International Stem Cell Corporation Initiates IND-Enabling Study in Parkinson's Disease Program

CARLSBAD, CA--(Marketwired - May 30, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies, announced today the initiation of its IND-enabling pharmacology and toxicology non-human primate studies, under the direction of Yale School of Medicine Professor D. Eugene Redmond Jr. MD, the internationally recognized neurosurgeon and a leader in the use of stem cells for the treatment of Parkinson's disease.

The studies will use non-human primates with moderate to severe Parkinson's disease symptoms to assess the safety and functional efficacy of ISCO's proprietary stem cell-derived neuronal cells. The endpoints of these multi-dose studies include determining cell fate, biodistribution and primate behavioral evaluations using a standardized rating scale to assess potential extrapyramidal side effects associated with the cell engraftment. The first, interim results are expected in Q4 of 2013 with the final results available in Q2 of 2014.

Leading the studies will be Prof. Redmond, a recognized expert in the use of transplanted neural cells to treat parkinsonism in primates and the development of effective replacement strategies using stem cell derived neurons. In his career of over 25 years, Prof. Redmond has made many significant contributions in the field of cellular repair in the nervous system for Parkinson's disease. His accomplishments include establishing one of the first preclinical models for Parkinson's disease in primates, the first successful transplantation of fetal tissue into the brain of a primate and one of the first clinical studies of fetal tissue in Parkinson's patients.

"Building on the results from the successful primate and rodent studies we reported earlier this year, we expect these formal studies to be the final step allowing ISCO to file an IND for Parkinson's disease," said Dr. Ruslan Semechkin, Vice President of Research and Development. "As one of the leaders in this field, it's tremendously exciting for ISCO to have such an experienced and influential clinical scientist as Prof. Redmond to direct this research. His clinical experience will be invaluable as we prepare both our IND submission to the FDA and the subsequent phase I clinical trial," Dr. Semechkin continues.

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 StatementsStatements 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 Initiates IND-Enabling Study in Parkinson's Disease Program

Science news from Harvard Stem Cell Institute

Public release date: 29-May-2013 [ | E-mail | Share ]

Contact: Joseph N. Caputo joseph_caputo@harvard.edu 617-476-1492 Harvard University

May brought a major advancement in the science of aging when two Harvard Stem Cell Institute (HSCI) researchers announced their discovery of a protein circulating in the blood of mice and humans that shows potential to be a treatment for age-related heart failure. The protein, called GDF-11, reduced the size and thickness of the heart walls when injected into old mice.

There are hundreds of investigators in the HSCI network solving different problems related to cell biology and illness. This month, we feature recently published work by three laboratories on: a therapy for graft-versus-host disease, intestinal stem cell circadian rhythms, and new hope for people suffering from a rare blood disorder.

Human Clinical Trials Move Forward With Promising Therapy for Graft-Verses-Host Disease

HSCI investigators have developed a better picture of why a recently discovered therapy for graft-versus-host disease (GVHD) is more effective than anything currently available to patients.

In 2011, human clinical trials showed that immune system signaling molecule interleukin 2 (IL-2) both improved GVHD symptoms in patients and completely stopped the progression of the condition. Surprisingly, HSCI Executive Committee member Jerome Ritz, MD, and his team at the Dana-Farber Cancer Institute found that patients who received a continuous low dose of IL-2, which is an FDA-approved drug that stimulates immune cells to attack certain types of cancers, saw reduced GVHD symptoms because their immune response was suppressed. "It's interesting because it changes the paradigm," Ritz said. "You think something stimulates the immune system, but actually what it does is the opposite."

Bone marrow transplants are life-saving treatments for patients with leukemia and lymphoma that completely replace a recipient's faulty blood-forming stem cells with those of a matching donor. Despite immunologic differences between the donor and recipient, the donor immune system often recognizes that it is in a new place and adapts. When recognition does not happen, the donor's immune system begins to attack the recipient's tissues, causing the uncomfortable and difficult-to-manage symptoms of GVHD.

