Archive for the ‘Cell Therapy’ Category
Factbox: Neurotechnologies in spotlight of UK ethics review
LONDON (Reuters) - Britain's Nuffield Council on Bioethics, which examines ethical issues raised by new developments in biology and medicine, launched a consultation on Thursday on the ethics of new technologies and devices that intervene in the human brain.
The three main areas of the group's focus are brain-computer interfaces, neurostimulation and neural stem cell therapy.
Here are some details about each area of research and how it is being explored.
* Brain computer interfaces (BCIs)
BCIs measure and analyze a person's brain signals and convert them into an output such as movement.
A paralyzed person, for example, could use a BCI to operate a wheelchair, or someone who has extreme difficulty speaking could use a BCI to communicate via a computer voice.
These sorts of applications have been shown to be successful in a few reported cases, but the technology has not yet been developed for regular clinical use and there are questions over whether these technologies are reliable enough for use in everyday life.
Military applications, such as remote control of vehicles and machinery are not yet in wide use but are being researched and tested, mainly in the United States.
Some commercial BCI developments are already on the market in the gaming sector. Gamers can buy a wireless headset that aims to replace a joystick by controlling game play through brain signals.
The use of BCIs sometimes require surgery to implant electrodes into a person's brain, although the most successful current developments are less invasive ones That detect brain signals from the scalp.
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Factbox: Neurotechnologies in spotlight of UK ethics review
Nuvilex Reveals Goldman Small Cap Research Cites Groundbreaking Cancer Therapy in Updating Buy Recommendation
SILVER SPRING, Md.--(BUSINESS WIRE)--
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, announced today Goldman Small Cap Research has reissued its buy recommendation on Nuvilex with a short term price target of $0.50 per share.
According to the research report prepared by Goldman, The current share price represents but a fraction of its true value, in our view. With recently increased interest and valuation in the pancreatic cancer treatment arena, we believe that Nuvilex is worth $0.20 just on the oncology therapies alone and that the shares will reach $0.50 in the next six months. Looking ahead, as milestone events occur, $1.00 per share is within reach over the next 12-18 months.
Goldman bases this value projection, in part, on the pending acquisition of SG Austria assets, and with it complete control over the cell encapsulation technology that forms the backbone of Nuvilexs planned biotechnology development. The report states in part the following:
Following execution of the SG Austria asset acquisition, we expect to see a flurry of events and progress on the development side which will serve as catalysts, including when management submits its protocol for the next stage pancreatic cancer trial. We would not be surprised to see the stock break through the $0.50 price on such news as well as progress on the next stage of trials for other therapies.
One reason we are so convinced of the great buying opportunity is the fact that pancreatic cancer treatments are currently at the forefront of the biotech space and are enjoying very high valuations. Although Nuvilex is a not a drug producer, but an existing therapy enhancer through the use of its live cell encapsulation enhancement platform, the timing of these milestone events could not be better for Nuvilex and a re-valuation of its offering.
The Goldman report also compares alternative oncology therapies, including Gemzar from Threshold Pharmaceuticals and Merrimack Pharmaceuticals drug encapsulation technology, noting that, contrary to these treatments, the Nuvilex live-cell encapsulation technology is not limited to one specific use, but can be adapted to use for a host of cell types. The report states, Its difficult to compare apples-to-apples in this space as Nuvilex is the only firm utilizing live-cell encapsulation therapy for cancer, while all the other treatments are based upon a particular drug usage. Contrasting the results of different Phase II clinical trials, the Goldman report comments that the pancreatic cancer therapy, based on completed Phase 1/2 data, appears to have yielded statistically greater results than competing technologies.
Commenting on The Goldman Report, Nuvilex Chief Executive Officer, Dr. Robert Ryan, stated, The report did an excellent job highlighting the value and capabilities of our cell encapsulation technology, not just for cancer therapy, but also for the vast array of treatments where live-cell encapsulation can aid multiple diseases. In the case of the completed cancer trials, it generated superior results with lower drug dosages, and reduced chemotherapeutic side effects. As we move forward with diabetes and stem cell therapy treatments, we are confident our success will, as Goldman predicts prompt leaders in multiple treatment segments to partner with Nuvilex in order to maintain their respective market shares.
Investors are recommended to study the Goldman Research Report for a detailed review and valuation methodology regarding Nuvilex.
About Nuvilex
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Nuvilex Reveals Goldman Small Cap Research Cites Groundbreaking Cancer Therapy in Updating Buy Recommendation
Stem Cell Therapy Procedure and Outcome – Video
28-02-2012 14:48 Albert Rodriguez, MD administers stem cell therapy for Hereditary Spastic Paraplegia. stemcelldrR.com, email airpainmd@aol.com
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Stem Cell Therapy Procedure and Outcome - Video
BrainStorm Featured on CNBC
NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a developer of innovative stem cell technologies for neurodegenerative disorders, announced that NurOwn™, its autologous stem cell therapy for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's Disease, was profiled yesterday on CNBC. In the Feature Story about the impact of Iran's nuclear threat, Israeli business and scientific leaders were interviewed about Israel's thriving economy and cutting edge technologies. Among those leaders that met with CNBC were Brainstorm’s President Mr. Chaim Lebovits and Prof. Dimitrios Karussis, Principal Investigator of Brainstorm's Phase I/II clinical trial currently underway at the Hadassah Medical Center in Jerusalem.
