Category Archives: California Stem Cells

Harvard University researchers have pioneered a technique to grow by the billions the insulin-producing cells people with diabetes lack, a breakthrough that may create new ways to treat the disease.

The breakthrough comes after 15 years of seeking a bulk recipe for making beta cells, which sense the level of sugar in the blood and keep it in a healthy range by making precise amounts of insulin, according to Harvard scientists led by Douglas Melton, who published their work today in the journal Cell. The process begins with human stem cells, which have the ability to become any type of tissue or organ.

The technique is an important step toward understanding and treating diabetes, a condition in which the pancreass beta cells are insufficient or dead. Diabetes affects 347 million people worldwide, and its chronic high blood sugar levels can injure hearts, eyes, kidneys, the nervous system and other tissues.

This is part of the holy grail of regenerative medicine or tissue engineering, trying to make an unlimited source of cells or tissues or organs that you can use in a patient to correct a disease, said Albert Hwa, director of discovery science at JDRF, a New York-based diabetes advocacy group that funded Meltons work.

Human stem cell derived beta cells that have formed islet-like clusters in a mouse. Cells were transplanted to the kidney capsule and photo was taken two weeks later by which time the beta cells were making insulin and had cured the diabetes in the mouse. Close

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Human stem cell derived beta cells that have formed islet-like clusters in a mouse. Cells were transplanted to the kidney capsule and photo was taken two weeks later by which time the beta cells were making insulin and had cured the diabetes in the mouse.

The procedure for making mature, insulin-secreting beta cells has taken years of painstaking research that led to a 30-day, six-step recipe, Melton said. Laboratories will be able to use the cells to test drugs and learn more about how diabetes occurs, he said.

They had to go through an awful lot of trial and error to get to this, said Jeanne Loring, director of the Scripps Research Institutess Center for Regenerative Medicine in La Jolla, California. The proof will be in how well this protocol works for people in other laboratories.

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Harvard Breakthrough Grows Insulin-Control Cells in Bulk

Overview of Cancer Immunotherapy

The immune system deals with cells and organisms that express foreign antigens by a process of antigen presentation to T cells then communication with B cells. This is followed by the production of cytotoxic T cells that can recognize antigens, and the production by differentiated B cells of antibodies that target those antigens. The system also has a memory process so that if an antigen is seen again, the immune response is mobilized even faster. T cells are capable of killing tumor cells. However, there are feedback mechanisms in many diseases, particularly cancer, that can turn off and/or repress the processes of antigen recognition and immune response.

Some experts have suggested that within 10 years, 60% of cancers will be treated with immunotherapy (Nature, Vol. 508, 3 April 2014). Immune responses can be induced and/or enhanced by vaccination using a single or handful of well-characterized tumor antigens. Injections of exogenously expanded cytotoxic T cells that recognize a single antigen on a patients cancer have been shown to eliminate metastatic disease in a subset of patients. However, cancers do not express a single antigen. Further, it is now known that most of these mutations are unique to that patients cancer; so it is not surprising that approaches that have involved immunization with only one or a few antigens, or injections of someone elses cultured tumor cells have not been successful.

We believe that a better approach would involve a broader array of antigens and would utilize the patients own tumor, also known as autologous tumor. A number of those methods that have been tried have sought to draw antigens from an entire tumor mass. However, the cells of interest are the cancer stem cells or replicating cells, those with indefinite multiplicative capability. Only a few of those cells are present in the tumor mass, perhaps as few as 1/100,000 cells have this potential. Moreover, the tumor mass by definition includes a variety of other cells, such as immune cells, blood cells and other cells, some or many of which may inhibit or otherwise interfere with antigen recognition.

NeoStems approach is different in two fundamental ways from other autologous therapies: (i) it presents to the patients immune system the entire spectrum of antigens from that patients own tumor and (ii) it separates out and re-administers just those cells from the patients tumor that are self-renewing, that is, those that can regenerate the cancer and cause metastatic spread against which an immune response is most needed. Those cells are pretreated with radiation and are connected to a dendritic cell to optimize presentation to the T cell.

