StemCell Therapy

TORONTO, ON Stem cells hold great promise for treating and curing numerous diseases; however, a major challenge facing scientists is how to produce stem cells in the massive quantities required for clinical use. The McEwen Centre for Regenerative Medicine (McEwen Centre) and the University of Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM) are partnering to establish a fund that will drive research in this area. Several University of Toronto regenerative medicine scientists are affiliated with CCRM and the Scientific Director is Dr. Peter Zandstra of the Institute of Biomaterials and Biomedical Engineering.

The McEwen Centre-CCRM Commercialization Impact Prize launches today, and will solicit innovative ideas from regenerative medicine scientists working in labs throughout the McEwen Centre. The winning team(s) will be awarded up to $600,000 to pursue research that will determine how to manufacture stem cells for clinical use and drug screening.

This private-public funding partnership is an important step forward to accelerating the advance of a discovery from a lab bench to the patient and onto the global market. Scientists at the McEwen Centre are making significant progress towards finding a cure for diseases such as Type 1 diabetes and heart disease. Collaborative partnerships are the key to discovering the cures sooner! says Rob McEwen, co-founder of the McEwen Centre, and Chief Owner, McEwen Mining.

Deadline for submissions is October 15, 2012. The Prize will fund up to two, 2-year projects that address the following challenges:

Making the transition from pre-clinical to clinical mass production; and, Scaling up stem cell manufacturing for high throughput drug screening.

Overcoming the scale-up and manufacturing challenge of stem cells would be a huge advancement for the regenerative medicine [RM] industry and this initiative fits in perfectly with our mandate to bridge the RM commercialization gap, explains Dr. Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. Were very pleased to be working with the McEwen Centre, already a partner of ours, to make this happen.

The Commercialization Impact Prize budget template and application form can be found here: http://ccrm.ca/Commercialization-Impact-Prize or http://mcewencentre.com/ccrm

About McEwen Centre for Regenerative Medicine The McEwen Centre for Regenerative Medicine was founded by Rob and Cheryl McEwen in 2003 and opened its doors in 2006. The McEwen Centre for Regenerative Medicine, part of Toronto-based University Health Network, is a world leading centre for stem cell research, facilitating collaboration between renowned scientists from 5 major hospitals in Toronto, the University of Toronto and around the world. Supported by philanthropic contributions and research grants, McEwen Centre scientists strive to introduce novel regenerative therapies for debilitating and life threatening illnesses including heart disease, spinal cord injury, diabetes, diseases of the blood, liver and arthritis.

About Centre for Commercialization of Regenerative Medicine (CCRM) CCRM, a Canadian not-for-profit organization funded by the Government of Canadas 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 Torontos Discovery District on June 14, 2011.

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New partnership to drive mass production of life-saving stem cells - Commercialization Impact Prize is first of its ...

Advanced Cell Technology Inc.Posted on:20 Aug 12

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Scotlands NHS Lothian has been confirmed as a site for its Phase I/II human clinical trial for Stargardts Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

NHS Lothian should be a superb partner for our EU clinical trial for SMD, said Gary Rabin, chairman and CEO of ACT. We are particularly pleased to be working with the Principal Investigator, Professor BaljeanDhillon, and his team. Additionally, we would like to thank the men and women of the Scottish Development Authority and Scottish National Blood Transfusion Service (SNBTS) for their tireless efforts to help make this history-making clinical trial a reality.

This approved, Phase I/II clinical trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD. It is similar in design to the companys US trials for SMD and dry age-related macular degeneration initiated in July 2011.

SMD represents an important unmet need in the wider clinical arena of macular degeneration, said Professor Dhillon, BMed Sci, BM BS, FRCS, Consultant Ophthalmic Surgeon, at the Princess Alexandra Eye Pavilion, NHS Lothian andHonorary Professor of Ophthalmology at the University of Edinburgh. This trial will evaluate a promising potential new treatment for this condition, using hESC-derived RPE cells.

Professor Marc Turner, Medical Director of SNBTS continued, hESC-derived RPE cells represent one of the first of a new generation of regenerative therapies and is an example of the high quality clinical research being conducted in, and supported by, NHS Scotland which we hope will help to transform medicine over the coming decades.

On July 30, the company announced that the third patient in this SMD clinical trial had been treated.

More information on the companys clinical trials will be posted today on Mr. RabinsChairmans blog.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that 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, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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Press Release

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Scotlands NHS Lothian has been confirmed as a site for its Phase I/II human clinical trial for Stargardts Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

NHS Lothian should be a superb partner for our EU clinical trial for SMD, said Gary Rabin, chairman and CEO of ACT. We are particularly pleased to be working with the Principal Investigator, Professor BaljeanDhillon, and his team. Additionally, we would like to thank the men and women of the Scottish Development Authority and Scottish National Blood Transfusion Service (SNBTS) for their tireless efforts to help make this history-making clinical trial a reality.

