Study Indicates Benefits of Stem Cells in Treating MS Declines With Donor’s Age

Durham, NC (PRWEB) September 09, 2013

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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Study Indicates Benefits of Stem Cells in Treating MS Declines With Donor’s Age

Gamida Cell Announces the Successful Transplantation of the First Patient in the Company’s Phase I/II Study of NiCord® …

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the first patient has been successfully transplanted in the companys second Phase I/II study of NiCord, as an alternative, experimental treatment for blood cancers. The transplant took place at Duke University Medical Center. Of great significance: This is the first study researching the outcome of a whole umbilical cord blood unit (UCBU) expanded in culture and transplanted in myeloablated patients without the support of un-manipulated stem cells derived from a second UCBU. The approach using NiCord, as a single stem cell graft, has the potential to broaden accessibility, reduce toxicity and improve the clinical and economic outcomes of cord blood transplantation.

NiCord is an expanded cell graft derived from an entire CBU and enriched with stem cells. NiCord was developed based on Gamida Cells proprietary NAM technology.

Until NiCord, even though expanded stem cells have been demonstrated to decrease the time to neutrophil engraftment, they disappeared shortly thereafter and the long-term engraftment was always provided by the second un-manipulated unit. Thus, the clinical benefit could be achieved only when two UCBUs were transplanted: one unit expanded in culture to shorten time to neutrophil engraftment and the second un-manipulated unit to provide the long and durable engraftment. Then came the Phase I/II study of NiCord in a double cord configuration. In this study, for the first time, a robust short and long-term engraftment (over two years) was achieved entirely from the expanded stem cell graft. The reduced time to neutrophil and platelet engraftment and the durable, long-term engraftment provided by NiCord also led to a shorter time of hospitalization, which also led to reduced costs for both the patient and the hospital. These outcomes provided the scientific basis for the second Phase I/II study of NiCord in a single UCBU transplant modality.

Clinical sites will enroll up to 20 patients, ages 18-65, with hematological malignancies (blood cancers) following myeloablative therapy in the study: Allogeneic Stem Cell Transplantation of NiCord, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells, in Adult Patients with high risk Hematological Malignancies. The principal investigator is Dr. Mitchell E. Horwitz, associate professor ofmedicine at Duke Medicine. Dr. Horwitz was also a principal investigator of the first Phase I/II study of NiCord in a double cord configuration as an alternative, experimental treatment for blood cancers.

Dr. Horwitz said, The protracted time to neutrophil and platelet engraftment and prolonged hospitalization has been a critical limitation of umbilical cord blood transplantation. The results of the first Phase I/II study were encouraging and suggest that NiCord has the potential to address both of these limitations. It also suggested that transplantation of a second, un-manipulated cord blood unit was not necessary, so we are interested in pursuing this single cord Phase I/II study of NiCord to determine whether those results bear out.

Gamida Cell is a world pioneer in cord blood transplantation, and with this new single cord approach we have indeed turned a corner and reached an intended milestone on the road to achieving a market paradigm change, said Gamida Cell CEO Dr. Yael Margolin.

We have witnessed in the clinic a small glimpse of the potential of NiCord that we have extensively studied in the lab and animal models. The novel finding of the first NiCord Phase I/II study is that cord blood-derived hematopoietic stem cells that are expanded in culture are capable of providing both, fast and robust long-term engraftment. This outstanding clinical outcome inspires us to continue developing our entire pipeline of therapeutic stem cell treatments, said Tony Peled, VP of R&D and co-founder of Gamida Cell.

The board is proud of Gamida Cells ongoing ability to maintain its leadership role in the cell therapy industry and is confident and steadfast in its support of the companys important and extremely valuable work, said chairman of the board of Gamida Cell Ruben Krupik.

About Gamida Cell Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The companys pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, neutropenia and acute radiation syndrome, autoimmune diseases and genetic metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cells therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, bone marrow and peripheral blood, which are expanded in culture. Gamida Cells current shareholders include: Elbit Imaging (NASDAQ: EMITF), Clal Biotechnology Industries (TASE: CBI), Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information please visit http://www.gamida-cell.com.

