Category Archives: Regenerative Medicine

To: HEALTH, MEDICAL AND NATIONAL EDITORS

SCOTTSDALE, Ariz., Feb. 21, 2012 /PRNewswire-USNewswire/ -- Makucell, Inc., a new life science company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions, has presented important pre-clinical and clinical information on its proprietary molecule, Asymmtate, at the 36th Annual Hawaii Dermatology Seminar, Waikoloa, Hawaii. Asymmtate(TM) is the active key ingredient in Makucell's new topical skin care line Renewnt(TM) (pronounced "Re-new-int").

Asymmtate(TM) is a selective modulator of the Wnt (pronounced "wint") signaling pathway that encourages optimal signaling to stimulate skin stem cells to replenish themselves, keratinocytes, fibroblasts and other dermal cells, which produce collagen, elastic tissue, matrix and other substances to foster a more healthy, rejuvenated appearing skin. Renewnt(TM) will be available through aesthetic dermatology professionals in April 2012.

Mark Dahl, M.D. Makucell's, Vice President and Chief Medical Officer, presented the two scientific poster presentations. The presentation titles and conclusions are summarized below.

-- The Safety and Efficacy of Asymmtate - Asymmtate(TM) penetrates into human epidermis and dermis and remains active. Asymmtate in its cream vehicles is non-mutagenic, non-irritating, and non-sensitizing. -- Asymmtate(TM) Analog Mitigates Photoaging Effects of UVB in Mice - An analog of Asymmtate applied topically can mitigate the subsequent visible appearance of photoaging changes in mice after exposures of their skin to UVB.

In addition to the pre-clinical/clinical information presented this week, Makucell has initiated a 100 subject Use Study to evaluate the safety and efficacy of Renewnt(TM) for Hydration Day and Night Moisturizer in a real world setting. This four-week study will include 12 investigator sites across the U.S. "This large multicenter study is very important to validate aspects of clinical product performance of Asymmtate(TM) under real world conditions. The diverse geographical study sites will allow us to evaluate effects on unique skin types in different climates," said Lawrence A. Rheins, President and CEO of Makucell.

The innovative technology that resulted in the formulation of Renewnt was developed by distinguished research scientist Michael Kahn, Ph.D. and colleagues at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California, Keck School of Medicine. "This is an exciting time for Makucell," said Makucell co-founder and inventor Michael Kahn, Ph.D. "This technology will be utilized for commercial topical applications to address the challenges of photoaging skin and other hair and nail conditions."

For media and investment inquiries please contact please contact Lawrence Rheins, lrheins@makucellinc.com or 1-855-MAKUCELL.

About Makucell

Makucell (www.makucell.com) is a new life science technology transfer company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions in an entirely new way. Using a patent-pending new molecule, Asymmtate, Makucell has developed the Renewnt brand of non-prescription products that work with the skin's own stem cells to produce healthier, and more youthful appearing skin. This innovative technology was developed by researchers at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California Keck School of Medicine. Makucell is financed through private investors and is not in receipt of government funding.

About the USC Stevens Institute for Innovation

The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a university-wide resource in the Office of the Provost at the University of Southern California that helps identify, nurture, protect, and transfer to the market the most exciting innovations from USC. It also provides a central connection for industry seeking cutting-edge innovations in which to invest. As part of this role, the USC Stevens Institute manages the university's intellectual property portfolio stemming from its $560M annual research program. Furthermore, the USC Stevens Institute develops the innovator as well as innovations, through educational programs, community-building events, and showcase opportunities.

Media Contact:

Lawrence Rheinslrheins@makucellinc.com1-480-305-2061

SOURCE USC Stevens Institute for Innovation

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Makucell(TM) Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate(TM)

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

BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present at the 7th Annual New York Stem Cell Summit at Bridgewaters New York City on Tuesday, February 21, 2012 at 8:48 a.m. ET. Dr. West will provide an update and new information on the Company's manufacturing technologies and cell-based therapeutics in development. The presentation will be available online at http://www.biotimeinc.com.

The annual New York Stem Cell Summit provides investors, industry, practitioners, and analysts with the latest developments and investment opportunities in the stem cell marketplace.

About BioTime, Inc.

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

Forward-Looking Statements

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

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BioTime CEO Michael D. West to Present at New York Stem Cell Summit

Current treatments for facial injuries often lead to disfigurement or speech impediments, but the Biomask could change regenerative medicine.

It's estimated that 85 percent of injuries to our armed forces in the field cause damage to the extremities or the face. Innovations in regenerative medicine are moving along at an amazing pace, but the common current facial burns treatment typically involves removing damaged areas, followed by skin grafting, which usually leads to disfigurement and the possibility of speech impediments and scarring.

