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Category Archives: Stem Cell Therapy

Stem cell therapy for 13-year-old dog helps with its arthritis

Posted: March 28, 2012 at 5:22 pm

COLUMBIA, SC (WIS) - A few weeks ago, we told you the story of Maggie, the 13-year-old Boykin Spaniel who was suffering from arthritis.

Maggie is enjoying life once again thanks to a new type of surgery. The dog received stem cell therapy surgery six weeks ago.

Doctors were able to use adult stem cells from Maggie's blood and fat samples to collect repair cells. They then took the cells and repaired the dog's arthritic spine.

Maggie's owner, Beth Phibbs, says she could tell the dog had been in pain.

"You could tell she didn't feel well, but yet now she is like she's 5 and she's 13. She just runs out and she plays. I think she knows. She can feel the difference," Phibbs said.

The surgery costs about $2,000, but Medi-vet America says this costs about half as much as the older treatments.

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Stem cell segment in India to touch $8 billion mark by 2015: Report

Posted: March 28, 2012 at 5:22 pm

HYDERABAD: Lack of legislation and awareness coupled with quality and ethical Issues has been deterrent to the growth of stem cell therapy sector in India, where the bio-tech market is expected to achieve a market size of $ 8 billion by 2015, according to a report by the Yes bank.

Special provisions such as 10-year tax benefits, duty exemptions, fast tracking the approval process by giving it a status of orphan drug (as done in the US) are some measures which could be very helpful to become leaders in this sector, the report 'Stem Cells--an emerging Bio-sector' suggested.

"The legislation for this sector still is at the draft stage. A regulatory framework governing the sector, instead of the guidelines existing at present is essential for the proper growth of stem cell research and applications in India. There are also no guidelines regarding pricing which results in certain unproven injections being sold for around Rs 80,000," the report said.

Several companies are taking advantage of the lack of laws governing the stem cell segment and advertise their therapies and clinical trials as ICMR approved.

However, given the multi-tiered system of registration and approvals recommended in the ICMR's guidelines, some of these are based on fraudulent or exaggerated claims. Further, there are also ethical worries on the side-effects of such treatment, it further said.

In India, there are very few players in the stem cell sector and these are all in very nascent stages and industry consolidation with global players entering into the market through mergers and acquisition route could propel industry growth, it opined.

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Stem cell segment in India to touch $8 billion mark by 2015: Report

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Stem cell therapy for 13-year-old dog helps with its arthritis

Posted: March 28, 2012 at 11:56 am

COLUMBIA, SC (WIS) - A few weeks ago, we told you the story of Maggie, the 13-year-old Boykin Spaniel who was suffering from arthritis.

Maggie is enjoying life once again thanks to a new type of surgery. The dog received stem cell therapy surgery six weeks ago.

Doctors were able to use adult stem cells from Maggie's blood and fat samples to collect repair cells. They then took the cells and repaired the dog's arthritic spine.

Maggie's owner, Beth Phibbs, says she could tell the dog had been in pain.

"You could tell she didn't feel well, but yet now she is like she's 5 and she's 13. She just runs out and she plays. I think she knows. She can feel the difference," Phibbs said.

The surgery costs about $2,000, but Medi-vet America says this costs about half as much as the older treatments.

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Copyright 2012 WIS. All rights reserved.

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Stem cell therapy for 13-year-old dog helps with its arthritis

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Cell Therapy Improves Damaged Heart In Study

Posted: March 27, 2012 at 3:10 pm

March 27, 2012

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

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

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

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

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

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

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

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

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

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Cell Therapy Improves Damaged Heart In Study

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Cell Therapy Improves Damaged Heart In Study

Posted: March 27, 2012 at 2:31 pm

March 27, 2012

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

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

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

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

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

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

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

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

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

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Cell Therapy Improves Damaged Heart In Study

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Houston study shows stem-cell’s potential for heart treatment

Posted: March 27, 2012 at 1:04 pm

Houston researchers are reporting that adult stem cells have a modest benefit in younger patients with heart failure, the first large-scale evidence that the controversial yet promising new therapy can be developed to help millions of people with the disease.

In a study presented at a cardiology conference Saturday, Texas Heart Institute doctors presented results of a clinical trial showing that cells derived from patients' own bone marrow produce a small but significant increase in the heart's ability to pump oxygen-rich blood.

"This study moves us one step closer to being able to help patients with severe heart failure who lack other alternatives," said Dr. James Willerson, president of the Texas Heart Institute and the study's principal investigator. "It also points to a future in which stem cells regenerate the heart."

