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Archive for the ‘Regenerative Medicine’ Category

Cell-based Cancer Immunotherapies. Some metrics..

Sunday, May 20th, 2012

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Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics
As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
Commercial:
  • Dendreon's Provenge
    • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
    • Efficacy: prolongs survival
    • Markets: only the United States (approved April 2010)
    • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
    • 2011 Revenue $290,000
    • Projected 2012 Revenue: ~$380,000

Phase III or II/III:

Phase II or I/II

  • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
    • ~10 of these are expected to have readouts yet this year
    • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
    • Expected enrollment of 3,500+
Investment:

The following are notable cash infusions into the sector for 2012 to-date:
  • Bellicum Pharmaceuticals.  $20M series B. 
  • CellMedica. $15M grant from CPRIT in Texas.
  • Argos Therapeutcs. $25M Series D.
  • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  












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Cell-based Cancer Immunotherapies. Some metrics..

Sunday, May 20th, 2012

Tweet 


Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics
As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
Commercial:
  • Dendreon's Provenge
    • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
    • Efficacy: prolongs survival
    • Markets: only the United States (approved April 2010)
    • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
    • 2011 Revenue $290,000
    • Projected 2012 Revenue: ~$380,000

Phase III or II/III:

Phase II or I/II

  • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
    • ~10 of these are expected to have readouts yet this year
    • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
    • Expected enrollment of 3,500+
Investment:

The following are notable cash infusions into the sector for 2012 to-date:
  • Bellicum Pharmaceuticals.  $20M series B. 
  • CellMedica. $15M grant from CPRIT in Texas.
  • Argos Therapeutcs. $25M Series D.
  • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  












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

Sunday, May 20th, 2012

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.

Forward-Looking Statements

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Regenerative medicine company begins enrollment in critical limb ischemia trial

Thursday, May 17th, 2012

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

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New Teva Representative Joins Mesoblast Board of Directors

Friday, May 11th, 2012

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

Friday, May 11th, 2012

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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Another > $100M month for companies in the cell therapy space

Sunday, May 6th, 2012

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Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


..


So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


--Lee


p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


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Another > $100M month for companies in the cell therapy space

Sunday, May 6th, 2012

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Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


..


So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


--Lee


p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


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New Fund Established to Stimulate Regenerative Medicine Industry

Monday, April 30th, 2012

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

Wednesday, April 25th, 2012

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 3 Tijuana Stem Cells Dr. Jesus Perez – Video

Wednesday, April 25th, 2012

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

Wednesday, April 25th, 2012

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.

Forward-Looking Statements

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ACT Announces Third Dry AMD Patient Treated in Clinical Trial

Sunday, April 22nd, 2012

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

Saturday, March 24th, 2012

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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BioTime CEO Michael D. West to Present at 2012 Maxim Group Growth Conference

Friday, March 23rd, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer, Michael D. West, Ph.D., will present a corporate overview of BioTime and its subsidiaries with an update on recent developments at the 2012 Maxim Group Growth Conference on Monday, March 26, 2012, 11:00 a.m. EDT, at the Grand Hyatt in New York City. The presentation will be webcast and available online at the Investors section of the BioTime website at http://www.biotimeinc.com.

The 5th annual Maxim Group Growth Conference is designed to provide institutional clients with the opportunity to gain an in-depth perspective on the issues affecting the growth of presenting companies. The one-day event will feature more than 80 company presentations across six designated industry tracks including the healthcare and biotechnology sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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Cosmetic Regenerative Medicine – Video

Thursday, March 15th, 2012

13-03-2012 16:42 Hear Dr. Bowen talk about the exciting field of Regenerative Medicine. The type of regenerative medicine Dr. Bowen practices uses our own adult stem cells to achieve desired results.

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Cosmetic Regenerative Medicine - Video

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Thursday, March 15th, 2012

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Millipore and Toronto non-profit cultivate stem cells in bioreactor

Monday, March 12th, 2012

Robert Shaw, left, commercial director of EMD Millipores Stem Cell Initiative, and Michael May, CEO of the Centre for Commercialization of Regenerative Medicine in Toronto.

EMD Millipore, the Billerica-based life science division of Merck KGaA, said today that it is collaborating with the Centre for Commercialization of Regenerative Medicine in Toronto to develop optimized conditions to cultivate stem cells in a bioreactor.

The two parties will focus on developing a proprietary monitoring and control methodology for robust growth of adherent human pluripotent stem cells in EMD Millipores Mobius CellReady stirred tank bioreactor. The aim is to produce a commercial kit with reagents and associated methodologies for bioreactor culture of stem cells on microcarriers. No value was given for the collaboration.

As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will require large-scale, industrialized production under tightly controlled conditions, Robert Shaw, commercial director of EMD Millipores Stem Cell Initiative, said in a statement. He added that current production uses stacks of 2D tissue culture vessels, an expensive and labor-intensive process. The joint project is tackling those challenges, with the goal of large-scale cultivation of stem cells. Shaw said that may accelerate the progress of therapies into the clinic.

EMD Millipore is the first project partner of the regenerative medicine center, said Michael May, CEO of the center, which is using Millipores bioreactor in its product development facility at the University of Torontos Banting Institute. The work began on Feb. 27, 2012.