Ritz's team found that IL-2 affects the relationship between the immune cells that mount the body's immune response (effector T cells) and the immune cells that maintain the body's ability to differentiate between self and non-self tissue (regulatory T cells). The researchers observed that patients with GVHD have a lower level of regulatory T cells and higher level of effector T cells than normal. Low doses of IL-2 can increase the presence of regulatory T cells sevenfold and help them survive longer. The growing population of regulatory T cells then competes for IL-2 with effector T cells, preventing them from getting switched on.

"The immune system functions in checks and balances," Ritz said. "We found that not only was their relatively less IL-2 in GVHD patients, but there was relative more other cytokines, IL-7 and IL-15, that primarily supported effector T cells and didn't support regulatory T cells." Ritz's work is inspiring multi-center studies looking at how IL-2 can work in other immune diseases, and whether early use of IL-2 can reduce tissue damage caused by GVHD.

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Adventist Hospital offers stem cell therapy

THE Davao Adventist Hospital is now offering services for autologous stem cell therapy.

Marketing officer Kim Endrei Go said the therapy is the first in Davao City and an alternative treatment for degenerative diseases of joints and bones caused by sports injuries and chronic pains.

Go said the treatment allows the patient to continue the normal routine even after the treatment. He said the therapy is non-surgical and has a healing period of only three days.

The modalities in extracting stem cells in the therapy are either through the Platelet Rich Plasma (PRP) and through Bone Marrow Aspiration Concentrate.

Go said autologous means that the stem cells will be extracted from the patient himself and will be regenerated through an equipment.

The hospital uses the Harvest technologies from the United States which introduced the SmartPrePtm2.

SmartPrePtm2 is used to redefine platelet concentrate systems. Its latest innovation will further expand and enhance the use of autologous bioactive proteins as well as help optimize the condition for healing.

Go said that the therapy session depends on the severeness of the patient's condition. He added that most patients had 3 sessions but some had once or twice.

He said the technology was first practice in their Cebu branch and is now adopted for Davao. He said that in Cebu there about almost 90 treatments since November last where it was launched.

Each session costs P80,000 where about 60 cc of platelet and stem cells will be collected from the patient.

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Adventist Hospital offers stem cell therapy

Significantly improved survival rates for stem cell transplant recipients

May 28, 2013 Survival rates have increased significantly among patients who received blood stem cell transplants from both related and unrelated donors, according to a study published in the Journal of Clinical Oncology today. The study authors attribute the increase to several factors, including advances in HLA tissue typing, better supportive care and earlier referral for transplantation.

The study analyzed outcomes for more than 38,000 transplant patients with life-threatening blood cancers and other diseases over a 12-year period -- capturing approximately 70 to 90 percent of all related and unrelated blood stem cell transplants performed in the U.S. It was led by Theresa Hahn, Ph.D., of Roswell Park Cancer Institute (RPCI), in collaboration with the Center for International Blood and Marrow Transplant Research (CIBMTR), the research arm of the National Marrow Donor Program (NMDP) and Be The Match.

"This study shows that we are making significant progress, on a national level, in survival after transplantation. Patients across the country have benefited from the collaborative efforts of the CIBMTR, the NMDP and clinical researchers at individual transplant centers," said Dr. Hahn, an Associate Member and Associate Professor of Oncology in RPCI's Department of Medicine and first author on the study. "Our results demonstrate that these efforts have yielded improvement in early survival rates, and we will continue to work together to further improve long-term survival."

At 100 days post-transplant, the study shows survival significantly improved for patients with myeloid leukemias (AML) receiving related transplants (85 percent to 94 percent) and unrelated transplants (63 percent to 86 percent). At one-year post-transplant, patients who received an unrelated transplant showed an increased survival rate from 48 to 63 percent, while the survival rate for related transplant recipients did not improve. Similar results were seen for patients with acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS).

"The existence of the CIBMTR, which is a collaboration of the NMDP and the Medical College of Wisconsin, and its database of more than 330,000 patient outcomes made it possible for us to study whether and how the use of blood stem cell transplants, both related and unrelated, have changed over time," said Navneet Majhail, M.D., co-author of the study and medical director at the NMDP. "The significant improvements we saw across all patient and disease populations should offer patients hope and, among physicians, reinforce the role of blood stem cell transplants as a curative option for life-threatening blood cancers and other diseases."

