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Archive for the ‘Stem Cell Therapy’ Category

Cell Therapy Improves Damaged Heart In Study

Tuesday, March 27th, 2012

March 27, 2012

According to a new study, using a patients own bone marrow may help repair damaged areas of the heart caused by heart failure.

Researchers found that left ventricular ejection fraction increased by 2.7 percent in patients who received stem cell therapy.

The study, which was presented at the American College of Cardiologys 61st Annual Scientific Session, revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow.

This is the kind of information we need in order to move forward with the clinical use of stem cell therapy, Emerson Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute and the studys lead investigator, said at the event.

The study included 92 patients who were randomly selected to receive stem cell treatment or placebo. The patients all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure.

Doctors placed a catheter in the hearts left ventricle to inject 3 ccs, or 100 million stem cells, into an average of 15 sites of the stem cell patients hearts.

The doctors used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

With this mapping procedure, we have a roadmap to the heart muscle, said Dr. Perin. Were very careful about where we inject the cells; electromechanical mapping allows us to target the cell injections to viable areas of the heart.

The trial was designed to determine whether left ventricular end systolic volume and myocardial oxygen consumption improved in patients who received stem cell treatment.

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Cell Therapy Improves Damaged Heart In Study

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Midlands Vet Uses Stem Cell Therapy for Pets in Pain

Tuesday, March 27th, 2012

Columbia, SC (WLTX) --What if your pet couldn't walk anymore? One Midlands vet is using stem cell therapy to help.

For Beth Phibbs it's almost like a turning back of the hands of time.

"I call her my little miracle dog, because she's doing things she used to do," said Phibbs. "Now she's not on any medication, and she can go up and down the steps and she runs and jumps and things that she used to do when she was five."

Phibbs has spent the last 13 years loving and looking after her pet dog Maggie, and when she pet began to develop arthritis and a limp she had to take action. But when the first treatments stopped working, Phibbs and Maggie had to look to another options, dog stem cell therapy.

"I had no idea that animals were able to have they type of procedures," she said.

Dr. Kenneth Banks a veterinarian with the Bank Animal Hospital, performed the surgery for Maggie using her own stem cells in the one day procedure.

Banks said the stem cell therapy not only cost less than some other options, but was less invasive and had a quicker recovery time as well.

Still with about three similar procedures under his belt, even he didn't expect to see a such change in maggie just 40 days after the surgery.

"I wasn't sure we were gonna get the results this fast, we were expecting results, maybe not a good as she's done. We're real happy with her results," said Banks.

Now, after three years on medication and walking with a limp, Maggie's getting used to a new way of life -- one with out pain in her golden years.

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Stem cell therapy possibly helpful in heart failure patients

Monday, March 26th, 2012

Public release date: 24-Mar-2012 [ | E-mail | Share ]

Contact: Beth Casteel bcasteel@acc.org 240-328-4549 American College of Cardiology

CHICAGO -- A new study found that using a patient's own bone marrow cells may help repair damaged areas of the heart caused by heart failure, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

Millions of Americans suffer from heart failure, the weakening of the heart muscle and its inability to pump blood effectively throughout the body. If medications, surgery, or stents fail to control the disease, doctors often have few treatment options to offer.

This is the largest study to date to look at stem cell therapy, using a patient's own stem cells, to repair damaged areas of the heart in patients with chronic ischemic heart disease and left ventricular dysfunction. Researchers found that left ventricular ejection fraction (the percentage of blood leaving the heart's main pumping chamber) increased by a small but significant amount (2.7 percent) in patients who received stem cell therapy. The study also revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow information that will be helpful in evaluating and designing future therapies and trials.

"This is the kind of information we need in order to move forward with the clinical use of stem cell therapy," said Emerson Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute and the study's lead investigator.

This multi-center study was conducted by the Cardiovascular Cell Therapy Research Network and took place between April 2009 and 2011. At five sites, 92 patients were randomly selected to receive stem cell treatment or placebo. The patients, average age 63, all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure and/or angina, and were no longer candidates for revascularization.

"Studies such as these are able to be completed much faster because of the team approach of the network," said Sonia Skarlatos, PhD, deputy director of the division of cardiovascular sciences at the National, Heart, Lung and Blood Institute, and program director of the network.

Bone marrow was aspirated from the patients and processed to obtain just the mononuclear fraction of the marrow. In patients randomly selected to receive stem cell therapy, doctors inserted a catheter into the heart's left ventricle to inject a total of 3 ccs comprising 100 million stem cells into an average of 15 sites that showed damage on the electromechanical mapping image of the heart. Dr. Perin said the procedure is relatively quick and painless, involving only an overnight stay at the hospital.

The study used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

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Bone Marrow Stem Cell Therapy Trial – Clues, But No Answers

Monday, March 26th, 2012

(RTTNews.com) - An important clinical trial, which evaluated the use of autologous bone-marrow-cell therapy in patients with chronic ischemic heart failure, has failed to meet the prespecified end points of improvement in most measures of heart function, according to the results presented at the American College of Cardiology 2012 Scientific Sessions.

The trial dubbed, FOCUS - a phase II study, is the largest study to date to investigate if a patient's own bone marrow cells improved myocardial perfusion, reduced left ventricular end-systolic volume or enhanced maximal oxygen consumption in patients with coronary artery disease or LV dysfunction, and limiting heart failure or angina. The FOCUS trial was undertaken by the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network.

