Monthly Archives: May 2013

Cytomedix to Present at the World Stem Cells & Regenerative Medicine Congress 2013

Posted: May 17, 2013 at 8:46 am

GAITHERSBURG, MD--(Marketwired - May 17, 2013) - Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Edward Field, the Company's Chief Operating Officer, has been invited to make a presentation on Partnering & Collaboration at the World Stem Cells & Regenerative Medicine Congress 2013, which will be held May 21-23, 2013 in London, United Kingdom.

Presentation Details

Time: Tuesday, May 21, 2013 @ 11:55am BST (6:55 am EST)

Track Title: Commercialisation through Collaboration: What Does Partnering In This Industry Actually Look Like?

Location: Victoria Park Plaza Hotel, London, UK

During the presentation, Mr. Field will highlight Cytomedix's two collaborations that are advancing clinical stage therapies.The first is a collaboration with the National Institute of Health (NIH) and the Cardiovascular Cell Therapy Research Network (CCTRN) for conduct of the PACE study, an 80 patient, double-blind, placebo-controlled clinical trial designed to look at the safety and efficacy of ALD-301 in peripheral artery disease patients diagnosed with intermittent claudication.This is the first ever randomized clinical trial to look at the benefits of autologous stem cell therapy in this indication.The second collaboration is with Duke University Medical Center, which is conducting a Phase 1 clinical study with ALD-451 in patients that have been treated for glioblastomas, which is the most aggressive form of brain cancer.This open-label study is designed to enroll up to 12 patients and is intended to demonstrate the safety and feasibility of ALD-451 when administered intravenously in patients with grade IV malignant glioma following surgery, radiation therapy and treatment with temozolomide.

About the World Stem Cells Regenerative Medicine Congress 2013The World Stem Cells & Regenerative Medicine Congress 2013 is Europe's largest and most senior conference for the stem cell research and regenerative medicine community.It is now in its 8th year. Topics covered will include streamlining clinical development, commercialising a stem cell-based therapy and exploiting alternative sources of funding. For more information please visit: http://www.terrapinn.com/2013/stemcells/index.stm.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDH") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement - Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company's ability to successfully integrate the Aldagen acquisition, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2012, as amended to date, and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix to Present at the World Stem Cells & Regenerative Medicine Congress 2013

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TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China

Posted: May 17, 2013 at 8:44 am

TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ --TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Approval is expected in the first half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs of the Economic Cooperation Framework Agreement (ECFA) between Taiwan and mainland China. It is also the first new drug from Taiwan to meet the requirements of CFDA's Category 1.1 New Drug. Drugs under this classification have to be new chemical entities (NCEs) that have not been marketed in any country in the world. Nemonoxacin, thus, represents a landmark in the continued development of cross-strait relationship between the pharmaceutical industry and regulatory agencies.

Nemonoxacin is a NCE, broad spectrum antibiotic with excellent efficacy and safety profile. The NDA submission for nemonoxacin is supported by a pivotal Phase 3 trial with 532 patients in community-acquired pneumonia (CAP). The trial was conducted in both Taiwan and mainland China (441 patients from mainland China and 91 patients from Taiwan) that met all primary and secondary endpoints including non-inferiority to the comparator, levofloxacin. TaiGen is currently conducting Phase 2 trial for the intravenous formulation of nemonoxacin in moderate to severe CAP patients. In addition to CAP, nemonoxacin has also shown efficacy in diabetic foot infections in a Phase 2 trial conducted in the US, Taiwan, and South Africa. In the clinical trials conducted to this point, nemonoxacin have demonstrated excellent activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the worldwide patent portfolio of nemonoxacin that protects composition, use, and processes until 2029.

Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "Since the founding of TaiGen, we have been focusing on the development of First-in-class and Best-in-class novel drugs. The submission of the NDA for nemonoxacin is the culmination of efforts by our experienced management team and all the staff at TaiGen. I am very pleased with the groundbreaking achievement of using one NDA dossier for submissions to TFDA and CFDA. Not only nemonoxacin is our first product to the market, it is also an indication that a world class medicine can be discovered and developed in Taiwan. TaiGen is well positioned to advance in the world's fastest pharmaceutical market, mainland China."