This approved, Phase I/II clinical trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD. It is similar in design to the companys US trials for SMD and dry age-related macular degeneration initiated in July 2011.

SMD represents an important unmet need in the wider clinical arena of macular degeneration, said Professor Dhillon, BMed Sci, BM BS, FRCS, Consultant Ophthalmic Surgeon, at the Princess Alexandra Eye Pavilion, NHS Lothian and Honorary Professor of Ophthalmology at the University of Edinburgh. This trial will evaluate a promising potential new treatment for this condition, using hESC-derived RPE cells.

Professor Marc Turner, Medical Director of SNBTS continued, hESC-derived RPE cells represent one of the first of a new generation of regenerative therapies and is an example of the high quality clinical research being conducted in, and supported by, NHS Scotland which we hope will help to transform medicine over the coming decades.

On July 30, the company announced that the third patient in this SMD clinical trial had been treated.

More information on the companys clinical trials will be posted today on Mr. RabinsChairmans blog.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that 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, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

Excerpt from:
ACT Announces Scotland’s NHS Lothian as Additional Site for EU Clinical Trial Using hESC-Derived RPE Cells for Macular ...

BACKGROUND: According to the U.S. Department of Health and Human Services, regenerative medicine is the next evolution of medical treatments. Regenerative medicine offers the potential for the body to heal itself. Scientists at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, N.C., were the first in the world to engineer lab-grown organs that were successfully implanted into humans. Now, the team of researchers is working to engineer more than 30 different replacement tissues and organs to develop cell therapies with the goal of curing a variety of diseases. (SOURCE: Wake Forest Institute for Regenerative Medicine)

LAB-GROWN URETHRAS: Researchers from Wake Forest were the first in the world to use patients own cells to build tailor-made urine tubes in the lab and successfully replace damaged tissue in five boys in Mexico. The boys were unable to urinate due to a pelvic injury. After receiving the lab-grown urethras, all the boys continue to do well with normal or near-normal urinary flow. The urethras were grown on biodegradable mesh scaffolds made of a polyester compound. The scaffolds were seeded with cells taken from the patients own bladders and incubated in the lab for four to seven weeks. They were then used to repair damaged segments of the boys urethras. For us, really, our goal here at the Institute is really to try to complete technologies that we can get to patients to make their lives better, so anytime that were able to do that, improve the quality of patients lives, we feel like thats part of our mission, Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine, told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Atala and WebMD article)

GROWING EARS: Scientists are working on printing ears in the lab. What we can do is we can take any three dimensional image of an ear, and it can be put into the computer, and that will generate an image within the printer that then prints that specific three dimensional structure, John Jackson, Ph.D., Associate Professor, Wake Forest Institute for Regenerative Medicine, told Ivanhoe. Right now, implants that are commercially-available are hard and rigid. They also cause problems with erosion through the skin. The new, tailor-made ears are flexible and patient-specific. In animal studies, the lab-grown ears have been shown to cause less erosion. The next step is to print the ears for use in humans. To be able to take a structure, generate a 3D implant and have that as a potential treatment for a patient who has lost an ear, thats very exciting, Dr. Jackson told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Jackson)

ENGINEERING MUSCLE: Researchers are also looking to see if they can engineer tissue that resembles muscle to repair small injuries in the body. They take biopsies from skeletal muscles and culture out the stem cells from the muscle. They then seed the cells onto a scaffold and condition the scaffold and a bioreactor to exercise muscle in-vitro. Then, they use that construct as an implant to accelerate regeneration and repair of injured muscle in the body. Scientists have been studying the engineered muscle in animals, and the next step is to try it in humans. For me, personally, its fantastic because you dont often get an opportunity to do research thats not only compelling but that can result in therapies that can help people on a daily basis and really improve their quality of life, George Christ, Ph.D., Professor of Regenerative Medicine, Wake Forest Institute for Regenerative Medicine, told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Christ)

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Building Body Parts: Ears, Muscles and More!

CLEARWATER, FL--(Marketwire -08/13/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company) is a fully reporting public company in the stem cell regenerative medicine sciences sector. President, John Satino announced today that the Pizarro Hair Restoration Clinic in Orlando, Florida is now equipped and ready to begin offering The Biostem Method of hair re-growth using the patient's own adult cells in a minimally invasive, painless procedure. In addition, Biostem Medical Director and Trainer, Dr. Marina Pizarro is ready to offer onsite training to new Biostem affiliates.

