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Archive for the ‘Stem Cell Therapy’ Category

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."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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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

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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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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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."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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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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Stem cell, heart heath study

Sunday, March 25th, 2012

HOUSTON -

Doctors from the Texas Heart Institute at St. Luke's Episcopal Hospital have found that patients with heart failure may be able to repair the damaged areas of the heart with stem cells from the patient's own bone marrow.

Doctors presented the findings at the American College of Cardiologys 61st Annual Scientific Session Saturday.

The results are from a multi-center clinical study that measured the possible benefits of using a patients own bone marrow cells to repair damaged areas of the heart suffering from severe heart failure, a condition that affects millions of Americans.

The study, which was the largest such investigation to date, found that the hearts of the patients receiving bone marrow derived stem cells showed a small but significant increase in the ability to pump oxygenated blood from the left ventricle, the hearts main pumping chamber, to the body.

The expectation is that the study will pave the way for potential new treatment options and will be important to designing and evaluating future clinical trials.

This is exactly the kind of information we need to move forward with the clinical use of stem cell therapy, said Emerson Perin, MD, PhD, Director of Clinical Research for Cardiovascular Medicine at THI, and one of the studys lead investigators.

The bone-marrow derived stem cells are helpful to the injured heart when they are themselves biologically active, added Dr. James T. Willerson, the studys principal investigator and President and Medical Director of THI.

This study moves us one step closer to being able to help patients with severe heart failure who have no other alternatives.

The study was conducted by the Cardiovascular Cell Therapy Research Network, the national consortium to conduct such research funded by the National Institutes of Healths National Heart, Lung, and Blood Institute.

Read more:
Stem cell, heart heath study

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Stem cell therapy `may repair heart damage`

Sunday, March 25th, 2012

Johannesburg, Mar 25 : Stem cells could repair damage in people with advanced heart disease, a new study has claimed.

According to researchers at a major US cardiology conference, patients with advanced heart disease who received an experimental stem cell therapy showed slightly improved heart function.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

The patients all had chronic heart disease, along with either heart failure or angina, and their left ventricles were pumping at less than 45 percent of capacity.

All the participants in the study were ineligible for revascularisation surgery, such as coronary bypass to restore blood flow, because their heart disease was so advanced.

Those who received the stem cell therapy saw a small but significant boost in the heart's ability to pump blood, measuring the increase from the heart's main pumping chamber at 2.7 percent more than placebo patients.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

"This is the kind of information we need in order to move forward with the clinical use of stem cell therapy," News24 quoted Emerson Perin, the lead investigator from Texas Heart Institute as saying.

Perin's research, which was conducted between 2009 and 2011 across five US sites, was presented at the annual American College of Cardiology Conference in Chicago.

Read more from the original source:
Stem cell therapy `may repair heart damage`

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Stem cell therapy could repair some heart damage: Study

Sunday, March 25th, 2012

Published on Mar 25, 2012

CHICAGO (AFP) - Patients with advanced heart disease who received an experimental stem cell therapy showed slight improvements in blood pumping but no change in most of their symptoms, United States researchers said on Saturday.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

Previous studies have established that the approach is safe in human patients, but none had examined how well it worked on a variety of heart ailments.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

Excerpt from:
Stem cell therapy could repair some heart damage: Study

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Cell therapy using patient's own bone marrow may present option for heart disease

Sunday, March 25th, 2012

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

Contact: Kristin Wincek kwincek@mhif.org 612-863-0249 Minneapolis Heart Institute Foundation

CHICAGO Cell therapy may present an option for patients with ischemic heart disease to use their own bone marrow cells to repair the damaged areas of their hearts, and may pave the way for future treatment options, according to the FOCUS trial, which will be presented as a late-breaking clinical trial March 24 at the 61st annual American College of Cardiology (ACC) scientific session.

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 progenitor cells (CD34+ and CD133+) in the bone marrow; and this information will help in evaluating and designing future therapies and trials.

"FOCUS is an incredibly important trial, as it has informed the cell therapy community how to better treat this high-risk patient population, and allows us to enter into an exciting, next generation of stem cell therapy armed with more data," said study investigator Timothy D. Henry, MD, an interventional cardiologist at the Minneapolis Heart Institute (MHI) at Abbott Northwestern Hospital in Minneapolis and director of research with the Minneapolis Heart Institute Foundation.

This multicenter study was conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), which is supported through a research grant from the National Institutes of Health's National, Heart, Lung and Blood Institute (NHLBI), with the goal to evaluate novel stem cell-based treatment strategies for individuals with cardiovascular disease.

