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Category Archives: Cell Medicine
Cytomedix to Showcase Aldagen’s Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings
Posted: February 16, 2012 at 1:56 pm
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
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Stem Cell Stocks Skyrocket in 2012 — Cytori Therapeutics and Cord Blood America on the Upswing
Posted: February 16, 2012 at 4:22 am
NEW YORK, NY--(Marketwire -02/15/12)- Stem cell stocks have performed well of late, outperforming the S&P 500 by a large margin over the last three months. Since mid-November, TickerSpy's Stem Cell Stocks index (RXSTM) has returned more than 20 percent, as favorable news from some of stem cell industry heavyweights has boosted investor optimism in the sector. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Cytori Therapeutics, Inc. (NASDAQ: CYTX - News) and Cord Blood America, Inc. (OTC.BB: CBAI.OB - News). Access to the full company reports can be found at:
http://www.paragonreport.com/CYTX
http://www.paragonreport.com/CBAI
Shares of Cytori Therapeutics have skyrocketed nearly 70 percent year-to-date. The company develops, manufactures, and sells medical products and devices to enable the practice of regenerative medicine. The Company's technology is the Celuion family of products, which processes patients' adipose-derived stem and regenerative cells (ADRCs) at the point of care.
In late January, Cytori received an Investigational Device Exemption (IDE) approval from the U.S. FDA to begin the "ATHENA" trial. ATHENA will investigate the use of the Celution System to treat a form of coronary heart disease, chronic myocardial ischemia (CMI).
The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at http://www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.
Cord Blood America, Inc. is a holding company that, through its subsidiaries, is engaged in the business of collecting, testing, processing and preserving umbilical cord blood, thereby allowing families to preserve cord blood at the birth of a child for potential use in stem cell therapy.
USA Today recently reported that umbilical cord blood stem cells have been successfully used to treat individuals with type 1 diabetes, highlighting the importance of storing stem cells at birth. The USA Today article says that stem cells from cord blood have been used to "reeducate" the immune system T cells of people with type 1 diabetes so their pancreas started producing insulin again - thereby reducing the amount of insulin they needed to inject.
The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.paragonreport.com/disclaimer
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Stem Cell Stocks Skyrocket in 2012 -- Cytori Therapeutics and Cord Blood America on the Upswing
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Bone Repair Stem Cell Breakthrough Shows Promise
Posted: February 16, 2012 at 4:22 am
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Main Category: Stem Cell Research
Article Date: 15 Feb 2012 - 8:00 PST
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According to a study published in the February issue of the STEM CELL Translational Medicine Journal , a world-first technique for generating adult stem cells (mesenchymal stem cells [MSCs]) has been developed by researchers at the University of Queensland. This new method can be used to repair bone and possibly other organs, and will considerably affect individuals suffering from a variety of serious diseases.
Professor Nicholas Fisk, who leads the collaborative study between the UQ Clinical Research Center (UQCCR) and the UQ's Australian Institute for Bioengineering and Nanotechnology (AIBN), explained:
"We used a small molecule to induce embryonic stem cells over a 10 day period, which is much faster than other studies reported in the literature.
The technique also worked on their less contentious counterparts, induced pluripotent stem cells.
To make the pluripotent mature stem cells useful in the clinic, they have to be told what type of cell they need to become (pre-differentiated), before being administered to an injured organ, or otherwise they could form tumors.
Because only small numbers of MSCs exist in the bone marrow, and harvesting bone marrow from a healthy donor is an invasive procedure, the ability to make our own MSCs in large number in the laboratory is an exciting step in the future widespread clinical use of MSCs.
We were able to show these new forms of stem cells exhibited all the characteristics of bone marrow stem cells and we are currently examining their bone repair capability."
Ernst Wolvetang, co-researcher on the study and AIBN Associate Professor, explained that the technique had overcome a considerable obstacle in the translation of stem cell-based therapy.
Wolvetang said: "We are very excited by this research, which has brought together stem cell researchers from two of the major UQ research hubs UQCCR and AIBN."