In June 2012, TaiGen signed an agreement with Zhejiang Medicine Company, Limited ("ZMC") to out-license the exclusive marketing and manufacturing rights of nemonoxacin in China. ZMC is a leading manufacturer and marketer of antibiotics in China and is a publicly listed company in the Shanghai Stock Exchange. This partnership combines TaiGen's R&D expertise and ZMC's antibiotic marketing knowhow to compete in China's US$11 billion antibiotic market.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. In addition to nemonoxacin, TaiGen has two other in-house discovered NCEs in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 2. Both TG-0054 and TG-2349 are currently in clinical trials in patients in the US.

Disclaimer

Certain statements in this press release are forward-looking. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on TaiGen's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain regulatory authority clearances or approvals and noncompliance with regulatory regulations. As with any drugs under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TaiGen does not undertake an obligation to update or revise any forward-looking statement.

TaiGen Contact:

Peter W. Tsao, PhD, Vice President ofBusiness Development Tel: +886-2-8177-7072 ext 1705 ptsao@taigenbiotech.com.tw

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Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State

Posted: May 16, 2013 at 11:42 pm

The good news out of Oregon is that
some diligent scientists in the Beaver State have accomplished a
major advance in stem cell research --- the cloning of human stem
cells.

That bad news is that their research
would have been illegal in California, and probably will be banned
for decades, if not longer – thanks to Proposition 71 of 2004.
The proposition was the ballot
initiative that created the $3 billion California stem cell agency,
which is hailed internationally as being one of the world leaders in
financing stem cell science. Unfortunately, the 10,000-word
initiative also contains language that was aimed at winning voter
approval of the measure -- not promoting good science.
The team writing the initiative, led by
Robert Klein, the former and first chairman of the stem cell agency,
put in a provision that made it illegal to pay women for their eggs.
The Oregon researchers paid women $3,000 to $7,000 each for their eggs, reflecting the current market rate based on prices paid in
connection with IVF. In some cases for IVF, the compensation is
dramatically higher. (See here and here.) Stem cell researchers in
recent years in the United States have found that they cannot secure
an adequate number of donors without matching IVF donor compensation.
While compensation for eggs is a matter
of some controversy, strong cases have been made that women
should make their own decisions about selling their eggs – not the what some call the nanny state. Of course, that should occur under well-regulated
situations. But Proposition 71 backers wanted to remove any possible
campaign objections by opponents of stem cell research, and so they
inserted the ban along with management minutia and other dubious
material.
Can't that be changed, one might ask?
Not without a herculean effort. That means another ballot measure or
a super, super majority vote in the California legislature plus the
signature of the governor. Imagine a measure on the ballot to
allow women to sell their eggs. The uproar would be heard
internationally. In 2004, when Proposition 71 was approved, it would
have been better to leave the compensation issue unaddressed. Then it
could have been dealt with through regulation or normal legislation,
both of which are far more flexible than ballot measures that alter
the state Constitution and state law.
Our quick and limited survey of the
news coverage indicated that many of the mainstream media stories
omitted the price of the eggs, which may suggest that the issue of
compensation is becoming moot.
In related news about the Oregon
accomplishment, UC Davis stem cell researcher Paul Knoepfler has
posted a good look at the some of the misinformation that is
surfacing on the Internet about the research, including its
implications.
He said,

“Keep in mind that on day one of the
iPS cell era in the stem cell field we had a huge number of
misconceptions because we simply had so much to learn. Same is true
here.”