Basic and clinical research have established that in some patients there is the ability to recognize tumor antigens, but as a result of their disease there are mechanisms that interfere with this process, while other patients have an existing immune recognition of tumor antigens, but their immune response is being suppressed. This is the basis for the new monoclonal antibody therapies such as anti-CTLA4, anti-PD-1, and anti-PD-L1 that are providing clinical benefit in the setting of metastatic melanoma. These so-called checkpoint inhibitors, i.e., drugs that block checkpoint proteins, work by either stimulating an existing immune response to tumor antigens, or liberating a repressed immune response to tumor antigens. However, their mechanisms of action rely on pre-existing recognition of tumor antigens by the immune system. NeoStems approach is different in that it is designed to induce or enhance recognition of all the tumor antigens expressed on the tumors self-renewing cells. In other words, the therapys intent is to increase the target specifically, its self-renewing stem cells.

The lead candidate in the program is the Companys DC/TC (dendritic cell/tumor cell) product*, a treatment for malignant melanoma. In a Phase 2 randomized clinical trial of subcutaneously injected DC/TC,DC/TC improved two year overall survival in patients with advanced melanoma (recurrent Stage III or Stage IV) to 72% compared to 31% for control patients treated with only their own tumor cells suspended in granulocyte macrophage colony stimulating factor (GM-CSF) (p=0.007). The toxicity profile was favorable with no grade IV and only one grade III (allergic reaction) event in the study. The allergic reaction was attributed to the granulocyte macrophage colony-stimulating factor (GMCSF), an FDA-approved immune stimulant used in the final drug formulation. There were no other significant toxicities seen in either an earlier single-arm Phase 2 trial or this randomized Phase 2 trial. Local injection site reactions, such as skin irritation and itching, did occur, but the symptoms dissipated within hours after the injection. There were no significant adverse effects on hematopoietic cells or renal function, liver function, or patient performance status. View Phase 2 trial results.

NeoStems immunotherapeutic approach is a platform technology that NeoStem believes could be expanded into other indications, such as hepatocellular carcinoma and other immune responsive tumor types.

* NeoStem has submitted a United States Adopted Names Council application for the Companys DC/TC product for metastatic melanoma to use the generic name Melapuldencel-T.

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California Stem Cell, Inc.

PUBLIC RELEASE DATE:

21-Sep-2014

Contact: Susan Brown scinews@ucsd.edu 858-246-0161 University of California - San Diego @UCSanDiego

Biochemists working at the University of California, San Diego, have developed a program that predicts the placement of chemical marks that control the activity of genes based on sequences of DNA. They describe their analysis and report results from its application to human embryonic cells in a paper published in Nature Methods online September 21.

"All of our cells have the same blueprint, the same DNA, although they serve separate functions," said John Whitaker, lead author of the report. "Skin cells protect, nerve cells send signals, and these differences emerge because different subsets of genes are active or silent within particular kinds of cells."

These patterns of activity are controlled by modifications of the DNA that do not alter its sequencechemical tags that influence which genes are read and which are skipped within a particular cell.

By comparing sequences with and without epigenomic modification, the researchers identified DNA patterns associated with the changes. They call this novel analysis pipeline Epigram and have made both the program and the DNA motifs they identified openly available to other scientists.

"The interplay between genetic and epigenomic regulation has only begun to be deciphered," said Wei Wang, professor of chemistry and biochemistry who directed the work. "This study revealed that there are specific DNA sequences that are recognized by DNA-binding proteins," which specify exactly where other enzymes place epigenomic marks.

The epigenome guides the development of complex organisms from single fertilized eggs. The researchers analyzed epigenomic patterns in human embryonic stem cells and four cell lineages derived from them to catalogue genetic elements that shape the epigenome during development.

