StemCell Therapy

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

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

GAITHERSBURG, MD--(Marketwire -02/16/12)- Cytomedix, Inc. (OTC.BB: CMXI.OB - News) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that Chief Operating Officer Edward L. Field will present a clinical overview of Aldagen's autologous cell therapy technology at two upcoming meetings: The Cell Society's 2nd Annual Clinical Meeting being held February 17-18 at the Coronado Marriott Resort in San Diego; and the 7th Annual New York Stem Cell Summit being held on February 21 at Bridgewaters New York in New York City.

Mr. Field will present during the session, "Commercialization Opportunities with Adult Stem Cell Therapies," on Friday, February 17 from 8:00 a.m. to 10:00 a.m. Pacific time at the Cell Society meeting.

Cell Society International is a non-profit organization dedicated to advancing the clinical application of adult stem cell therapies worldwide. Cell Society's 2nd Annual Clinical Meeting will continue in the tradition established at the 1st Annual Meeting and will offer a unique opportunity for multidisciplinary, international clinical collaboration designed to enhance understanding and thought-provoking insight into treatments and cures for disease and agonizing medical conditions. This year's clinical focus will center on therapies particularly relevant to cardiology, neurology, and orthopedic and plastic surgery.

At the Stem Cell Summit, Mr. Field will present at 2:35 p.m. Eastern time. This meeting showcases more than 30 of the world's leaders in this rapidly evolving industry. The New York Stem Cell Summit brings the future of this dynamic industry to life for investors, industry, practitioners and analysts so they can learn about the investment opportunities in the stem cell marketplace, groundbreaking stem cell products that physicians use today and the growing market potential in terms of revenues.

About Cytomedix, Inc.

Cytomedix, Inc. develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. On February 8, 2012 Cytomedix announced the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit http://www.cytomedix.com

Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including many among others, risks and uncertainties related to the Company's ability to successfully integrate this acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and intergrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix to Showcase Aldagen's Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings

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

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

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

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

About Stargardt's Disease

Stargardt’s disease or Stargardt’s 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.

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 Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...

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.

Excerpt from:
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.

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

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Regenerative medicine company encouraged by heart failure trial

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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.
______


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.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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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.
______


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.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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CIRM has funded a $5.5 million Disease Team to develop a follow on clinical trial that uses a patient's own heart stem cells to regenerate scarred tissue damaged by a heart attack. The team is led by Eduardo Marban, MD, PhD, Director of the Cedars-Sinai Heart Institute

Read more:
Stem Cell Clinical Trial for Heart Failure: Eduardo Marban - CIRM Spotlight on Disease - Video

Direct Download http://www.ezdl.org In the first half, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr. Richard Burt at Northwestern University's School of Medicine has been successfully using patients own bone marrow stem cells to treat a variety of autoimmune diseases like Lupus, and Type 1 Diabetes.

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Coast To Coast AM: 15.11.2011 - Regenerative Medicine/ Dulce Base - Video

Following is a list of cell therapy products approved recently (2010-11):    

•  Dendreon                           Provenge                           US
•  FCB-Pharmicell                 Hearticellgram-AMI           Korea
•  Fibrocell Sciences              Laviv                                  US
•  Living Cell Technologies    DIABECELL                     Russia

 Honorable mention goes to TiGenix' ChondroCelect approved in late 2009 representing the first EMA approval of an ATMP:

• TiGenix                              ChondroCelect                   EU

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In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

•     Aastrom              BRCs
•     Aldagen              ALD-101
•     Arblast               AMT-301
•     Avax                  Mvax
•     HepaLife Tech      HepaMate
•     KeraCure             KeraPac
•     t2cure                BMCs
•     TVAX                 TV-Brain
•     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

•     ABH (now Shire)        Dermgraft
•     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Following is a list of cell therapy products approved recently (2010-11):    

•  Dendreon                           Provenge                           US
•  FCB-Pharmicell                 Hearticellgram-AMI           Korea
•  Fibrocell Sciences              Laviv                                  US
•  Living Cell Technologies    DIABECELL                     Russia

 Honorable mention goes to TiGenix' ChondroCelect approved in late 2009 representing the first EMA approval of an ATMP:

• TiGenix                              ChondroCelect                   EU

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

•     Aastrom              BRCs
•     Aldagen              ALD-101
•     Arblast               AMT-301
•     Avax                  Mvax
•     HepaLife Tech      HepaMate
•     KeraCure             KeraPac
•     t2cure                BMCs
•     TVAX                 TV-Brain
•     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

•     ABH (now Shire)        Dermgraft
•     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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http://feeds.feedburner.com/CellTherapyBlog

Major General James Gilman, Commanding General of the US Army Medical Research and Material Command, outlined the US army's extensive research efforts in stem cell technologies and their mission to discover, develop and translate regenerative medicine. He spoke about the military's desire to partner with academia and industry to generate effective treatments for volume, bone, muscle and tissue injuries and about spinal cord regeneration as the military's biggest challenge and hope.

See the article here:
2011 Summit: Harnessing Regenerative Medicine for US Service-members, Major General James K. Gilman - Video

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

• 52% (12) are autologous
• 33% (7) are allogeneic
• Two are gene-modified allogeneic
• One involves autologous and allogeneic cells

• 24% (5) are for cardiac-related indications
• 33% (7) are for oncology or related indications
• Two are for cartilage repair

• Assistance Publique - Hôpitaux de Paris (France)
• Association of Dutch Burn Centres (Netherlands)
• Barts and The London NHS Trust (UK)
• Erasmus Medical Center (Netherlands)
• European Group for Blood and Marrow Transplantation (Europe)
• Leiden University Medical Center (Netherlands)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Ministry of Health (Malaysia)
• Royan Institute (Iran)
• Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
• Third Military Medical University (Chia)
• University of Minnesota, Masonic Cancer Center (US)
• University of Minnesota, Masonic Cancer Center (US)
• University Hospital of North Norway (Norway)
• University of Utah (US)

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

• 52% (12) are autologous
• 33% (7) are allogeneic
• Two are gene-modified allogeneic
• One involves autologous and allogeneic cells

• 24% (5) are for cardiac-related indications
• 33% (7) are for oncology or related indications
• Two are for cartilage repair

• Assistance Publique - Hôpitaux de Paris (France)
• Association of Dutch Burn Centres (Netherlands)
• Barts and The London NHS Trust (UK)
• Erasmus Medical Center (Netherlands)
• European Group for Blood and Marrow Transplantation (Europe)
• Leiden University Medical Center (Netherlands)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Ministry of Health (Malaysia)
• Royan Institute (Iran)
• Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
• Third Military Medical University (Chia)
• University of Minnesota, Masonic Cancer Center (US)
• University of Minnesota, Masonic Cancer Center (US)
• University Hospital of North Norway (Norway)
• University of Utah (US)

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

William Bruyea, host of StemCellTV talks to Morrie Ruffin, co-founder and managing director of Alliance for Regenerative Medicine at the Meeting on the Mesa partnering forum at Sanford Consortium in La Jolla, CA. Morrie discusses regenerative medicine, stem cells and development.

Go here to read the rest:
StemCellTV Talks to Morrie Ruffin of Alliance for Regenerative Medicine at Meeting on the Mesa - Video