Hospitals performing stem cell therapy are yet to be accredited – DOH

By: Azer N. Parrocha, Philippine News Agency March 28, 2013 3:16 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - Although guidelines for stem cell therapy in the country have already been released, the Department of Health (DOH) on Wednesday reminded the public that hospitals performing the treatment are as of the moment, not accredited.

Health Secretary Enrique Ona, in a press conference, explained that for a hospital or clinic to be considered accredited, a years worth of tests and studies have to be done to prove that the procedure is indeed safe and effective.

I hope the general public understands that these stem cells, although called innovative (form of treatment) is not standard and should not be advertised as though it is already an accepted form of treatment, Ona said.

Ona explained that the DOH still continues to look on the capacity of the treatment and will make sure that the stem cells used for procedure are accepted as protocol.

Stem cells like those coming from embryos or animals which are restricted will also be looked into by the DOH to see if there are any hospitals or clinics that do not abide by the administrative order.

If the protocol is accepted, report of results should be evaluated, he said. They are evaluated about a year to see if their claim is effective [and if it is] it will be validated.

At present, there are no hospitals or clinics completely accredited for the stem cell therapy yet. Given that, certain processes must be followed before doctors are allowed to use the treatment.

I cannot see a so-called clinic yet certifying that there is a process that is very effective, Ona explained. We have to see the type of stem cell, the type of claim they have.

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Hospitals performing stem cell therapy are yet to be accredited – DOH

International Stem Cell Corporation Announces Fourth Quarter 2012 Financial Results and Provides Business Update

CARLSBAD, CA--(Marketwire - Mar 27, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based biotechnology company focused on therapeutic and biomedical products, today announced financial results for the three and twelve months ended December 31, 2012.

FY 2012 Highlights:

Three Months Ended December 31, 2012

Revenue for the three months ended December 31, 2012 totaled $1.25 million compared to $1.06 million for the same period in 2011. Sales for Lifeline Skin Care (LSC) and Lifeline Cell Technology (LCT) increased by 39% and 3%, respectively. LSC and LCT accounted for 48% and 52% of total revenue in the three months ended December 31, 2012.

Development expenses decreased by 8% to $3.65 million due primarily to reductions in cost of sales and consulting expenses relating to our research and development projects, partially offset by an increase in sales and marketing spending. General and administrative expenses were $1.89 million, reflecting relatively constant expense compared to the fourth quarter of 2011.

Twelve Months Ended December 31, 2012

Sales for the twelve months ended December 31, 2012 were $4.57 million compared to $4.53 million in 2011. LCT sales were $2.38 million, up 14% from 2011, representing 52% of total revenue in 2012. LSC revenues were $2.19 million compared to $2.45 million in 2011 reflecting a decrease of 11%.

Cost of sales was $1.27 million, or 28% of revenue, compared to $1.62 million or 36% of revenue in 2011. The Company successfully implemented efficiencies in its manufacturing and supply chain management for both LSC and LCT.

Net loss from development activities was $9.81 million, compared to $11.36 million in 2011 reflecting a reduction of $1.55 million or 14% primarily due to favorable reductions in cost of sales, research and development and general and administrative expenses.

Cash and cash equivalents totaled $0.65 million at December 31, 2012 compared to $1.34 million at December 31, 2011.

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International Stem Cell Corporation Announces Fourth Quarter 2012 Financial Results and Provides Business Update

ReNeuron Group to begin stem cell treatment of critical limb ischaemia

LONDON (ShareCast) - ReNeuron Group (Other OTC: RNUGF - news) has received regulatory approval to begin the first phase of a clinical trial in the UK for the company's ReN009 stem cell therapy treatment for critical limb ischaemia.

Critical limb ischaemia, a condition which leads to blood vessel blockage in limbs such as toes and can lead to amputation, is ReNeuron's second major disease target after stroke in its CTX stem cell line.

The stem cell therapeutics group said ReN009 has the potential to restore sufficient blood flow in the affected lower limb of patients with the condition.

The Phase 1 clinical trial will be undertaken though NHS Tayside at Ninewells Hospital and Medical School in Dundee, Scotland.

ReN009 cells will be administered via straightforward intramuscular injection into the affected lower limb of nine patients with peripheral arterial disease.

ReNeuron was recently awarded a late stage biomedical catalyst grant of 0.4m from the Technology Strategy Board, the UK Government's innovation agency, to be deployed towards the cost of the study.

"These clinical trial approvals for our next major disease target, together with the recently announced biomedical catalyst funding for the Phase I critical limb ischaemia study, represent strong endorsements of the strength of ReNeuron's technologies and its CTX stem cell therapy candidate," said Chief Executive Officer Michael Hunt.

Shares climbed 1.94% to 3.15p at 10:08 Tuesday.

RD

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ReNeuron Group to begin stem cell treatment of critical limb ischaemia

COFEPRIS leniency opens doors to stem cell therapies

NEW YORK, March 25, 2013 /PRNewswire/ --Celltex in Houston moved operations to Mexico early this year along with stem cell companies in India and China who have been inquiring about the Mexican market. According to ReHealth, COFEPRIS, which 2 years ago was closed to stem cell treatment has had a complete change of heart when they approached them again just about a month ago. ReHealth's core business is the development of autologous stem cells for diabetes types 1 and 2, COPD, cardiovascular diseases and sports injuries.

The Biopharma Mexico conference, from the 29th-30th October in Mexico City, will usher stem cell and regenerative medicine companies in the US , Europe and Asia into the Mexican market.

Join us and learn how to:

If you offer tools, consumables, reagents, products and services in stem cell development, contact us to find out how you can participate.