The study did not find improvements in a number of heart function measures, but Willerson and other study leaders said it yielded key information about the specific adult stem cells with the greatest therapeutic potential. The trial used a number of stem cell types.

Transplants limited

About 6 million people in the United States have heart failure, a progressive and eventually fatal disease in which the heart loses the ability to effectively pump sufficient amounts of blood to the body's organs. Better therapy is needed because the limited availability of donor hearts makes transplants an option for only about 2,300 people in the United States annually.

Adult stem cells have become the subject of studies for a variety of conditions - the Texas Heart Institute has many involving the heart - since laboratory research in the late 1990s showed they have the ability to grow into most any kind of tissue. This is the first intermediate-stage study in the United States, characterized by multiple centers and many dozens of patients.

The idea of therapy involving adult stem cells formerly was considered non-controversial, a more ethical alternative to destroying embryos to obtain their stem cells. But it has come under fire recently because it is increasingly being used outside of research studies and for profit, particularly in Texas, where Gov. Rick Perry received it last year for his ailing back. The unregulated activity has prompted complaints to the U.S. Food and Drug Administration and a Texas Medical Board draft policy requiring oversight for any use of experimental drugs.

3.1 percent increase

The new study, presented at an American College of Cardiology conference and to be published in the Journal of the American Medical Association, involved 92 patients at five locations - two-thirds at the Texas Heart Institute - whose hearts were pumping at less than 45 percent of capacity and could not be treated with surgery. Doctors injected patients' own stem cells or placebos into their hearts.

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Houston study shows stem-cell's potential for heart treatment

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Midlands Vet Uses Stem Cell Therapy for Pets in Pain

Posted: March 27, 2012 at 11:06 am

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

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

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

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

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

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

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

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

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

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

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Midlands Vet Uses Stem Cell Therapy for Pets in Pain

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Houston study shows stem-cell's potential for heart treatment

Posted: March 27, 2012 at 11:06 am

Houston researchers are reporting that adult stem cells have a modest benefit in younger patients with heart failure, the first large-scale evidence that the controversial yet promising new therapy can be developed to help millions of people with the disease.

In a study presented at a cardiology conference Saturday, Texas Heart Institute doctors presented results of a clinical trial showing that cells derived from patients' own bone marrow produce a small but significant increase in the heart's ability to pump oxygen-rich blood.

"This study moves us one step closer to being able to help patients with severe heart failure who lack other alternatives," said Dr. James Willerson, president of the Texas Heart Institute and the study's principal investigator. "It also points to a future in which stem cells regenerate the heart."

The study did not find improvements in a number of heart function measures, but Willerson and other study leaders said it yielded key information about the specific adult stem cells with the greatest therapeutic potential. The trial used a number of stem cell types.

Transplants limited

About 6 million people in the United States have heart failure, a progressive and eventually fatal disease in which the heart loses the ability to effectively pump sufficient amounts of blood to the body's organs. Better therapy is needed because the limited availability of donor hearts makes transplants an option for only about 2,300 people in the United States annually.

Adult stem cells have become the subject of studies for a variety of conditions - the Texas Heart Institute has many involving the heart - since laboratory research in the late 1990s showed they have the ability to grow into most any kind of tissue. This is the first intermediate-stage study in the United States, characterized by multiple centers and many dozens of patients.

The idea of therapy involving adult stem cells formerly was considered non-controversial, a more ethical alternative to destroying embryos to obtain their stem cells. But it has come under fire recently because it is increasingly being used outside of research studies and for profit, particularly in Texas, where Gov. Rick Perry received it last year for his ailing back. The unregulated activity has prompted complaints to the U.S. Food and Drug Administration and a Texas Medical Board draft policy requiring oversight for any use of experimental drugs.

3.1 percent increase

The new study, presented at an American College of Cardiology conference and to be published in the Journal of the American Medical Association, involved 92 patients at five locations - two-thirds at the Texas Heart Institute - whose hearts were pumping at less than 45 percent of capacity and could not be treated with surgery. Doctors injected patients' own stem cells or placebos into their hearts.

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

Posted: March 25, 2012 at 7:51 pm

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

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

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

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

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

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

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

For comments and feedback: contact editorial@rttnews.com

http://www.rttnews.com

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

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International Stem Cell Corporations Announces 2011 Financial Results

Posted: March 25, 2012 at 4:02 pm

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
To subscribe to receive ongoing corporate communications, please click on the following link:
Contacts:
International Stem Cell Corporation
Linh Nguyen, CFO
760-940-6383
Or
Dr. Ruslan Semechkin, Vice President
760-940-6383
ras@intlstemcell.com

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

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