Brainstorm recently announced positive initial results from the clinical trial, resulting in approval from Hadassah's Helsinki committee to proceed with the trial. Accordingly, additional patients have been enrolled in the study, and Brainstorm will announce additional results in the coming months.
To see the video online, follow the link at: http://video.cnbc.com/gallery/?video=3000074883
To read the Feature Story online, follow the link at: http://www.cnbc.com/id/46484576
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.
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BrainStorm Featured on CNBC
China medicdal tourism– Cirrhosis–Stem cells therapy 3.mp4 – Video
20-02-2012 01:33 Many of our patients travel to Guangzhou from all over the world for medical treatment and tourism. China medical tourism can help with becoming a patient, travel arrangements and language assistance. If you want to know more about our services, please browse the web:htttp://www.medicaltourism.hk/ or mail to us: giels-x@medicaltourism.hk firstcare-china@hotmail.com Adult stem cells provide real improvement for cirrhosis patients Breakthrough adult stem cell research has shown that stem cells are able to regenerate and repair damaged or destroyed liver cells. For patients with cirrhosis, this means improved liver function, decreased pain and a significantly improved quality of life. Stem cell therapy offers the safest and most effective treatment alternative for liver cirrhosis and it is quickly becoming a preferred treatment in Asia. China medical tourism offers unique access to the best stem cell therapies available at leading medical facilities. Supporting data and statistics Three out of every four patients treated experienced a significant improvement in their condition following stem cell treatment. The following clinical results were observed: •Improved liver function •Decreased pain •Improved values for liver function, PLT (blood platelet) and blood ammonia You may see improvements during your hospitalization due to neurotrophic factors released during the stem cell transplantation, which stimulate nerve activity; new cells will grow for up to six months after you ...
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China medicdal tourism-- Cirrhosis--Stem cells therapy 3.mp4 - Video
Celling Biosciences Sponsors 7th Annual Stem Cell Summit
AUSTIN, Texas, Feb. 21, 2012 /PRNewswire/ -- Celling Biosciences announces a sponsorship of the 7th Annual Stem Cell Summit being held on February 21st at Bridgewaters New York in New York City. The Stem Cell Summit is consistently the premiere venue for the world's leaders in regenerative medicine to network and promote next generation technologies and cell therapies.
The meeting will feature more than 30 thought leaders in stem cell therapy including Dr. Kenneth Pettine of the Orthopedic Stem Cell Institute in Loveland, Colorado. Dr. Pettine has teamed up with Celling Biosciences' SpineSmith Division to present "Adult Stem Cell Therapy for Orthopedic and Spine Conditions Resulting from Injury or Aging." Dr. Pettine has become an innovator in the regenerative cell therapy market and believes "regenerative therapies will become the next standard of care in treating many orthopedic conditions."
Following the Stem Cell Summit, Dr. Pettine will be presenting a discussion on regenerative therapies to the trainers and medical staff attending this year's NFL combine. The NFL has recently gained attention from Peyton Manning going oversees to receive a cell therapy treatment for his cervical spine condition. Dr. Pettine envisions a day when these professional athletes stop going to foreign countries to receive medical treatment.
The Orthopedic Stem Cell Institute provides state-of-the-art regenerative cell therapy using Celling Biosciences' ART 21 system. The ART 21 system processes bone marrow from the patient at the point of care to consistently produce a concentrate of regenerative cells with high yields of mononuclear stem cells in less than 15 minutes. Celling Biosciences provides the cell separation systems along with the biomaterials and devices necessary to recreate the environment to promote healing.
Kevin Dunworth, founder of Celling Biosciences, believes regenerative cell therapy has more to do with creating the optimal environment then just providing cells. "We believe autologous cell therapy is a viable solution but physicians need to understand that these cells require the necessary substrate for delivery and the proper techniques for retrieval. Our focus has been on providing not only cell separation technologies, medical devices and biomaterials but also the registered nurses to deliver the service so physicians can have the most consistent, reliable and predictable regenerative cell therapy for their patients."
Contact:
Tracy Gladden
Communications Manager
Tgladden@spinesmithusa.com
512-637-2050
About Celling Biosciences
Celling Biosciences, works closely with surgeons, scientists and engineers to research and develop innovative technologies in the field of regenerative medicine. http://www.cellingbiosciences.com and http://www.spinesmithusa.com
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Celling Biosciences Sponsors 7th Annual Stem Cell Summit
VistaGen Therapeutics Engages MissionIR as Its Investor Relations Advisor
ATLANTA, GA--(Marketwire -02/21/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has retained MissionIR, a national investor relations consulting firm, to develop and implement a strategic investor relations campaign. Through a network of investor-oriented online websites and full suite of investor awareness services, MissionIR broadens the influence of publicly traded companies and enhances their ability to attract growth capital and improve shareholder value.
"VistaGen's work with human stem cell technology is groundbreaking," said Sherri Snyder, Director of Marketing at MissionIR. "The company's versatile platform, Human Clinical Trials in a Test Tube™, provides clinically relevant predictions of potential heart toxicity of new drug candidates long before they are ever tested on humans. Guided by a management team with decades of experience, VistaGen's stem cell technology can potentially save billions of dollars in the healthcare industry while recapturing prior R&D investment in once-promising new drug candidates."