FOCUS will be presented at ACC.12 by its lead investigator Emerson C. Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute, one of the five sites in the CCTRN. The Minneapolis Heart Institute is another site of the five in the network, and a large number of CCTRN patients were enrolled in Minnesota.

For this study, which took place between April 2009 and April 2011, the five sites randomly selected 92 patients to receive stem cell treatment or placebo. The symptomatic patients, with an average age 63, all had chronic ischemic heart disease and an ejection fraction of less than 45 percent (baseline 34 percent) along with heart failure and/or angina and were no longer candidates for revascularization. "These patients had no other options, as medical management failed to improve their symptoms," explained the study's co-investigator Jay Traverse, MD, an interventionalist cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital and physician researcher with the Minneapolis Heart Institute Foundation.

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, physicians inserted a catheter into the heart's left ventricle to inject 100 million stem cells in more than 15 sites that showed damage on the electromechanical mapping image of the heart.

"Studies such as these are able to be completed much faster because of the team approach of the network" said Sonia I. Skarlatos, PhD, NHBLI's deputy director of the division of cardiovascular sciences and program director of CCTRN.

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Cell therapy using patient's own bone marrow may present option for heart disease

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Stem-Cell Trial Failed to Treat Heart Failure

Sunday, March 25th, 2012

SATURDAY, March 24 (HealthDay News) -- An innovative approach using patients' own bone marrow cells to treat chronic heart failure came up short in terms of effectiveness, researchers report.

Use of stem cell therapy to repair the slow, steady damage done to heart muscle and improve heart function is safe, but has not been shown to improve most measures of heart function, the study authors said.

"For the measures we paid most attention to, we saw no effect, there is no question about that," said researcher Dr. Lemuel Moye, a professor of biostatistics at the University of Texas School of Public Health in Houston.

"Ultimately, this is going to pay off handsomely for individuals and for public health in general, but it's going to take years of work," Moye said. "We are the vanguard looking for new promising lines of research."

While the hoped-for results didn't materialize, there appeared to be a small improvement in some patients, he said. "When we looked at another commonly used measure of heart function called ejection fraction, or the strength of the heart's pumping, that's where all the action was," Moye noted.

It's hard to know which measures of heart function to look at, Moye explained. "We have had some difficulty with that," he said.

Future research will look at other measures of heart function, pay more attention to the characteristics of the cells that are injected and determine which cells are best, he added.

Cardiac cells and other types of specially prepared cells are available now that were not accessible when this study started in 2009, Moye pointed out.

The results of the trial, which was sponsored by the U.S. National Heart, Lung, and Blood Institute, were to be presented Saturday at the American College of Cardiology's annual meeting in Chicago. The report was also published online March 24 in the Journal of the American Medical Association.

For the study, Moye and colleagues worked with 92 patients, average age 63 and mostly male, who had heart failure with and without chest pain. They were randomly assigned to receive either an injection of 100 million bone marrow cells from their own bone marrow, or an inactive placebo. Patients in both groups also received aggressive medical therapy.

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Stem-Cell Trial Failed to Treat Heart Failure

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Stem cell treatment could repair heart damage

Sunday, March 25th, 2012

CHICAGO - Patients with advanced heart disease who received an experimental stem cell therapy showed slightly improved heart function, researchers said at a major U.S. cardiology conference on Saturday.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

The patients all had chronic heart disease, along with either heart failure or angina, and their left ventricles were pumping at less than 45 per cent of capacity.

All the participants in the study were ineligible for revascularization surgery, such as coronary bypass to restore blood flow, because their heart disease was so advanced.

Those who received the stem cell therapy saw a small but significant boost in the heart's ability to pump blood, measuring the increase from the heart's main pumping chamber at 2.7 per cent more than placebo patients.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

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

Perin's research, which was conducted between 2009 and 2011 across five U.S sites, was presented at the annual American College of Cardiology Conference in Chicago.

The technique involved taking bone marrow samples from the patients and processing the marrow to extract stem cells. Doctors then injected the cells via catheter into the heart's left ventricle.

The injections, comprising some 100 million stem cells in all, were specifically targeted at damaged areas, identified by real-time electromechanical mapping of the heart.

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Stem cell treatment could repair heart damage

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Vet-Stem Announces StemInsure(R): A Small Fat Sample Now, a Lifetime of Stem Cells Later

Friday, March 23rd, 2012

POWAY, CA--(Marketwire -03/22/12)- Vet-Stem announced today the introduction of StemInsure. The StemInsure service provides banked stem cells that can be grown to supply a lifetime of stem cell therapy for dogs. One fat collection, in conjunction with another anesthetized procedure, gives access to a lifetime of stem cells.