Damage to the epigenome not only disrupts development, but can happen at any point in our lives and sometimes leads to illness. Identification of the DNA sequences that guide the placement of epigenomic could guide experimental analysis, the authors say. By editing DNA sequences that control epigenomic modifications, scientists could probe their functions and perhaps in the future mend epigenomic mistakes that cause harm. Susan Brown

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Program predicts placement of chemical tags that control gene activity

PUBLIC RELEASE DATE:

16-Sep-2014

Contact: Scott Lafee slafee@ucsd.edu 619-543-6163 University of California - San Diego @UCSanDiego

Researchers at the University of California, San Diego School of Medicine have launched a phase 1 human clinical trial to assess the safety and efficacy of a new monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), the most common form of blood cancer in adults.

The new antibody targets ROR1, a protein used by embryonic cells during early development and exploited by cancer cells to promote tumor growth and metastasis, the latter responsible for 90 percent of all cancer-related deaths.

Because ROR1 is not expressed by normal adult cells, scientists believe it is a biomarker of cancer cells in general and cancer stem cells in particular. Because it appears to drive tumor growth and disease spread, they believe it also presents an excellent target for anti-cancer therapy.

Developed at UC San Diego Moores Cancer Center by Thomas Kipps, MD, PhD, who holds the Evelyn and Edwin Tasch Chair in Cancer Research, and colleagues, the antibody is called cirmtuzumab (also known as UC-961). In previous animal studies, Kipps' team reported that ROR1 is singularly expressed on CLL and also on a variety of different cancers, including cancers of the breast, pancreas, colon, lung and ovary. In mouse models of CLL, ROR1 acts as an accelerant when combined with another oncogene to produce a faster-growing, more aggressive cancer.

Cirmtuzumab was developed under the auspices of the California Institute for Regenerative Medicine's HALT leukemia grant awarded to Dennis Carson, MD, principal investigator, and Catriona Jamieson, MD, PhD, co-principal investigator to develop six distinct therapies against cancer stem cells. Kipps led one of the six projects and generated antibodies against ROR1, leading to the cirmtuzumab trial in patients with CLL.

"The primary goal of this phase I clinical trial is to evaluate whether cirmtuzumab is a safe and well-tolerated cancer stem cell-targeted agent in patients with CLL," said Jamieson, chief of the Division of Regenerative Medicine, associate professor of medicine, director of stem cell research at UC San Diego Moores Cancer Center, deputy director of the Sanford Stem Cell Clinical Center and a principal investigator of the cirmtuzumab clinical trial.

Michael Choi, MD, assistant clinical professor of medicine and co-principal investigator of the clinical trial said, "The trial will involve patients with relapsed or refractory CLL, who will receive an intravenous infusion every 14 days at Moores, followed by regular monitoring and clinic visits to assess efficacy and identify and manage any adverse effects. Initial treatment is planned for two months."

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Novel drug targeting leukemia cells enters clinical trial

PUBLIC RELEASE DATE:

12-Sep-2014

Contact: Cristy Lytal lytal@med.usc.edu 323-442-2172 University of Southern California - Health Sciences

Unlike salamanders, mammals can't regenerate lost limbs, but they can repair large sections of their ribs.

In a new study in the Journal of Bone and Mineral Research, a team directed by USC Stem Cell researcher Francesca Mariani takes a closer look at rib regeneration in both humans and mice.

The first author of the paper, USC medical student Marissa K. Srour, was a USC undergraduate when she started the project, which earned a 2011 USC Discovery Scholar Prize. Each year, 10 graduating seniors win these coveted prizes, which recognize exceptional new scholarship.

Using CT imaging, Srour, Mariani and their colleague Janice Lee from the University of California, San Francisco, monitored the healing of a human rib that had been partially removed by a surgeon. The eight centimeters of missing bone and one centimeter of missing cartilage did partially repair after six months.

To better understand this repair process, they surgically removed sections of rib cartilage ranging from three to five millimeters from a related mammal, mice. When they removed both rib cartilage and its surrounding sheath of tissue called the "perichondrium," the missing sections failed to repair even after nine months. However, when they removed rib cartilage but left its perichondrium, the missing sections entirely repaired within one to two months.

They also found that a perichondrium retains the ability to produce cartilage even when disconnected from the rib and displaced into nearby muscle tissue further suggesting that the perichondrium contains progenitor or stem cells.