A new project called Biomask, a collaboration between engineers at the University of Texas, Arlington; Northwestern University regenerative medicine specialists; leaders in burn treatment at Brooke Army Medical Center; and consultants Army Institute of Surgical Research seeks to improve burn treatment outcomes with the latest in medical electronics and regenerative medicine.

The Biomask consists of two layers: The top layer is a hard shell that protects the wearer's face and stores the electronic components. The second layer is a polymer mask that will fit around the contours of the face. The polymer also acts as a seal around the wounds which compresses them to prevent lumpy scar formation. The polymer shell is also embedded with a number of sensors and actuators to monitor the healing process and send data to physicians.

While the mask itself will already improve treatment outcomes, Biomask takes it a step further by featuring a network of microtubes and valves in the polymer layer that will constantly deliver therapeutics, such as painkillers, antibiotics, and stem cells to the parts of the face that the onboard sensors determine.

Altogether, this makes Biomask a highly customized and automated 24/7 treatment system that researchers hope will make healing faster and better.

This post also appears on medGadget, an Atlantic partner site.

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Biomask: Improving Facial Burn Treatment for Soldiers in the Field

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

Histogenics Corporation, a privately held regenerative medicine company, today announced that the Company will present at the 7th Annual New York Stem Cell Summit on February 21st at Bridgewaters New York City. Kirk Andriano, Ph.D., Vice President of Research and Development for Histogenics, will speak about current and future cell therapies being developed by the Company as it works toward commercialization. Lead candidates include NeoCart®, an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions, and VeriCart™, a three-dimensional cartilage matrix designed to stimulate cartilage repair in a simple, one-step procedure. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met and a favorable safety profile was demonstrated.

Dr. Andriano earned his BS in chemistry and biology from Utah State University and his MS and Ph.D. in bioengineering from the University of Utah. Prior to his work at Histogenics, he was the Chief Technology Officer for ProChon Biotech, Ltd. which was acquired by Histogenics in May 2011.

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 orthopaedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials of its NeoCart autologous tissue implant and is currently in a Phase 3 IND clinical study. Based in Waltham, Massachusetts, the company is privately held. For more information, visit http://www.histogenics.com.

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Histogenics to Present at 7th Annual New York Stem Cell Summit

RED BANK, NJ--(Marketwire -02/08/12)- American CryoStem Corporation (OTCQB: CRYO.OB - News), a commercial developer, manufacturer and marketer of clinical products and services involving adipose tissue and adipose derived adult stem cells, announced its association with the Alliance for Regenerative Medicine (ARM).

ARM is a Washington, DC-based non-profit organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. American CryoStem's decision to join ARM was based on the alignment of its ongoing mission to offer the highest quality products and services to help accelerate the regenerative medicine industry and ARM's support of policy efforts toward safe and reliable cellular products.

Morrie Ruffin, Managing Director for the Alliance for Regenerative Medicine, commented, "We are delighted to have American CryoStem as part of the Alliance and look forward to working together to advance the field of adipose-derived stem cells for a variety of therapeutic applications."

ARM's membership is diverse, representing leading regenerative medicine companies and investors, university-based and non-profit research institutions, patient advocacy groups, pharmaceutical companies engaged in regenerative medicine research and other organizations supporting regenerative medicine. American CryoStem has created and commercialized core proprietary products and platforms for processing, storing and quality management of adipose tissue and adipose derived adult stem cells that are broadly relevant to ARM's membership.

"American CryoStem is committed to working with industry organizations to develop cutting edge adipose tissue based treatments and therapies. One unique component of our clinical laboratory product and service suite is offering individuals the opportunity to cryogenically store their younger, healthier adult stem cells for their own future use in regenerative medicine," stated John Arnone, American CryoStem CEO. "We are pleased and honored to work with the Alliance for Regenerative Medicine to educate the public and regulators on the safe uses of adult stem cells and their potential life changing applications."

In support of these goals, the Company recently launched ACS Laboratories, thus expanding its clinical processing technology to companies, institutions and medical professionals. ACS Laboratories offers a wide range of adipose tissue specific services. Through ACS laboratories patented ACSelerate™ cell culture media, a ten product suite, American CryoStem can leverage its technology and products to participate in a broad range of clinical application opportunities.

