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Category Archives: Stem Cells

CIRM Board Eyes Florida Researcher for $6.7 Million Grant

Posted: September 9, 2012 at 3:57 pm


The board of the California stem cell agency is discussing a proposal to award $6.7 million to recruit a Florida scientist to the Parkinson's Institute in Sunnyvale, Ca.

The scientist is Dennis Steindler of the University of Florida. The recruitment award received a score of 57, although the scores ranged from 30 to 75.  Jeff Sheehy, a member of the grant review group and CIRM board member, said the score reflected two extremely divergent positions by two reviewers.

The board has awarded four grants in its recruitment round over the past couple of years, but this is the first extended discussion of an award recommended by reviewers. It is also the first to have a representative of the applicant institution speaking publicly for the grant.

CIRM directors have now moved into executive session to discuss matters they prefer to air in private.

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StemCells, Inc., Hails $40 Million in Awards from California Stem Cell Agency

Posted: September 9, 2012 at 3:57 pm


StemCells, Inc., was quick this morning
with a press release about winning a $20 million award last night from the
California stem cell agency.

The publicly traded, Newark, Ca., firm
also pointed out that the CIRM board in July awarded another $20
million to the business.
The news release hailed the awards as
validating its science and business. Martin McGlynn, who personally
appeared before the CIRM board last night, said,

 "CIRM's approval of two
awards to StemCells illustrates the tremendous promise of
our neural stem cell technology and the high degree of confidence in
the world class team of scientists and clinicians who will be working
to translate this technology into potential treatments and cures for
these devastating diseases." 

On the Alzheimer's award last night,
McGlynn said,

 "With the recent spate of late-stage clinical
failures in Alzheimer's disease, it is clear that the field could
benefit from alternative approaches to lessen the huge burden on
families, caregivers and our healthcare system.

He continued,

"Our recently reported preclinical
data, which showed that our neural stem cells restored memory and
enhanced synaptic function in two animal models relevant to
Alzheimer's disease, shows our approach has promise. We greatly
appreciate the support from CIRM, which should help us accelerate our
efforts to test our HuCNS-SC cells in Alzheimer's disease."

The news release did not note that the
board has required that the firm must show proof that it has access
to $20 million in matching funds prior to receiving cash from the
agency on the Alzheimer's grant. The California Stem Cell Report is
asking CIRM whether that requirement extends to the earlier grant as
well.
One of the analysts who follows the
company released a special report on the firm this morning. Stephen
Dunn
of LifeTech Capital said,

 “We are reiterating our strong
speculative buy with a price target of $4.50 as StemCells Inc.
continues to distinguishing themselves as one of the most advanced
players in the stem cell space.”

At the time of this writing, the firm's
stock was trading at $2.20 up seven cents. Its 52 week high is $2.67
and its 52 week low is 59 cents.  

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StemCells, Inc., Wins Another $20 Million From California Stem Cell Agency

Posted: September 9, 2012 at 3:57 pm


Following a second impassioned pitch by its former chairman, Robert Klein, the governing board of the California stem cell agency approved a $20 million award to a financially strapped biotech firm, StemCells, Inc., of Newark, Ca.

Approval came on a 7-5 vote with the condition that the company demonstrate it has access to $20 million in matching funds prior to funding.  It is the second $20 million award that the company has received in the disease team round, which now totals $214 million. Another disease team application has been tabled and will not be considered until October.

The current CIRM chairman, J.T. Thomas, a Los Angeles bond financier, asked for the financial proof because he said some concerns were expressed during an executive session that CIRM would now "account for such a large part of the assets of the company." Martin McGlynn, CEO of StemCells, Inc., also told the board that the company might have to drop its Alzheimer's research if it did not receive the CIRM award.

The StemCells, Inc., application was rejected twice by reviewers. The original rejection came before the July meeting at which Klein first appeared (see here and here). The proposal was then sent back for re-review, during which it was rejected again.

However, the 29-member board narrowly approved the application following discussion tonight and following its rejection of another Alzheimer's research proposal from USC. Both applicants produced a number of witnesses, including patients, on behalf of their appeals.