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Gamida Cell Announces the Successful Transplantation of the First Patient in the Company’s Phase I/II Study of NiCord® ...

Stem Cell Therapeutics Advances CD47 Antagonist Program Into IND-Enabling Phase

TORONTO, ONTARIO--(Marketwired - Sep 9, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical company developing cancer stem cell- related therapeutics, today announced that it has advanced its CD47 antagonist program into an Investigational New Drug (IND) enabling phase. In collaboration with a contract manufacturing organization, Stem Cell Therapeutics (SCT) will begin the manufacturing process to generate drug for formal toxicology studies and a subsequent phase I clinical study, which is anticipated to begin in H2/2015.

SCT's program targets the activity of CD47, a molecule upregulated on many leukemias and solid tumors. CD47 delivers a "do not eat" signal that suppresses macrophage phagocytosis, allowing cancer cells, including cancer stem cells, to escape immune-mediated destruction. SCT has chosen to block the CD47 protein using a modified version of its natural ligand, SIRP, fused to an immunoglobulin Fc region. The SIRPaFc fusion protein has shown excellent anti-leukemic activity both in vitro and in human xenograft models, and exhibits a unique binding profile compared to other CD47 blocking agents. These results, as well as encouraging safety data emerging from a recently completed non-human primate study, will be reported at a future scientific conference.

"We believe that SIRPaFc, through its ability to activate the innate immune response and eliminate cancer stem cells, holds great promise as a novel immunotherapy," commented Dr. Niclas Stiernholm. "The transition from the research to the IND-enabling phase is a key milestone for the SIRPFc program, and we will continue on the path towards clinical testing."

About Cancer Stem Cells:

The cancer stem cell (CSC) concept postulates that the growth of tumors is driven by a rare population of dedicated cells that have stem cell-like properties, including self-renewal. While the bulk of a tumor consists of rapidly proliferating cells and differentiated cells, neither of which is capable of self-renewal, a small population of CSCs provides for long-term maintenance of the cancer. Although the CSC concept was first postulated in the 1960s, it wasn't until 1994 that proof of their existence was demonstrated, when Dr. John Dick and colleagues in Toronto isolated CSCs (known as leukemic stem cells, or LSCs) from bulk acute myeloid leukemia cells. More recently, CSCs have been identified in many other human malignancies, including solid tumors such as bladder, brain, breast, colon, ovarian and prostate cancers. There is accumulating evidence that CSCs are resistant to conventional chemotherapies and radiation. Thus, CSCs are thought to be responsible for a phenomenon well known to oncologists: most patients will experience an initial response to conventional chemotherapies but will ultimately relapse. To cure cancer CSCs need to be destroyed, but the current armament of therapies is poorly equipped to do so.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT) is a biopharmaceutical company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to a group of Toronto academic research institutes and cancer treatment centers, representing one of the world's most acclaimed cancer research hubs. The Company has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. SCT's clinical stage programs include the recently in-licensed program focused on the structure of tigecycline, which is currently being evaluated in a multi-centre Phase I study in patients with acute myeloid leukemia (AML), as well as TTI-1612, a non-cancer stem cell asset that recently completed a 28-patient Phase I trial in interstitial cystitis ("IC") patients. For more information, visit: http://www.stemcellthera.com.

Caution Regarding Forward-Looking Information:

This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Stem Cell Therapeutics Advances CD47 Antagonist Program Into IND-Enabling Phase

International Stem Cell Corporation Advances Parkinson's Disease Program Towards IND Stage

CARLSBAD, CA--(Marketwired - Sep 9, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell-based therapies, announced today further progress in its Parkinson's disease program with a recently held key opinion leader meeting facilitated by the study's principal investigator, Dr. Mark Stacy of Duke Medicine.