"We are pleased to bring MissionIR on board as our external investor relations partner," said Shawn Singh, VistaGen's Chief Executive Officer. "The crucial work our company is doing can fundamentally change the way medicine is developed. Paired with MissionIR's global presence and sound investor relations programs, we can further grow our shareholder base and accelerate internal initiatives already in place to bring our stem cell technology platform to the forefront of drug development."
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. Through a full suite of investor relations and consultancy services, we help public companies develop and execute a strategic investor awareness plan as we've done for hundreds of others. Whether it's capital raising, increasing awareness among the financial community, or enhancing corporate communications, we offer a variety of solutions to meet the objectives of our clients.
For more information, visit http://www.MissionIR.com
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during development due to heart toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.
Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen plans to initiate Phase 2 clinical development of AV-101 in the fourth quarter of 2012. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.
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VistaGen Therapeutics Engages MissionIR as Its Investor Relations Advisor
Pathfinder Presents Preliminary Data on New Regenerative Approach to Diabetes Treatment
CAMBRIDGE, Mass., Feb. 21, 2012 (GLOBE NEWSWIRE) -- Pathfinder Cell Therapy, Inc. ("Pathfinder," or "the Company") (OTCQB:PFND.PK - News), a biotechnology company focused on the treatment of diabetes and other diseases characterized by organ-specific cell damage, today presented preliminary data highlighting the potential of the Company's unique cell-based therapy for treating diabetes at the 7th Annual New York Stem Cell Summit. Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder, provided an overview of the Company's Pathfinder Cell ("PC") technology, and presented preclinical evidence demonstrating how treatment with PCs was able to reverse the symptoms of diabetes in two different mouse models.
Pathfinder Cells are a newly identified non-stem cell mammalian cell type that has the ability to stimulate regeneration of damaged tissue without being incorporated into the new tissue. In today's presentation, Dr. Franklin showed how recent experiments performed using a non-obese diabetic (NOD) mouse strain were supportive of earlier data that demonstrated complete reversal of diabetes in mice. The earlier results, which used a drug-induced diabetic mouse model, were published in Rejuvenation Research1. Though preliminary, the recent results are encouraging because the NOD mouse model is widely used and highly regarded as being predictive of human type-1 diabetes.
In three separate experiments using this model, 30-50% of the mice treated with PCs at the onset of diabetes returned to normal blood glucose levels. Of the mice that responded well to treatment, the effects tended to be long lasting, up to two months in some cases after just two doses. These results, which were generated by intravenous injection of PC's derived from rat pancreatic tissue, further demonstrate the remarkable ability of Pathfinder Cells to elicit their positive effect regardless of the organ, or even species, of origin.
"We are very encouraged by these preclinical results using NOD mice. This model is the gold standard for type-1 diabetes and the fact that recent experiments mirror what we've seen in previous models may be highly significant," stated Dr. Franklin. "We have many questions to answer about how PCs act in the body, but we believe, based on previous experiments, that PCs may stimulate regeneration of damaged islet cells that produce insulin. The current NOD mouse data also suggest that PCs may have an effect in modulating the auto-immune process in type 1 diabetes. We continue to conduct experiments aimed at elucidating the optimal dosing and other factors that may be responsible for producing a robust and long-lasting response, as this will be critical as we start to think about how PCs may be used in treating human diabetes."
In his presentation today, Dr. Franklin also provided further insight into the mechanism of action of PCs, based on recent animal experiments. It was observed previously that PCs produce microvesicles, which are known to play a role in intercellular communication, but through mechanisms that are poorly understood. In a recent experiment, Pathfinder was able to isolate these microvesicles from the PCs and treat animals directly with an injection containing microvesicles only. Remarkably, both PC- and microvesicle-treated mice exhibited similar reductions in blood glucose compared to controls using the same drug-induced diabetes mouse model. This suggests, not only that the microvesicles produced by PCs are central to the mechanism of action, but that the microvesicles alone appear to be sufficient to produce the full effect.
Dr. Franklin commented, "If confirmed, this finding could have a significant positive impact on the future of PC-based therapy. Due to the relatively small amount of material contained within the microvesicles, determining the specific factor(s) that are responsible for regenerating damaged tissue could be more straightforward than we first anticipated, bringing us closer to understanding the mechanism of action. There may also be a number of potential manufacturing and storage benefits to using microvesicles versus PCs that will be interesting to explore in parallel as we work to advance this innovative new therapeutic approach closer to human clinical development."
The New York Stem Cell Summit brings together cell therapy company executives, researchers, investors and physicians to explore investment opportunities in cell therapy research and innovation. More information can be found at http://www.stemcellsummit.com.
Presentation details Event: 7th Annual New York Stem Cell Summit Date: Tuesday, February 21, 2012 Place: Bridgewaters New York, 11 Fulton Street, New York, NY Time: 3:35 pm ET
About Pathfinder
Pathfinder is developing a novel cell-based therapy and has generated encouraging preclinical data in models of diabetes, renal disease, myocardial infarction, and critical limb ischemia, a severe form of peripheral vascular disease. Leveraging its internal discovery of Pathfinder Cells ("PCs") Pathfinder is pioneering a new field in regenerative medicine.