According to Satino, "This week, Dr. Pizarro treated her first two patients using The Biostem Method of hair re-growth in her Orlando office. This paves the way for Biostem to start offering affiliate agreements throughout the country in response to the many inquiries from physicians who want to offer this transplant alternative to their patients. We are making plans to open affiliate offices in major cities soon, after which we will expand the services to rural and international locations focusing first on Europe and Asia."

As a side note, Satino stated that, "While the industry typically sees more males requesting hair transplant for hair re-growth solutions, it is interesting that the first two treatments Dr. Pizarro performed were on women. Statistics do show that women suffer hair loss in significant numbers, yet are less likely to go through the transplant procedure. The Biostem Method finally offers women as well as men, a viable and proven alternative."

About Biostem U.S. Corporation Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on 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.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem Medical Director, Dr. Marina Pizarro Performs First Biostem Method(TM) of Hair Re-Growth Procedures at Orlando ...

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CLEARWATER, FL--(Marketwire -08/07/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced the appointment of Marina Pizarro, M.D. to its Scientific and Medical Board of Advisors (SAMBA). Chief Executive Officer Dwight Brunoehler stated, "The addition of Dr. Pizarro to Scientific and Medical Board of Advisors rounds out our team with expertise in the field of hair re-growth using stem cells. We look forward to her interaction with the members to help advance the Company's mission to improve the quality and longevity of life for all mankind through the use of ethically sourced stem cells."

Dr. Pizarro is currently the Medical Director for Biostem U.S. as well as their trainer for the Company's hair re-growth Affiliate Program. As the company accepts qualified affiliate physicians to administer The Biostem Method of hair re-growth throughout the United States, Dr. Pizarro will oversee their training at her Orlando, Florida location, where she is currently accepting patients. Dr. Pizarro will begin offering the Biostem Method in her Tampa and Jacksonville, Florida offices in the coming months. She will also assist in overseeing the set-up of another training facility overseas as the company expands its Medical Affiliate Program internationally.

Dr. Marina Pizarro holds the distinction of being the first female hair transplant physician in the industry and belongs to the elite group of surgeons who have performed over 30,000 hair transplant procedures in their careers. She received her medical degree from Ponce School of Medicine in Puerto Rico in 1985. After completing her residency in Orlando, Dr. Pizarro worked with world renowned hair transplant surgeon Dr. Constantine Chambers building one of the largest hair restoration practices in history. After five years, and after having performed thousands of procedures around the world while lecturing at hair restoration conventions, Dr. Pizarro opened her first two facilities in Orlando and Jacksonville, Florida in 1994, specializing in hair transplantation for both men and women. She currently has three facilities in Florida with the addition of her clinic in Tampa. Dr. Pizarro is a member of The International Society of Hair Restoration Surgery and the European Society of Hair Restoration Surgery.

About Biostem U.S. Corporation

Biostem U.S., Corporation (HAIR) (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on 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.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Appoints Marina Pizarro, M.D. to Scientific and Medical Board of Advisors (SAMBA)

HOUSTON, Aug. 2, 2012 /PRNewswire/ --Celltex Therapeutics Corporation, a leader in regenerative medicine services, today announced the appointments of Andrea Ferrenz, Executive Vice President, Legal Counsel, and Jane Shen Young, Manufacturing Research Scientist. Ferrenz's primary responsibility will be overseeing operations, including compliance with federal and state regulatory agencies. Young's primary responsibility will be research and development of manufacturing processes and products in regenerative science.

"Celltex is a fast growing company. The additions of Andrea and Jane will enhance our capabilities as we continue to grow," said David Eller, Chief Executive Officer of Celltex. "At Celltex, we firmly believe in the great therapeutic potential for adult stem cells and we are committed to the highest quality banking and multiplication services for clients and physicians."

Ferrenz has more than 15 years of experience in regulatory compliance and litigation, with expertise in food, drug and health law. Prior to Celltex, Ferrenz was Principal Attorney at Emord & Associates, P.C., in Washington, D.C.There, she counseled both national and international clients in health products industries operating under the jurisdiction of the FDA and FTC.Early in her career, Ferrenz worked with the U.S. Department of Health and Human Services and Children's National Medical Center's Center for Cancer and Transplantation Biology.

Ferrenz received her Bachelor's degree in biology from University of Mary Washington in Fredericksburg, Virginia, and her juris doctorate from George Washington University Law School in Washington, D.C.

