Category Archives: news

Geron gets FDA OK for embryonic stem-cell based therapy

From BizJournals.com

The U.S. Food and Drug Administration has granted clearance of an investigational new drug application that lets Geron Corp. move forward with the world’s first study of a human embryonic stem cell based therapy in man, the company said late Thursday.

Menlo Park-based Geron (NASDAQ:GERN) said it plans to initiate a Phase I multi-center trial that is designed to establish the safety of the drug GRNOPC1 in patients with “complete” American Spinal Injury Association grade A subacute thoracic spinal cord injuries.

“The FDA’s clearance of our GRNOPC1 IND is one of Geron’s most significant accomplishments to date,” said Dr. Thomas B. Okarma, Geron’s president and CEO. “This marks the beginning of what is potentially a new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells.”

The ultimate goal for the use of GRNOPC1 is restore spinal cord function by injecting hESC-derived oligodendrocyte progenitor cells directly into the patient’s injured spinal cord.”

Geron funded the original research at the University of Wisconsin-Madison that led to the first isolation of hESCs. The production of oligodendrocytes from hESCs is covered by patent rights licensed to Geron from the University of California.

Stem cell trial to be held in Scotland

From UK Trade & Invetment

Scotland is to trial a new stem cell treatment which could help patients with corneal blindness.

An innovative new treatment which uses stem cells to combat certain types of blindness is to be tested in Scotland.

Researchers at the Princess Alexandra Eye Pavilion in Edinburgh and Glasgow’s Gartnavel General Hospital will start a two-year trial using around 20 patients with corneal disease.

The technique will take stem cells from dead adult donors, which are then transplanted onto the surface of the cornea in the hope it could help to restore sight.

By using material from deceased donors, the method has avoided the controversy which surrounds embryonic stem cell research.

Professor Bal Dhillon, Consultant Ophthalmic Surgeon at Princess Alexandra and the project’s leader, commented: “This study is the first of its kind anywhere in the world and it is exciting to be involved in such groundbreaking work.

Last year, international pharmaceutical giant Pfizer established a biotechnology hub in the UK to carry out research into stem cell treatments for degenerative diseases and damaged organs.

A Stem Cell Treatment ‘against AIDS’

From Hindu.com

Scientists claim to have achieved a major breakthrough in the fight against AIDS with a new stem cell treatment which “protects the immune system from HIV that causes the disease”.

According to them, the pioneering technique involves isolating three genes which curb the spread of HIV inside the body, introducing them into human stem cells in a lab and then transplanting the stem cells into a patient’s bone marrow.

“What we are doing is genetically modifying a fraction of the patient’s stem cells with genes that target three diffe -rent aspects of HIV that allow it to get in the immune cells and replicate.

“When those stem cells are transplanted into patients, they create mature immune cells that circulate in the patient and protect against HIV,” ‘The Daily Telegraph’ quoted David DiGiusto of City of Hope Medical Centre in California, where the research was carried out, as saying.

In the first human trial, the scientists transplanted anti-HIV stem cells into five AIDS patients undergoing bone- marrow replacement as part of treatment for a form of cancer known as lymphoma.

Preliminary results showed that small quantities of the transplanted stem cells were able to grow and produce new white blood cells resistant to HIV resulting in an improvement in the patients’ conditions.

Now, they are planning further research to establish whether the treatment could even rid patients of HIV infection altogether.

“It is still an experimental treatment at the moment, but we hope that eventually we will be able to give AIDS pati- ents one transplant and that would then protect them for life.

We have data to show that the resistant cells are persisting in our lymphoma patients,” DiGiusto said.

International Stem Cell Begins Pre-Clinical Testing of Its Parthenogenetic Stem Cells for Treatment of Retinal Disease

First Company To Grow Human Corneal Tissue From Stem Cells

Oceanside, California,  January 13, 2009 — International Stem Cell Corporation
(OTCBB: ISCO) has created layered human tissue from its unique parthenogenetic stem cells and transplanted this tissue into animals in pre-clinical trials to establish a potential new treatment for human retinal diseases, such as macular degeneration or retinitis pigmentosa.