Jessica Cussins over at the
Berkeley-based Biopolitical Times also has a solid roundup of the
coverage of the Oregon research and the analysis of its significance.
Here are links to two blog items from
the California stem cell agency on the Oregon research, including one
dealing with “cloning hysteria” and a more general look.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A4AXZfPs3dc/oregon-style-stem-cell-cloning-research.html

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Apple Cell Serum Review – Apple Stem Cells Aging Creams Offer Hope for Aging and Damaged Skin – Video

Posted: May 16, 2013 at 5:45 am


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Via cloning, human stem cells

Posted: May 15, 2013 at 10:49 pm

Oregon Health&Science University

Donor egg held by pipette prior to nuclear extraction.

By Maggie Fox, Senior Writer, NBC News

Researchers say they have finally managed to use cloning technology to make human embryos and grow stem cells from them in the hopes of making perfectly matched grow-your-own tissue transplants.

They used a human egg cell and parts of a human skin cell to grow a very early human embryo, then transformed cells from this ball of cells into beating heart cells and skin cells. The process may eventually help treat a range of diseases, from Parkinsons to rare inherited conditions, they reported Wednesday in the journal Cell.

The researchers, at Oregon Health & Science University, say their embryos almost certainly could not grow into living human babies or even start a pregnancy theyre deficient in a key way. But they admit also that they havent quite overcome ethical qualms about working with human embryos.

However, the work opens another route to treatments using human embryonic stem cells, the bodys master cells. These stem cells are kind of very early unprogrammed cells but they have the capacity to become any other cell type, says Shoukhrat Mitalipov, who led the research.

These cells are very different from so-called adult stem cells, like those taken from bone marrow. Adult stem cells cannot give rise to cells of other tissue types -- blood cells cannot be used to make brain cells, for instance.

Dr. George Daley, a stem cell expert at Harvard Medical School, called it a "beautiful piece of work".

When human embryonic stem cells were first discovered in 1998, scientists immediately dreamed of using cloning technology to help people grow their own organ and tissue transplants, and to use them to study disease. Theyd be perfect genetic matches for each patient, meaning an end to a lifetime of taking dangerous immune-suppressing drugs after an organ transplant.

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Success! Human stem cells cloned

Posted: May 15, 2013 at 10:49 pm

Stem cells viewed on a computer screen at the University of Connecticut's Stem Cell Institute.

STORY HIGHLIGHTS

(TIME.com) -- It's been 17 years since Dolly the sheep was cloned from a mammary cell. And now scientists applied the same technique to make the first embryonic stem cell lines from human skin cells.

Ever since Ian Wilmut, an unassuming embryologist working at the Roslin Institute just outside of Edinburgh stunned the world by cloning the first mammal, Dolly, scientists have been asking -- could humans be cloned in the same way?

Putting aside the ethical challenges the question raised, the query turned out to involve more wishful thinking than scientific success. Despite the fact that dozens of other species have been cloned using the technique, called nuclear transfer, human cells have remained stubbornly resistant to the process.

Until now. Shoukhrat Mitalipov, a professor at Oregon Health & Science University, and his colleagues report in the journal Cell that they have successfully reprogrammed human skin cells back to their embryonic state.

The purpose of the study, however, was not to generate human clones but to produce lines of embryonic stem cells. These can develop into muscle, nerve, or other cells that make up the body's tissues. The process, he says, took only a few months, a surprisingly short period to reach such an important milestone.

TIME.com: Stem cell scientists awarded Nobel Prize in Physiology and Medicine

Nuclear transfer involves inserting a fully developed cell -- in Mitalipov's study, the cells came from the skin of fetuses -- into the nucleus of an egg, and then manipulating the egg to start dividing, a process that normally only occurs after it has been fertilized by a sperm.

After several days, the ball of cells that results contains a blanket of embryonic stem cells endowed with the genetic material of the donor skin cell, which have the ability to generate every cell type from that donor.

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Stem Cells Pulled From Cloned Embryos

Posted: May 15, 2013 at 10:49 pm

Scientists have finally recovered stem cells from cloned human embryos, a longstanding goal that could lead to new treatments for such illnesses as Parkinson's disease and diabetes.

A prominent expert called the work a landmark, but noted that a different, simpler technique now under development may prove more useful.