"As a pioneer in stem cell banking, Celltex is paving the way for this new frontier," said Ferrenz."I hope my background in health and FDA law will be an asset to Celltex and I look forward to helping Celltex grow while maintaining positive relationships with government regulators who work to ensure the safety of health products."

Young joins Celltex from Pharmaceutical Product Development, Inc. in Middleton, Wisconsin, where she served as Associate Research Scientist. Formerly an Internal physician in the Department of Medicine at Wang-Jiang-Shan Hospital in Zhejiang, China, and a Visiting Scientist and Ph.D. in molecular biology and biochemistry at the Lund University, Sweden, Young has expertise in cell biology, molecular genetics and biochemistry. She has also co-authored publications on the development and optimization of laboratory assays, and cell sort and flow cytometry analysis.

Young received her medical degree from Zhejiang University School of Medicine. Zhejiang, China. She received her doctoral degree from Lund University, Faculty of Medicine in Sweden.

"Stem cell banking is cutting edge technology in a field that holds great potential," noted Young. "Quality and safety are tantamount to the growth of this industry and I am excited to help Celltex provide stem cell banking and multiplication of the highest quality to its clients."

For more information on Celltex Therapeutics Corporation and its staff please visit http://www.CelltexBank.com.

About Celltex

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Celltex Therapeutics Corporation Expands Laboratory Operations And Adds Depth To Its Management Team

CLEARWATER, FL--(Marketwire -08/02/12)- Biostem U.S., Corporation, (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, Chief Executive Officer Dwight Brunoehler stated, "Dr. Prendergast is a very talented and very active clinical and research surgeon. Biostem is fortunate to have his guidance in our scientific and medical pursuits. He will be playing an ever increasingly important role in the company's future regarding the use of stem cells and regenerative medicine."

According to Dr. Prendergast, "The Robert Wood Johnson Medical School currently has several stem cell related projects including the use of stem cells to reduce the risk of kidney related dysfunction following cardiac surgery. As Biostem grows, I look forward to assisting in implementing the Company's stem cell regenerative medicine goals in multiple areas."

Dr. Prendergast is a 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 Los Angeles, 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.

About Biostem U.S. Corporation

Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on 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.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

For further information on Biostem U.S. Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Scientific and Medical Board of Advisors Member Appointed Chief of Cardiothoracic Surgery at ...

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the final patient in the first patient cohort in its Phase 1/2 clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, July 27 at Moorfields Eye Hospital in London, the same site as the first two treatments, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The outpatient transplant surgery was performed successfully without any complications, and the patient is recovering uneventfully. This is the tenth patient overall to now be treated with the RPE cell therapy developed by the company.

Our European trial is making very steady progress, having now completed enrollment of the first patient cohort, commented Gary Rabin, chairman and CEO. We are very encouraged and look forward to receiving clearance to initiate the treatment of the second patient cohort in the coming weeks.

The Phase 1/2 trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the studys primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. It is similar in design to the U.S. trial for SMD that was initiated in July 2011.

This is a significant month for the company, continued Mr. Rabin. One year ago we treated the first of our patients in our two U.S. clinical trials. The one-year follow-up for those initial patients indicates that the improvements in visual acuity we initially reported have in fact persisted now for a year. Indeed, we are consistently observing improvements in subjective and objective visual acuity for patients being treated at the various clinical centers involved in our trials. Again, these trials are still at very early stages, but these preliminary results indicate that we are on the right track.

The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially designated ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells as an orphan medicinal product for the treatment of SMD.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that 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, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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 Treats 10th Patient in Embryonic Stem Cell Trials for Macular Degeneration

As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....

--Lee

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As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....

--Lee

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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 it has been issued a patent in Australia, patent number 2005325753, Improved modalities for the treatment of degenerative diseases of the retina. The patent broadly covers the use of human retinal pigment epithelial (RPE) cells generated from pluripotent stem cells in the manufacture of pharmaceutical preparations of RPE cells, and the use of those preparations to treat patients with degenerative diseases of the retina such as Age-related Macular Degeneration. The patent covers the pharmaceutical formulation of human RPE cells made from a range of pluripotent stem cells, including both human embryonic stem cells (hESCs) and human induced pluripotent stem (iPS) cells.

We continue to make great progress with our patent estate covering RPE therapies, said Gary Rabin, chairman and CEO of ACT. Our ongoing success in securing broad patent protection around the world, including this newly-issued Australian patent, is a testament to our innovative chief scientific officer, Dr. Robert Lanza, and the rest of our scientific team.