The re-review on the StemCells, Inc., application said in reference to a statement by Klein to board in July,

“The reviewers did not feel there was compelling data for neuron migration in the submitted manuscript. This is the manuscript specifically referenced at the ICOC (CIRM governing board) meeting (in July) that prompted the call for additional analysis. The manuscript is not yet accepted, it is 'potentially acceptable' but requires 'major revisions' according to the journal editor note. In addition, however, the studies in this manuscript used mouse NSCs, not the human NSCs proposed for the disease team award....”

In July, Klein said, “....(W)e have brand-new data that demonstrates and totally contradicts the key weakness on which it was downgraded.” 

A footnote: The CIRM staff said that as a result of two StemCells application, a proposal is being prepared to limit applications to one per entity in later rounds.

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Stem-cell-protecting drug could prevent the harmful side effects of radiation therapy

Posted: September 7, 2012 at 6:11 am

ScienceDaily (Sep. 6, 2012) Radiation therapy is one of the most widely used cancer treatments, but it often damages normal tissue and can lead to debilitating conditions. A class of drugs known as mammalian target of rapamycin (mTOR) inhibitors can prevent radiation-induced tissue damage in mice by protecting normal stem cells that are crucial for tissue repair, according to a preclinical study published by Cell Press in the September issue of the journal Cell Stem Cell.

"We can exploit the emerging findings for the development of new preventive strategies and more effective treatment options for patients suffering this devastating disease," says senior study author J. Silvio Gutkind of the National Institute of Dental and Craniofacial Research.

In response to radiation therapy, cancer patients often develop a painful condition called mucositis -- tissue swelling in the mouth that can leave these patients unable to eat or drink and force them to rely on opioid-strength pain killers. Radiation therapy may cause this debilitating condition by depleting normal stem cells capable of repairing damaged tissue.

In the new study, Gutkind and his team found that the mTOR inhibitor rapamycin protects stem cells taken from the mouths of healthy individuals (but not cancer cells) from radiation-induced death and DNA damage, dramatically extending the lifespan of these normal stem cells and allowing them to grow. Rapamycin exerted these protective effects by preventing the accumulation of harmful molecules called reactive oxygen species. Moreover, mice that received rapamycin during radiation treatment did not develop mucositis.

Because rapamycin is approved by the Food and Drug Administration and is currently being tested in clinical trials for the prevention and treatment of various types of cancer, the new findings could have immediate and important implications for a large proportion of cancer patients. "Mucositis prevention would have a remarkable impact on the quality of life and recovery of cancer patients and at the same time would reduce the cost of treatment," Gutkind says. "Our study provides the basis for further testing in humans, and we hope that these findings can be translated rapidly into the clinic."

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Stem-cell-protecting drug could prevent the harmful side effects of radiation therapy

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Stem Cells & Immune System: “Missing Link” Found

Posted: September 7, 2012 at 6:11 am

Researchers have discovered a cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, according to a release from the University of California, Los Angeles. This finding promises to lead to a more profound understanding of how a healthy immune system is created and as well as how disease can cause poor immune function.

The study's senior author, Dr. Gay Crooks, was quoted as saying, " We felt it was especially important to do these studies using human bone marrow, as most research into the development of the immune system has used mouse bone marrow.The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of post-natal life."

Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, cancers of the blood. The findings were published online in the journal Nature Immunology.

"The identification of a progenitor in human bone marrow primed for full lymphoid differentiation will now permit delineation of the molecular regulation of the first stages of lymphoid commitment in human hematopoiesis," the authors wrote. "It will also allow understanding of how these processes are affected during aberrant hematopoiesis in disease states."

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Stem Cells & Immune System: "Missing Link" Found

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State stem cell research funding agency awards $37.3 million to aid UC Irvine efforts

Posted: September 7, 2012 at 6:11 am

Collaborations set to advance Alzheimers disease and retinitis pigmentosa treatments

Irvine, Calif., September 06, 2012

UC Irvine scientists will be part of two research teams garnering CIRM Disease Team Therapy Development Awards, which are designed to accelerate collaborative translational research leading to human clinical trials. In one, Dr. Henry Klassen, an associate professor of ophthalmology in UC Irvines Sue & Bill Gross Stem Cell Research Center, and his collaborators at UC Santa Barbara, UC Davis and Cedars-Sinai Medical Center, received $17.3 million to cultivate therapeutically potent retinal progenitor stem cells to treat the blinding effects of retinitis pigmentosa.