The meeting was a significant step towards clinical studies to evaluate the use of stem cell-derived neuronal cells to treat Parkinson's disease (PD). By bringing together leading experts from throughout North America in the field of cell therapy and movement disorders, ISCO gains critical feedback and guidance that can be included in the final pre-clinical primate studies and the design of the first-in-man study, which is expected to begin in 2014.

"This is an interesting new approach for the treatment of PD," said Stacy, Vice Dean for Clinical Research, Neurology at Duke University School of Medicine. "This meeting increases the chances of a successful clinical outcome by allowing us to not only build on previous studies, but also gain in-depth insight from some of the principal clinicians and neurosurgeons working in this field."

The participants, consisting of a number of pre-eminent clinicians, some of whom have conducted cell therapy trials in PD using fetal-derived tissue, discussed the study design for the first-in-man trial, including the specific sites in the brain where the cells will be implanted, the necessity for placebo controls, and the duration that may be required to see clinically meaningful changes.

"There is still much debate in the literature concerning the most effective ways to treat Parkinson's patients with human cells. Gathering such a distinguished clinical group together, although challenging, helped answer a number of open questions regarding the phase I clinical study," commented Dr. Ruslan Semechkin, Chief Scientific Officer at International Stem Cell Corporation. "It's a testament to Dr. Stacy and Duke's reputation in this area to be able to draw together such experience; we feel very confident that we have the right approach and every chance for a successful IND and subsequent phase I study."

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. The hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (1) differentiate into dopaminergic neurons, and (2) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new and revolutionary opportunity for the treatment of Parkinson's disease, especially in cases where current dopamine-replacement approaches fail to adequately control the symptoms.

About International Stem Cell Corporation

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

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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International Stem Cell Corporation Advances Parkinson's Disease Program Towards IND Stage

Will you consider stem cell therapy for your child with autism?

There is no doubt that parents of persons with autism will exhaust all possible means to look for ways to improve the lives of their children. Some will even look for the ''cure'' at all costs literally, especially if they can afford it.

The buzz word for possible autism cure these last few years is stem cell therapy, a medical intervention that involves extracting the body's repair cells and injecting them back to the body to replace old cells. The controversies about this therapy as autism ''cure'' include its high cost.

Angels Talk recently asked parent members of Autism Society Philippines the following question: If money was not an issue, will you consider stem cell therapy for your child with autism? Some were willing to take the chance while others were either cautious of trying ''cures'' that still need to be validated, or consider their children's autism as a gift. Here are some of their sentiments.

''Yes, I would. Whatever will help my nine-year old Sean, I will take the chance. I accept Sean and his condition but not everyone is accepting of autism. If stem cell therapy will give Sean a chance to enjoy life like an average kid, then I will pursue this.'' - JASMINE NADJA PINUGU, a parent who represents the views of 22 other respondents

''No. I would not subject my child to a treatment that has questionable therapeutic claims and safety issues. What we read in the news now are anecdotal reports from celebrity parents that include endorsement of a certain clinic or doctor. Our son Jorel, is doing well trying to adapt in the ''normal'' world. We would rather spend the money for his job or independent living training later on.'' - MENCHIE ALEGRE

''Not at this time but I am open to the possibility. I attended Dr. Samuel Bernal's talk on this topic at Medical City early this year and even this expert is not making claims that stem cell can ''cure'' autism. They are still doing further studies. I have also not heard about the results on the six children who've undergone the test for it. The procedure is quite scary and there will surely be side effects. Until such time that the procedure becomes less invasive, I will not agree to have this procedure done to my child. I appreciate though the efforts of all the people trying to find solution to improve the lives of our children. I pray that God may guide them well.'' - OLIVE MEDINA

''NO! I love him for what he is and he was born unique. Autism is not an illness; all special children need love, support and understanding from family, friends and especially our society. Special children are God's gift to society, to help us be humble, happy and content of what we have.'' - BERNADETTE TABARES

''No, I have two autistic sons and I have learned to respect their condition as God allowed it. I asked God for wisdom in rearing them and I enjoy their company. They showered me with so much attention and love. After 20 years of searching for solution for my two boys to act normal and be able to conform to the norms of society, I have witnessed that each one of us also have abnormalities. Being with them at all given time is the best treatment. Integrating them in all house activities boost their self-esteem.''- LOURY JACOB

''Autism is not the problem. Only ACCCEPTANCE can CURE AUTISM.'' - WHENG DOLLENTE

''What is the point of compelling your child to be someone he is not?'' - GERARD ATIENZA

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Will you consider stem cell therapy for your child with autism?