Vet-Stem has trained over 3,500 veterinarians, provided stem cells for over 8,000 animals in the US and Canada and currently banks more than 25,000 doses for future therapeutic use. Many veterinarians and their clients have requested a method to collect and store stem cells when a dog is young, before it needs the regenerative cells for therapy. StemInsure was designed to meet this need.

A Vet-Stem credentialed veterinarian can collect as little as 5 grams of fat (about the size of a grape) from a dog or puppy during an anesthetized procedure. Many veterinarians and owners are electing to do this fat collection in conjunction with a spay or neuter. This small amount of fat is processed and stem cells are cryopreserved in Vet-Stem's state-of-the-art facility. The cells can be cultured in the future to provide enough stem cells to last for the lifetime of the dog. More information can be found at http://www.vet-stem.com/steminsure.php.

"Vet-Stem is pleased to provide StemInsure as a solution to the thousands of veterinarians and dog owners who recognize the value of Vet-Stem cell therapy. The ability to store the cells in conjunction with another procedure is a great way to ensure that the dog will have access to a lifetime of cell therapy while reducing the number of anesthetic events," said Dr. Bob Harman, DVM, MPVM, and CEO of Vet-Stem. Dr. Harman continued, "Currently, Vet-Stem Regenerative Cell Therapy is widely used to treat osteoarthritis, and tendon/ligament injuries. It is our expectation that the therapeutic use of adipose derived stem cells will continue to expand and add to the value of a lifetime supply of stem cells for dogs."

About Vet-Stem:In January of 2004, Vet-Stem introduced the first veterinary stem cell service in the United States. Since that time there has been rapid adoption of this technology for treatment of tendon, ligament, and joint injuries by the veterinary community. Studies have shown that mesenchymal stem cells can dramatically improve the healing of injuries and diseases that have had very few treatment options in the past.

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Vet-Stem Announces StemInsure(R): A Small Fat Sample Now, a Lifetime of Stem Cells Later

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Stem Cell Therapy Used To Treat 9/11 Search And Rescue Dog

Friday, March 23rd, 2012

ANNAPOLIS, Md. (WJZ)One of the last search and rescue dogs from 9/11 lives here in Maryland. She was suffering from a painful condition until her owner took action with breakthrough technology.

Mary Bubala has the story.

Red is a search and rescue dog from Annapolis, but has traveled across the country. Her missions include Hurricane Katrina, the La Plata tornadoes and the Pentagon after 9/11.

They credit them with finding 70 percent of the human remains so that helped a whole lot of those families actually get closure, said Heather Roche, Reds owner.

Sept. 11 was Reds first search. Today shes one of the last 9/11 search and rescue dogs still alive.

She retired last summer due to severe arthritis.

It would be nice if her arthritis, if she felt better, that she could do those kinds of things that she misses, Reds owner said while fighting back tears. Alright I am going to cry.

Roche did some research and found an animal hospital in northern Virginia that uses breakthrough stem cell therapy to treat arthritis in dogs.

The Burke Animal Clinic is one of just a few across the country that use stem cell therapy.

The vet harvests 1 to 2 ounces of the dogs fatty tissue, activates the stem cells and then injects them back into the troubled areas.

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Stem Cell Therapy Used To Treat 9/11 Search And Rescue Dog

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2nd Lee Co. doctor's license restricted in stem cell case

Wednesday, March 21st, 2012

2nd Lee Co. doctor's license restricted in stem cell case

FORT MYERS, Fla.- Another Lee County doctor is caught in the center of a stem cell controversy. The State Department of Health has issued an emergency license restriction to Dr. Konstantine Yankopolus, a general practitioner.

Dr. Yankopolus is still allowed to practice general medicine and is treating patients. The license restriction mandates he can't do anything involving stem cell treatment.

It's business as usual at his office on Colonial Blvd.

The doctor is still treating patients, but an emergency order issued from the Florida Department of Health, Monday prevents him from doing anything with stem cells.

The order says Dr. Yankopolus' license "is hereby immediately restricted from providing, collaborating, facilitating, procuring, referring or advising on any stem cell treatment."

The action comes after the state suspended the license of his colleague, Dr. Zannos Grekos' earlier this month.

The emergency order says Dr. Yankopolus helped Dr. Grekos perform stem cell therapy on the late Richard Polling despite knowing the Bonita Springs cardiologist was not allowed to do such a procedure.

The state Surgeon General alleges, Dr. Yankopolus falsified Polling's records.

He writes, "Subsequent to the death of patient R.P., Dr. Yankopolus entered a false medical progress note in R.P.'s chart falsely indicating that no stem cell preparation was infused."

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2nd Lee Co. doctor's license restricted in stem cell case

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