Stem cells can turn into any cell of the body, so scientists are interested in using them to create tissue for treating disease. Transplanting brain tissue might treat Parkinson's disorder, for example, and pancreatic tissue might be used for diabetes.

But transplants run the risk of rejection, so more than a decade ago, researchers proposed a way around that: Create tissue from stem cells that bear the patient's own DNA, obtained with a process called therapeutic cloning.

If DNA from a patient is put into a human egg, which is then grown into an early embryo, the stem cells from that embryo would provide a virtual genetic match. So in theory, tissues created from them would not be rejected by the patient.

That idea was met with some ethical objections because harvesting the stem cells involved destroying human embryos.

Scientists have tried to get stem cells from cloned human embryos for about a decade, but they've failed. Generally, that's because the embryos stopped developing before producing the cells. In 2004, a South Korean scientist claimed to have gotten stem cells from cloned human embryos, but that turned out to be a fraud.

In Wednesday's edition of the journal Cell, however, scientists in Oregon report harvesting stem cells from six embryos created from donated eggs. Two embryos had been given DNA from skin cells of a child with a genetic disorder, and the others had DNA from fetal skin cells.

Shoukhrat Mitalipov of the Oregon Health & Science University, who led the research, said the success came not from a single technical innovation, but from revising a series of steps in the process. He noted it had taken six years to reach the goal after doing it with monkey embryos.

Mitalipov also said that based on monkey work, he believes human embryos made with the technique could not develop into cloned babies, and he has no interest in trying to do that. Scientists have cloned more than a dozen kinds of mammals, starting with Dolly the sheep.

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Human stem cells created by cloning

Posted: May 15, 2013 at 10:49 pm

Seeing double: human embryonic stem cells have finally been made using cloning techniques.

OHSU Photos

It was hailed some 15 years ago as the great hope for a biomedical revolution: the use of cloning techniques to create perfectly matched tissues that would someday cure ailments ranging from diabetes to Parkinsons disease. Since then, the approach has been enveloped in ethical debate, tainted by fraud and, in recent years, overshadowed by a competing technology. Most groups gave up long ago on the finicky core method production of patient-specific embryonic stem cells (ESCs) from cloning. A quieter debate followed: do we still need therapeutic cloning?

A paper published this week1 by Shoukhrat Mitalipov, a reproductive biology specialist at the Oregon Health and Science University in Beaverton, and his colleagues is sure to rekindle that debate. Mitalipov and his team have finally created patient-specific ESCs through cloning, and they are keen to prove that the technology is worth pursuing.

Therapeutic cloning, or somatic-cell nuclear transfer (SCNT), begins with the same process used to create Dolly, the famous cloned sheep, in 1996. A donor cell from a body tissue such as skin is fused with an unfertilized egg from which the nucleus has been removed. The egg reprograms the DNA in the donor cell to an embryonic state and divides until it has reached the early, blastocyst stage. The cells are then harvested and cultured to create a stable cell line that is genetically matched to the donor and that can become almost any cell type in the human body.

Many scientists have tried to create human SCNT cell lines; none had succeeded until now. Most infamously, Woo Suk Hwang of Seoul National University in South Korea used hundreds of human eggs to report two successes, in 2004 and 2005. Both turned out to be fabricated. Other researchers made some headway. Mitalipov created SCNT lines in monkeys2 in 2007. And Dieter Egli, a regenerative medicine specialist at the New York Stem Cell Foundation, successfully produced human SCNT lines3, but only when the eggs nucleus was left in the cell. As a result, the cells had abnormal numbers of chromosomes, limiting their use.

Mitalipov and his group began work on their new study last September, using eggs from young donors recruited through a university advertising campaign. In December, after some false starts, cells from four cloned embryos that Mitalipov had engineered began to grow. It looks like colonies, it looks like colonies, he kept thinking. Masahito Tachibana, a fertility specialist from Sendai, Japan, who is finishing a 5-year stint in Mitalipovs laboratory, nervously sectioned the 1-millimetre-wide clumps of cells and transferred them to new culture plates, where they continued to grow evidence of success. Mitalipov cancelled his holiday plans. I was happy to spend Christmas culturing cells, he says. My family understood.