"We believe that the development of this model in the mouse is important for making progress in the field of skeletal repair, where an acute clinical need is present for ameliorating skeletal injury, chronic osteoarthritis and the severe problems associated with reconstructive surgery," said Mariani, assistant professor of Cell and Neurobiology and principal investigator in the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC. "At the early stages in our understanding, the mouse provides us with an exceptional ability to make progress, and we are excited about the potential for using cells derived from the rib perichondrium or using rib perichondrium-like cells for regenerative therapy."

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USC researchers discover the healing power of 'rib-tickling'

PUBLIC RELEASE DATE:

11-Sep-2014

Contact: Mary Beth O'Leary moleary@cell.com 617-397-2802 Cell Press @CellPressNews

Using human induced pluripotent stem cells (hiPSCs), researchers have gained new insight into what may cause schizophrenia by revealing the altered patterns of neuronal signaling associated with this disease. They did so by exposing neurons derived from the hiPSCs of healthy individuals and of patients with schizophrenia to potassium chloride, which triggered these stem cells to release neurotransmitters, such as dopamine, that are crucial for brain function and are linked to various disorders. By discovering a simple method for stimulating hiPSCs to release neurotransmitters, the findings in the International Society for Stem Cell Research's journal Stem Cell Reports, published by Cell Press, could provide new insights into how neurons communicate with each other and could lead to a better understanding of the neural mechanisms underlying a range of brain disorders.

"This study is novel because it shows that stem cell neurons derived from patients can provide new insight into neurotransmitter mechanisms occurring in brain disorders such as schizophrenia," says senior study author Vivian Hook of the University of California, San Diego. "The approach of this study has broad opportunities for uncovering the neurochemistry of brain cell communication in numerous brain disorders, via these studies of human disease in a dish. Findings from these studies will lead to new therapeutic strategies for brain disorders, especially those mental and neurological diseases for which no drug treatments exist today."

hiPSCS are cells that are taken from adults, genetically reprogrammed to an embryonic stem cell-like state, and then converted into specialized cells such as neurons. Patient-derived hiPSCs offer the possibility of modeling an individual's disease in a dish and assessing which drugs will most effectively treat the disease. Because dysfunction in neural communication is linked to brain disorders such as schizophrenia, Hook and Fred Gage of The Salk Institute and Kristen Brennand of the Icahn School of Medicine at Mount Sinai set out to determine whether hiPSC-derived neurons can be induced to release important brain signaling chemicals, allowing disease mechanisms to be studied in a dish.

To address this question, the researchers exposed hiPSC-derived neurons from healthy individuals and patients with schizophrenia to a chemical known to stimulate the release of neurotransmitters. They found that these cells contained neurotransmitter-producing enzymes and were capable of secreting dopamine, norepinephrine, and epinephrineneurotransmitters that are crucial for brain function and that are linked to various disorders. Moreover, secretion of the three neurotransmitters was enhanced in hiPSC-derived neurons from schizophrenia patients compared with those from healthy individuals.

"The significance of this study is that patient-derived stem cell neurons can uncover previously unknown neurotransmitter brain mechanisms occurring in schizophrenia," Hook says. "Because in vivo human brain research is limited, hiPSC neurons derived from patients create new opportunities to understand changes occurring in brain cells occurring in nervous system disorders. These approaches can potentially define new drug targets for the development of therapeutic agents to improve the lives of schizophrenia patients."

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Stem Cell Reports, Hook et al.: "Human iPSC Neurons Display Activity-Dependent Neurotransmitter Secretion: Aberrant Catecholamine Levels in Schizophrenia Neurons."

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Stem cells help researchers understand how schizophrenic brains function

ViaCyte is developing a drug delivery system that enables implanted pancreatic progenitor cells to survive and differentiate into functioning insulin-producing islet cells.

Correction: The number to call for more information on the diabetes clinical trial is 858-657-7039. An incorrect number was originally provided.)

ViaCyte has started a clinical trial of its diabetes treatment derived from stem cells, the first such treatment ever tested in people.

