ras@intlstemcell.com

INTERNATIONAL STEM CELL CORPORATION AND SUBSIDIARIES (A Developmental Stage Company) Consolidated Balance Sheets (in thousands, except share data)
				December 31,
				2011											2010
Assets
Current assets
Cash and cash equivalents				$	1,337										$	5,782
Accounts receivable					140											739
Inventory, net					1,268											856
Prepaid assets					274											228
Total current assets					3,019											7,605
Property and equipment, net					1,420											1,296
Intangible assets, net					1,282											986
Deposits and other assets					16											40
Total assets				$	5,737										$	9,927
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable				$	885										$	583
Accrued liabilities					752											545
Deferred revenue					189											760
Convertible debt and advances					250											250
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, respectively					1											1
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, respectively					0											0
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, respectively					2											2
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, respectively					80											75
Subscription receivable on common stock					-											(5	)
Additional paid-in capital					63,995											56,170
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
				2011								2010
Product sales				$	4,532							$	1,568							$	7,631
Royalties and license					-								-								135
Total revenue					4,532								1,568								7,766
Development expenses
Cost of sales					1,618								725								3,334
Research and development					4,434								3,374								18,294
Marketing					1,475								860								3,874
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 income					1								28								94
Interest expense					-								(14	)							(2,225	)
Change in market value of warrants					2,335								(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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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

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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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."

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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.

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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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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 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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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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The Star-Ledger - NJ.com

State's 'incubator' lab facility helps new biotechnology companies grow The Star-Ledger - NJ.com Twenty-five biotechnology firms have set up shop in the Commercialization Center for Innovative Technologies, a 10-year-old "incubator" for companies in the early stages of their research or foreigners beginning to conduct research in America.

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ScienceDaily (Mar. 24, 2012) Use of a patient's bone marrow cells for treating chronic ischemic heart failure did not result in improvement on most measures of heart function, according to a study appearing in JAMA. The study is being published early online to coincide with its presentation at the American College of Cardiology's annual scientific sessions.

Cell therapy has emerged as an innovative approach for treating patients with advanced ischemic heart disease, including those with heart failure. "In patients with ischemic heart disease and heart failure, treatment with autologous [derived from the same individual] bone marrow mononuclear cells (BMCs) has demonstrated safety and has suggested efficacy. None of the clinical trials performed to date, however, have been powered to evaluate specific efficacy measures," according to background information in the article.

Emerson C. Perin, M.D., Ph.D., of the Texas Heart Institute and St. Luke's Episcopal Hospital, Houston and colleagues conducted a study to examine the effect of transendocardial administration (use of a special catheter and injection procedure to deliver stem cells to the heart muscle) of BMCs to patients with chronic ischemic heart disease and left ventricular (LV) dysfunction with heart failure and/or angina. The patients in the phase 2 randomized trial were receiving maximal medical therapy at 5 National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 2009 and April 2011. Patients were randomized to receive transendocardial injection of BMCs or placebo. The primary outcomes measured for the study, assessed at 6 months, were changes in left ventricular end-systolic volume (LVESV) assessed by echocardiography, maximal oxygen consumption, and reversibility of perfusion (blood flow) defect on single-photon emission tomography (SPECT). Of 153 patients who provided consent, a total of 92 (82 men; average age: 63 years) were randomized (n = 61 in BMC group and n = 31 in placebo group).

Analysis of data indicated no statistically significant differences between the groups for the primary end points of changes in LVESV index, maximal oxygen consumption, and reversible defect. There were also no differences in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion (the movement of the wall of the heart during contraction), and clinical improvement.

In an exploratory analysis, the researchers did find that when LVEF was assessed, patients age 62 years or younger showed a statistically significant effect of therapy. Patients in the BMC group demonstrated an average increase in LVEF of 3.1 percent from baseline to 6 months, whereas patients in the placebo group showed a decrease of -1.6 percent.

"In the largest study to date of autologous BMC therapy in patients with chronic ischemic heart disease and LV dysfunction, we found no effect of therapy on prespecified end points. Further exploratory analysis showed a significant improvement in LVEF associated with treatment. Our 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 write.

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The above story is reprinted from materials provided by JAMA and Archives Journals.

See the article here:
Treatment of ischemic heart failure with bone marrow cells does not show improvement for certain heart function measures

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

Contact: Jade Waddy Jade.Waddy@uth.tmc.edu 713-500-3030 JAMA and Archives Journals

Use of a patient's bone marrow cells for treating chronic ischemic heart failure did not result in improvement on most measures of heart function, according to a study appearing in JAMA. The study is being published early online to coincide with its presentation at the American College of Cardiology's annual scientific sessions.