Ninety two patients with chronic ischemic heart disease , having a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography, or SPECT, who were no longer candidates for revascularization, were enrolled in the trial. Sixty one patients in the study were administered bone marrow cells through transendocardial injections while thirty one patients were administered placebo.

An assessment of primary endpoints at 6 months has revealed that there is no statistically significant difference between the treatment group and placebo arm in left ventricular end-systolic volume assessed by echocardiography, maximal oxygen consumption, and reversibility on SPECT. The secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement, also has not exhibited any difference between the two arms.

However, according to the study authors, exploratory analyses have revealed that left ventricular ejection fraction improved in the treatment group compared with the placebo group by 2.7%.

The authors, led by Emerson Perin, concluded that the findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy, the authors noted.

The results were published online March 24 in the Journal of the American Medical Association.

For comments and feedback: contact editorial@rttnews.com

http://www.rttnews.com

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International Stem Cell Corporations Announces 2011 Financial Results

Sunday, March 25th, 2012
CARLSBAD, California – March 20, 2012 - International Stem Cell Corporation (OTCBB: ISCO) http://www.internationalstemcell.com  today announced year-end financial results for the year ended December 31, 2011.  ISCO is a California-based development-stage biotechnology company that is focused on therapeutic, biomedical and cosmeceutical product development and commercialization with multiple long-term therapeutic opportunities and two revenue-generating businesses offering potential for increased future revenue.
ISCO reported revenue of $1.1 million for the fourth quarter ended December 31, 2011, reflecting a 110% increase from the same period of the prior year.  For the twelve months ended December 31, 2011, the Company reported revenue of $4.5 million, reflecting a year-over-year increase of 189%.  The increases in revenues in both periods were primarily driven by strong sales at ISCO’s wholly-owned subsidiary Lifeline Skin Care (LSC).  In addition, steady growth in sales from ISCO’s other wholly-owned subsidiary, Lifeline Cell Technology (LCT), contributed to the increases in revenues for both periods. 
While the Company continued to invest in therapeutic projects, development of new technologies, and expansion of products and channels of distribution, to date we have generated limited revenue to support our core therapeutic research and development efforts.  For the three months ended December 31, 2011, development expenses, excluding cost of sales, increased $507,000 or 17% compared with the same period of 2010, a reflection of increased G&A expenses resulting from higher stock-based compensation expenses. 
For the twelve months ended December 31, 2011, development expenses, excluding costs of sales, increased approximately $3.0 million or 26% when compared with the prior year period. The majority of the increase was primarily due to increases in general and administrative and research and development activities.  General and administrative expenses increased largely due to increased non-cash stock-based compensation, higher headcount, and increased expenses related business development activity and general corporate expenses. Research & Development expenses increased mainly due to increased number and complexity of experiments associated with our scientific projects. The increase in development expenses was also related to increased research activities on therapeutic products and product research activities for LSC and LCT coupled with increased sales and marketing expenses related to our skin care products.
Some of the 2011 Highlights:
-- A number of donors willing to provide oocytes for research purposed were enrolled in ISCO's program to establish a bank of clinical grade hpSC capable of being immune-matched to millions of patients.
-- The Research and Development team successfully completed the first series of preclinical studies that supports the therapeutic use of hepatocytes (liver cells) and neuronal cells derived from human parthenogenetic stem cells (hpSC). These in vivo experiments demonstrated that the derived cells are able to survive in targeted location in mice without causing tumors.
-- We became Sarbanes-Oxley compliant and maintained, in all material respects, effective internal controls over financial reporting as of December 31, 2011.
-- We strengthened our Management Team through the appointments of well-known industry executives: Kurt May as President & Chief Operating Officer; Linh Nguyen as Chief Financial Officer; Donna Queen as Vice President of Marketing and Business Development for LSC.
--  Lifeline Skin Care launched a number of new sales and marketing initiatives including positioning the brand as the first bio-tech skin care company vested in technology-driven proprietary ingredients, opening new destination and resort spa sales and marketing channels and developing close working relationships and strategic partnerships with peer-group influencers in dermatology and plastic surgery clinics.  LSC was also featured in the national media promoting its products and ISCO's technology, began distributing products in Australia and New Zealand, and initiated marketing agreements in other selected international markets.
-- Lifeline Cell Technology opened new international distribution channels in Singapore, Malaysia, Indonesia, Korea and India, providing a well-balanced distribution system consisting of direct domestic sales, private label manufacturing contracts and added international distribution partners.  
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic application of human
parthenogenetic stem cells 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). hpSCs avoid ethical issues
associated with the use or destruction of viable human embryos. ISCO scientists have created
the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with
minimal immune rejection after transplantation into hundreds of millions of individuals of
differing genders, ages and racial background. This offers 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, and
cell-based skin care products through its subsidiary Lifeline Skin Care. More information is
available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link:
http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
Contacts:
International Stem Cell Corporation
Linh Nguyen, CFO
760-940-6383
lnguyen@intlstemcell.com
Or
Dr. Ruslan Semechkin, Vice President
760-940-6383
ras@intlstemcell.com