In the other, StemCells, Inc. in Newark, Calif., received $20 million and will collaborate with Frank LaFerla and Mathew Blurton-Jones neurobiologists with the stem cell research center and the Institute for Memory Impairments and Neurological Disorders (UCI MIND) to advance research using the companys proprietary purified human neural stem cells to improve memory in people with Alzheimers disease.

CIRMs support for UC Irvines efforts to advance stem cell-based treatments for a variety of diseases is extremely gratifying, said Peter Donovan, director of the Sue & Bill Gross Stem Cell Research Center. Henrys work on retinitis pigmentosa and Frank and Mathews on Alzheimers disease hold great promise, and we are delighted that they have the support to see their work move toward the clinic.

Klassens objective is to introduce stem cells that rescue and reactivate damaged and dying photoreceptor rods and cones, thus reversing the course of RP even at relatively advanced stages. The current CIRM funding will allow Klassen and his collaborators to grow these cells under conditions ensuring that pharmaceutical standards are met. The resulting cells will be tested in animals for safety and to make certain that they are therapeutically potent. Then the team, which has partnered with investigators at the NIH, will seek FDA approval for the use of these cells in early clinical trials, in which a small number of patients with severe RP will be injected with cells in their worse-seeing eye and followed clinically for a specified period of time to determine the safety and effectiveness of the treatment.

We believe its possible to rejuvenate a portion of inactive cones in the degenerating retina, said Klassen, whose work also has received long-standing support from the Discovery Eye Foundation. Our methods have been validated, and Im optimistic that stem cell-based treatments can help restore clinically significant vision in people going blind due to retinal degeneration. The CIRM award will further LaFerla and Blurton-Joness efforts with StemCells, Inc. to understand how human neural stem cells can treat Alzheimers disease, the leading cause of dementia in the U.S. Earlier this year, the researchers reported findings showing that neural stem cells restored memory and enhanced synaptic function in two animal models relevant to Alzheimers disease, possibly by providing growth factors that protect neurons from degeneration. With these studies establishing proof of concept, the team intends to conduct further animal studies necessary to seek FDA approval to start testing this therapeutic approach in human patients.

Our goal is to research ways to make memories last a lifetime, and were excited to investigate the potential efficacy of stem cells for Alzheimers disease, said LaFerla, the UCI MIND director and Chancellors Professor and chair of neurobiology & behavior.

CIRMs governing board gave $63 million to four institutions and companies statewide on Wednesday. The funded projects are considered critical to the institutes mission of translating basic stem cell discoveries into clinical cures. UCIs portion of the awards it shares is $5.6 million for the Alzheimers disease effort and $6 million for the RP program, bringing the campuss total CIRM funding to $96.25 million.

The two grants are the second and third CIRM Disease Team Therapy Development Awards given to Sue & Bill Gross Stem Cell Research Center scientists. In July, Aileen Anderson and Brian Cummings and StemCells, Inc. received a $20 million commitment to fund the collection of data necessary to establish human clinical trials in the U.S. for cervical spinal cord injury.

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State stem cell research funding agency awards $37.3 million to aid UC Irvine efforts

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Global Markets for Stem Cells

Posted: September 7, 2012 at 6:11 am

NEW YORK, Sept. 6, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

http://www.reportlinker.com/p0958103/Global-Markets-for-Stem-Cells.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

INTRODUCTION

The report examines strategies employed by companies specializing in this field to meet the challenges of a competitive and fast-growing market.

REASONS FOR DOING THE STUDY

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced a number of significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its practical applications so far, evaluate the participating companies and look to its future.