PCs are a newly identified mammalian cell type present in very low quantities in a variety of organs, including the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood. Early studies indicate that PCs stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue. Based on testing to date, the cells appear to be "immune privileged," and their effects appear to be independent of the tissue source of PCs. For more information please visit: http://www.pathfindercelltherapy.com.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to obtain additional required financing; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results, if any; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; and government regulation. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
1Karen Stevenson, Daxin Chen, Alan MacIntyre, Liane M McGlynn, Paul Montague, Rawiya Charif, Murali Subramaniam, W.D. George, Anthony P. Payne, R. Wayne Davies, Anthony Dorling, and Paul G. Shiels. Rejuvenation Research. April 2011, 14(2): 163-171. doi:10.1089/rej.2010.1099
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Pathfinder Presents Preliminary Data on New Regenerative Approach to Diabetes Treatment
Adult Stem Cell Treatments for COPD – Real patient results, USA Stem Cells – Marian H. Testimonial – Video
20-12-2011 08:50 If you would like more information please call us Toll Free at 877-578-7908. Or visit our website at http://www.usastemcells.com Or click here to have a Free Phone Constultation with Dr. Matthew Burks usastemcells.com Real patient testimonials for USA Stem Cells. Adult stem cell therapy for COPD, Emphysema, and Pulmonary fibrosis.
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Adult Stem Cell Treatments for COPD - Real patient results, USA Stem Cells - Marian H. Testimonial - Video
China medicdal tourism– Cirrhosis–Stem cells therapy 1.mp4 – Video
16-02-2012 20:19 Many of our patients travel to Guangzhou from all over the world for medical treatment and tourism. China medical tourism can help with becoming a patient, travel arrangements and language assistance. If you want to know more about our services, please browse the web:htttp://www.medicaltourism.hk/ or mail to us: giels-x@medicaltourism.hk firstcare-china@hotmail.com Adult stem cells provide real improvement for cirrhosis patients Breakthrough adult stem cell research has shown that stem cells are able to regenerate and repair damaged or destroyed liver cells. For patients with cirrhosis, this means improved liver function, decreased pain and a significantly improved quality of life. Stem cell therapy offers the safest and most effective treatment alternative for liver cirrhosis and it is quickly becoming a preferred treatment in Asia. China medical tourism offers unique access to the best stem cell therapies available at leading medical facilities. Supporting data and statistics Three out of every four patients treated experienced a significant improvement in their condition following stem cell treatment. The following clinical results were observed: •Improved liver function •Decreased pain •Improved values for liver function, PLT (blood platelet) and blood ammonia You may see improvements during your hospitalization due to neurotrophic factors released during the stem cell transplantation, which stimulate nerve activity; new cells will grow for up to six months after you ...
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China medicdal tourism-- Cirrhosis--Stem cells therapy 1.mp4 - Video
Cytomedix to Showcase Aldagen’s Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings
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
Pathfinder to Present at New York Stem Cell Summit
CAMBRIDGE, Mass., Feb. 16, 2012 (GLOBE NEWSWIRE) -- Pathfinder Cell Therapy, Inc. ("Pathfinder," or "the Company") (OTCQB:PFND.PK - News), a biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage, today announced that Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder, will present at the 7th Annual New York Stem Cell Summit being held on Tuesday, February 21, 2012.
Event: 7th Annual New York Stem Cell Summit
Date: Tuesday, February 21, 2012
Place: Bridgewaters New York, 11 Fulton Street, New York, NY
Time: 3:35 pm ET
Dr. Franklin will be providing an overview of the Company's novel Pathfinder Cell therapy.
The New York Stem Cell Summit brings together stem cell company executives, researchers, investors and physicians to explore investment opportunities in stem cell research and innovation. More information can be found at http://www.stemcellsummit.com.
About Pathfinder
Pathfinder is developing a novel cell-based therapy and has generated encouraging preclinical data in models of diabetes, renal disease, myocardial infarction, and critical limb ischemia, a severe form of peripheral vascular disease. Leveraging its internal discovery of Pathfinder Cells ("PCs") Pathfinder is pioneering a new field in regenerative medicine.
PCs are a newly identified mammalian cell type present in very low quantities in a variety of organs, including the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood. Early studies indicate that PCs stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue. Based on testing to date, the cells appear to be "immune privileged," and their effects appear to be independent of the tissue source of PCs. For more information please visit: http://www.pathfindercelltherapy.com.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to obtain additional required financing; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results, if any; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; and government regulation. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
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Pathfinder to Present at New York Stem Cell Summit
Stem Cell Stocks: Mending Scarred Hearts
A new study at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. This is certainly exciting news considering heart failure is still the No. 1 cause of death in men and women.
The study included 25 heart attack victims, 17 of whom got the stem cell treatment. Those patients saw a 50% reduction in cardiac scar tissue after one year, while the eight control patients saw no improvement.
The procedure involves removing a tiny portion of heart tissue through a needle, cultivating the stem cells from that tissue, and reinserting them in a second minimally invasive procedure, according to Bloomberg.
"If we can regenerate the whole heart, then the patient would be completely normal," said Eduardo Marban, director of Cedars-Sinai Heart Institute who was the study's lead author. "We haven't fulfilled that yet, but we've gotten rid of half of the injury, and that's a good start."