INTERNATIONAL STEM CELL CORPORATION AND SUBSIDIARIES (A Developmental Stage Company)
Consolidated Balance Sheets
(in thousands, except share data)
 
December 31,
20112010
Assets
Current assets
Cash and cash equivalents$1,337$5,782
Accounts receivable140739
Inventory, net1,268856
Prepaid assets 274  228 
 
Total current assets3,0197,605
Property and equipment, net1,4201,296
Intangible assets, net1,282986
Deposits and other assets 16  40 
 
Total assets$5,737 $9,927 
 
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable$885$583
Accrued liabilities752545
Deferred revenue189760
Convertible debt and advances250250
Warrants to purchase common stock 38  2,400 
 
Total liabilities 2,114  4,538 
 
Stockholders' Equity
Series D Preferred stock, $0.001 par value 50 shares authorized, 43 issued and outstanding for 2011 and 2010--
Series A Preferred stock, $0.001 par value 5,000,000 shares authorized, 500,000 issued and outstanding for 2011 and 2010, liquidation preferences of $615,000 and $585,000 in 2011 and 2010, respectively11
Series B Preferred stock, $0.001 par value 5,000,000 shares authorized, 300,000 issued and outstanding for 2011 and 2010, liquidation preferences of $367,000 and $349,000 in 2011 and 2010, respectively00
Series C Preferred stock, $0.001 par value 3,000,000 shares authorized, 2,000,000 issued and outstanding for 2011 and 2010, liquidation preferences of $2,387,000 and $2,267,000 in 2011 and 2010, respectively22
Common stock, $0.001 par value 200,000,000 shares authorized, 80,036,315 and 74,771,107 issued and outstanding for 2011 and 2010, respectively8075
Subscription receivable on common stock-(5)
Additional paid-in capital63,99556,170
Deficit accumulated during the development stage (60,455) (50,854)
 
Total stockholders' equity 3,623  5,389 
 
Total liabilities and stockholders' equity$5,737 $9,927 
 
See accompanying notes to consolidated financial statements
             
INTERNATIONAL STEM CELL CORPORATION AND SUBSIDIARIES (A Developmental Stage Company)
Consolidated Statements of Operations
(in thousands, except per share data)
 
Year Ended December 31,Inception
(August 17, 2001)
through
December 31,
2011
20112010
 
Product sales$4,532$1,568$7,631
Royalties and license -  -  135 
 
Total revenue 4,532  1,568  7,766 
 
Development expenses
Cost of sales1,6187253,334
Research and development4,4343,37418,294
Marketing1,4758603,874
General and administrative 8,360  7,071  31,684 
 
Total development expenses 15,887  12,030  57,186 
 
Loss from development activities(11,355)(10,462)(49,420)
Other income (expense)
Settlement with related company--(93)
Miscellaneous(163)(26)(180)
Dividend and interest income12894
Interest expense-(14)(2,225)
Change in market value of warrants2,335(2,501)(1,395)
Sublease income 11  252  309 
 
Total other income (expense) 2,184  (2,261) (3,490)
 
Loss before income taxes(9,171)(12,723)(52,910)
Provision for income taxes -  -  7 
 
Net loss$(9,171)$(12,723)$(52,917)
 
Dividend on preferred stock (430) (1,561) (7,968)
 
Net loss applicable to common stockholders$(9,601)$(14,284)$(60,885)
 
Net loss per common share-basic and diluted$(0.12)$(0.21) n/a 
 
Weighted average shares-basic and diluted 77,320  68,762  n/a 
 
See accompanying notes to consolidated financial statements
International Stem Cell Corporation
Linh Nguyen, CFO
760-940-6383
lnguyen@intlstemcell.com
or
Dr. Ruslan Semechkin, Vice President
760-940-6383
ras@intlstemcell.com

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‘Scandal’ in Vatican Over Stem Cell Conference: Appearances by Trounson and Others Cancelled

Sunday, March 25th, 2012


The Vatican has cancelled a controversial scientific conference that would have featured scientists, including the president of the California stem cell agency, who support human embryonic stem cell research.

The conference reportedly created a "scandal" in the Vatican, according to a report by David Kerr of the Catholic News Agency. Kerr wrote,

"'I am infinitely relieved that the Church has avoided a major blunder which would have confused the faithful for decades to come,'” said one member of the Pontifical Academy who asked for anonymity in commenting to (the Catholic News Agency)."

The Catholic church opposes hESC research because of its belief that it destroys human life.

The conference would have taken place at the Vatican April 25-28 and included an audience with the pope. In addition to an appearance by CIRM's Alan Trounson, the key lecture was scheduled to have been given by George Daley of Harvard.

Kerr quoted the member of the Vactican's Pontifical Academy for Life as saying,

"The Holy Spirit has certainly shown to be present through those faithful members who drew attention to the ambiguity of the choice of speakers. I hope and pray that a review will be affected of the basis on which these congresses are planned."

Kerr also quoted another anonymous member of the academy as saying that the presence of speakers such as Trounson and Daley was "a betrayal of the mission of the academy and a public scandal."

Source:
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CIRM Directors Mulling Changes in Funding Direction

Sunday, March 25th, 2012


The California Stem Cell Report is concluding its coverage today of the meeting of the governing board of the directors meeting of the California stem cell agency.