“Intact layers of retinal progenitor cells have been shown to restore lost visual responses in several retinal degeneration rodent models,” said Dr. Hans Keirstead, Co-Director of the Sue and Bill Gross Stem Cell Research Center at the University of California, Irvine.
“Thus, we are developing intact retinal layers derived from International Stem Cell’s human parthenogenetic stem cells which could become a sustainable, FDA-approved therapeutic supply for patients with retinal degenerative diseases.”

ISCO’s human parthenogenetic stem cells have the potential to treat human disease yet possess key medical and ethical advantages over other kinds of stem cell products. They can be matched to common immune types and thus reduce the chance of transplant rejection among large segments of the population. Because they are created from unfertilized human eggs, they do not require the destruction of human embryos.

“We are aggressively pushing forward safe treatments for human diseases using
parthenogenetic stem cells,” said Jeffrey Janus, President of International Stem Cell.

“If we are successful in this work, our next step is to manufacture this layered human tissue for further tests, including human trials. This illustrates the strengths of combining scientific collaborations with outside researchers such as Dr. Keirstead with ISCO’s science and cell manufacturing expertise.”

For more information, visit the ISCO website at: www.internationalstemcell.com

Cellartis Deposits Cell Lines with U.S. National Stem Cell Bank

All NIH Human Embryonic Stem Cell Registry Lines Now on Deposit at NSCB

January 12, 2009, Madison, Wis.–The U.S. National Stem Cell Bank (NSCB) has announced that it has received deposits of two human embryonic stem cell lines from Cellartis AB, a biotechnology company based in Sweden. With the addition of the new lines, the National Stem Cell Bank now has received all 21 cell lines from the six providers listed on the National Institutes of Health (NIH) federal registry.

Currently, 16 of these lines have completed the NSCB’s extensive quality control process and are available for distribution to research scientists around the world. The NSCB’s initial testing process, which can take several months or longer to finalize, begins upon receipt of a new cell line and is carried out to ensure the identity of the cell line, cell characteristics and that the starting cell material is free from contaminants.

The NIH established the country’s first National Stem Cell Bank at the WiCell™ Research Institute, a private, nonprofit supporting organization to the University of Wisconsin-Madison, in September 2005. Its mission is to obtain, characterize and distribute the 21 human embryonic stem cell lines that currently may be used in U.S. federally funded research. All six providers of the NIH-registry stem cell lines – WiCell at the University of Wisconsin-Madison, University of California, San Francisco and Novocell in the U.S.; ES Cell International (ESI) in Singapore; Technion in Israel; and Cellartis in Sweden – were invited to deposit their cells by the NSCB shortly after it was established.

Derek Hei, a University of Wisconsin-Madison researcher and leader of the National Stem Cell Bank, says the availability of a variety of human embryonic stem cell lines for study is critical to advancing the field. “The addition of the Cellartis lines to the National Stem Cell Bank is extremely important because now we’ll be able to distribute these lines to the worldwide research community,” he states. “We’ll also be able to generate data unique to these lines that is valuable to the advancement of stem cell research.”

Mats Lundwall, CEO of Cellartis, says, “We are delighted to have this collaboration with the U.S. National Stem Cell Bank that will increase the amount of NIH eligible lines readily available in the U.S. The Cellartis cell lines are among the most extensively characterized in the world and now their distribution within the U.S. has been further facilitated through this partnership.”

See NationalStemCellBank.org for complete article.

Revolutionary stem cell therapy boosts body’s ability to heal itself

British researchers hope treatment will help repair heart attack damage or broken bones
By Ian Sample, science correspondent, guardian.co.uk

A stem cell emerging from rat bone marrow. By stimulating the release of stem cells after a heart attack, the healing process could be accelerated. Photograph: Imperial College London

A stem cell emerging from rat bone marrow. By stimulating the release of stem cells after a heart attack, the healing process could be accelerated. Photograph: Imperial College London

A groundbreaking medical treatment that could dramatically enhance the body’s ability to repair itself has been developed by a team of British researchers.