Business section: Investing ideas
Interested in investing in the promise that stem cell therapy holds? For a look at the investing landscape, we compiled a list of the 10 largest companies involved in stem cell therapy.
Do you think this industry will see growth from stem cell research? (Click here to access free, interactive tools to analyze these ideas.)
1. BioTime (NYSE: BTX ) : Focuses on regenerative medicine and blood plasma volume expanders. Market cap at $291.95M. The company develops and markets research products in the field of stem cells and regenerative medicine. It develops therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases; cardiovascular and blood diseases; therapeutic applications of stem cells to treat orthopedic diseases, injuries, and cancer; and retinal cell product for use in the treatment of age-related macular degeneration.
2. Cleveland BioLabs (Nasdaq: CBLI ) : Market cap at $111.50M. Its products include Protectan CBLB502, a radioprotectant molecule with multiple medical and defense applications for reducing injury from acute stresses, such as radiation and chemotherapy by mobilizing various natural cell protecting mechanisms, including inhibition of apoptosis, reduction of oxidative damage, and induction of factors that induce protection and regeneration of stem cells in bone marrow and the intestines, and Protectan CBLB612, a modified lipopeptide mycoplasma that acts as a stimulator and mobilizer of hematopoietic stem cells to peripheral blood, providing hematopoietic recovery during chemotherapy and during donor preparation for bone marrow transplantation.
3. Gentium: Focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. Market cap at $128.29M. The company develops defibrotide for the treatment and prevention of hepatic veno-occlusive disease (VOD), a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation.
4. Geron (Nasdaq: GERN ) : Develops biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure, and diabetes. Market cap at $265.57M. The company has licensing agreement with the University Campus Suffolk to develop human embryonic stem cell-derived chondrocytes for the treatment of cartilage damage and joint disease.
5. Harvard Bioscience: Develops, manufactures, and markets apparatus and scientific instruments used in life science research in pharmaceutical and biotechnology companies, universities, and government laboratories in the United States and internationally. Market cap at $118.28M. Develops devices used by clinicians and researchers in the field of regenerative medicine, including bioreactors for growing tissue and organs outside the body, and injectors for stem cell therapy.
6. Lydall (NYSE: LDL ) : Designs and manufactures specialty engineered products for thermal/acoustical, filtration/separation, and bio/medical applications in the United States. Market cap at $163.44M. In addition, it offers Cell-Freeze, a medical device used for cryogenic storage of peripheral blood stem cells.
8. Osiris Therapeutics (Nasdaq: OSIR ) : Focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas. Market cap at $157.26M. A stem cell company, focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas.
7. Verastem: Market cap at $229.00M. Focuses on discovering and developing proprietary small molecule drugs targeting cancer stem cells (CSCs) in breast and other cancers.
Interactive Chart: Press Play to compare changes in analyst ratings over the last two years for the stocks mentioned above. Analyst ratings sourced from Zacks Investment Research.
Kapitall's Alexander Crawford does not own any of the shares mentioned above.
See the rest here:
Stem Cell Stocks: Mending Scarred Hearts
Bone gives ‘some’ heart healing
14 February 2012 Last updated at 19:10 ET By James Gallagher Health and science reporter, BBC News
Bone marrow stem cell therapy offers "moderate improvement" to heart attack patients, according to a large UK review of clinical trials.
The analysis by the Cochrane Collaboration looked at 33 trials involving more than 1,700 patients.
It said longer-term studies were needed to see if the experimental therapy affected life expectancy.
The review comes a day after doctors reported the first case of using heart cells to heal heart attack damage.
If a patient survives a heart attack, dead heart muscle is replaced with scar tissue - leaving the patient weaker and possibly on a lifetime of medicine.
Researchers are beginning to show that taking cells from a heart, growing millions of new heart cells in the laboratory and pumping those back into the heart may reduce scar tissue and lead to new heart muscle.
Continue reading the main story “Start Quote
Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far”
End Quote Dr Enca Martin-Rendon Lead researcher
However, the trials are at a very early stage and in only a handful of patients. Using a similar technique with cells taken from the bone marrow, which is a prime source of stem cells, has a much longer pedigree.
The report by Cochrane pooled the data from all 33 bone marrow trials which had taken place up to 2011.
It concluded that bone marrow therapy "may lead to a moderate long-term improvement" in heart function which "might be clinically very important".
Longer life uncertain
It said there was still no evidence of "any significant effect on mortality" in comparison with standard treatment. However, this may be due to the size of the studies and that patients were followed for a short period of time.
Lead author Dr Enca Martin-Rendon, from NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, said: "This new treatment may lead to moderate improvement in heart function over standard treatments.
"Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."
Prof Anthony Mathur, from Barts and the London School of Medicine and Dentistry, is leading the largest ever trial of stem cells in heart attack patients.
It starts this year, however, he told the BBC that the results could come quite quickly. Three thousand patients across Europe will take part. They will be injected with stem cells five days after a heart attack and then followed for two years to see if the therapy affects life expectancy.
Prof Peter Weissberg, medical director at the British Heart Foundation, said: "This review reflects the consensus of opinion about these trials - cell therapy has a modestly beneficial effect.