The efficient production of highly pure RPE cell preparations represents a critical step in the creation of renewable sources of transplantable cells that can be used to target degenerative diseases of the eye such as Stargardts Macular Dystrophy (SMD) and dry Age-related Macular Degeneration (dry AMD).

Our current embryonic stem cell trials pave the way for other pluripotent stem cell therapies, commented Dr. Lanza. ACTs cellular reprogramming technologies using iPS cells are in an advanced stage of development, and we hope to be in a position to move toward clinical translation in the not-too-distant future. Since iPS cells can be made from the patients own cells such as skin or blood cells they may allow us to expand our cell therapies beyond immune-privileged sites such as the eye without the risk of immune rejection.

Mr. Rabin concluded, We are aggressively pursuing patent protection for a variety of aspects of our programs. Our intellectual property strategy includes both vigilance in pursuing comprehensive coverage from our initial patent filings, such as this new Australian patent, and filing for protection around our scientific teams various innovations. At the same time we are paying close attention to including within our patent coverage those ways others may wish to adapt our technology for commercial use, such as through the choice of stem cell source, or the use of solid supports or cell suspensions for delivery. Following this strategy, we are establishing both formidable barriers-to-entry for potential competitors, as well as strong potential licensing opportunities for others, translating into solid revenue generation possibilities for the company.

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

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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ACT Issued Broad Patent for Human RPE Cells Derived From All Types of Pluripotent Stem Cells

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

Regenerative medicine company Histogenics Corporation, announced today the completion of a $49 million round of financing. The syndicate was led by Sofinnova Ventures with participation from additional new investors Split Rock Partners, BioMed Ventures and FinTech GIMV Fund, L.P. Existing investors ProChon Holdings BV, Altima Partners, Foundation Medical Partners, Inflection Point Capital and Boston Millennia Partners also participated in the financing. Proceeds will be used to complete the ongoing Phase 3 clinical program for lead product candidate NeoCart, which is currently enrolling patients. NeoCart is an autologous neocartilage tissue implant that utilizes the patients own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee. Funds will also support efforts to obtain regulatory clearance in the European Union for product candidate VeriCart, a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patients own stem cells, to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Garheng Kong, MD, PhD of Sofinnova Ventures and Josh Baltzell of Split Rock Venture Partners will join Histogenics Board of Directors. Arnold Freedman of Boston Equity Advisors served as the exclusive placement agent.

Patrick ODonnell, President and Chief Executive Officer of Histogenics, commented, We believe the quality of the investors and the significant level of commitment demonstrated in this financing speak to the potential of our product candidates to transform the treatment of cartilage injury with the goal of returning patients to their pre-injury level of activity. Each year, 1.8 million active adults and elite athletes undergo arthroscopy for the diagnosis and treatment of painful cartilage defects in the knee. With continued positive clinical results, we believe our Phase 3 product candidate, NeoCart, has considerable potential as a much-needed treatment alternative for a significant portion of these patients. The successful completion of this financing fully funds the Company to reach key clinical and commercial milestones for NeoCart and VeriCart and allows us to focus our full attention on continued successful clinical and regulatory execution.

Garheng Kong, MD, PhD, General Partner of Sofinnova Ventures added, NeoCart has the potential to dramatically change the way knee cartilage injuries are treated. Current treatments for knee cartilage damage frequently do not produce the lasting effects that individuals need to avoid serious knee pain and improve functionpreventing them from getting back to their active, daily lives. Published data have shown that patients treated with NeoCart experienced a very durable response that is sustained throughout a period of four years or more. Sofinnova is pleased to support Histogenics efforts to receive approval for NeoCart and address this unmet clinical need.

About NeoCart NeoCartis an autologous bioengineered neocartilage grown outside the body using the patients own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met, and NeoCart was found to be generally well tolerated.

About VeriCart VeriCart is a single step, off-the-shelf, cell-free collagen scaffold, specifically designed for cartilage applications, which when reconstituted with the patients own bone marrow or augmenting marrow stimulation procedures, is intended for the improved repair of cartilage tissue. VeriCart is currently in development.

About Histogenics Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

About Sofinnova Ventures Sofinnova Ventures has over 40 years of experience building start-ups and later stage companies into market leaders. With $1.4 billion under management, the firm applies capital and expertise to build companies from inception to exit. Sofinnova closed its life science-focused $440M, SVP VIII, in late 2011. The firms investment team of MDs and PhDs has significant scientific, operational and strategic experience, and specializes in financing later stage clinical products. The Sofinnova team partners with entrepreneurs to address patients unmet medical needsand has had a string of recent exits through companies, including Movetis, Preglem, Amarin, Vicept and Intellikine.