No decisions were made on the general direction of future funding -- basic research and training vs development of therapies. Some of the directors differed sharply on the issues, however. We will have more on this subject later.

Here are slides from the presentation on the progress report on the agency's $230 million disease team round. One $19 million grant was cancelled.
Progress Report: Disease Team Grants by California Stem Cell Agency

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Stem Cell Scientist Impressed by CIRM Oversight Over Huge Grants

Sunday, March 25th, 2012


A California stem cell researcher, who must remain anonymous, made the following emailed comment today on the progress report on the $230 million in disease team grants from the California stem cell agency and termination of a $19 million grant.

"I'm impressed that CIRM is following through on monitoring the huge disease team grants and has actually curtailed the funding of one that didn't meet a key milestone. I hope that makes the other grant holders nervous! Too many scientists (in my humble opinion) forget that they need to do what they said they'd do- or - if the first plan fails, have the expertise and desire to adapt and find another way to reach the goals."

Source:
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CIRM Hires New PR Chief

Sunday, March 25th, 2012


The $3 billion California stem cell agency announced today that it has hired Kevin McCormack, currently media relations manager at California Pacific Medical Center in San Francisco, as its new director of communications.

CIRM Chairman Jonathan Thomas told the agency's directors at their meeting this morning in Sacramento that the appointment comes "not a moment too soon." Thomas told directors last June that the agency was engaged in a "communications war." Directors have been concerned about the lack of media coverage of the agency, which is largely below the radar of the mainstream media.

Thomas said that McCormack has "lots of experience" in media crisis management and "pressure cooker situations."

McCormack also served as media relations manager, Division of Research at Kaiser Permanente, and was a health/medical producer at KRON-TV in San Francisco.

The agency did not immediately release McCormack's salary. He will begin work April 2.

Source:
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California Stem Cell Agency Pulls $19 Million Grant

Sunday, March 25th, 2012


The California stem cell agency has terminated a $19 million grant to a UC San Francisco researcher involved in the agency's ambitious attempts to push stem cell therapies into clinics.

The agency said the research effort led by Mitchel Berger, chairman of the department of neurological surgery at UCSF, "did not meet a go/no-go milestone" stipulated in the grant. His research was funded in 2010 to treat brain tumors with genetically modified neural brain cells. No further explanation for the termination was provided by CIRM in a report prepared for tomorrow's meeting of the CIRM governing board. The agency estimated the cancellation would save $13 million.

The California Stem Cell Report has asked Berger and his co-PIs for comment on the CIRM action. The other researchers are Evan Snyder of Sanford-Burnham and Webster Cavanee of the Ludwig Cancer Institute. Their remarks will be carried verbatim when they are received.

The CIRM action was disclosed in the progress report on the $230 million disease team effort launched by the agency in 2009. The amount climbed to more than $250 million with contributions from partnering countries. Three of the 14 funded applicants – Irv Weissman and Gary Steinberg, both of Stanford, and Karen Aboody of the City of Hope – were approved only after they appealed to the CIRM board to overturn rejections by grant reviewers. (See  here , here and here for their written appeals. See here and here for coverage of the 2009 board action.)

One other disease team grant was modified to limit its scope and revise its funding. No savings were announced by CIRM. The PI on the $20 million project is Dennis Carson of UC San Diego. Co-PIs are Catriona Jamieson, also of UC San Diego, and John Dick of the University Health Network of Canada. The research is aimed at leukemia.

The actions on the disease team grants were not entirely unexpected. From their inception, CIRM directors have been told not to expect all the grants to finish successfully.

Ellen Feigal, senior vice president for research and development at CIRM, prepared the 19-page update on the disease team efforts. The grants are aimed at generating an investigational new drug application with the FDA within the four-year term of the grant.

She said that the funding decisions were made following evaluation of the projects by panels of clinical development advisors. Their recommendations were then considered by CIRM staff.

Feigal's report laid out accomplishments of the research so far and discussed changes in direction.

She said two companies have been formed since the grants were awarded to commercialize the hoped-for products. She said that in June 2011 Aboody founded TheraBiologics Inc., Newport Beach, Ca., of which she is chief scientific officer and director. Another company, Regenerative Patch Technologies, Glendale, Ca., was created by the team working on an hESC treatment for age-related macular degeneration. That $16 million grant involves Mark Humayan and David Hinton of USC, Dennis Clegg of UC Santa Barbara and Peter Coffey, formerly with University College, London, but now at UC Santa Barbara. The effort has generated seven patent filings.

The Feigal update also discussed the efforts of companies involved in other disease team grants. The lack of CIRM funding for biotech firms has been a bone of contention with industry and troublesome for some CIRM directors.

CIRM indicated the projects involving the firms were moving on schedule with no major difficulties reported. The companies involved are ViaCyte of San Diego, Calimmune of Tucson, Az., and Sangamo Inc. of Richmond, Ca.

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Stem Cell Agency Proposes 7 Percent Budget Hike, Seeks $50 Million in Private Funds

Sunday, March 25th, 2012


The California stem cell agency is proposing an operational budget of $17.8 million for the coming fiscal year, an increase of 7.2 percent over estimated spending for the current year ending June 30.

