StemCell Therapy

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Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

• Baxter Therapeutics' Auto-CD34+ cells
• phase III trial actively recruiting
• Indication:  refractory angina and chronic myocardial ischemia
• Estimated enrollment:  444
• Estimated primary completion: June 2016 
• Cytori
• phase II/III trial actively recruiting
• Indication: ST-elevation acute myocardial infarction
• Estimated enrollment: 360
• Estimated primary completion: July 2014

• Miltenyi Biotec
• phase III trial actively recruiting
• Indication: myocardial ischemia or coronary artery disease
• Estimated enrollment: 142
• Estimated primary completion: July 2012

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Tweet


Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

• Baxter Therapeutics' Auto-CD34+ cells
• phase III trial actively recruiting
• Indication:  refractory angina and chronic myocardial ischemia
• Estimated enrollment:  444
• Estimated primary completion: June 2016 
• Cytori
• phase II/III trial actively recruiting
• Indication: ST-elevation acute myocardial infarction
• Estimated enrollment: 360
• Estimated primary completion: July 2014

• Miltenyi Biotec
• phase III trial actively recruiting
• Indication: myocardial ischemia or coronary artery disease
• Estimated enrollment: 142
• Estimated primary completion: July 2012

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SACRAMENTO California's stem cell agency today approved two grants to UC Davis Health System researchers for their innovative work in regenerative medicine.

Kyriacos A. Athanasiou, distinguished professor of orthopaedic surgery and professor and chair of biomedical engineering, and the Child Family Professor of Engineering at UC Davis, is investigating the use of skin-derived stem cells to heal cartilage injuries and debilitating conditions of the knee such as osteoarthritis.

W. Douglas Boyd, professor of surgery, plans to further refine a novel approach to treating cardiovascular injuries suffered during a heart attack by using stem cells and a tissue-like scaffold to repair cardiac damage.

The pair received individual grants totaling approximately $6.6 million from the California Institute for Regenerative Medicine's (CIRM) governing board.

Athanasiou's and Boyd's multi-year grants were among the proposals submitted to CIRM for its third round of Early Translational Awards, which are intended to enable clinical therapies to be developed more rapidly.

"Both of these scientists are conducting exciting research that could have far-reaching implications in health care," said Jan Nolta, director of the UC Davis Institute for Regenerative Cures and the university's stem cell program director. "Dr. Athanasiou is bioengineering new cartilage that could have the same physiological integrity as the cartilage a person is born with. Dr. Boyd is developing a treatment that uses a paper-thin patch embedded with stem cells to harness their regenerative powers to repair damaged heart muscle."

Boyd, who's a pioneering cardiothoracic surgeon, pointed out in his CIRM proposal that heart disease is the nation's number-one cause of death and disability. An estimated 16.3 million Americans over the age of 20 suffer from coronary heart disease, which in 2007 accounted for an estimated 1 in 6 deaths in the U.S. Boyd plans to use bone-marrow derived stem cells -- known as mesenchymal stem cells -- in combination with a bioengineered framework known as an extracellular matrix, to regenerate damaged heart tissue, block heart disease and restore cardiac function, something currently not possible except in cases of a complete and very invasive heart transplant.

An expert in biomedical engineering, Athanasiou is focusing on developing a cellular therapy using stem cells created from an individual's own skin -- known as autologous skin-derived stem cells -- which have shown great promise in animal models. He plans to use the new funding to conduct extensive toxicology and durability tests to determine the technique's long-term safety and efficacy. Such tests are among the many steps needed to advance toward human clinical trials.

Cartilage is the slippery tissue that covers the ends of bones in joints, allowing bones to glide over each other and absorbing the shock of movement. Cartilage defects from injuries and lifelong wear and tear can eventually degenerate into osteoarthritis. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, osteoarthritis is the most common form of arthritis and affects an estimated 27 million Americans over the age of 25.

"For anyone suffering from osteoarthritis or other debilitating cartilage conditions, Dr. Athanasiou's goal of using stem cells to regenerate new tissue could have enormous quality-of-life and economic benefits," said Nolta, who is the recipient of a prior translational grant from CIRM to develop potential therapies for Huntington's disease . "Dr. Boyd's work is equally promising because he's using a bioengineered structure to encourage cardiac tissue repair, which could have important benefits in the treatment of heart disease."