About Split Rock Partners Split Rock Partners, with offices in Minneapolis and Menlo Park, seeks emerging opportunities in healthcare as well as software and internet services. Since 2005, Split Rock has raised $575 million over two funds. Representative companies backed by Split Rock's team include Ardian, Atritech, DFine, Entellus, eBureau, Evalve, Guardian Analytics, HireRight, Intacct, LowerMyBills, MyNewPlace, QuinStreet (QNST), SPS Commerce (SPSC) and Tornier (TRNX). Additional information about the firm can be found atwww.splitrock.com.

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Histogenics Closes $49 Million Series A Fundraising to Support Commercial Development of Transformational Cartilage ...

CLEARWATER, FL--(Marketwire -07/23/12)- Biostem U.S., Corporation, (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, enters into an agreement with Pizarro Hair Restoration Clinics to offer The Biostem Method of stem cell hair re-growth treatments.

Biostem U.S., Corporation announced today that it has entered into a contractual affiliate agreement with Dr. Marina Pizarro and her multi-location practice, Pizarro Hair Restoration Clinics http://www.DrPizarro.com. Additionally, Dr. Pizarro will serve as the Medical Director for the company.

Dr. Pizarro's Orlando, Florida office will serve as the national training center for future Biostem U.S. affiliates.

Dwight Brunoehler, Chief Executive Officer for Biostem, stated, "We have been seeking the right partner to become our first affiliate. We have also been seeking a qualified Medical Director as well as a first rate training facility to accommodate the many requests for affiliation that we have received nationwide from physicians wanting to offer our services to their clientele. The Company is extremely fortunate to have filled these multiple needs in one place. Dr. Pizarro's impeccable credentials and extensive experience rank her among the best in her field. We look forward to a long and prosperous relationship."

According to Dr. Pizarro, "I have been following the discovery and development of hair re-growth technology on the cellular level for some time. Biostem's unique approach using Platelet Rich Plasma along with other proven treatments has shown to be highly effective for many qualified male and female patients. I am excited to be able to offer this service to my patients, and to be on the ground floor of this growing industry."

Dr. Marina Pizarro holds the distinction of being the first female hair transplant physician in the industry and belongs to the elite group of surgeons who have performed over 30,000 hair transplant procedures in their careers. She received her Medical Degree from Ponce School of Medicine in Puerto Rico in 1985. After completing her residency in Orlando, Dr. Pizarro worked with world renowned hair transplant surgeon Dr. Constantine Chambers building one of the largest hair restoration practices in history. After five years, and performing thousands of procedures around the world while lecturing at hair restoration conventions, Dr. Pizarro opened her first two facilities in Orlando and Jacksonville, Florida in 1994 specializing in hair transplantation for both men and women. She currently has three facilities in Florida with the addition of her clinic in Tampa. Dr. Pizarro is a member of The International Society of Hair Restoration Surgery and the European Society of Hair Restoration Surgery.

About Biostem U.S., Corporation:

Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on 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.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

For further information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Enters Into Medical Affiliate Agreement With Pizarro Hair Restoration Clinics

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

BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced the signing of an exclusive sublicense agreement and a supply agreement with Jade Therapeutics, LLC, a developer of an ophthalmological therapeutic sustained-release drug delivery platform. Under the agreements, BioTime will provide Jade with clinical-grade HyStem hydrogels and certain patented technology for use by Jade Therapeutics in the development of new pharmaceutical products for ophthalmologic use. Jade plans to utilize the hydrogels to facilitate time-release topical delivery of recombinant human growth hormone to help heal lesions on the ocular surface. Jade Therapeutics will retain rights to market their product upon completion of development and obtaining marketing approval. Financial terms of the transaction were not disclosed.

William P. Tew, Ph.D., BioTimes Chief Commercialization Officer, stated that Numerous published scientific reports have established the efficacy of HyStem to facilitate cell transplantation in animal models, and we currently plan on a near-term approval to market one HyStem-related product, ReneviaTM, in the EU for reconstructive and cosmetic surgery. We believe our HyStem technology may also be useful as a device for the slow, timed release of therapeutic agents such as those being developed by Jade Therapeutics, as well as for the controlled release of proteins secreted from BioTimes stem cell lines.

The HyStem product line has potential utility in a wide array of human therapeutic products, said Michael West, Ph.D., BioTimes CEO. We intend to seek additional industry partners for applications that are not core to our own therapeutic product development.