The success came through minor technical tweaks. The researchers used inactivated Sendai virus (known to induce fusion of cells) to unite the egg and body cells, and an electric jolt to activate embryo development. When their first attempts produced six blastocysts but no stable cell lines, they added caffeine, which protects the egg from premature activation.

None of these techniques is new, but the researchers tested them in various combinations in more than 1,000 monkey eggs before moving on to human cells. They made the right improvements to the protocol, says Egli. Its big news. Its convincing. I believe it.

The experiments took only a few months, Mitalipov says. People say, you did it in monkeys in 2007. Why did it take six years in humans? Most of the time, he says, was spent navigating US regulations on embryo research.

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Stem Cells Made From Cloned Human Embryos

Posted: May 15, 2013 at 10:49 pm

Scientists in the United States have hailed a major breakthrough after recovering stem cells from cloned human embryos for the first time.

Researchers described the use of skin to generate embryonic stem cells - which removes one of the obstacles to human cloning - as a "milestone".

The cells could potentially be used to make newbrain tissue for Parkinson's sufferers, new heart muscle for people with cardiovascularproblems or pancreatic tissue to treat diabetes.

But while the breakthrough will help the development of stem cell therapies that avoid fertilised human embryos, the cloning technique used in the process is expected to fuel controversy and claims of Brave New World-style science.

The scientists dismissed such criticism, saying they were not interested in cloning humans and did not believe their methods could successfully be used in this way.

Lead researcher Professor Shoukhrat Mitalipov said: "While nuclear transfer breakthroughs often lead to a public discussion about the ethics of human cloning, this is not our focus, nor do we believe our findings might be used by others to advance the possibility of human reproductive cloning.

"Our finding offers new ways of generating stem cells for patients with dysfunctional or damaged tissues and organs," he explained in the journal Cell.

"Such stem cells can regenerate and replace those damaged cells and tissues and alleviate diseases that affect millions of people."

The stem cells demonstrated an ability to convert into several different cell types, including nerve, liver and heart cells.

"While there is much work to be done in developing safe and effective stem cell treatments, we believe this is a significant step forward in developing the cells that could be used in regenerative medicine," MrMitalipovadded.

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Breakthrough: stem cells from a cloned embryo

Posted: May 15, 2013 at 10:49 pm

Scientists have used caffeine to achieve a stem cell breakthrough that many researchers thought impossible but that could lead to new therapies for many crippling diseases.

A US team used a human skin cell to create a cloned human embryo from which they were able to extract embryonic stem cells, a world first.

The technique, known as somatic cell nuclear transfer, or therapeutic cloning, is ethically controversial because it involves the production, and subsequent destruction, of a human embryo.

Its medical promise is that the embryonic stem cells obtained which can turn into all cell types in the body for possible organ repair and transplant are genetically matched to the person who donated the skin cell.

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"This study is a breakthrough development that overcomes a major scientific hurdle with significant implications for potentially treating a range of diseases," said Bryce Vissel, the head of the Neurodegeneration Research Program at the Garvan Institute of Medical Research.

Scientists, including Australian researchers, have spent years attempting to create embryonic stems cells from cloned human embryos. "Our finding offers new ways of generating stem cells for patients with dysfunctional or damaged tissues and organs," said the study leader, Shoukhrat Mitalipov, from the Oregon Health & Science University.

"Such stem cells can regenerate and replace those damaged cells and tissues and alleviate diseases that affect millions of people," said Professor Mitalipov.

The chair of stem cell sciences at the University of Melbourne, Martin Pera, said the new method also offered a unique approach to preventing inherited mitochondrial diseases, which cause debilitating degeneration in the brain and heart of affected individuals.

The discovery is published in the prestigious journal Cell.

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