About American CryoStem: American CryoStem Corporation (OTCQB: CRYO.OB - News) markets clinical processing products and services for adipose (fat) tissue and adipose derived adult stem cells. CRYO's clinical processing and preservation platform supports the science and applications being discovered globally by providing the highest quality, clinically processed cells and assuring their sterility, viability and growth cap abilities, while at the same time developing cutting edge application, therapies and laboratory products and services for consumers and physicians.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain of the statements contained herein, which are not historical facts, are forward-looking statements with respect to events, the occurrence of which involve risks and uncertainties. These forward-looking statements may be impacted, either positively or negatively, by various factors. Information concerning potential factors that could affect the Company is detailed from time to time in the Company's reports filed with the Securities and Exchange Commission.

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American CryoStem Joins Alliance for Regenerative Medicine

09-12-2011 00:46 Yash Sanghavi a visionary distributor in the pharmaceutical sector with his futuristic approach established Regenerative Medical Services in 2008. Regenerative Medical Services more popularly known as Regrow is one of the key players in stem cell therapy and cell banking in India. Sanghvi has done B. Com and MBA.

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IndiaMART Leaders of Tomorrow AWards 2011 - Regenerative Medical Services Pvt Ltd - Video

NEW YORK--(BUSINESS WIRE)--

IntelliCell BioSciences, Inc. (OTCQB: SVFC.PK) (PINKSHEETS: SVFC.PK); (“IntelliCell”) or the (“Company”), was invited to demonstrate its stromal vascular fraction technology at the recent Baseball Injuries Symposium at the Andrews Sports Medicine Institute in Alabama held and sponsored by USA Baseball. The course Chairman is Dr. James Andrews, and moderated by PT Kevin Wilk, and Dr. Jeff Dugas. One of the courses presented during the three day event was on stem cell technology presented by Dr. Joshua Hackel. Dr. Hackel presented the state of regenerative medicine technology in the role of treating sports injuries. The link is http://www.mediafire.com/?u7bfa662e3r1sdp.

Dr. Hackel compared the IntelliCell SVF technology to several other methods of regenerative medicine being considered to be used by the leading orthopedic sports medicine doctors. Dr. Steven Victor, CEO of IntelliCell stated, "We are extremely excited that IntelliCell’s technology compares very favorably to all the other technologies, for procedures common to all major sports industries. We are extremely grateful to have the opportunity to present to over 200 leading doctors and trainers looking to treat major league, collegiate and amateur baseball players with regenerative medicine. IntelliCell Biosciences believes that its technology will be utilized by such experts this year."

About IntelliCell BioSciences, Inc.

IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using stromal vascular fraction derived from adult adipose tissue. IntelliCell intends to initially focus on selling laboratory suites and licensing its technology to doctors for use in their offices for their patients. The company is also setting up Centers of Excellence where doctors can treat their patients. In addition, IntelliCell BioSciences is exploring storing the stromal vascular fraction in cryo-storage for future uses. The company is also starting FDA IND clinical trials at major medical centers for clinical indication approval. IntelliCell intends to pursue expansion to secondary markets and beyond the U.S. through a combination of company-owned and licensed clinical facilities.

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IntelliCell Demonstrates at the American Sports Medicine Institute Held in Conjunction with and at the Andrews Sports ...

Halfway through its initial ten-year mandate, the California Institute for Regenerative Medicine (CIRM) in San Francisco is confronting a topic familiar to anyone at middle age: its own mortality.

The publicly funded institute, one of the world’s largest supporters of stem-cell research, was born from a state referendum in 2004. Endorsements from celebrities such as then-state governor Arnold Schwarzenegger and the late actor Christopher Reeve, who had been paralysed by a spinal injury, helped to garner voter support for a public bond to underwrite the institute. But with half of the US$3 billion that it received from the state now spent and the rest expected to run out by 2021, CIRM is now actively planning for a future that may not include any further state support.

“It would be premature to even consider another bond measure at this time,” wrote Jonathan Thomas, CIRM’s chairman, in a draft of a transition plan requested by the state legislature. Thomas outlined the plan on 24 January at a public hearing held in San Francisco by the US Institute of Medicine, which CIRM has asked to review its operations.

Given that California is facing severe budget shortfalls, several billion dollars more for stem-cell science may strike residents as a luxury that they can ill afford. It may also prove difficult for CIRM’s supporters to point to any treatments that have emerged from the state’s investment. So far, the agency has funded only one clinical trial using embryonic stem cells, and that was halted by its sponsor, Geron of Menlo Park, California, last November.

Yet the institute has spent just over $1 billion on new buildings and labs, basic research, training and translational research, often for projects that scientists say are crucial and would be difficult to get funded any other way. So the prospect of a future without CIRM is provoking unease. “It would be a very different landscape if CIRM were not around,” says Howard Chang, a dermatologist and genome scientist at Stanford University in California.

“It would be a very different landscape if CIRM were not around.”