Novartis announces an exclusive global licensing and research collaboration with Regenerex, leveraging a novel cell …

Novartis International AG / Novartis announces an exclusive global licensing and research collaboration with Regenerex, leveraging a novel cell platform to broaden presence in the cell therapy space . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Basel, September 6, 2013 - Novartis today announced that it has entered into an exclusive global licensing and research collaboration agreement with Regenerex LLC, a biopharmaceutical company based in Louisville, Kentucky, for use of the company's novel Facilitating Cell Therapy (FCRx) platform. The hematopoietic stem cell-based FCRx platform has been investigated in kidney transplantation to induce stable immunological tolerance, resulting in graft survival without the need for lifelong immunosuppression. This collaboration reaffirms the Novartis commitment to transplant. Beyond transplant, Regenerex's novel platform potentially has curative potential for multiple underserved diseases and will be investigated in the rescue of serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies.

"As the field of biomedicine sits on the cusp of a new transformation, we are excited to announce this agreement which supports the Novartis leadership position in cell therapy," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "Thirty years ago, Novartis developed ciclosporin, which changed transplantation treatment paradigms and enabled countless lives to be saved. Now, this collaboration, along with our internal cell therapy assets, has the potential to transform medicine once again through innovation."

FCRx will broaden the current Novartis cell therapy portfolio, which includes two novel cell therapy platforms initially being investigated in hematological malignancies. HSC835 is a novel cell therapy approach that enables an expanded single umbilical cord blood derived hematopoietic stem cell transplant in patients with limited treatment options. HSC835 is currently in a Phase II trial in patients with high-risk hematological malignancies. A second cell therapy product, CTL019 is a chimeric antigen receptor T cell therapy currently in Phase II development in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).

About FCRx FCRx is a novel allogeneic hematopoietic stem cell based therapy platform that also contains facilitating cells derived from a donor. The platform supports the development of tolerance, or "bone marrow chimerism," in transplant recipients, providing a better side effect profile than current human hematopoietic stem cell transplantation protocols. Chimerism may eventually render the recipient tolerant to cell, tissue or organ transplants from the same donor, thereby enabling transplant patients to discontinue immunosuppressive medications after building stable immunological tolerance. Results from a Phase II study in 15 kidney transplant recipients are extremely encouraging with six patients fully withdrawn from immunosuppression without loss of engraftment, and a further two with planned full withdrawal at 1 year[1]. Currently, solid organ transplant recipients must take immunosuppressive drugs for life to prevent rejection. This approach may also allow for treatment of inherited metabolic diseases like metachromatic leukodystrophy or sickle cell disease.

Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "goal," "potential," "commitment," "potentially," "will," "on the cusp," "being investigated," "may," "eventually," "encouraging," "planned," or similar expressions, or by express or implied discussions regarding potential approvals for the FCRx platform, HSC835 or CTL019, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the FCRx platform, HSC835 or CTL019 will be approved for use or sale in any market, or at any particular time. Nor can there be any guarantee that such products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding such products could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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Novartis announces an exclusive global licensing and research collaboration with Regenerex, leveraging a novel cell ...

New Way to Track Stem Cell Migration Could Advance Treatments for Brain Tumors and More

Durham, NC (PRWEB) September 06, 2013

A new study in the current issue of STEM CELLS Translational Medicine shows how a team of scientists led by Rex Moats, Ph.D., and Karen Aboody, M.D., discovered a safe, effective way to track the migration and distribution of neural stem cells used in treating invasive brain tumors. Their method, which involves pre-loading the cells before transplantation with ultra-small, super paramagnetic iron oxide nanoparticles that can then be detected via magnetic resonance imaging (MRI), has been approved for clinical trials in humans and has the potential to greatly accelerate the search for new treatments for deadly brain tumors and other diseases.