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State awards stem cell grants to medical researchers

ROCKVILLE, Md., May 21, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that Richard Garr, CEO and President, will present at the World Stem Cells & Regenerative Medicine Congress in London (http://www.terrapinn.com/2012/stemcells/index.stm) on Tuesday, May 22nd at 12:30 PM. Mr. Garr's presentation, "Stem Cell Applications for Neurodegenerative Disorders," will review Neuralstem's cellular therapy trial in ALS, its neurogenic small molecule trial in major depressive disorder (MDD), and provide an overview on plans to expand the cellular therapy program.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

For more information, please visit http://www.neuralstem.com or connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2011 and the Form 10-Q for the period ended March 30, 2012.

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Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London

NEW YORK, May 22, 2012 /PRNewswire/ --IntelliCell BioSciences, Inc.("Company") (SVFC.PK) announced today that it has entered a sponsored research agreement with the Institute for Cell Engineering and Regenerative Medicine (ICERM) at the University of Florida. A portion of the collaborative work will be to explore the physiological characteristics of the adult autologous vascular cells that are also referred to as stromal vascular fraction cells which form the basis of the IntelliCell product. The company also intends to explore combination therapies with patent pending bio-engineered products under development. The Company believes that the IntelliCell product is an efficient cellular delivery platform for a variety of therapeutic applications and will look to partner with technology developers.

Said Jon Dobson, Ph.D., Professor of biomedical engineering and biomaterials at the University of Florida, "We are pleased to be working with IntelliCell. Their technology is innovative and appears to hold promise for future regenerative medicine applications. The use of adult autologous (your own) stem cells to repair and regenerate tissues are of great interest to personalized medicine researchers." Professor Dobson is a leading researcher in bionanotechnology and nanomedicine applications and apart from regenerative medicine, his work also spans across fields as diverse as gene therapy, stem cell therapy and tumor targeting. He is also the Director of the newly formed Institute for Cell Engineering and Regenerative Medicine at the University of Florida.

Dr. Steven Victor, CEO of IntelliCell, added "This is a very exciting time for regenerative medicine companies. We are looking forward to long and productive research collaboration with the University of Florida and Professor Dobson. IntelliCell believes that important contributions for better medicine will result from research collaborations with our university research colleagues." Robert Sexauer, Executive Vice President, ICBS Research, stated that "we would like to take a thought leadership position by working closely with those at the vanguard of regenerative medicine development."

About IntelliCell BioSciences

IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using adult autologous vascular cells (SVC's) derived from the blood vessels in the adult adipose tissue. IntelliCell Biosciences has developed its own patent pending protocol to separate adult autologous vascular cells from adipose tissue without the use of enzymes. IntelliCell will also be seeking to develop technology licensing agreements with technology developers, universities, and international business entities.

About University of Florida

The University of Florida is one of the nation's largest public universities. A member of the Association of American Universities, UF receives more than $619 million annually in sponsored research funding. Through its research and other activities, UF contributes more than $8.76 billion a year to Florida's economy and has a total employment impact of more than 100,000 jobs statewide. http://www.ufl.edu.University of Florida Research: Working for Florida.

Forward-LookingStatements

Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will likely," "should," "could," "would," "may" or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's limited operating history, the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of new or additional competition, and changes in Federal or State laws. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.

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IntelliCell BioSciences Announces Collaborative Agreement with the University of Florida on Stem Cell and Tissue ...

Newswise About 3 percent of the babies born in the United States have a birth defect. Children without a birth defect are also susceptible to injury or disease. At The University of Texas Health Science Center at Houston (UTHealth), regenerative medicine researchers are exploring innovative ways to treat these conditions.

The Department of Pediatric Surgery at the UTHealth Medical School operates a research program devoted to childhood conditions that is seeking to harness the bodys regenerative powers to repair malformed organs and to mitigate injury from illness or trauma. It is called the Childrens Regenerative Medicine Program.

Kevin Lally, M.D., chairman of the Department of Pediatric Surgery at the UTHealth Medical School and surgeon-in-chief at Children's Memorial Hermann Hospital, announced the recruitment of four stem cell scientists to the program. The researchers are associate professor Yong Li, M.D., Ph.D., and assistant professors Scott Olson, Ph.D., Fabio Triolo, M.Phil., D.d.R., Ph.D., and Pamela Wenzel, Ph.D.