Financial documents (proposed budget and finance report) prepared for tomorrow's CIRM governing board meeting also showed that CIRM hopes to snag "$50 million in new, outside financial commitment for CIRM programs." This would represent the first major effort in recent years by CIRM to solicit private funds. The "draft goal" is in keeping with the agency's move to build a base of non-governmental funding.

Currently it is financed with cash that the state, which is mired in a financial crisis, must borrow. While CIRM's budget is increasing, the general fund budget for the entire state has plummeted from $103 billion in 2007-2008 to $87 billion this year.

The proposed CIRM budget also disclosed the agency will be facing substantial new costs – $1 million annually – for rent beginning in November 2015. CIRM has been operating rent-free since 2005 because of an $18 million recruitment package put together by the city of San Francisco.

The largest item in the proposed budget is salaries and benefits at $11 million, up from a projected $9.3 million for this year. The agency, which is administering $1.3 billion in grants involving hundreds of researchers, projects an increase in staff to 59. The agency currently has 51 employees, according to the finance report.

Outside contracts are the second largest expense at $3.4 million ($3 million this year) with grant reviews, meetings and workshops at $2.2 million(no comparable figure for this year).

By law, the stem cell agency operates under a budget cap of 6 percent of bond proceeds under the terms of Proposition 71, the ballot initiative that created CIRM.

In addition to tomorrow's review, the budget will be examined by the directors Finance Subcommittee April 2 before coming back for final approval in late May.

(Editor's note: An earlier version of this item incorrectly stated that the rent costs would rise to $1 million beginning in 2016. In fact, the increase will begin in November 2015. CIRM has revised the start date.)

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The AP on the California Stem Cell Agency: No Cures, Hazy Future

Sunday, March 25th, 2012


The Associated Press news service, whose reports circulate worldwide, has taken the measure of the $3 billion California stem cell agency, declaring that it has produced no cures and that it "faces an uncertain future."

The piece by science writer Alicia Chang asked whether the agency is "still relevant" nearly eight years after it was created by California voters and whether it will exist after the money for new grants runs out in about five years.

She wrote,

"Midway through its mission, with several high-tech labs constructed, but little to show on the medicine front beyond basic research, the California Institute for Regenerative Medicine faces an uncertain future."

Chang's piece carries more weight than those in most publications. The AP is the backbone of news coverage in the United States. Its news feeds appear automatically on hundreds, perhaps thousands of web sites in this country. Her article will also serve as a baseline in the future as other reporters examine the stem cell agency.

Here are excerpts from the piece:

"So what have Californians received for their money so far?

"The most visible investment is the opening of sleek buildings and gleaming labs at a dozen private and public universities built with matching funds. Two years ago, Stanford University unveiled the nation's largest space dedicated to stem cell research - 200,000 square feet that can hold 550 researchers.

"There are no cures yet in the pipeline and CIRM has shifted focus, channeling money to projects with the most promise of yielding near-term results."

Chang wrote,

"Several camps that support stem cell research think taxpayers should not pay another cent given the state's budget woes.

"'It would be so wrong to ask Californians to pony up more money,' said Marcy Darnovsky of the Center for Genetics and Society, a pro-stem cell research group that opposed Proposition 71, the state ballot initiative that formed CIRM."

The article quoted UC Davis stem cell researcher Paul Knoepfler as favoring another bond measure to keep CIRM afloat, although he said he recognizes the average Californian may disagree.

Roger Noll, professor emeritus of economics at Stanford, was quoted as saying that "CIRM's legacy has yet to be written."

"'CIRM spent a lot of money and there's a lot of stuff going on, but it's too early to know whether it was worth it,' Noll said."

Chang concluded with these four paragraphs:

"David Jensen, who runs the blog California Stem Cell Report, said Californians have benefited, but whether it will be worth the $6 billion the state has to pay back remains unclear.

"'The agency's responsibility is now to get the biggest bang for the buck, which is no easy task given the tentative nature of much of the science involved,'" he said in an email.

"Some think CIRM has left a mark whether or not it will exist in the future.

Its 'legacy will be felt in part by the stimulus that it has had on stem cell' research in California, said Fred Gage of the Salk Institute for Biological Studies."

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Coverage of Wednesday’s Stem Cell Board Meeting

Sunday, March 25th, 2012


The California Stem Cell Report has found its cyberspace connection again on Isla Taboga about 10 miles offshore of Panama City. We expect to bring you live coverage via an Internet audiocast of Wednesday's meeting of the board of the California stem cell agency. The directors are scheduled to discuss a progress report on the agency's ambitious, $250 million disease team program and the termination of one grant. Directors are also expected to consider the agency's proposed budget for the coming year, its plans for its next few years of life and its plans to give away $3 million for stem cell programs for high school students. The meeting begins at 9 a.m. PDT.

http://www.cirm.ca.gov/summaries-review-applications-rfa-11-04-cirm-creativity-awards

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International Stem Cell Corporations Announces 2011 Financial Results