"Despite that, no-one knows why, or even if, cell therapies will translate into better survival or sustained improvement in damaged hearts. It's much too early to judge the likely long-term benefits."
Read the original post:
Bone gives 'some' heart healing
Stem cell treatments improve heart function after heart attack
Public release date: 14-Feb-2012
[ | E-mail | Share ]
Contact: Jennifer Beal
healthnews@wiley.com
44-124-377-0633
Wiley-Blackwell
Stem cell therapy moderately improves heart function after a heart attack, according to a systematic review published in The Cochrane Library. But the researchers behind the review say larger clinical trials are needed to establish whether this benefit translates to a longer life.
In a heart attack, the blood supply to parts of the heart is cut off by a blocked artery, causing damage to the heart tissue. The cells in the affected area start to die. This is called necrosis and in the days and weeks that follow, the necrotic area may grow, eventually leaving a large part of the heart unable to contract and increasing the risk of further heart problems. Stem cell therapy uses cells from the patient's own bone marrow to try to repair and reduce this damage. Currently, the treatment is only available in facilities with links to scientific research.
The authors of the review drew together all the available evidence to ask whether adult bone marrow stem cells can effectively prevent and repair the damage caused by a heart attack. In 2008, a Cochrane review of 13 stem cell therapy clinical trials addressed the same question, but the new review adds 20 more recent trials, drawing its conclusions from all 33. By incorporating longer follow up, the later trials provide a better indication of the effects of the therapy several years after treatment.
The total number of patients involved in trials was 1,765. All had already undergone angioplasty, a conventional treatment that uses a balloon to open the blocked artery and reintroduce the blood supply. The review's findings suggest that stem cell therapy using bone marrow-derived stem cells (BMSCs) can produce a moderate long-term improvement in heart function, which is sustained for up to five years. However, there was not enough data to reach firm conclusions about improvements in survival rates.
"This new treatment may lead to moderate improvement in heart function over standard treatments," said lead author of the study, Enca Martin-Rendon, of the Stem Cell Research laboratory, NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, UK. "Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."
It is still too early to formulate guidelines for standard practice, according to the review. The authors say further work is required to establish standard methods, including cell dosage, timing of cell transplantation and methods to measure heart function. "The studies were hard to compare because they used so many different methods," said Martin-Rendon. "Larger trials with standardised treatment procedures would help us to know whether this treatment is really effective.
Recently, the task force of the European Society of Cardiology for Stem Cells and Cardiac Repair received funding from the European Union Seventh Framework Programme for Research and Innovation (EU FP7-BAMI) to start such a trial. Principal Investigator for the BAMI trial, and co-author of this Cochrane review, Anthony Mathur, said, ''The BAMI trial will be the largest stem cell therapy trial in patients who have suffered heart attacks and will test whether this treatment prolongs the life of these patients."
###
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Continued here:
Stem cell treatments improve heart function after heart attack
Scarred Hearts Can Be Mended With Stem Cell Therapy
February 14, 2012, 3:17 PM EST
By Ryan Flinn
(Adds comment from researcher in 13th paragraph.)
Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.
In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.
“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”
The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.
“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”
Minimally Invasive
The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.
A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.
While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.
Heart Regeneration
“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”
While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.
“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.
The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Linda Marban, is also a founder and chief executive officer.
“We’d like to study patients who are much sicker and see if we can actually spare them early death, or the need for a heart transplant, or a device,” Eduardo Marban said.
--Editors: Angela Zimm, Andrew Pollack
#<184845.409373.2.1.99.7.25># -0- Feb/14/2012 17:13 GMT
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Read more:
Scarred Hearts Can Be Mended With Stem Cell Therapy
Dog Receives First-Ever Stem Cell Therapy in Kansas City
KANSAS CITY, Mo. — An 11-year-old yellow Labrador suffering from severe arthritis underwent stem cell therapy on Valentine’s Day. It’s the first time a dog has received in-clinic adult stem cell therapy in Kansas City.
According to Stanley Veterinary Clinic where Jake the dog is being treated, adult animal stem cell technology uses the body`s own regenerative healing power to help cure dogs, cats and horses suffering from arthritis, hip dysplasia and tendon, ligament and cartilage injuries and other ailments.
Fat tissue is removed from the animal, the stem cells are separated from the fat and activated, and then injected into the affected areas.
Within two months of the procedure, Jake should be moving well, with little or no pain.
Severe arthritis affects up to 40 percent of the 164 million dogs and cats in the United States.
As for Jake, FOX 4’s Kim Byrnes will have an update on his condition tonight on FOX 4 News at 5 and 6.
Read more here:
Dog Receives First-Ever Stem Cell Therapy in Kansas City
Stem Cells May Help Regenerate Heart Muscle
A promising stem cell therapy approach could soon provide a way to regenerate heart muscle damaged by heart attacks.
Researchers at Cedars-Sinai Heart Institute and The Johns Hopkins University harvested stem cells from the hearts of 17 heart attack patients and after prepping the cells, infused them back into the patients' hearts. Their study is published in the current issue of The Lancet.
The patients received the stem cell infusions about three months after their heart attacks.
Researchers found that six months after treatment, patients had significantly less scarring of the heart muscle and also showed a considerable increase the amount of healthy heart muscle, compared to eight post-heart attack patients studied who did not receive the stem cell infusions. One year after, scar size was reduced by about 50 percent.