We were able to recruit outstanding investigators thanks in part to the generous support of Mrs. Clare Glassell and Mrs. Evelyn Griffin, said Lally, who is the A.G. McNeese Chair in Pediatric Surgery and the Richard Andrassy, M.D., Endowed Distinguished Professor at UTHealth. Our program in regenerative medicine is committed to a collaborative environment in which clinicians work with basic researchers.

Lally has a special interest in the treatment of a potentially life-threatening condition known as congenital diaphragmatic hernia that occurs in as many as one in every 2,500 live births and is often treated surgically. The diaphragm is a muscle separating the chest cavity and belly and is important for breathing.

The core fundamental problem is infants born with structural problems that need to be repaired, said Lally, who believes doctors may be able to use stem cells to replace the diaphragm or repair defects in the abdominal wall.

Stem cells may also help children with traumatic brain injuries. Charles Cox Jr., M.D., professor of pediatric surgery, director of the Pediatric Trauma Program at the UTHealth Medical School/Childrens Memorial Hermann Hospital and The Childrens Fund Inc. Distinguished Professor in Pediatric Surgery, is leading clinical research on the use of these versatile cells to address this leading cause of death and lifelong disability among children.

Yong Li, M.D., Ph.D.

Li previously served as a tenure track assistant professor in the Stem Cell Research Center at Childrens Hospital of Pittsburgh, where his laboratory studied the regenerative power of newts and salamanders in the hope of applying this information to the care of people.

Newts are able to regenerate missing body parts including limbs, spine and heart. Li has studied growth factors that facilitate this regeneration process in some amphibians and how they could be used for stem cell population and tissue engineering.

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UTHealth Pediatric Surgery Expands Regenerative Medicine Program

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MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.

Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).

ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

About SMD, Dry AMD and Degenerative Diseases of the Retina

Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.

The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.

Juventas technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.

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CLI has become a very exciting clinical opportunity, Aras said. Its becoming a growing area of interest for a number of biotech and pharma companies.

Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.

Among the top advantages of Juventas CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the companys therapeutic in an easy procedure at a physician office, and the approach doesnt require bone marrow aspiration to obtain patients own stem cells or complex cell processing as some competing therapeutics do.

Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.

The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.

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Regenerative medicine company begins enrollment in critical limb ischemia trial

MELBOURNE, Australia, May 10, 2012 /PRNewswire/ -- Global regenerative medicine company Mesoblast Limited (MSB.AX) today announced the appointment of Dr Ben-Zion Weiner, Special Adviser to the CEO of Teva Pharmaceutical Industries Ltd, as a non-executive Director of Mesoblast, effective immediately.

Dr Weiner has been Teva's head of global research and development for over three decades, most recently as Chief R&D Officer and a member of the Teva Executive Committee. In this role, he has directly overseen all pharmaceutical R&D and innovative branded product pipeline development.

Dr Weiner has been responsible for the development of hundreds of generic products for the US, EU and other markets. In parallel, he has been responsible for the development and regulatory approval of Teva's innovative product portfolio. Dr Weiner has twice been the recipient of the Rothschild prize for innovation, including for the commercialization of Copaxone in the treatment of multiple sclerosis.

Dr Weiner said: "I am happy and proud to be a Board member of Mesoblast. I trust that stem cell technology is the future of medicine, and that Mesoblast is at the cutting edge of this exciting new field.

"I believe that Mesoblast's unique technology and professional execution capabilities have the potential to deliver multiple innovative biologic products across a broad range of clinical indications," added Dr Weiner.

Mesoblast Chairman, Mr Brian Jamieson, said: "Dr Weiner's extensive pharmaceutical industry experience and his current role as Special Adviser to the Teva CEO make him a very valuable and strategic addition to the Board. We also acknowledge the important contributions and insights provided by Teva's retiring board representative, Kevin Buchi, and wish him well.

"As Mesoblast expands its clinical product portfolio and approaches product commercialization, we will continue to broaden the mix of skills and international expertise of our Directors to ensure that the Board is in the best position to deliver maximal shareholder value."

About Mesoblast Mesoblast Limited (MSB.AX) is a world leader in commercialising biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). http://www.mesoblast.com

For further information, please contact: Julie Meldrum Corporate Communications Mesoblast Limited E: julie.meldrum@mesoblast.com

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New Teva Representative Joins Mesoblast Board of Directors

ScienceDaily (May 10, 2012) This summer's action film, "The Amazing Spider-Man," is another match-up between the superhero and his nemesis the Lizard. Moviegoers and comic book fans alike will recall that the villain, AKA Dr. Curt Connors, was a surgeon who, after losing an arm, experimented with cell generation and reptilian DNA and was eventually able to grow back his missing limb.