The therapy, which makes the body release a flood of stem cells into the bloodstream, is designed to heal serious tissue damage caused by heart attacks and even repair broken bones. It is expected to enter animal trials later this year and if successful will mark a major step towards the ultimate goal of using patients’ own stem cells to regenerate damaged and diseased organs.
‘This would allow bodies to heal themselves’ Link to this audio

When the body is injured, bone marrow releases stem cells that home in on the damaged area. When they arrive, they start to grow into new tissues, such as heart cells, blood vessels, bone and cartilage.

Scientists already know how to make bone marrow release a type of stem cell that can only make fresh blood cells. The technique is used to collect cells from bone marrow donors to treat people with the blood cancer leukaemia.

Now a team led by Sara Rankin at Imperial College London has discovered a way to stimulate bone marrow to release two other types of stem cell, which between them can repair bone, blood vessels and cartilage. Giving mice a drug called mozobil and a naturally occuring growth factor called VEGF boosted stem cell counts in their bloodstream more than 100-fold.

“This has huge and broad implications. It’s an untapped process,” said Rankin, whose study appears in the US journal Cell Stem Cell. “Suppose a person comes in to hospital having had a heart attack. You give them these drugs and stem cells are quickly released into the blood. We know they will naturally home in on areas of damage, so if you’ve got a broken bone, or you’ve had a heart attack, the stem cells will go there. In response to a heart attack, you’d accelerate the repair process.”

Research shows cell’s inactive state is critical for effectiveness of cancer treatment

by Esther Napolitano, napolite@mskcc.org
Memorial Sloan-Kettering Cancer Center

A new study sheds light on a little understood biological process called quiescence, which enables blood-forming stem cells to exist in a dormant or inactive state in which they are not growing or dividing. According to the study’s findings, researchers identified the genetic pathway used to maintain a cell’s quiescence, a state that allows bone marrow cells to escape the lethal effects of standard cancer treatments.

Researchers at Memorial Sloan-Kettering Cancer Center (MSKCC) found elevated levels of the tumor suppressor protein p53 in hematopoietic stem cells (HSCs) immature cells in the bone marrow that have the capacity to differentiate into all types of mature blood cells. They showed that when chemotherapy or radiation is delivered to a cell that lacks both p53 and a gene called MEF, the cell not only becomes less quiescent, but also becomes more susceptible to being killed. These findings are published in the January 9, 2009, issue of Cell Stem Cell.

“This is the first time that anyone has established that p53 has a role in defining a cell’s state of quiescence. Furthermore, it is surprising that some cells that lose p53 can actually be killed more readily than those that have p53 intact,” said the study’s senior author, Stephen Nimer, MD, Chief of the Hematology Service and Member of the Molecular Pharmacology and Chemistry Program at MSKCC. “Our findings have important implications for developing therapeutic strategies that could eliminate quiescent cancer stem cells.”

Click here for compete article

‘Scrawny’ gene keeps stem cells healthy

Stem cells are the body’s primal cells, retaining the youthful ability to develop into more specialized types of cells over many cycles of cell division. How do they do it? Scientists at the Carnegie Institution have identified a gene, named scrawny, that appears to be a key factor in keeping a variety of stem cells in their undifferentiated state. Understanding how stem cells maintain their potency has implications both for our knowledge of basic biology and also for medical applications. The results will be published in the January 9, 2009 print edition of Science.

“Our tissues and indeed our very lives depend on the continuous functioning of stem cells,” says Allan C. Spradling, director of the Carnegie Institution’s Department of Embryology. “Yet we know little about the genes and molecular pathways that keep stem cells from turning into regular tissue cells—a process known as differentiation.”

In the study, Spradling, with colleagues Michael Buszczak and Shelley Paterno, determined that the fruit fly gene scrawny (so named because of the appearance of mutant adult flies) modifies a specific chromosomal protein, histone H2B, used by cells to package DNA into chromosomes. By controlling the proteins that wrap the genes, scrawny can silence genes that would otherwise cause a generalized cell to differentiate into a specific type of cell, such as a skin or intestinal cell.