"The damaged tissue of the heart was replaced by what looks like healthy myocardium," said Dr. Peter Johnston, a study co-author and an assistant professor of medicine at The Johns Hopkins University School of Medicine. "It's functioning better than the damaged myocardium in the control subjects, and there's evidence it's starting to contract and generate electrical signals the way healthy heart tissue does."
While this research is an early study designed to demonstrate that this stem cell therapy is safe, cardiologists say it's an approach that could potentially benefit millions of people who have suffered heart attacks. Damage to the heart muscle is permanent and irreparable, and little can be done to compensate for loss of heart function.
"In the U.S., six million patients have heart failure, and the vast majority have it because of a prior heart attack," said Johnston.
The damaged scar tissue that results from a heart attack diminishes heart function, which can ultimately lead to enlargement of the heart.
At best, Johnston said, there are measures doctors can try to reduce or compensate for the damage, but in many cases, heart failure ultimately sets in, often requiring mechanical support or a transplant.
"This type of therapy can save people's lives and reduce the chances of developing heart failure," he said.
Cardiac Regeneration A Promising Field
Other researchers have also had positive early results in experiments with stem cell therapy using different types of cells, including bone marrow cells and a combination of bone marrow and heart cells.
"It's exciting that studies using a number of different cell types are yielding similar results," said Dr. Joshua Hare, professor of cardiology and director of the University of Miami Interdisciplinary Stem Cell Institute.
The next steps, he said, include determining what the optimal cell types are and how much of the cells are needed to regenerate damaged tissue.
"We also need to move to larger clinical trials and measure whether patients are improving clinically and exhibiting a better quality of life after the therapy."
In an accompanying comment, Drs. Chung-Wah Siu amd Hung-Fat Tse of the University of Hong Kong wrote that given the promising results of these studies, health care providers will hopefully recognize the benefits that cardiac regeneration can offer.
And Hare added that someday, this type of regeneration can possibly offer hope to others who suffered other types of organ damage.
"This stategy might work in other organs," he said. "Maybe this can work in the brain, perhaps for people who had strokes."
Here is the original post:
Stem Cells May Help Regenerate Heart Muscle
VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates
SOUTH SAN FRANCISCO, CA--(Marketwire -02/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has identified its initial Top 10 drug rescue candidates and plans to launch two formal drug rescue programs by the end of next quarter.
VistaGen's goal for each of its stem cell technology-based drug rescue programs is to generate and license a new, safer variant of a once-promising large market drug candidate previously discontinued by a pharmaceutical company no earlier than late-preclinical development.
"We are now at an advanced stage in our business model," said Shawn Singh, VistaGen's Chief Executive Officer. "After more than a decade of focused investment in pluripotent stem cell research and development, we are now at the threshold where game-changing science becomes therapeutically relevant to patients and commercially relevant to our shareholders. We have positioned our company and our stem cell technology platform to pursue multiple large market opportunities. We plan to launch two drug rescue programs by the end of the next quarter."
Over the past year, VistaGen, working with its network of strategic partners, identified over 525 once-promising new drug candidates that meet the Company's preliminary screening criteria for heart toxicity-focused drug rescue using CardioSafe 3D™, its human heart cell-based bioassay system. After internally narrowing the field to 35 compounds, VistaGen, working together with its external drug rescue advisors, including former senior pharmaceutical industry executives with drug safety and medicinal chemistry expertise, analyzed and carefully narrowed the group of 35 to the current Top 10.
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during development due to heart toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.
Additionally, VistaGen's oral small molecule prodrug candidate, AV-101 (4-Cl-KYN), is in Phase 1b development for treatment of neuropathic pain. Unlike other NMDA receptor antagonists developed previously, AV-101 readily crosses the blood-brain barrier and is then efficiently converted into 7-chlorokynurenic acid (7-Cl-KYNA), one of the most potent and specific glycineB site antagonists currently known, and has been shown to reduce seizures and excitotoxic neuronal death. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. The Company anticipates pursuing Phase 2 development for neuropathic pain and other neurological indications, including depression, epilepsy, and/or Parkinson's disease in the event it receives additional non-dilutive development grant funding from the NIH or private foundations.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue activities, ongoing AV-101 clinical studies, its ability to enter into drug rescue collaborations and/or licensing arrangements with respect to one or more drug rescue variants, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variant identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
Originally posted here:
VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates
Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows
February 13, 2012, 9:47 PM EST
By Ryan Flinn
Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.
In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.
“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”
The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.
“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”
Minimally Invasive
The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.
A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.
While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.
Heart Regeneration
“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”
While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.
“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.
The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.
--Editors: Angela Zimm, Andrew Pollack
-0- Feb/13/2012 22:32 GMT
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
See the original post here:
Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows
Scarred Hearts Can Be Mended With Novel Stem Cell Therapy, Study Finds
Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.
In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.
“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”
The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University (43935MF) in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.
“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”
Minimally Invasive
The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.
A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.
While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.
Heart Regeneration
“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”
While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.
“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.
The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Please enable JavaScript to view the comments powered by Disqus.
Here is the original post:
Scarred Hearts Can Be Mended With Novel Stem Cell Therapy, Study Finds
Vet offers stem cell therapy for dogs
COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.
Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.
Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.