The latest issue of the journal Physiology contains a review article that looks at possible routes that unlock cellular regeneration in general, and the principles by which hair and feathers regenerate themselves in particular.

The authors apply what is currently known about regenerative biology to the emerging field of regenerative medicine, which is being transformed from fantasy to reality.

Review Article

While the concept of regenerative medicine is relatively new, animals are well known to remake their hair and feathers regularly by normal regenerative physiological processes. In their review, the authors focus on (1) how extrafollicular environments can regulate hair and feather stem cell activities and (2) how different configurations of stem cells can shape organ forms in different body regions to fulfill changing physiological needs.

The review outlines previous research on the role of normal regeneration of hair and feathers throughout the lifespan of various birds and mammals. The researchers include what is currently known about the mechanism behind this re-growth, as well as what gaps still exist in the knowledge base and remain ripe for future research.

The review examines dozens of papers on normal "physiological regeneration" -- the re-growth that happens over the course of an animal's life and not in response to an injury. This regeneration takes place to accommodate different stages in an animal's life (e.g., replacing downy chick feathers with an adult chicken's, or replacing the fine facial hair of a young boy with the budding beard of an adolescent), or in response to various environmental conditions (e.g., cats shedding a thick winter coat in the summer heat but re-growing it when the seasons change again, or snowshoe hares switching from brown in the summer to white in the winter for camouflage).

These changes seem to respond both to internal cues such as physiology of the hair follicle itself, or external cues such as the environment, but the mechanisms behind these normal alterations are largely unknown. Stem cells inside the follicle prompt hair and feather regeneration, but researchers are still unsure how to guide those cells to form the shape, size, and orientation of these "skin appendages" so that controlled re-growth is possible. Additionally, scientists are still unsure how to re-grow hair on skin in people after severe injuries that lead to scar tissue.

Importance of the Findings

The reviewed studies suggest that while researchers are making headway in understanding how and why hair and feathers regenerate after normal loss or in response to different life stages, much still remains unknown. This missing knowledge could hold valuable clues to learning how to regenerate much more complicated and valuable structures after loss to injury, such as fingers and toes.

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Regenerative medicine: Could the ways animals regenerate hair and feathers help restore human fingers and toes?

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MONTREAL, QUEBEC--(Marketwire -04/30/12)- With a shared goal of supporting development projects that will boost innovation in the growing field of stem cells and biomaterials-based products, Pfizer Canada and the Centre for Commercialization of Regenerative Medicine (CCRM) have established the Pfizer-CCRM Innovation Fund to accelerate regenerative medicine (RM) technologies for drug screening and therapeutic applications. The announcement is being made at the first annual Till & McCulloch Meetings (April 30-May 2), Canada's premier stem cell meeting, jointly hosted by the Stem Cell Network and CCRM.

"CCRM was created on the premise that it would work with academia and industry on projects that will hopefully move RM technologies and innovations from the bench to the bedside," says Michael May, CEO of CCRM. "Canada is already a leader in this field and additional funding to advance novel research through early product development will only make us stronger. We're very pleased to be partnering with Pfizer Canada and appreciate their confidence in joining with us."

"Pfizer Canada is pleased to contribute to this new fund which will support important research here in Canada," explains Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada. "With the novel resources offered through CCRM's development capabilities, we hope to help advance the RM field in this country."

Pfizer Canada has contributed a total of $500,000 to the Pfizer-CCRM Innovation Fund and CCRM will contribute matching dollars to any approved projects undertaken in the duration of this fund.

About Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading biopharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc. invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas. Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. For more information, visit http://www.pfizer.ca

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New Fund Established to Stimulate Regenerative Medicine Industry

23-04-2012 17:37 Warning! After spending $25000 on stem cells, the Regenerative Medicine Institute is IGNORING ME. They do not want to give me more stem cells unless I pay another $25000.00!!! THEY TOLD ME I ONLY NEEDED ONE TREATMENT!!!

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Hospital Angeles Regenerative Medicine Institute PART 1 Tijuana Dr. Jesus Perez stem cells - Video

23-04-2012 22:03 Caution! Warning! After spending $25000 on stem cells, the Regenerative Medicine Institute is IGNORING ME. They do not want to give me more stem cells unless I pay another $25000.00!!! THEY TOLD ME I ONLY NEEDED ONE TREATMENT!!!