UC San Diego said Tuesday it is hosting the Phase 1 trial in partnership with San Diego-based ViaCyte. The biotech company grows islet cells from human embryonic stem cells. The cells are placed into a semi-permeable envelope and implanted into the patient. In animals, the stem cells mature into islet cells, successfully controlling blood sugar.

The treatment could provide what the company calls a virtual cure for Type 1 diabetes, which is caused by a lack of insulin-producing "islet" cells in the pancreas. About 40 people are being sought for the trial. Those interested should call Todd May at 858-657-7039.

Success would not only provide a tremendous boost for the privately held biotech company, but also California's stem cell agency, which has provided nearly $40 million in funding.

The agency, the California Institute for Regenerative Medicine, is scheduled to vote Wednesday on approving a recommended $16.6 million for ViaCyte to help with clinical trials. CIRM will eventually have to get more money as the $3 billion approved by California voters under Prop. 71 in 2004 is used up.

Paul Laikind, CEO of ViaCyte, which is making a treatment for diabetes from human embryonic stem cells.

The ViaCyte trial's goals are to assess safety and whether the cells are actually making insulin, said Paul Laikind, ViaCyte's chief executive. A longer-term goal is to determine if the cells made other hormones that regulate blood sugar levels. These are glucagon, which in contrast to insulin raises blood sugar levels, and somatostatin, which regulates both insulin and glucagon.

If the full array of hormones are produced, it's hoped that ViaCyte's product will perform like a natural pancreas, Laikind said. While the trial is starting at UCSD, Laikind said the company intends to expand it to other centers.

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ViaCyte starts diabetes trial

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Newswise La Jolla, Calif., September 7, 2014Researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham) have developed a novel technique to promote tissue repair in damaged muscles. The technique also creates a sustainable pool of muscle stem cells needed to support multiple rounds of muscle repair. The study, published September 7 in Nature Medicine, provides promise for a new therapeutic approach to treating the millions of people suffering from muscle diseases, including those with muscular dystrophies and muscle wasting associated with cancer and aging.

There are two important processes that need to happen to maintain skeletal-muscle health. First, when muscle is damaged by injury or degenerative disease such as muscular dystrophy, muscle stem cellsor satellite cellsneed to differentiate into mature muscle cells to repair injured muscles. Second, the pool of satellite cells needs to be replenished so there is a supply to repair muscle in case of future injuries. In the case of muscular dystrophy, the chronic cycles of muscle regeneration and degeneration that involve satellite-cell activation exhaust the muscle stem-cell pool to the point of no return.

Our study found that by introducing an inhibitor of the STAT3 protein in repeated cycles, we could alternately replenish the pool of satellite cells and promote their differentiation into muscle fibers, said Alessandra Sacco, Ph.D., assistant professor in the Development, Aging, and Regeneration Program at Sanford-Burnham. Our results are important because the process works in mice and in human muscle cells.

Our next step is to see how long we can extend the cycling pattern, and test some of the STAT3 inhibitors currently in clinical trials for other indications such as cancer, as this could accelerate testing in humans, added Sacco.

These findings are very encouraging. Currently, there is no cure to stop or reverse any form of muscle-wasting disordersonly medication and therapy that can slow the process, said Vittorio Sartorelli, M.D., chief of the Laboratory of Muscle Stem Cells and Gene Regulation and deputy scientific director at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). A treatment approach consisting of cyclic bursts of STAT3 inhibitors could potentially restore muscle mass and function in patients, and this would be a very significant breakthrough.

Revealing the mechanism of STAT3 STAT3 (signal transducer and activator of transcription 3) is a protein that activates the transcription of genes in response to IL-6, a signaling protein released by cells in response to injury and inflammation. Prior to the study, scientists knew that STAT3 played a complex role in skeletal muscle, promoting tissue repair in some instances and hindering it in others. But the precise mechanism of how STAT3 worked was a mystery.