Sunday, March 25th, 2012
CARLSBAD, California – March 20, 2012 - International Stem Cell Corporation (OTCBB: ISCO) http://www.internationalstemcell.com  today announced year-end financial results for the year ended December 31, 2011.  ISCO is a California-based development-stage biotechnology company that is focused on therapeutic, biomedical and cosmeceutical product development and commercialization with multiple long-term therapeutic opportunities and two revenue-generating businesses offering potential for increased future revenue.
ISCO reported revenue of $1.1 million for the fourth quarter ended December 31, 2011, reflecting a 110% increase from the same period of the prior year.  For the twelve months ended December 31, 2011, the Company reported revenue of $4.5 million, reflecting a year-over-year increase of 189%.  The increases in revenues in both periods were primarily driven by strong sales at ISCO’s wholly-owned subsidiary Lifeline Skin Care (LSC).  In addition, steady growth in sales from ISCO’s other wholly-owned subsidiary, Lifeline Cell Technology (LCT), contributed to the increases in revenues for both periods. 
While the Company continued to invest in therapeutic projects, development of new technologies, and expansion of products and channels of distribution, to date we have generated limited revenue to support our core therapeutic research and development efforts.  For the three months ended December 31, 2011, development expenses, excluding cost of sales, increased $507,000 or 17% compared with the same period of 2010, a reflection of increased G&A expenses resulting from higher stock-based compensation expenses. 
For the twelve months ended December 31, 2011, development expenses, excluding costs of sales, increased approximately $3.0 million or 26% when compared with the prior year period. The majority of the increase was primarily due to increases in general and administrative and research and development activities.  General and administrative expenses increased largely due to increased non-cash stock-based compensation, higher headcount, and increased expenses related business development activity and general corporate expenses. Research & Development expenses increased mainly due to increased number and complexity of experiments associated with our scientific projects. The increase in development expenses was also related to increased research activities on therapeutic products and product research activities for LSC and LCT coupled with increased sales and marketing expenses related to our skin care products.
Some of the 2011 Highlights:
-- A number of donors willing to provide oocytes for research purposed were enrolled in ISCO's program to establish a bank of clinical grade hpSC capable of being immune-matched to millions of patients.
-- The Research and Development team successfully completed the first series of preclinical studies that supports the therapeutic use of hepatocytes (liver cells) and neuronal cells derived from human parthenogenetic stem cells (hpSC). These in vivo experiments demonstrated that the derived cells are able to survive in targeted location in mice without causing tumors.
-- We became Sarbanes-Oxley compliant and maintained, in all material respects, effective internal controls over financial reporting as of December 31, 2011.
-- We strengthened our Management Team through the appointments of well-known industry executives: Kurt May as President & Chief Operating Officer; Linh Nguyen as Chief Financial Officer; Donna Queen as Vice President of Marketing and Business Development for LSC.
--  Lifeline Skin Care launched a number of new sales and marketing initiatives including positioning the brand as the first bio-tech skin care company vested in technology-driven proprietary ingredients, opening new destination and resort spa sales and marketing channels and developing close working relationships and strategic partnerships with peer-group influencers in dermatology and plastic surgery clinics.  LSC was also featured in the national media promoting its products and ISCO's technology, began distributing products in Australia and New Zealand, and initiated marketing agreements in other selected international markets.
-- Lifeline Cell Technology opened new international distribution channels in Singapore, Malaysia, Indonesia, Korea and India, providing a well-balanced distribution system consisting of direct domestic sales, private label manufacturing contracts and added international distribution partners.  
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic application of human
parthenogenetic stem cells 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). hpSCs avoid ethical issues
associated with the use or destruction of viable human embryos. ISCO scientists have created
the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with
minimal immune rejection after transplantation into hundreds of millions of individuals of
differing genders, ages and racial background. This offers 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, and
cell-based skin care products through its subsidiary Lifeline Skin Care. More information is
available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link:
http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
Contacts:
International Stem Cell Corporation
Linh Nguyen, CFO
760-940-6383
lnguyen@intlstemcell.com
Or
Dr. Ruslan Semechkin, Vice President
760-940-6383
ras@intlstemcell.com

INTERNATIONAL STEM CELL CORPORATION AND SUBSIDIARIES (A Developmental Stage Company)
Consolidated Balance Sheets
(in thousands, except share data)
 
December 31,
20112010
Assets
Current assets
Cash and cash equivalents$1,337$5,782
Accounts receivable140739
Inventory, net1,268856
Prepaid assets 274  228 
 
Total current assets3,0197,605
Property and equipment, net1,4201,296
Intangible assets, net1,282986
Deposits and other assets 16  40 
 
Total assets$5,737 $9,927 
 
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable$885$583
Accrued liabilities752545
Deferred revenue189760
Convertible debt and advances250250
Warrants to purchase common stock 38  2,400 
 
Total liabilities 2,114  4,538 
 
Stockholders' Equity
Series D Preferred stock, $0.001 par value 50 shares authorized, 43 issued and outstanding for 2011 and 2010--
Series A Preferred stock, $0.001 par value 5,000,000 shares authorized, 500,000 issued and outstanding for 2011 and 2010, liquidation preferences of $615,000 and $585,000 in 2011 and 2010, respectively11
Series B Preferred stock, $0.001 par value 5,000,000 shares authorized, 300,000 issued and outstanding for 2011 and 2010, liquidation preferences of $367,000 and $349,000 in 2011 and 2010, respectively00
Series C Preferred stock, $0.001 par value 3,000,000 shares authorized, 2,000,000 issued and outstanding for 2011 and 2010, liquidation preferences of $2,387,000 and $2,267,000 in 2011 and 2010, respectively22
Common stock, $0.001 par value 200,000,000 shares authorized, 80,036,315 and 74,771,107 issued and outstanding for 2011 and 2010, respectively8075
Subscription receivable on common stock-(5)
Additional paid-in capital63,99556,170
Deficit accumulated during the development stage (60,455) (50,854)
 