Numerous stem cell-based therapies are currently under investigation, including an FDA-approved clinical trial focused on employing neural stem cells (NSCs) in delivering drugs targeting invasive brain tumors. The ability to monitor the time course, migration and distribution of stem cells following transplantation into these patients would provide critical information for optimizing treatment regimens, Dr. Moats said. However, no effective cell-tracking methodology had yet garnered clinical acceptance.

A labeling and imaging protocol using clinical grade ferumoxytol an iron replacement product currently approved to treat iron deficiency anemia in patients with chronic kidney disease has shown promise in some studies as a possible tracking agent. The Moats-Aboody team, in conjunction with Dr. Joseph A. Frank, a co-investigator at NIH, had previously demonstrated that the combination of ferumoxides with protamine sulfate showed promise in labeling the NSCs for this purpose.

In this most recent study, they wanted to build upon their work by testing how adding heparin to the ferumoxytol and protamine sulfate mix (a combination called HPF) might affect the NSC labeling.

The results showed great promise in the lab. Additionally, Dr. Aboody said, when we tested it on mice with brain tumors we were able to track the NSC distribution using an MRI at multiple time-points following intracerebral or intravenous injection. The mice demonstrated no significant clinical or behavioral changes, no neuronal or systemic toxicities and no abnormal accumulation of iron in the liver or spleen.

Overall, we propose that ferumoxytol-labeling is an effective cell-tracking method that is safe for clinical use, contributing little to the risk side of a given risk/benefit analysis, Dr. Moats concluded.

Dr. Moats is a member of the Department of Radiology at Children's Hospital of Los Angeles and University of Southern Californians Keck School of Medicine while Dr. Aboody is with the Department of Neurosciences at City of Hope National Medical Center & Beckman Research Institute in Duarte, Calif. The investigative team also included researchers from the National Institutes of Health, the University of Chicago and the University of British Columbia.

An important aspect of advancing neural stem cells as a treatment for brain tumors is being able to track the cells ability to adequately target and distribute throughout the tumor sites, said Anthony Atala, M.D., editor of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. The current study is important because it identifies an effective cell-tracking method that appears safe for clinical use.

The full article, MRI Tracking of Ferumoxytol-labeled Human Neural Stem Cells: Studies Leading to Clinical Use, can be accessed at http://www.stemcellstm.com.

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Stem Cell Therapeutics Announces Participation at the 15th Annual Rodman & Renshaw Global Investment Conference in New …

TORONTO, ONTARIO--(Marketwired - Sep 6, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical company developing cancer stem cell-related therapeutics, today announced it will be featured as a presenting company at the 15th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held September 8-10, 2013, at the Millennium Broadway Hotel in New York City. Dr. Niclas Stiernholm, the CEO of Stem Cell Therapeutics, will provide an overview of the Company's business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT) is a biopharmaceutical company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to a group of Toronto academic research institutes and cancer treatment centers, representing one of the world's most acclaimed cancer research hubs. The Company has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. SCT's clinical stage programs include the recently in-licensed program focused on the structure of tigecycline, which is currently being evaluated in a multi-centre Phase I study in patients with acute myeloid leukemia (AML), as well as TTI-1612, a non-cancer stem cell asset that recently completed a 28-patient Phase I trial in interstitial cystitis ("IC") patients. For more information, visit: http://www.stemcellthera.com.

Caution Regarding Forward-Looking Information:

This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Stem Cell Therapeutics Announces Participation at the 15th Annual Rodman & Renshaw Global Investment Conference in New ...

An end to the stem cell ‘hammer’ and ‘nail’

Medical Files By Rafael Castillo M.D. Philippine Daily Inquirer

(Conclusion)

A saying goesif youre a hammer, you see everything as a nail.