In addition to improved survival, the authors note a significant increase in the overall number of patients receiving transplants. Related and unrelated transplant as treatment for ALL, AML, MDS and Hodgkin and non-Hodgkin lymphomas increased by 45 percent -- from 2,520 to 3,668 patients annually. This is likely due to the use of reduced-intensity conditioning therapy and a greater availability of unrelated volunteer donors, a result of efforts by the NMDP and Be The Match to increase and diversify the Be The Match Registry.

"As evidenced by this data, the transplantation community has clearly made momentous progress toward improving survival rates," said Jeffrey W. Chell, M.D., chief executive officer of the NMDP. "Together with our research arm, CIBMTR, and our global partners, we will continue advancing the science of transplant to extend the curative power of this therapy to more patients and more diseases and help all patients live longer, healthier lives."

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Grant Funds Research Into Cardiac Stem Cells as Treatment for Heart Disease Related to Duchenne Muscular Dystrophy

Life Education Keywords: New Book Looks at How Social Class Shapes College Decisions

Many valedictorians from less affluent families dont even apply to prestigious colleges and universities, according to a new book by Alexandria Walton Radford, Ph.D., associate program director in postsecondary education at RTI International.

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A new guideline from the American Academy of Neurology advises that it is likely safe to continue taking blood thinners before minor procedures such as dental procedures, cataract surgery or dermatologic procedures. The guideline is published in Neurology.

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Shannon Galyan, a 2013 University of Evansville graduate, will spend her first year out of college halfway across the world in South Korea, where she has been awarded a Fulbright grant to teach English for the 2013-14 academic year.

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Grant Funds Research Into Cardiac Stem Cells as Treatment for Heart Disease Related to Duchenne Muscular Dystrophy

Cell Booster Infusion Mask – the Most Advanced Anti and Pre-aging Facial Treatment is in Flawless

Cell Booster Infusion Mask - the Most Advanced Anti and Pre-aging Facial Treatment is in Flawless

"Refreshing! I feel like I'm now ready for another long-week battle." that's exactly the feeling I got right after I was pampered using Flawless' new revolutionary offering - the Cell Booster Infusion Mask facial treatment.

It seems theres no stopping Flawless, the countrys preferred clinic for face, body and medical services, from dominating the local beauty arena. Still hot from the successful launch of the countrys first affordable stem cell-based product line, the brand now marks another milestone with the introduction of its most advanced facial treatment yet, Cell Booster Infusion Mask.

Were really proud of this new facial as it is set to once again raise the bar for anti- and preventive-aging treatments in the country, starts Rubby Sy, CEO of Flawless. In a nutshell, Cell Booster Infusion Mask is designed to perform two main functions: one, to combat the effects of and protect the skin from the destructive free radicals that we encounter every day; two, to rejuvenate and improve our skins cell architecture by nourishing it and encouraging the tissue regeneration process.

The science used for Cell Booster Infusion Mask allows it to deliver essential nutrients to the skin at cellular level. Using an advanced cellular repair hydrogel mask which contains highly concentrated essence of cell-activating nutrients, it promises to increase the skin's elasticity, minimize pores and the appearance of fine lines and wrinkles while giving the skin an undeniable glow. According to Sy, the technology for hydrogel is innovative in that it coagulates nutritious substances into a gel format and delivers active ingredients into the skin by reacting to the skins temperature rather than the air. It also leaves the skin feeling cool, fresh and invigorated.

We feel very lucky to have been able to bring this one-of-a-kind technology to the country, shares Sy. Flawless is very proud of the fact that with this new treatment, the brand is once again able to fulfill its promise to consistently bring medically-sound beauty solutions closer to Filipinos without the Class-A prices."