BioTime's HyStem hydrogels are proprietary biocompatible hydrogels that mimic the human extracellular matrix (ECM), a web of molecules surrounding cells that is essential to cellular function. When cells lacking the ECM (or an ECM substitute) are introduced into the body, they typically die or fail to function correctly after transplantation. BioTime's HyStem hydrogels are currently being used by researchers at a number of leading medical schools in studies of stem cell therapies for facilitating wound healing and for the treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct.

About Jade Therapeutics

Jade Therapeutics, LLC, a privately-held company headquartered in Park City, Utah, focuses on the development of locally administered, sustained-release therapeutics that improve corneal healing following damage from disease or injury, thus improving visual function and quality of life. The Companys initial product is designed to deliver recombinant human growth hormone, a well characterized biologic that has already been demonstrated to have significant healing properties. Jade recently secured a prestigious Utah Science Technology and Research (USTAR) grant to continue to conduct preclinical and market research and is in negotiation with several prominent academic and military affiliates to further product development. Examples of ocular disorders addressed by the Companys technology includes persistent corneal epithelial defects and corneal damage due to dry eye disease.

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 enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerateTM cell lines, HyStem hydrogels, culture media, and differentiation kits. BioTime is developing ReneviaTM (formerly known as HyStem-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. 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. 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. 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 subsidiary LifeMap Sciences, Inc. markets GeneCards, the leading human gene database, and is developing an integrated database suite to complement GeneCards that will also include the LifeMapTM database of embryonic development, stem cell research, and regenerative medicine, and MalaCards, the human disease database. LifeMap will also market BioTime research products. 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 Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

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BioTime Signs Agreements with Jade Therapeutics for Ophthalmological Drug Delivery Applications of HyStem® Technology

CLEVELAND, July 16, 2012 /PRNewswire/ --Juventas Therapeutics, a clinical-stage regenerative medicine company, announced today that it has closed a $22.2 million Series B financing that was co-led by Triathlon Medical Venture Partners and New Science Ventures. All previous venture firms, including Fletcher Spaght Ventures, Reservoir Venture Partners and Early Stage Partners participated in the round. Also joining the syndicate are new investors Takeda Ventures, Venture Investors, Global Cardiovascular Innovation Center, Tri-State Growth Fund, Glengary and select angel investors.

The proceeds will fund completion of ongoing Phase II clinical trials investigating the use of JVS-100 in treating patients with chronic heart failure or critical limb ischemia. Both trials are actively enrolling patients. JVS-100, the Company's lead product, encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevent ongoing cell death and restore blood flow.

"The funds raised through this Series B will carry us through significant clinical milestones," states Rahul Aras, Ph.D., President & CEO of Juventas Therapeutics. "The fact that the round was oversubscribed and added several new investors to an already strong syndicate speaks to the excitement that is building around regenerative medicine, and specifically, the unique factor-based strategy employed by Juventas."

Clinical studies by several companies have demonstrated that delivery of adult stem cells to patients suffering from heart failure or critical limb ischemia has the potential to promote tissue repair and improve clinical outcomes. In spite of these clinical findings, questions remain about the affordability and accessibility of cell-based therapy for the general population. Rather than deliver cells, Juventas delivers JVS-100, which activates natural stem cell based repair pathways that lie dormant in a patient. This allows the benefits of regenerative medicine without the complexity of cell therapy. While currently focused on cardiovascular disease, the clinical potential for JVS-100 is broad.

Last year, Juventas Therapeutics spun-off SironRX Therapeutics to focus on development of dermal and bone related applications for JVS-100. In 2011, SironRX raised $3.4 million through a Series A financing led by North Coast Angel Fund and received $1 million in grant funding through the Ohio Third Frontier program. The Company is currently enrolling a Phase Ib randomized, placebo-controlled, double-blinded clinical trial investigating dermal JVS-100 delivery to accelerate wound closure and reduce scar formation.

"Juventas provides a commercially viable solution to delivering regenerative therapies and has the potential to address a broad range of clinical applications" states George Emont, Managing Partner for Triathlon Medical Ventures and Chairman for Juventas. We are pleased to have raised these funds for the two Phase II clinical trials and additional development as the company looks toward its Phase III trials and eventual commercialization".

About Juventas TherapeuticsJuventas Therapeutics, (www.juventasinc.com) headquartered in Cleveland, OH, is a privately-held clinical-stage biotechnology company developing a pipeline of regenerative therapies to treat lifethreatening diseases. Founded in 2007 with an exclusive license from Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to initiation of mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Takeda Ventures, Triathlon Medical Venture Partners, Venture Investors, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, Glengary, The Global Cardiovascular Innovation Center, Tri-State Growth Fund, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received non-dilutive grant support through the Ohio Third Frontier-funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center and Center for Stem Cell & Regenerative Medicine.