Chang has a CIRM grant to examine epigenetics in human embryonic stem cells, and is part of another CIRM-funded team that is preparing a developmental regulatory protein for use as a regenerative therapy. Both projects would be difficult to continue without the agency, he says. Federal funding for research using human embryonic stem cells remains controversial, and could dry up altogether after the next presidential election (see Nature 481, 421–423; 2012). And neither of Chang’s other funders — the US National Institutes of Health (NIH) and the Howard Hughes Medical Institute in Chevy Chase, Maryland — supports his interdisciplinary translational work. Irina Conboy, a stem-cell engineer at the University of California, Berkeley, who draws half of her lab’s funding from CIRM, agrees that in supporting work that has specific clinical goals, the agency occupies a niche that will not easily be filled by basic-research funders. “The NIH might say that the work does not have a strong theoretical component, so you’re not learning anything new,” she says.

CIRM is developing plans to help its grantees to continue their work if the agency closes. One option is a non-profit ‘venture philanthropy’ fund that would raise money from private sources to support stem-cell research. The agency is also writing a strat­egic plan for the rest of its ten-year mandate that focuses on translating research into the clinic, acknowledging that CIRM’s best shot at survival — and at sustaining future funding for stem-cell researchers — could come from a clinical success.

As CIRM board member Claire Pomeroy, chief executive of the University of California, Davis, Health System in Sacramento, noted at the agency’s board meeting on 17 January: “If you asked the public what they would define as success, they would say a patient benefited.”

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Stem-cell agency faces budget dilemma

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Aberdeen Royal Infirmary, the largest of the Grampian University Hospitals in Scotland, has been confirmed as a site for its Phase 1/2 human clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The Phase 1/2 trial is a prospective, open-label study designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD.

“A leading medical institution in the United Kingdom, Aberdeen Royal Infirmary is an ideal partner for our European clinical trial for SMD,” said Gary Rabin, chairman and CEO of ACT. “Moreover, we are particularly pleased that the lead investigator is Dr. Noemi Lois, a leading expert in SMD. We continue to forge ties with some of the best eye surgeons and hospitals in the world and work towards bringing this cutting-edge therapy closer to fruition. Our preliminary results to date keep us optimistic that we are on the right path both in terms of our science and the clinical team we are working with, particularly eye surgeons such as Dr. Lois.”

Stargardt's Macular Dystrophy affects an estimated 80,000 to 100,000 patients in the U.S. and Europe, and causes progressive vision loss, usually starting in people between the ages of 10 to 20, although the disease onset can occur at any age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, the retinal pigment epithelium. “The first Stargardt’s patient to be treated in the U.S. with stem cell-derived RPE cells was a patient who was already legally blind as a consequence of this disease” stated Dr. Robert Lanza M.D., the chief scientific officer at ACT. Preliminary results from the treatment of the first SMD patient were recently reported in The Lancet (23 January 2012) and have been characterized by experts in the field of regenerative medicine as providing early signs of safety and efficacy.

This approved SMD clinical trial that Dr. Lois and her team will participate in 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, and is similar in design to the FDA-cleared US trial initiated in July 2011.

“It is an honor to have been designated as a site for this path-breaking clinical trial,” said Noemi Lois, M.D., Ph.D. “We could not be more pleased to be a part of this trial for a promising potential new treatment for SMD, using hESC-derived RPE cells.” Dr. Lois is a is a member of the Department of Ophthalmology, NHS Grampian, and associated to the University of Aberdeen, Scotland, United Kingdom. Dr. Lois practices at the Aberdeen Royal Infirmary; she is an Ophthalmologist with special interest in Medical retina and Retinal surgery.

On January 23, 2012, the company announced that the first patient in this SMD clinical trial in Europe had been treated at Moorfields Eye Hospital in London.

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 company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s 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 company’s 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 Company’s clinical trials will be successful.

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ACT Announces Aberdeen Royal Infirmary in Scotland as Additional Site for Phase 1/2 Clinical Trial Using hESC-Derived ...

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What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". 


In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.


I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date.  I'll post an update here when I have something useful.
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In January, the following product was classified as a tissue engineered product - not combined:

• Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions

In April, the following product was classified as a tissue engineered product, combined: 

• Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology

In May, the following product was classified as a somatic cell therapy medicinal product: 

• Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis

In July, the following product was classified as a Tissue Engineered Product, non-combined:

• Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures. 

In September, the following product was classified as a Tissue Engineered Product, non-combined:

• Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy

     and the following product was not classified as an ATMP: 

• Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)

In October, the following product was classified as a somatic cell therapy medicinal product: 

• Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma

In November, the following products were classified as tissue-engineered products:

• Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
• CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI

In December, the following product was classified as somatic cell therapy medicinal product:

• Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.

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