Total stockholders' equity 3,623  5,389 
 
Total liabilities and stockholders' equity$5,737 $9,927 
 
See accompanying notes to consolidated financial statements
             
INTERNATIONAL STEM CELL CORPORATION AND SUBSIDIARIES (A Developmental Stage Company)
Consolidated Statements of Operations
(in thousands, except per share data)
 
Year Ended December 31,Inception
(August 17, 2001)
through
December 31,
2011
20112010
 
Product sales$4,532$1,568$7,631
Royalties and license -  -  135 
 
Total revenue 4,532  1,568  7,766 
 
Development expenses
Cost of sales1,6187253,334
Research and development4,4343,37418,294
Marketing1,4758603,874
General and administrative 8,360  7,071  31,684 
 
Total development expenses 15,887  12,030  57,186 
 
Loss from development activities(11,355)(10,462)(49,420)
Other income (expense)
Settlement with related company--(93)
Miscellaneous(163)(26)(180)
Dividend and interest income12894
Interest expense-(14)(2,225)
Change in market value of warrants2,335(2,501)(1,395)
Sublease income 11  252  309 
 
Total other income (expense) 2,184  (2,261) (3,490)
 
Loss before income taxes(9,171)(12,723)(52,910)
Provision for income taxes -  -  7 
 
Net loss$(9,171)$(12,723)$(52,917)
 
Dividend on preferred stock (430) (1,561) (7,968)
 
Net loss applicable to common stockholders$(9,601)$(14,284)$(60,885)
 
Net loss per common share-basic and diluted$(0.12)$(0.21) n/a 
 
Weighted average shares-basic and diluted 77,320  68,762  n/a 
 
See accompanying notes to consolidated financial statements
International Stem Cell Corporation
Linh Nguyen, CFO
760-940-6383
lnguyen@intlstemcell.com
or
Dr. Ruslan Semechkin, Vice President
760-940-6383
ras@intlstemcell.com

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‘Scandal’ in Vatican Over Stem Cell Conference: Appearances by Trounson and Others Cancelled

Sunday, March 25th, 2012


The Vatican has cancelled a controversial scientific conference that would have featured scientists, including the president of the California stem cell agency, who support human embryonic stem cell research.

The conference reportedly created a "scandal" in the Vatican, according to a report by David Kerr of the Catholic News Agency. Kerr wrote,

"'I am infinitely relieved that the Church has avoided a major blunder which would have confused the faithful for decades to come,'” said one member of the Pontifical Academy who asked for anonymity in commenting to (the Catholic News Agency)."

The Catholic church opposes hESC research because of its belief that it destroys human life.

The conference would have taken place at the Vatican April 25-28 and included an audience with the pope. In addition to an appearance by CIRM's Alan Trounson, the key lecture was scheduled to have been given by George Daley of Harvard.

Kerr quoted the member of the Vactican's Pontifical Academy for Life as saying,

"The Holy Spirit has certainly shown to be present through those faithful members who drew attention to the ambiguity of the choice of speakers. I hope and pray that a review will be affected of the basis on which these congresses are planned."

Kerr also quoted another anonymous member of the academy as saying that the presence of speakers such as Trounson and Daley was "a betrayal of the mission of the academy and a public scandal."

Source:
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Stem Cell Scientist Impressed by CIRM Oversight Over Huge Grants

Sunday, March 25th, 2012


A California stem cell researcher, who must remain anonymous, made the following emailed comment today on the progress report on the $230 million in disease team grants from the California stem cell agency and termination of a $19 million grant.

"I'm impressed that CIRM is following through on monitoring the huge disease team grants and has actually curtailed the funding of one that didn't meet a key milestone. I hope that makes the other grant holders nervous! Too many scientists (in my humble opinion) forget that they need to do what they said they'd do- or - if the first plan fails, have the expertise and desire to adapt and find another way to reach the goals."

Source:
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CIRM Directors Mulling Changes in Funding Direction

Sunday, March 25th, 2012


The California Stem Cell Report is concluding its coverage today of the meeting of the governing board of the directors meeting of the California stem cell agency.

No decisions were made on the general direction of future funding -- basic research and training vs development of therapies. Some of the directors differed sharply on the issues, however. We will have more on this subject later.

Here are slides from the presentation on the progress report on the agency's $230 million disease team round. One $19 million grant was cancelled.
Progress Report: Disease Team Grants by California Stem Cell Agency

Source:
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CIRM Hires New PR Chief

Sunday, March 25th, 2012


The $3 billion California stem cell agency announced today that it has hired Kevin McCormack, currently media relations manager at California Pacific Medical Center in San Francisco, as its new director of communications.

CIRM Chairman Jonathan Thomas told the agency's directors at their meeting this morning in Sacramento that the appointment comes "not a moment too soon." Thomas told directors last June that the agency was engaged in a "communications war." Directors have been concerned about the lack of media coverage of the agency, which is largely below the radar of the mainstream media.

Thomas said that McCormack has "lots of experience" in media crisis management and "pressure cooker situations."