SCOPE OF REPORT

This report discusses the implications of stem cell research and commercial trends in the context of the current size and growth of the pharmaceutical market, both in global terms and analyzed by the most important national markets. The important technologies supporting stem cells are reviewed, and the nature and structure of the stem cell industry is discussed with profiles of the leading companies, including recent M&A activity. Five-year sales forecasts are provided for the national markets and the major therapeutic categories of products involved.

MARKET ANALYSES AND FORECASTS

Market figures are based on revenues at the manufacturer level and are projected at 2012-dollar value without attempting to predict the effect of inflation/deflation. Therapeutic categories quantified and forecast include cancer, CNS diseases, infections and cardiovascular. Major country markets in three regionsAmericas, Europe and Asiaare analyzed and forecast, with a summary for the rest of the world.

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Global Markets for Stem Cells

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CIRM’s latest round of funding

Posted: September 7, 2012 at 6:11 am

>>UC Irvine photos

The California Institute for Regenerative Medicine awarded $63 million in CIRM Disease Team Therapy Development Awards to four research teams. UCLA's Stanley Nelson and collaborators also are recipients, for research on Duchenne muscular dystrophy.

CIRM also granted Basic Biology IV awards to a number of UC researchers:

UC Berkeley: Robert Tjian UC Davis: Deborah Lieu UCLA: Kathrin Plath, Owen Witte UC San Diego: George Sen, Gene Yeo, Maike Sander, Ananda Goldrath, Miles Wilkinson, David Traver UC San Francisco: Jeremy Reiter, Barbara Panning, Miguel Ramalho-Santos

>>CIRM press release

IRVINE Efforts to begin human clinical trials using stem cells to treat Alzheimer's disease and retinitis pigmentosa received a $37.3 million boost from the California Institute for Regenerative Medicine during its most recent round of funding on Wednesday (Sept. 5).

UC Irvine scientists will be part of two research teams garnering CIRM Disease Team Therapy Development Awards, which are designed to accelerate collaborative translational research leading to human clinical trials. In one, Dr. Henry Klassen, an associate professor of ophthalmology in UC Irvine's Sue & Bill Gross Stem Cell Research Center, and his collaborators at UC Santa Barbara and Cedars-Sinai Medical Center, received $17.3 million to cultivate therapeutically potent retinal progenitor stem cells to treat the blinding effects of retinitis pigmentosa.

In the other, StemCells, Inc. in Newark, Calif., received $20 million and will collaborate with Frank LaFerla and Mathew Blurton-Jones neurobiologists with the stem cell research center and the Institute for Memory Impairments and Neurological Disorders (UCI MIND) to advance research using the company's proprietary purified human neural stem cells to improve memory in people with Alzheimer's disease.

"CIRM's support for UC Irvine's efforts to advance stem cell-based treatments for a variety of diseases is extremely gratifying," said Peter Donovan, director of the Sue & Bill Gross Stem Cell Research Center. "Henry's work on retinitis pigmentosa and Frank and Mathew's on Alzheimer's disease hold great promise, and we are delighted that they have the support to see their work move toward the clinic."

Klassen's objective is to introduce stem cells that rescue and reactivate damaged and dying photoreceptor rods and cones, thus reversing the course of RP even at relatively advanced stages. The current CIRM funding will allow Klassen and his collaborators to grow these cells under conditions ensuring that pharmaceutical standards are met. The resulting cells will be tested in animals for safety and to make certain that they are therapeutically potent. Then the team will seek FDA approval for the use of these cells in early clinical trials, in which a small number of patients with severe RP will be injected with cells in their worse-seeing eye and followed clinically for a specified period of time to determine the safety and effectiveness of the treatment.

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CIRM's latest round of funding

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A look at stem cells and their current use

Posted: September 5, 2012 at 3:20 pm

Dear Dr. Donohue Since starting to clip your articles, I haven't found any that deal with using adult stem cells for breakthrough treatments, such as repairing heart damage. Could they help if one needs an aortic valve replacement? A.R.

Answer Stem cells are primitive cells that have the potential of spawning mature cells that carry out specific bodily functions, like skin cells, liver cells, lung cells, heart muscle cells, and on and on. Embryonic stem cells have the greatest potential for differentiating into any of the many varieties of cells that make up all body organs, structures and tissues.