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Hospital Angeles Regenerative Medicine Institute PART 3 Tijuana Stem Cells Dr. Jesus Perez - Video

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the Companys three ongoing clinical trials, have recently authorized the Company to move forward with enrollment and treatment of additional patients with Stargardts disease (SMD). In the U.S. SMD trial, ACT will screen and enroll patients for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells - as compared with the 50,000 cell dose used in the patients of the first cohort. The Company has also been approved to treat the final two patients to round out the initial dosing arm in its European trial. The use of pluripotent stem cells to derive RPE cells, and the use of the resulting RPE cells for treating a wide range of macular degenerative disorders, are covered by a robust patent portfolio owned by ACT, including a number of issued broad patents in key world markets.

DSMB authorization to move to the next higher dosage of cells in our U.S. clinical trial and complete the treatment of the first cohort of patient in our European trial represents yet another significant advancement for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. We are pleased with the pace of progress and the continued finding of safety amongst the participants in both the U.S. and European trials. The results so far have been encouraging, and with our SMD programs having been granted orphan medicinal product designation in both the U.S. and Europe, we look forward to eventually reaching a stage at which we can further avail ourselves of all the regulatory and financial benefits this designation brings.

The three procedures comprising the first cohort of patients in the U.S. SMD trial were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. The first procedure in the E.U. trial was conducted at Moorfields Eye Hospital in London, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London.

We are gratified to be moving to the next stage in both of our SMD trials, commented Robert Lanza, M.D., ACTs chief scientific officer. We remain very encouraged by the preliminary data in the first four SMD patients treated with the lowest dose of RPE cells at UCLA and Moorfields Eye Hospital. We are doubling the number of cells that will be transplanted in the next group of patients in the U.S. trial. We will be anxious to see if the higher dosage of RPE cells will impact visual function and photoreceptor rescue.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. On January 20, 2012, the first SMD patient enrolled in the Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006, NCT01469832 and NCT01344993.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Increase RPE Dosage for Stargardt’s Disease Patients ...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The outpatient transplantation surgery was performed successfully, and the patient is recovering uneventfully.

Gary Rabin, chairman and CEO of ACT, commented, The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.

The procedures at UCLA were all conducted by the team led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute.

The six patients treated at UCLA to date have tolerated the surgical procedure well. commented Dr. Schwartz. There have been no complications in the procedure, nor any issues relating to the safety of the injected stem cell-derived RPE cells in any of the patients. We continue to regularly evaluate all patients in the trial, and while still preliminary, I am encouraged by the patients progress and the relative straightforwardness of the surgical procedure.

We are extremely pleased with the progress being made in all three of our clinical trials here in the U.S. and the U.K., commented Robert Lanza, M.D., ACTs chief scientific officer. The data we are reviewing seems to be pointing in the appropriate direction, With the treatment of the latest two dry AMD patients, we look forward to having more significant points of reference to understand the progress of the trial and consider the endpoint design for the next phase. Both Stargardts disease and dry AMD are progressive diseases that result vision loss and blindness due to the thinning of the layer of RPE cells in the patient's macula, the central portion of the retina responsible for central vision. We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration. We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 , NCT01469832 and NCT01344993.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Announces Third Dry AMD Patient Treated in Clinical Trial

22-03-2012 12:16 Dr. Victor Dzau is a physician and pioneering translational research scientist, and is widely recognized as one of the most influential medical leaders worldwide. He is currently the James B. Duke Professor of Medicine at Duke University and the President and CEO of Duke University Health System. Dr. Dzau's groundbreaking research established the curent understanding of the renin-angiotensin system, which is now known to underlie a wide range of heart and blood vessel diseases, from hypertension to heart failure. His work led directly to the development of drugs that inhibit this system, that now represent the foundation of modern medical therapy for many cardiac disorders. Dr. Dzau continues to lead an innovative and productive reseach lab, pioneering innovative stem cell and genetic treatments for heart and blood vessel diseases. Dr. Dzau has received numerous honors for his contributions to research and medicine, including the 2011 Henry G. Friesen International Prize in Health Research.

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Stem Cells and Regenerative Medicine for Cardiac Care by Dr. Victor Dzau - Video