About Flawless

Established in 2001, Flawless is the countrys preferred clinic for face, body and medical services. It was founded on the premise of providing Filipinos easier access to top-notch, medically-sound beauty solutions. While cost has made the brands offerings more accessible, the quality of Flawless products and services remains first class. Powered by Skin Professionals, all of Flawless doctors and staff regularly attend medical and dermatological conferences in and out the country and receive constant up trainings. The brand is famed for employing equipment and technologies that are at par with those used by most international dermatological facilities.

For more information visit a Flawless Clinic near you or visit our website https://flawless.com.ph/. Stay connected, know the latest from Flawless, follow us on Facebook, Facebook.com/FlawlessFaceandBody and Twitter, Twitter.com/MyFlawless.

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Cell Booster Infusion Mask - the Most Advanced Anti and Pre-aging Facial Treatment is in Flawless

Stem-cell trial gives fresh hope to stroke patients

Professor Keith Muir, from Glasgow University, said the results were "not what we would have expected" from the group of patients, who had previously shown no indications of their conditions improving.

He stressed it is too soon to tell whether the effect is due to the treatment they are receiving.

The trial involves injecting stem cells directly into the damaged parts of the patients' brains, with the hope they would turn into healthy tissue or kick-start the body's own repair processes.

Nine patients, in their 60s, 70s and 80s are taking part in the trial at Glasgow's Southern General Hospital to assess the safety of the procedure.

Among the patients to have shown improvements is former teacher Frank Marsh, who had a stroke five years ago.

The stroke left him with poor strength and co-ordination in his left hand, and poor balance. He needs a walking stick to help him move around the house.

The 80-year-old took part in the trial at Glasgow's Southern General Hospital, and said he had seen improvements in the use of his left hand.

Mr Marsh said: "I can grip certain things that I never gripped before, like the hand rail at the baths, with my left hand as well as my right.

"It still feels fairly weak and it's still a wee bit difficult to co-ordinate but it's much better than it was."

Mr Marsh said he hoped the improvements would continue, adding: "I'd like to get back to my piano. I'd like to walk a bit steadier and further."

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Stem-cell trial gives fresh hope to stroke patients

Spine function improves following cell replacement therapy with fetal human stem cells

Public release date: 27-May-2013 [ | E-mail | Share ]

Contact: Hilary Glover hilary.glover@biomedcentral.com 44-020-319-22370 BioMed Central

Human foetal stem cell grafts improve both motor and sensory functions in rats suffering from a spinal cord injury, according to research published this week in BioMed Central's open access journal Stem Cell Research and Therapy. This cell replacement therapy also improves the structural integrity of the spine, providing a functional relay through the injury site. The research gives hope for the treatment of spinal cord injuries in humans.

Grafting human neural stem cells into the spine is a promising approach to promote the recovery of function after spinal injury. Sebastian van Gorp, from the University of California San Diego, and team's work looks specifically at the effect of intraspinal grafting of human foetal spinal cord-derived neural stem cells on the recovery of neurological function in a rats with acute lumbar compression injuries.

A total of 42 three month-old female Sprague-Dawley rats, with spinal compression injuries, were allocated to one of three groups. The rats in the first group received a spinal injection with the stem cells, those in the second group received a placebo injection, while those in the third group received no injection.

Treatment effectiveness was assessed by a combination of measures, including motor and sensory function tests, presence of muscle spasticity and rigidity which causes stiffness and limits residual movement. The team also evaluated of how well the grafted cells had integrated into the rodents' spines.

Gorp and colleagues found that, compared to rats who received either the placebo injection or no injection, those who received the stem cell grafts showed a progressive and significant improvement in gait/paw placement, reduced muscle spasticity as well as improved sensitivity to both mechanical and thermal stimuli. In addition to these behavioural benefits, the researchers observed long-term improvements in the structural integrity of previously injured spinal cord segments.

The authors say: "Importantly, spinal cavity formation and muscle spasticity are frequently observed in human patients with high-speed, high-impact induced spinal cord injuries. Our findings demonstrate that human foetal spinal cord-derived neural stem cells, with an already established favorable clinical safety profile, represent a potential cell candidate for cell replacement therapy in patients with traumatic spinal injuries."

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Spine function improves following cell replacement therapy with fetal human stem cells