Cell therapy has emerged as an innovative approach for treating patients with advanced ischemic heart disease, including those with heart failure. "In patients with ischemic heart disease and heart failure, treatment with autologous [derived from the same individual] bone marrow mononuclear cells (BMCs) has demonstrated safety and has suggested efficacy. None of the clinical trials performed to date, however, have been powered to evaluate specific efficacy measures," according to background information in the article.

Emerson C. Perin, M.D., Ph.D., of the Texas Heart Institute and St. Luke's Episcopal Hospital, Houston and colleagues conducted a study to examine the effect of transendocardial administration (use of a special catheter and injection procedure to deliver stem cells to the heart muscle) of BMCs to patients with chronic ischemic heart disease and left ventricular (LV) dysfunction with heart failure and/or angina. The patients in the phase 2 randomized trial were receiving maximal medical therapy at 5 National Heart, Lung, and Blood Institutesponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 2009 and April 2011. Patients were randomized to receive transendocardial injection of BMCs or placebo. The primary outcomes measured for the study, assessed at 6 months, were changes in left ventricular end-systolic volume (LVESV) assessed by echocardiography, maximal oxygen consumption, and reversibility of perfusion (blood flow) defect on single-photon emission tomography (SPECT). Of 153 patients who provided consent, a total of 92 (82 men; average age: 63 years) were randomized (n = 61 in BMC group and n = 31 in placebo group).

Analysis of data indicated no statistically significant differences between the groups for the primary end points of changes in LVESV index, maximal oxygen consumption, and reversible defect. There were also no differences in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion (the movement of the wall of the heart during contraction), and clinical improvement.

In an exploratory analysis, the researchers did find that when LVEF was assessed, patients age 62 years or younger showed a statistically significant effect of therapy. Patients in the BMC group demonstrated an average increase in LVEF of 3.1 percent from baseline to 6 months, whereas patients in the placebo group showed a decrease of 1.6 percent.

"In the largest study to date of autologous BMC therapy in patients with chronic ischemic heart disease and LV dysfunction, we found no effect of therapy on prespecified end points. Further exploratory analysis showed a significant improvement in LVEF associated with treatment. Our 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 write.

###

(JAMA. 2012;307(16):doi:10.1001/jama.2012.418. Available pre-embargo to the media at http://www.jamamedia.org)

View post:
Study examines treatment of heart failure with bone marrow cells

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.

Continued here:
Stem-Cell Trial Failed to Treat Heart Failure

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.

Read more from the original source:
Stem cell treatment could repair heart damage

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.

Read the original post:
Stem cell therapy could repair some heart damage: Study

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.

See the original post here:
Cell therapy using patient's own bone marrow may present option for heart disease

By Uduak Grace Thomas

Users of ChimerMarker, a short tandem repeat chimerism analysis software solution marketed by SoftGenetics, are reporting a significant reduction in the time required to analyze STRs in blood samples of patients who have undergone bone marrow transplants.

The tool automates the process of assessing the chimerism ratio the proportion of donor cells relative to the host patients own cells in post-transplant cases based on the presence of STRs that are unique to both the patient and the donor, Don Kristt, head of molecular pathology at the Rabin Medical Center in Israel, explained to BioInform this week.

According to SoftGenetics, the software can be used to monitor chimerism levels in allogeneic and autologous stem cell transplants or hematopoietic stem cell transplants; bone marrow transplants; and cord and peripheral blood stem cell transplant samples.

SoftGenetics partnered with Kristt to develop the software, which it released last March (BI 3/18/2011). The company later added a module for testing fetal samples for maternal cell contamination prior to performing genetic testing for cystic fibrosis or other diseases (BI 9/2/2011).

The software provides capabilities for genotyping and chimerism analysis and tools to automatically identify donor and recipient peaks in samples following bone marrow transplants. It also calculates percent chimerism and quality metrics for single donor or double donor cases.

Dawn Wagenknecht, who supervises the HLA-Vascular Biology Laboratory at Franciscan St. Francis Health, told BioInform this week that her team was able to reduce the time required to calculate the ratio of donor to recipient cells in blood samples by as much as 85 percent.

She explained that the team ran parallel analyses of 10 blood samples using both ChimerMarker and a manual approach that the lab had used prior to purchasing the software, which involved manually sorting data generated by capillary sequencing in Excel spreadsheets, and then calculating the ratios either on the sheet or using a hand calculator.

In addition to the time savings, ChimerMarker also simplifies the analysis process because all the steps of the workflow are in a single package, she said.

The software also maintains records of the donor sample and the patients blood before transplantation so that the results from subsequent tests after transplant can be compared to the initial samples, she said.

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Labs Report 85 Percent Reduction in STR Analysis Time with SoftGenetics' ChimerMaker Software

What used to be medical trash is now treating cancer. The University of Virginia's Medical Center is the first place in Virginia to take advantage of stem cells from umbilical cords and they are pleased with the results.

