Category Archives: Regenerative Medicine

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

Advanced Cell Technology, Inc. (ACT)(ACTC), a leader in the field of regenerative medicine, today issued a statement on the U.S. Appeals Courts ruling, upholding a lower courts dismissal of the case, Sherley v. Sebelius, 11-5241, U.S. Court of Appeals for the District of Columbia Circuit (Washington), on the permissibility of federal funding of embryonic stem cell research.

This court ruling should be of considerable benefit to ACT and our embryonic stem cell-based clinical programs, commented Gary Rabin, chairman and CEO. It effectively removes major speed bumps for the National Institutes of Health (NIH) in terms of approving the several stem cell lines that we have submitted for their consideration for funding. With Fridays decisive ruling, we expect that a number of our embryonic stem cell lines will be approved for funding in coming months.

Sherley v. Sebelius had sought to block the United States Health and Human Services Department and the NIH from spending federal funds for research with hESCs, contending that doing so would violate the Dickey-Wicker Amendment, a short rider attached to legislation passed in 1996.

This ruling removes a great deal of the ambiguity that has hampered legislative attempts to provide an efficient mechanism for federal funding of hESC research, continued Mr. Rabin. The path for legislators to enact such legislation has now been cleared, and in that case we are optimistic that there could be encouraging new developments in the legislative arena, as well, in coming months. We would certainly hope that our patented, proprietary embryo-safe single-cell blastomere technique would be a part of any such conversation. We feel that if we could educate more Americans about this technique, and how directly and effectively it addresses the various ethical objections to hESC research, that broad support for the technique and the field overall would quickly fall into place.

More commentary on Fridays court ruling will be posted today on Mr. RabinsChairmans blog.

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 Comments on U.S. Appeals’ Court’s Dismissal Ruling in Case Challenging Federal Funding of Embryonic Stem Cell ...

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 ...

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!

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.

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

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)

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 ...

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

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