Biopharma Mexico will also bring together biotechs developing biologics, particularly bio-comparables and vaccines in the country.

Visit: http://www.terrapinn.com/biopharmamexico

About Terrapinn:

Terrapinn is a business media company. Our products are trade exhibitions, conferences, training solutions and electronic and print publications. More information and a schedule of our events can be found at http://www.terrapinn.com.

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COFEPRIS leniency opens doors to stem cell therapies

House advances bill requiring KU Medical Center to establish stem cell research center

Topeka A bill supported by abortion opponents that would require the Kansas University Medical Center to start a center on adult stem cell research was advanced by the House on Tuesday.

State Rep. David Crum, R-Augusta, described the bill as "pro-life," in that adult stem cell research has the "potential to establish cures that improve the quality of life and extend life."

But opponents of Senate Bill 199 said legislators shouldn't mandate KU start a center without any state funding while many of those same legislators also voted to cut funding to the school in the state appropriations bill.

And the opponents said KU did not ask for the bill and that traditionally the startup of a research and treatment center requires a lengthy planning process that brings together school leaders, researchers and the business community before approaching the Legislature.

"We are in uncharted territory," state Rep. Barbara Bollier, R-Mission Hills, said.

"Stem cell research and therapy is incredibly complex," Bollier said. "The doctors and researchers who are involved know what they are doing and they don't need us to set up a specific stem cell treatment center."

Bollier tried to add an amendment to the bill that she said was needed to tighten up legal issues on the research, but her proposal failed 40-74.

State Rep. Susan Concannon, R-Beloit, said it was proper for the Legislature to direct the universities.

"Maybe this would never happen because of the political questions involved," Concannon said. "The stem cell center would possibly never be built if not for the direction of the state."

The bill would require the KU Medical Center to establish the Midwest Stem Cell Therapy Center to advance adult, cord blood and related stem cell therapies.

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House advances bill requiring KU Medical Center to establish stem cell research center

New rules will regulate stem – cell therapy use

The Consumer By Linda Bolido Philippine Daily Inquirer

All the publicity about stem-cell therapy (SCT), including endorsements from some of the countrys most powerful people and brightest stars, has made it seem like a miracle cure, even a cure-all.

From the treatment of life-threatening medical problems to reversing the effects of aging, people are now beginning to look to SCTespecially if they can afford itfor salvation.

But, according to a doctor I know, there are actually only two proven applications for the therapy right now. The rest, at this stage, is really still experimental. People have, of course, volunteered for pioneering procedures, hoping for a cure for whatever ails them.

Education still needed

Thats well and good, as long as they are fully informed and give their unequivocal consent to being experimented on. The problem, however, is some people undergo the therapy without fully understanding it. And there are groups that seem to think that because they have Googled the therapy and read everything on the Net about it, they are capable of doing the procedure.

I mentioned in this column previously that even beauty parlors were offering to do SCT. Although it would be only for cosmetic purposes, the procedure is too new and complex to leave in the hands of beauticians.

Finally, the Department of Health has issued rules and regulations to regulate the SCT practice, a move warmly welcomed by the medical community, particularly the Philippine Medical Association and Philippine Society for Stem Cell Medicine, which expressed concern before that the popularity of SCT would lead to abuse and illegal practice if left unregulated.

Health Secretary Enrique Ona, in published reports, said the guidelines aimed to safeguard the welfare of our patients and the general public by making [sure] safe, effective and ethical stem-cell modalities and practices are within emerging international and global standards considering the very complex nature of this therapy.

Among other things, the rules restrict the use of genetically altered stem cells and tissues of human adults and the umbilical cord, fat-derived human stem cells and live animal stem cells.

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New rules will regulate stem - cell therapy use

Complete 2012-13 Induced Pluripotent Stem Cell Industry Report

DUBLIN, March 25, 2013 /PRNewswire/ --

Research and Markets has announced the addition of the "Complete 2012-13 Induced Pluripotent Stem Cell Industry Report" report to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

Stem cell research and experimentation has been in process for well over five decades. Stem cells have the unique characteristics whereby they are able to divide and replicate repeatedly in addition to their being unspecialized with the ability to differentiate into specialized cell types. The possibilities that arise with the perfecting of cell replication has caused this area of exploration to remain on the forefront of scientific research, with ongoing hope that cures and treatment of diseases as well as reparative cell therapy, tissue regeneration and pharmacological testing on cell-specific tissue will one day become viable options within the medical community.

Traditionally, scientists have worked with both embryonic and adult stem cells. While the appeal of embryonic cells has been their ability to differentiate into any type of cell, there has been significant ethical, moral and spiritual controversy surrounding the use of embryonic cells for research. Although adult stem cells can differentiate slightly, they are typically limited to differentiation within their original tissue type, creating narrow options for their use.

Perhaps the most distinctive feature of this report are the breakthrough findings discovered as a result of surveying 293 researchers that identify as having induced pluripotent stem cells as their core research focus. Of the 293 respondents, 181 were U.S. based and 112 were international. These key survey findings reveal iPSC researcher wants and needs, technical preferences, and key factors influencing buying decisions. These vital findings can be used to direct the product development and product positioning decisions. Remember, to benefit from this lucrative product market, you need to anticipate and serve the needs of your clients, or your competitors will.

Key Findings Include:

- Charts, Timelines, Metrics and Financials for the iPSC Research Product Market

- Trends for iPSC Grants, Publications, Patents, and More

- 5-Year Market Projection Data for 2012-2017

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Complete 2012-13 Induced Pluripotent Stem Cell Industry Report