"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."
But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.
So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"
"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.
Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.
"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."
This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.
"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.
The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.
When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.
"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.
Copyright 2012 WIS. All rights reserved.
Read the original post:
Vet offers stem cell therapy for dogs
Stem Cell Treatment Might Reverse Heart Attack Damage
MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.
The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.
Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.
"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.
However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.
The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.
The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.
Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.
One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.
Initial muscle damage and healed tissue were measured using MRI scans.
After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.
In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."
Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.
"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.
Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.
And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.
"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."
Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."
It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."
Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."
As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.
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The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.
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Stem Cell Treatment Might Reverse Heart Attack Damage
Dogs who got stem cell therapy are well
WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.
Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.
Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.
This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.
Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.
"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."
Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.
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Dogs who got stem cell therapy are well
US begins stem cell trial for hearing loss
US researchers have begun a groundbreaking trial to test the potential of umbilical cord blood transplants, a kind of stem cell therapy, to treat and possibly reverse hearing loss in infants.
The phase I trial follows promising studies on mice showing that such transplants were able to rebuild the structures of the inner ear, and some anecdotal evidence from humans, sparking hope of a cure for some forms of deafness.
One of those people is two-year-old Finn McGrath, who suffered brain damage after being deprived of oxygen during a prolonged and complicated delivery, according to his mother, Laura.
"His doctors told us he was at high risk for cerebral palsy, vision issues, hearing problems and mental retardation," she said in an interview with AFP.
Finn's early days were an all-out struggle to survive, so for his parents, learning that he had failed his hearing tests and had damaged hair cells -- the sensory receptors in the inner ear that pick up sounds -- was almost an afterthought.
He had organ failure, breathing problems, and his cerebral palsy left him unable to roll, crawl or walk, hold his head up, talk or eat.
As his parents searched for ways to help him, they came upon stories online that told of studies using cord blood to help children with cerebral palsy and other disorders.
Prior to his birth, the McGraths had arranged to privately bank his umbilical cord blood, a procedure that costs around $2,000 plus storage fees, and remains controversial among pediatricians.
Private companies such as the Cord Blood Registry, which is funding the Texas study on hearing loss, urge expecting parents to bank their umbilical cord blood and reserve it for personal use as a way to protect their family.
That advice runs counter to the guidelines issues by the American Academy of Pediatrics in 2007, which calls such claims "unsubstantiated" and says banking for personal or family use "should be discouraged" but is "encouraged" if it is to be stored in a bank for public use.
Since Finn's parents had already banked his, they enrolled him in cord blood trial for cerebral palsy in North Carolina and he received his first transplant in November 2009 when he was about seven weeks old.
A second transfusion followed and by May, his parents began to notice a change.
Nighttime noises, like an alarm on his food pump or the sound of ripping medical tape, would suddenly startle him awake, his mother recalled.
"He started vocalizing sounds and we could tell that he was anticipating things that we would say. Like, if he had heard a story a number of times or a song, he would smile like he recognized the song or the story."
Finn had a third infusion in September 2010, when he was one year old. Four months later, an otoacoustic emissions test (OAE), which plays a sound and picks up vibrations in the cochlea and hair cells, came back normal.
The early hearing tests that showed hearing loss were not exactly the same as the later tests that came back normal, so McGrath is cautious about comparing them directly, but she believes the cord blood transfusions may have helped.
"All I can tell you is anecdotally he was not able to hear for probably the first three or four months of his life, and then when he was about six to eight months old, he started hearing."
The hearing trial in Texas aims to take a first step in testing the safety, and later the efficacy, of transfusing cord blood in children age six weeks to 18 months who have sustained post-birth sensorineural hearing loss.
Some reasons that children lose their hearing at or after birth may include oxygen deprivation, head injury, infection, strong doses of antibiotics or loud noises.
Sensorineural hearing loss affects approximately six per 1,000 children, and there is no available medical treatment. Hearing aids or cochlear implants are typically offered to boost the ability of the damaged tissues.
"Stem cell therapy may potentially repair the damaged structures of the inner ear and restore normal hearing," lead investigator Sami Fakhri told AFP.
"We are at the initial stages of this process and the results are looking promising," Fakhri added.
Research using stem cells in cord blood, known as hematopoietic cells, is already under way on some types of brain injury, cerebral palsy, juvenile diabetes, kidney and lung disease, he said.
The new study at Memorial Hermann-Texas Medical Center is being funded by the Cord Blood Registry, a private bank, and those eligible must have already banked their own umbilical cord blood with CBR.
But to Stephen Epstein, an otolaryngologist in Maryland, that does not pose a conflict of interest, because separate medical institutions in Texas and Georgia are conducting the Food and Drug Administration-approved research.
"If both of them can reproduce the same results then I would say it has some validity to it," said Epstein, who is not involved in the study.
"This is certainly a welcome, acceptable experiment, but it should be looked at with caution and time will tell."
One patient is already enrolled and the study, which runs for one year, has room for nine more.
While Finn McGrath still faces many challenges due to his cerebral palsy, his mother is grateful for the things he can do.
"I don't know how much worse off he would have been without the stem cell transfusion," McGrath said, pointing to his normal cognition, lack of seizures, good hearing and vision.
"We remain hopeful that he will continue to improve."
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US begins stem cell trial for hearing loss