McCormack also served as media relations manager, Division of Research at Kaiser Permanente, and was a health/medical producer at KRON-TV in San Francisco.

The agency did not immediately release McCormack's salary. He will begin work April 2.

Source:
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California Stem Cell Agency Pulls $19 Million Grant

Sunday, March 25th, 2012


The California stem cell agency has terminated a $19 million grant to a UC San Francisco researcher involved in the agency's ambitious attempts to push stem cell therapies into clinics.

The agency said the research effort led by Mitchel Berger, chairman of the department of neurological surgery at UCSF, "did not meet a go/no-go milestone" stipulated in the grant. His research was funded in 2010 to treat brain tumors with genetically modified neural brain cells. No further explanation for the termination was provided by CIRM in a report prepared for tomorrow's meeting of the CIRM governing board. The agency estimated the cancellation would save $13 million.

The California Stem Cell Report has asked Berger and his co-PIs for comment on the CIRM action. The other researchers are Evan Snyder of Sanford-Burnham and Webster Cavanee of the Ludwig Cancer Institute. Their remarks will be carried verbatim when they are received.

The CIRM action was disclosed in the progress report on the $230 million disease team effort launched by the agency in 2009. The amount climbed to more than $250 million with contributions from partnering countries. Three of the 14 funded applicants – Irv Weissman and Gary Steinberg, both of Stanford, and Karen Aboody of the City of Hope – were approved only after they appealed to the CIRM board to overturn rejections by grant reviewers. (See  here , here and here for their written appeals. See here and here for coverage of the 2009 board action.)

One other disease team grant was modified to limit its scope and revise its funding. No savings were announced by CIRM. The PI on the $20 million project is Dennis Carson of UC San Diego. Co-PIs are Catriona Jamieson, also of UC San Diego, and John Dick of the University Health Network of Canada. The research is aimed at leukemia.

The actions on the disease team grants were not entirely unexpected. From their inception, CIRM directors have been told not to expect all the grants to finish successfully.

Ellen Feigal, senior vice president for research and development at CIRM, prepared the 19-page update on the disease team efforts. The grants are aimed at generating an investigational new drug application with the FDA within the four-year term of the grant.

She said that the funding decisions were made following evaluation of the projects by panels of clinical development advisors. Their recommendations were then considered by CIRM staff.

Feigal's report laid out accomplishments of the research so far and discussed changes in direction.

She said two companies have been formed since the grants were awarded to commercialize the hoped-for products. She said that in June 2011 Aboody founded TheraBiologics Inc., Newport Beach, Ca., of which she is chief scientific officer and director. Another company, Regenerative Patch Technologies, Glendale, Ca., was created by the team working on an hESC treatment for age-related macular degeneration. That $16 million grant involves Mark Humayan and David Hinton of USC, Dennis Clegg of UC Santa Barbara and Peter Coffey, formerly with University College, London, but now at UC Santa Barbara. The effort has generated seven patent filings.

The Feigal update also discussed the efforts of companies involved in other disease team grants. The lack of CIRM funding for biotech firms has been a bone of contention with industry and troublesome for some CIRM directors.

CIRM indicated the projects involving the firms were moving on schedule with no major difficulties reported. The companies involved are ViaCyte of San Diego, Calimmune of Tucson, Az., and Sangamo Inc. of Richmond, Ca.

Source:
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Stem Cell Agency Proposes 7 Percent Budget Hike, Seeks $50 Million in Private Funds

Sunday, March 25th, 2012


The California stem cell agency is proposing an operational budget of $17.8 million for the coming fiscal year, an increase of 7.2 percent over estimated spending for the current year ending June 30.

Financial documents (proposed budget and finance report) prepared for tomorrow's CIRM governing board meeting also showed that CIRM hopes to snag "$50 million in new, outside financial commitment for CIRM programs." This would represent the first major effort in recent years by CIRM to solicit private funds. The "draft goal" is in keeping with the agency's move to build a base of non-governmental funding.

Currently it is financed with cash that the state, which is mired in a financial crisis, must borrow. While CIRM's budget is increasing, the general fund budget for the entire state has plummeted from $103 billion in 2007-2008 to $87 billion this year.

The proposed CIRM budget also disclosed the agency will be facing substantial new costs – $1 million annually – for rent beginning in November 2015. CIRM has been operating rent-free since 2005 because of an $18 million recruitment package put together by the city of San Francisco.

The largest item in the proposed budget is salaries and benefits at $11 million, up from a projected $9.3 million for this year. The agency, which is administering $1.3 billion in grants involving hundreds of researchers, projects an increase in staff to 59. The agency currently has 51 employees, according to the finance report.

Outside contracts are the second largest expense at $3.4 million ($3 million this year) with grant reviews, meetings and workshops at $2.2 million(no comparable figure for this year).

By law, the stem cell agency operates under a budget cap of 6 percent of bond proceeds under the terms of Proposition 71, the ballot initiative that created CIRM.

In addition to tomorrow's review, the budget will be examined by the directors Finance Subcommittee April 2 before coming back for final approval in late May.

(Editor's note: An earlier version of this item incorrectly stated that the rent costs would rise to $1 million beginning in 2016. In fact, the increase will begin in November 2015. CIRM has revised the start date.)

Source:
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