel solutions to improve the drug discovery and development process.

Working with Vitro Biopharma, we have indentified the need for assays that more closely mimic in vivo environments for drug discovery and development. Our goal is to help biopharma companies integrate these assays in their high throughput screening processes. The release of these CAFs is an important milestone towards our reaching this goal."

About Vitro Biopharma Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG; http://www.vitrobiopharma.com/), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending US patent for generation of pluripotent stem cells and an additional pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, the MSC-Gro Brand of optimized media for MSC self-renewal and lineage-specific differentiation.

In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships including an alliance with Neuromics, Inc. (http://www.neuromics.com/). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems We jointly manufacture stem cell assay systems with HemoGenix(R), Inc. (http://www.hemogenix.com/), known as the LUMENESC(TM) quantitative assay for determination of MSC quality, potency and response to toxic agents.

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Vitro Biopharma Expands its Product Lines While Targeting New Stem Cell Markets

Novartis Ties Up With Regenerex – Analyst Blog

In a bid to expand presence in the cell therapy space, Novartis ( NVS ) recently announced that it has entered into a global licensing and research collaboration agreement with privately-held biopharmaceutical company, Regenerex.

As per the agreement, Novartis will gain access to Regenerex's proprietary stem cell based therapy platform Facilitating Cell Therapy (FCRx) which is being evaluated for kidney transplantation.

The stem cell based therapy aims to induce stable immunological tolerance in kidney transplantation. Additionally, FCRx can also be evaluated for the treatment of serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies.

The addition of FCRx will expand Novartis' existing cell therapy portfolio which already has two cell therapy platforms - HSC835 and CTL019. Both are being evaluated for hematological malignancies.

While HSC835 is being evaluated in patients with high-risk hematological malignancies in a phase I study, CTL019 is being developed in a phase II study for the treatment of acute lymphoblastic leukemia and chronic lymphocytic leukemia.

We note that apart from stem cell therapy based treatments, Novartis also markets a drug - Glivec, which is approved for the treatment of ALL and chronic myeloid leukemia.

We remind investors that other companies which are developing cell based therapies include Celgene Corporation ( CELG ) and Israel-based Pluristem Therapeutics Inc. ( PSTI ).

While Celgene is carrying out research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases, Pluristem develops placenta-based cell therapies using the company's proprietary PluriX therapy.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals ( JAZZ ) looks well placed with a Zacks Rank #2 (Buy).

CELGENE CORP (CELG): Free Stock Analysis Report

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Novartis Ties Up With Regenerex - Analyst Blog

Patients warned of stem cell danger

Experts have warned patients to stay away from unproven and unsafe stem cell treatments which can have horrific consequences.

They cited one example where a woman who wanted to banish her wrinkles found her face turning to bone.

Around 10 clinics in Europe are thought to be offering stem cell therapies for a range of conditions, including serious brain diseases such as Alzheimer's and Parkinson's.

In China, patients have had huge infusions of stem cells pumped into their blood streams in the belief that this will prevent them ageing.

It is not known whether any such clinics operate in the UK, where the practice would be illegal.

The cells used in these treatments are mesenchymal stem cells (MSCs) which are widespread around the body.

They can develop into fat, cartilage, muscle and bone but there is no proof they can generate other kinds of tissue, such as nerves.

However research has shown they stimulate blood vessel growth and can attract other strains of stem cell.

Stem cell scientists attending the British Science Festival at the University of Newcastle told how some patients were being lured into undergoing potentially dangerous treatments using MSCs.

Professor Bruno Peault, from the University of Edinburgh, said: "It's very easy to fool lay people. You can say absolutely anything but this is really dangerous.

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Patients warned of stem cell danger

Benefits of stem cells for MS declines with donor’s age

Study finds that stem cells donated by older people are less effective than cells from younger donors.

As stem cell clinical trials for multiple sclerosis (MS) patients become more common, it is crucial for researchers to understand the biologic changes and therapeutic effects of older donor stem cells. A new study appearing in the latest issue of STEM CELLS Translational Medicine is the first to demonstrate that, in fact, adipose-derived stem cells donated by older people are less effective than cells from their younger counterparts.

MS is a neurodegenerative disease characterized by inflammation and scar-like lesions throughout the central nervous system (CNS). There is no cure and no treatment eases the severe forms of MS. But previous studies on animals have shown that transplantation of mesenchymal stem cells (MSCs) holds promise as a therapy for all forms of MS. The MSCs migrate to areas of damage, release trophic (cell growth) factors and exert neuroprotective and immunomodulatory effects to inhibit T cell proliferation.

MS-related clinical trials have all confirmed the safety of autologous MSC therapy. However what is unclear is whether MSCs derived from older donors have the same therapeutic potential as those from younger ones.

Aging is known to have a negative impact on the regenerative capacity of most tissues, and human MSCs are susceptible to biologic aging including changes in differentiation potential, proliferation ability and gene expression. These age-related differences may affect the ability of older donor cells to migrate extensively, provide trophic support, persist long-term and promote repair mechanisms, said Bruce Bunnell, Ph.D., of Tulane Universitys Center for Stem Cell Research and Regenerative Medicine. He served as lead author of the study, conducted by a team composed of his colleagues at Tulane.

In their study, mice were induced with chronic experimental autoimmune encephalomyelitis (EAE) and treated before disease onset with human adipose-derived MSCs derived from younger (less than 35 years) or older (over age 60) donors. The results corroborated previous studies suggesting that older donors are less effective than their younger counterparts.

We found that, in vitro, the stem cells from the older donors failed to ameliorate the neurodegeneration associated with EAE. Mice treated with older donor cells had increased inflammation of the central nervous system, demyelination leading to an impairment in movement, cognition and other functions dependent on nerves, and a proliferation of splenocytes [white blood cells in the spleen], compared to the mice receiving cells from younger donors, Dr. Bunnell noted.

In fact, the T cell proliferation assay results in the study indicated that older MSCs might actually stimulate the proliferation of the T cells, while younger stem cells are capable of inhibiting the proliferation of T cells. (T cells are a type of white blood cell in the bodys immune system that help fight off disease and harmful substances.)

As such, Dr. Bunnell said, A decrease in T cell proliferation would result in a decreased number of T cells available to attack the CNS in the mice, which directly supports the results showing that the CNS damage and inflammation is less severe in the young MSC-treated mice than in the old MSC-treated mice.

This study in an animal model of MS is the first to demonstrate that fat-derived stem cells from older human donors have less therapeutic effectiveness than cells from young donors, said Anthony Atala, M.D., editor of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. The results point to a potential need to evaluate cell therapy protocols for late-onset multiple sclerosis patients.

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Benefits of stem cells for MS declines with donor’s age