The research team first used normally aged mice and mice models of a form of muscular dystrophy that resembles the human disease to see what would happen if they were given a drug to inhibit STAT3. They found that the inhibitor initially promoted satellite-cell replication, followed by differentiation of the satellite cells into muscle fibers. When they injected the STAT3 inhibitor every seven days for 28 days, they found an overall improvement in skeletal-muscle repair, and an increase in the size of muscle fibers.

We were pleased to find that we achieved similar results when we performed the experiments in human muscle cells, said Sacco. We have discovered that by timing the inhibition of STAT3like an on/off light switchwe can transiently expand the satellite-cell population followed by their differentiation into mature muscle cells.

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Researchers Discover a Key to Making New Muscles

Los Angeles, California (PRWEB) September 03, 2014

Stem Cell technology is the future; looking younger and better without plastic surgery is here now. Stem Cell Beautys debut product line StemLife is spearheading the current beauty renaissance. Among websites that provide stem cell beauty products, Stem Cell Beauty is in a league of its own.

Science is always advancing, why shouldn't your beauty products? questions Albert Faleski, Director of Operations at StemCellBeauty.com.

Most products on the shelves are outdated, whereas we take a different approach to find a formula that works with your body, reinvigorating your own stem cells to provide actual results.

The science behind StemLife is nothing short of groundbreaking. Its trademarked FixT Technology was achieved through reverse engineering to understand how the body maintains and heals itself with our own endogenous combinations of adult stem cells. With this knowledge they developed a means to mimic the natural stem cell processes in our body. Unlike other beauty brands, StemLife uses specific combinations of stem cell types, each cultured under specific state-dependent conditions, using cell types and states that are ideal for the particular tissue. It then creates a set of molecules from multiple stem cell types that is complete and fully formed, rendering maximum benefit and efficiency. This approach of stem cell skin care is extremely unique.

Other leading stem cell-based beauty companies use simpler technology where one stem cell type is chosen to make their molecules. This one-size fits all approach is not efficient and lacks the complexity of StemLifes FixT technology. Some companies mash the cells without allowing their molecules to fully process, which again leads to underachieving results. Many of the largest companies have made no attempt to use new science to formulate better products, providing their customers with over-priced serums proven to be archaic.

StemLifes cutting edge formula is shaping the future of hair regrowth as well, providing an ultramodern solution to those looking to slow the hands of time. Their most popular product, The Advanced Hair Treatment for Women, is essentially the hidden gem the world has been waiting for.

Its popularity stems back to the fact that it actually works. Faleski explained.

Were not big on gimmicks. We prefer showing our customer actual people who have had actual results with our products. After seeing life-changing hair growth with their own eyes, we are confident new customers will try it and have amazing results of their own. The Advanced Hair Treatment for Women is an incredible product that sells itself.

StemLifes most interesting product to date is the Natural Lash & Brow Lash Extend. This product boasts ingredients that are formulated to generate eyelash growth. In a market where eyelash extensions have been the go-to fix for longer lashes, being able to naturally grow them is a revolutionary concept.

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Stem Cell Beauty: The Online Shop Revolutionizing the Beauty Industry

CARLSBAD, CA--(Marketwired - August 28, 2014) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today announced that Executive Vice President Dr. Simon Craw will present a corporate overview of ISCO and its subsidiaries at two upcoming investment conferences.

Rodman and Renshaw 16th Annual Global Investment Conference:

Date:Wednesday, September 10, 2014 Time:11:40 a.m. ET Location:New York Palace Hotel, New York, NY Room:Kennedy I

Conference details:http://www.meetmax.com//sched/event_23003/~public/conference_home.html?event_id=23003

AEGIS CAPITAL Corp. 2014 Healthcare and Technology Conference:Date:Thursday, September 11, 2014 Time:10:45 a.m. PT Location:The Encore at Wynn, Las Vegas, NV

Conference details:http://www.meetmax.com/sched/event_25932/~public/conference_home.html?event_id=25932

Please contact the conference organizers if you have an interest in attending the conference or if you would like to arrange a meeting with International Stem Cell Corporation's management team.

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 atwww.internationalstemcell.com.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

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International Stem Cell Corporation to Present at Two Upcoming Investment Conferences