EMD Millipore has about 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. The company is known as Merck Millipore outside of the United States and Canada.

The regenerative medicine center is a Canadian non-profit organization funded by the Government of Canadas Networks of Centres of Excellence program and six institutional partners. It supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based products. The center launched in Torontos Discovery District on June 14, 2011.

Just two weeks ago Charles River Laboratories International Inc. (NYSE: CRL) of Wilmington signed an exclusive license for EMD Millipores TrueSpike technology under which the two will collaborate to integrate TrueSpike into Charles Rivers viral clearance services that aim to improve drug product safety.

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Biostem U.S., Corporation Appoints Heart Surgeon, Thomas W. Prendergast, M.D. to Its Scientific and Medical Board of …

Monday, March 12th, 2012

CLEARWATER, FL--(Marketwire -03/12/12)- Biostem U.S., Corporation (OTCQB: BOSM.PK - News) (Pinksheets: BOSM.PK - News) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced today the addition of cardiothoracic surgeon Thomas W. Prendergast, M.D. to its Scientific and Medical Board of Advisors (SAMBA).

Biostem CEO, Dwight Brunoehler stated, "The Company is now positioned for growth and international expansion. Adding a world class team of clinical, laboratory, and regulatory experts for our Scientific and Medical Board of Advisors to guide our pursuits is essential. Dr. Prendergast brings a wealth of experience not only in the scientific aspects of stem cell use in regenerative medicine, but also in forging research and international economic development opportunities."

Dr. Prendergast is a busy clinical cardiothoracic surgeon, who performs 200-250 open-heart operations and 5 to 15 heart transplants each year. He is deeply involved in numerous clinical and research activities associated with stem cells and heart repair. He is presently Director of Cardiac Transplantation at Robert Wood Johnson University Hospital in New Brunswick, New Jersey where he holds an Associate Professorship of Surgery at the University of Medicine and Dentistry of New Jersey. In addition to being an active participant in stem cell research program development and teaching medical students and residents, his other interests include medical research funding and humanitarian development of programs for Disabled American Veterans.

Dr. Prendergast received his undergraduate degrees in biophysics and Psychology, as well as his medical degree, at Pennsylvania State University. His general surgery residency was for five years at the University of Massachusetts Medical School. His cardiothoracic surgery training was at the University of Southern California School of Medicine, including the Los Angeles County Medical Center. Subsequent fellowship training included pediatric cardiac surgery at Children's Hospital of LA, along with thoracic transplant fellowships at University of Southern California in Los Angeles and at Temple University Hospital in Philadelphia. He spent three years at the University of Kansas establishing thoracic transplant programs until returning to Temple University Hospital as one of their staff heart and lung transplant surgeons. Subsequent to his time at Temple, he joined up with Newark Beth Israel/St. Barnabas Hospitals, where he assumed directorship as the Chief of Cardiac Transplantation and Mechanical Assistance.

Regarding his appointment to the Biostem U.S. Scientific and Medical Board of Advisors, Dr. Prendergast said, "I am looking forward with excitement to working again with Dwight at Biostem. The expansion plan is sound, well paced, and will afford improved quality of life opportunities to many people around the world."

About Biostem U.S., Corporation

Biostem U.S., Corporation (OTCQB: BOSM.PK - News) (Pinksheets: BOSM.PK - News) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered around providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Kerry D'Amato, Marketing Director at 727-446-5000.

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EMD Millipore and the Centre for Commercialization of Regenerative Medicine Collaborate to Optimize Conditions for …

Monday, March 12th, 2012

BILLERICA, MASSACHUSETTS and TORONTO, ONTARIO--(Marketwire -03/12/12)- Editors Note: There is a photo associated with this press release.

EMD Millipore, the Life Science division of Merck KGaA, and the Centre for Commercialization of Regenerative Medicine (CCRM) today announced a collaboration to develop optimized conditions for bioreactor-based cultivation of stem cells.

This joint project will focus on the development of a proprietary monitoring and control methodology, enabling robust growth of adherent human pluripotent stem cells in EMD Millipore's Mobius CellReady stirred tank bioreactor. Ultimately, the project will deliver a commercially available kit containing reagents and associated methodologies for bioreactor culture of stem cells on microcarriers.

"As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will require large-scale, industrialized production under tightly controlled conditions," states Robert Shaw, Commercial Director of EMD Millipore's Stem Cell Initiative. "At this time, production is typically achieved using stacks of 2D tissue culture vessels, which is an expensive and labor intensive process. This joint project will address those challenges and facilitate optimized, large-scale cultivation of stem cells which can accelerate the progress of therapies into the clinic."

"When CCRM was created, we had industry partnerships like this in mind," says Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. "We are delighted to have EMD Millipore as our first project partner. Their production expertise and technologies will help CCRM to develop products that will benefit industry, academia, and the patient community. We appreciate that EMD Millipore has commissioned us to undertake this project and recognizes our strength in bioprocessing engineering."

CCRM will be employing EMD Millipore's Mobius CellReady stirred tank bioreactor in its product development facility at the University of Toronto's Banting Institute. The work began on February 27, 2012.

For more information, please visit http://www.millipore.com and http://www.ccrm.ca.

About EMD Millipore

EMD Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.

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