Hematopoietic stem cells are recovered from the bone marrow and, to a lesser extent, the circulating blood. They have been and are being used to restore the bone marrow's capability of generating blood cells.

At the present time, no stem cell therapy has been used in replacing a heart valve.

Dear Dr. Donohue I would like to know the risk of having a stroke when a carotid artery has a blockage. I was told that doctors don't go by percentage of blockage now. How is the risk determined? K.C.

Answer An obstruction in the carotid artery, the neck artery that supplies the brain with blood, is not the only cause of a stroke. A piece of a blood clot that has broken off of a main clot elsewhere in the body and been swept into a brain artery is another cause of stroke. I mention this to keep it clear that a blocked carotid is but one risk for a stroke.

The doctors I know still use percentage of reduction in the interior of a carotid artery as a criterion of stroke risk. With a 60 percent to 70 percent or greater narrowing of the carotid artery, people benefit from the opening up of the artery, using a variety of procedures. Some experts feel that a 60 percent narrowing requires only blood-thinning medication, such as aspirin. Others feel that surgical removal of the blockage is indicated.

Other factors have to be considered: the patient's age, the patient's wishes and the patient's health problems unrelated to the artery problem..

Dear Dr. Donohue I am an 85-year-old female, and my doctor has suggested a colonoscopy. I find it a degrading test. The doctor didn't say why I needed it. Should a woman my age have it? K.C.

Answer The American College of Physicians recommends against screening colonoscopies for people 75 and older or for those people with a life expectancy of less than 10 years. Some add that screening can be stopped only if prior colonoscopies have been normal. No one I know recommends screening at 85.

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A look at stem cells and their current use

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First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in …

Posted: September 5, 2012 at 4:14 am

- Safe and Effective Results from Adipose Derived Adult Stem Cells manufactured by RNL BIO

SEOUL, South Korea, Sept. 4, 2012 /PRNewswire/ -- Korean researchers, reporting the results of a major study in the Circulation Journal, found that the transplantation adipose (fat) derived stem cells resulted in the regeneration of blood vessels in patients who were otherwise expecting to receive limb amputations due to damaged arteries and lack of blood circulation.

Researchers at Pusan National University, led by Dr. Han Cheol Lee, describe how patients with critical limb ischemia (hereafter, CLI, example of which include Buergers Disease and diabetic foot ulcers) were injected with adipose tissue-derived mesenchymal stem cell manufactured by RNL BIO.

As a result of the remarkable adipose stem cell process of RNL BIO, researchers found that immediate new blood vessel generation was identified. (The title of article is "Safety and Effect of Adipose Tissue-Derived Stem Cell Implantation in Patients With Critical Limb Ischemia")

CLI results from lack of circulation due to small artery damage and subsequent tissue necrosis. Patients with severe CLI often face limb amputation. Buergers Disease, or diabetic foot ulcer, are of the same kind. Risk factors are diabetic mellitus, hypertension, high cholesterol and smoking. There is no known cure to date.

Currently percutaneous transluminal angioplasty or PTA may treat 60-70% of patients with CLI, but it doesnt work with those who suffer from Buergers Disease. Working under approval to conduct compassionate use research of stem cell to treat CLI by intra-muscular injection of adipose tissue derived stem cells in December, 2008 (KFDA IND approval # 1273), the researchers in this study enrolled 15 subjects: 12 with Buergers Disease, and 3 with Diabetic foot ulcers. 300 million stem cells were injected into each patients leg. No complications were observed, even six months after injection.

Only five patients, as they all had expected, required minor amputation during follow-up, and all amputation sites healed completely. At 6 months, significant improvement was noted in pain and in claudication walking distance. Digital subtraction angiography before and 6 months after ATMSC implantation showed formation of numerous vascular collateral networks across affected arteries.

Dr. Jeong-Chan Ra, President of RNL Stem Cell Technology Institute, said, "This new therapy through adipose tissue derived mesenchymal stem cell is expected to offer new hope for patients with CLI, hope that had been difficult to find before."

RNL Stem Cell Technology Institute

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First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in ...

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