This may symbolize whats happening to our practice of stem cell medicine in our country. Because of the media hype focusing on testimonials of celebrities on supposed spectacular healing or rejuvenation, stem cell practitioners coming from various medical practices have suddenly become overenthusiastic of the things stem cells could do for their patients. In every Tom, Dick and Harry, one or another indication for stem cell therapy can be seen at the end of a 5-minute consultation. It has been estimated that nine out of 10 Filipino patients administered stem cell treatment receive it for unproven and still experimental indications.

A neurosurgeon colleague asked the young doctor-son of a patient (who appeared to be fresh out of medical school) what his line of practice was, and he confidently replied that he administers stem cell medicine. When told that it seems to be a pretty complicated specialty, he answered without batting an eyelash that its not.

All of a sudden, a few hundred physicians from several specialtiesinternists, oncologists, surgeons, neurologists, dermatologists, OB-gynecologists, family medicine and practically all othershave seemingly converged to make stem cell medicine their specialty or subspecialty. I know that the doctors mean well. Most of them (including those who sent me angry SMS or e-mail messages after reading the first part of this column last week) sincerely believe they could offer something short of miraculous healing for their patients.

Not hammers at all

I dont doubt their well-meaning intentions but they just have to stop acting like a hammer, finding everything like a nailjudging practically everyone who comes to them as a potential stem cell treatment candidate. In fact, many colleagues who practice stem cell medicine should realize theyre not hammers at all. They should be honest enough to admit that they do not possess the competence to administer such a complicated therapy to their patients.

Being interested in stem cell medicine and considering oneself as an eager student wanting to learn more about this promising experimental form of treatment is good. But thinking that one can be good enough to administer it to patients after observing how others do it several times is definitely betraying ones sworn duty as a physicianto make patients well and not to administer anything that can potentially cause him or her more harm than good.

When I was a medical student at the University of Santo Tomas, every morning I would be reminded by the sculpted Latin phrase on the faade of the Medicine Building which said, Primum non nocere (First, do no harm). This is one of the principal precepts of medical ethics that all medical practitioners pledge to adhere to.

Excerpt from:
An end to the stem cell ‘hammer’ and ‘nail’

Stem-cell therapy 'can be lethal'

People considering stem-cell treatment have been advised to think again, with six groups of medical specialists issuing a strong warning yesterday that unlicensed stem-cell treatments on offer could kill a patient.

The medical societies that issued the statement include the Royal College of Physicians, the Dermatological Society, Heart Association of Thailand under the Royal Patronage of His Majesty the King, the Thai Society of Haematology, the Nephrology Society and the Neurology Society.

The statement said the Medical Council of Thailand had only approved the use of stem-cell treatment on blood diseases - namely leukaemia, malignant lymphoma, aplastic anaemia, multiple myeloma and thalassemia.

Clinical research on the use of stem-cell treatment is ongoing, but there is no scientific evidence that stem-cell therapy can effectively increasing a person's longevity, or delay organ degeneration or improve a patient's quality of life, Prof Kriang Tungsanga, president of the Royal College of Physicians, said.

The move by the medical societies was prompted by widespread ads about stem-cell-based "miracle pills" that claim to ease the symptoms of chronic symptoms such as diabetes and heart disease.

The unlicensed use of stem-cell therapy to treat heart disease, diabetes or for aesthetic purposes has become popular among celebrities and rich people who can afford the treatment, which can cost anything from Bt100,000 to Bt1 million.

Some patients even fly to private clinics in Germany to receive stem-cell injections extracted from unborn sheep that they believe will improve their health and make them look younger.

However, Kriang reiterated that stem-cell therapy is not recommended or included in the standard clinical practice guidelines of any disease other than some blood conditions.

Wrong usage 'can hurt'

Moreover, inappropriate use of stem-cell therapy may be harmful to patients as they could develop an allergy, clotting in blood vessels, contamination of the blood stream, foreign protein materials, chemicals microbial organisms and other non-pure types of cells and cancer transforming cells.

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Stem-cell therapy 'can be lethal'