The researchers observed the effects of scrawny on every major type of stem cell found in fruit flies. In the experiments, mutant flies without functioning copies of the scrawny prematurely lost their stem cells in reproductive tissue, skin, and intestinal tissue.

Stem cells function as a repair system for the body. They maintain healthy tissues and organs by producing new cells to replenish dying cells and rebuild damaged tissues. “Losing stem cells represents the cellular equivalent of eating the seed corn,” says Spradling.

While the scrawny gene has so far only been identified in fruit flies, very similar genes that may carry out the same function are known to be present in all multicellular organisms, including humans. The results of this study are an important step forward in stem cell research. “This new understanding of the role played by scrawny may make it easier to expand stem cell populations in culture, and to direct stem cell differentiation in desired directions,” says Spradling.

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The Carnegie Institution (www.CIW.edu) has been a pioneering force in basic scientific research since 1902. It is a private, nonprofit organization with six research departments throughout the U.S. Carnegie scientists are leaders in plant biology, developmental biology, astronomy, materials science, global ecology, and Earth and planetary science.

Composition Of Matter Patent Covering Adipose-Derived Stem And Progenitor Cells Issued

Cytori (NASDAQ: CYTX) announced today that U.S. patent # 7,470,537 (the ‘537 patent) has been issued to the University of California, which covers a population of stem cells, progenitor cells and other replicating cells, which can be obtained from human adipose tissue. The composition of matter patent is licensed to Cytori through its agreement with the University of California.

The ‘537 patent broadens Cytori’s current patent portfolio for adipose-derived cell therapies and strengthens the Company’s ability to freely develop future generation therapeutics. The cells covered by the issued claims are believed to encompass a clinically important subpopulation of cells within adipose tissue. The subpopulation of human cells described in the patent was defined by characterizing specific cell surface markers for cells, which posses the ability to self replicate and differentiate toward one or more lineages.

Specifically, the newly issued claims are directed to cells expressing certain combinations of STRO-1+, CD29+, CD44+, CD71+, CD49D+, CD90+, CD105+, SH3, CD45-, CD31- and low or undetectable levels of CD106. Such cell surface marker studies are a robust method of describing stem and other cells and were performed at the University of California. The patent application containing these claims is jointly owned by the University of California and the University of Pittsburgh.

The ‘537 patent is distinct from the issued, allowed, and pending patents and patent applications related to Cytori’s Celution® System product platform, which is protected by a family of patents related to U.S. Patent No. 7,390,484 (“the ‘484 patent”). The ‘484 patent describes the Celution System technology, which processes adipose-derived stem and regenerative cells at a patient’s bedside.

About Cytori
Cytori’s (NASDAQ: CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients’ adult stem and regenerative cells. The Celution® 800 System is being introduced in Europe into the reconstructive surgery market while the Celution® 900 System is commercialize globally for cryopreserving a patient’s own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs.

Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the “Risk Factors” in Cytori’s Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

Source
Tom Baker
Cytori Therapeutics
http://www.cytoritx.com

Scientists Create Monkey Stem Cells

(Ivanhoe Newswire) — The successful creation of the first induced pluripotent stem (iPS) cell line from adult monkey skin may have important implications for direct reprogramming capabilities across different species.

Previous studies have shown that induction of four key transcription factors can reprogram adult mouse and human skin cells into iPS cells. Until now, iPS cell creation had not been demonstrated in any other species.

Researchers at Peking University in Beijing, China retrofit viruses to express the four key factors to infect adult monkey skin cells. This technique led to the creation of cells that displayed multiple hallmarks of embryonic stem cells. These cells possessed the ability to develop into multiple types of differentiated cells.

These findings could potentially be useful for the creation of clinically valuable primate models for human disease. The direct reprogramming model may also be a universal strategy for generating iPS cells in other species.

SOURCE: Cell Stem Cell, 2008;3:587-590