Dr. Mary Laughlin, the director of stem cell transplantation at UVA,said, "These are cells that are routinely thrown away, these cells save lives."

A lab within the UVA Medical Center contains numerous tubes where non-embryonic stem cells reside. They come from umbilical cord blood and give hope topatients suffering leukemia, multiple myeloma and lymphoma.

Dr. Laughlin added, "They can completely replace a patient's bone marrow in the immune system. Oneof 10 cancer patients are able to find those cells through existing adult registries."

Thefive million babies that are born each year will soon solve that problem. The cells that are normally tossed out attack cancer cells.

Denise Mariconda, a nurse within the stem cell transplant program, stated, "It looks like a blood transfusion." Dr. Laughlin added, "It is in many ways like a cancer vaccine."

The first transplants were made in January and the transplant program at the UVA Medical Center admits it takes getting used to.

Mariconda said, "It is a process that's not like having your heart fixed in a one-day setting and you know that it's better."

These cells are not cause for controversy. Dr. Laughlin said, "Use of cord-blood is approved by all religious groups including the Vatican."

Babies' immune systems are not fully educated at the time of birth, making these cells effective. Dr. Laughlin, added, "That allows us to cross transplant barriers."

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Stem Cell Transplant Program Offered at UVA Medical Center

A nodal public stem-cell bank in India is the need of the hour if blood cancer and thalassaemia patients are to benefit from stem-cell therapy, according to an expert.

We need an indigenous inventory of 30,000 units of umbilical cord-blood stem-cells, which would enable seven out of 10 patients seeking stem-cell transplant to find a ready match off the shelves, said P. Srinivasan, a pioneer in public cord-blood banking in the country, addressing members of the Ladies Study Group of the Indian Chamber of Commerce on Friday.

Cord blood, also called placental blood, is the blood remaining in the umbilical cord and placenta following childbirth after the cord is cut, and is routinely discarded with the placenta and umbilical cord as biological waste.

A rich source of stem cells, cord blood can be used to treat over 80 diseases, including certain cancers like leukaemia, breast cancer, blood disorders like thalassaemia major and autoimmune disorders like lupus, multiple sclerosis, Crohns Disease and rheumatoid arthritis.

Early clinical studies suggest these can even help avert corneal degeneration and restore vision in cases of blindness, help restore proper cardiac function to heart attack sufferers and improve movement in patients with spinal cord injury.

Since stem-cell matching is highly ethnicity dependent, the chances of an Indian finding a perfect match in a foreign country is a lot less compared to a resource pool of locally-donated units, the former resource person for WHO, now the chairman and managing trustee of Jeevan Blood Bank and Research Centre in Chennai, added.

Even if someone finds a match abroad, the cost of shipping the bag of matching cord blood could be as high as $40,000, as against the Rs 30,000 required for processing and storing one unit indigenously.

Srinivasan felt reaching the critical mass of 30,000 cord-blood units wasnt a big deal, given the fact that 20 million babies are born in India every year.

Purnima Dutta, the president of Ladies Study Group, agreed that raising awareness on the need to donate umbilical cord blood was the key.

As women and responsible citizens, the onus is on us to spread the word and encourage young couples to come forward and donate cord blood to ensure we can achieve this desired public-bank inventory which can save valuable lives, she said.

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Expert wants central bank for cord blood

ScienceDaily (Mar. 21, 2012) Powerful new cells created by Cardiff scientists from cheek lining tissue could offer the answer to disorders of the immune system. While the body's immune system protects against many diseases, it can also be harmful. Using white blood cells (lymphocytes), the system can attack insulin-producing cells, causing diabetes, or cause the body to reject transplanted organs.

A team from the School of Dentistry led by Professor Phil Stephens, with colleagues from Stockholm's Karolinska Institute, have found a new group of cells with a powerful ability to suppress the immune system's action.

The team took oral lining cells from the insides of patients' cheeks and cloned them. Laboratory tests showed that even small doses of the cells could completely inhibit the lymphocytes.

The breakthrough suggests that the cheek cells have wide-ranging potential for future therapies for immune system-related diseases. Existing immune system research has focused on adult stem cells, particularly those derived from bone marrow. The cheek tissue cells are much stronger in their action.

Dr Lindsay Davies, a member of the Cardiff team, said: "At this stage, these are only laboratory results. We have yet to recreate the effect outside the laboratory and any treatments will be many years away. However, these cells are extremely powerful and offer promise for combating a number of diseases. They are also easy to collect -- bone marrow stem cells require an invasive biopsy, whereas we just harvest a small biopsy from inside the mouth."

The findings have just been published online in Stem Cells and Development. The team has now been funded by the Medical Research Council to investigate the cloned cells further.

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The above story is reprinted from materials provided by Cardiff University.

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Powerful new cells cloned: Key to immune system disease could lie inside the cheek