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Juventas Therapeutics Raises $22.2 Million Series B Financing

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in its U.S. clinical trial for Stargardts Macular Dystrophy (SMD). The surgery was performed on Wednesday, July 11 at Wills Eye Institute in Philadelphia, by a surgical team lead by Carl D. Regillo, MD, FACS, director of the Wills Eye Clinical Retina Research Unit, attending surgeon in the Wills Eye Retina Service at the Wills Eye Institute, and professor of ophthalmology at Thomas Jefferson University. In keeping with trial protocol, the patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three patients of the first cohort. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

It is very gratifying to have second cohort, higher-dosage patient treatment underway in our U.S. clinical trial for SMD, commented Gary Rabin, chairman and CEO of ACT. We are also pleased to be working with Dr. Regillo and his team at Wills Eye Institute, a truly first-class institution that is ranked as one of the best ophthalmology hospitals in the country byU.S. News & World Report.

Initiated in July of last year, the Phase I/II trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the studys primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. As part of its RPE clinical program, the company is concurrently conducting a clinical trial for dry age-related macular degeneration and second trial for SMD in the United Kingdom.

Doubling the cell dosage marks an important milestone in our clinical programs, said Robert Lanza, MD, ACTs chief scientific officer. We look forward to continued progress and safety findings in the coming months, in both our U.S. and European trials.

Further information about patient eligibility for ACTs SMD study and the concurrent studies in the U.S. and Europe (for dry age-related macular degeneration and SMD, respectively) are available at http://www.clinicaltrials.gov, with the following Identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that 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, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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 First Stargardt Patient Treated With Higher Dosage of Embryonic Stem Cell-Derived Retinal Pigment ...

ScienceDaily (July 9, 2012) The ability to control whether certain stem cells ultimately become bone cells holds great promise for regenerative medicine and potential therapies aimed at treating metabolic bone diseases.

Now, UCLA School of Dentistry professor and leading cancer scientist Dr. Cun-Yu Wang and his research team have made a significant breakthrough in that direction. The scientists have discovered two key epigenetic regulating genes that govern the cell-fate determination of human bone marrow stem cells.

Wang's new research is featured on the cover of the July 6 issue of Cell Stem Cell, the affiliated journal of the International Society for Stem Cell Research.

The groundbreaking study grew out of Wang's desire to better understand the epigenetic regulation of stem cell differentiation, in which the structure of genes is modified while the sequence of the DNA is not. He and his team found that KDM4B and KDM6B, two gene-activating enzymes, can promote stem cells' differentiation into bone cells by removing methyl markers from histone proteins. This process occurs through the activation of certain genes favoring a commitment to one lineage and the concurrent deactivation of genes favoring other lineages.

The findings imply that chemical manipulation of these gene-activating enzymes may allow stem cells to differentiate specifically into bone cells, while inhibiting their differentiation into fat cells. The group's research could pave the way toward identifying potential therapeutic targets for stem cell-mediated regenerative medicine, as well as the treatment of bone disorders like osteoporosis, the most common type of metabolic bone disease.

"Through our recent discoveries on the lineage decisions of human bone marrow stem cells, we may be more effective in utilizing these stem cells for regenerative medicine for bone diseases such as osteoporosis, as well as for bone reconstruction," Wang said. "However, while we know certain genes must be turned on in order for the cells to become bone-forming cells, as opposed to fat cells, we have only a few clues as to how those genes are switched on."

The research group, through its study of aging mice, found that the two enzymes KDM4B and KDM6B could specifically activate genes that promote stem cell differentiation toward bone, while blocking the route toward fat.

"Interestingly, in our aged mice, as well as osteoporotic mice, we observed a higher amount of silencing histone methyl groups which were normally removed by the enzymes KDM4B and KDM6B in young and healthier mice," Wang said. "And since these enzymes can be easily modified chemically, they may become potential therapeutic targets in tissue regeneration and treatment for osteoporosis."

"The discovery that Dr. Wang and his team have made has considerable implications for craniofacial bone regeneration and treatment for osteoporosis," said Dr. No-Hee Park, dean of the UCLA School of Dentistry. "As a large portion of our population reaches an age where osteoporosis and gum disease could be major health problems, advancements in aging-related treatment are very valuable."

Professor Wang holds the No-Hee Park Endowed Chair in Dentistry at the UCLA School of Dentistry, where he is also chair of the division of oral biology and medicine and the associate dean for graduate studies.

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Discovery of epigenetic links in cell-fate decisions of adult stem cells paves way for new osteoporosis treatments