Written by: Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Visit our stem cell research section for the latest news on this subject. UniQuest, The University of Queensland's main commercialization company, invites parties interested in licensing the intellectual property relating to this discovery to contact UniQuest on 3365 4037 or lifesciences@uniquest.com.au.
Source: University of Queensland
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Bone Repair Stem Cell Breakthrough Shows Promise
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Favorable News From Advanced Cell Technology and StemCells Inc Boosts Optimism in Regenerative Medicine Industry
Posted: February 16, 2012 at 4:22 am
NEW YORK, NY--(Marketwire -02/15/12)- Stem cell stocks have performed well of late, outperforming the S&P 500 by a large margin over the last three months. Since mid-November, TickerSpy's Stem Cell Stocks index (RXSTM) has returned more than 20 percent, as favorable news from some of stem cell industry heavyweights has boosted investor optimism in the sector. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Advanced Cell Technology, Inc. (OTC.BB: ACTC.OB - News) and StemCells Inc. (NASDAQ: STEM - News). Access to the full company reports can be found at:
http://www.paragonreport.com/ACTC
http://www.paragonreport.com/STEM
Shares of StemCells Inc. have skyrocketed nearly 20 percent year-to-date. StemCells Inc. is focused on cellular medicine, or the use of stem and progenitor cells as the basis for therapeutics and therapies, and enabling technologies for stem cell research, or the use of cells and related technologies to enable stem cell-based research and drug discovery and development.
Earlier this month the company released a statement saying that it received U.S. Food and Drug Administration authorization to start a clinical trial of the company's potential treatment for dry age-related macular degeneration, or AMD. AMD is the leading cause of vision loss and blindness in people over 55 years old and about 30 million people worldwide are affected by the disease, the company said
The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at http://www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.
Shares of Advanced Cell Technology are up more than 30 percent this year - although they are down more than 20 percent over the last month. Advanced Cell Technology has acquired, developed and maintained a portfolio of patents and patent applications that forms the base for its research and development efforts in the area of embryonic and adult stem cell research.
Earlier this week Advanced Cell Technology announced that a third patient has been treated for Stargardt's macular dystrophy in its US. Phase I/II clinical trial. The therapy uses retinal pigment epithelial cells derived from human embryonic stem cells. 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.
The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.paragonreport.com/disclaimer
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Favorable News From Advanced Cell Technology and StemCells Inc Boosts Optimism in Regenerative Medicine Industry
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Advanced Cell Technology Announces Approval of Wills Eye Institute as Additional Site for Stem Cell Clinical Trial for …
Posted: February 16, 2012 at 4:22 am
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Wills Eye Institute in Philadelphia has received institutional review board (IRB) approval as a site for the company’s Phase I/II clinical trial for Stargardt’s Macular Dystrophy (SMD), a form of juvenile macular degeneration, using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. Earlier this year, the Company also announced that the IRB at Wills Eye Institute had approved the participation of the institution as a site for ACT’s clinical trial for dry age-related macular degeneration (dry AMD).
“We thank Wills Eye Institute once more for providing their IRB and their invaluable contribution to our macular degeneration studies,” said Gary Rabin, ACT’s chairman and CEO. “We are very happy that we can now report that Wills Eye Institute has been approved as a clinical trial site for both our SMD and dry AMD clinical trials. Ranked as one of the best ophthalmology hospitals in the country by U.S. News & World Report, the Wills Eye Institute is a truly world-class institution. Our team is eagerly anticipating working with Dr. Carl Regillo, a renowned retinal surgeon and director of clinical retina research at Wills Eye Institute, as well as a professor of ophthalmology at Thomas Jefferson University, along with the rest of his team as we move forward with these ground-breaking trials.”
The Phase I/II trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with SMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format. Preliminary results relating to both early safety and biological function for the first two patients in the U.S., one SMD patient and one dry AMD patient, were recently reported in The Lancet.
Specific patient enrollment for both trials at the Wills Eye Institute will be determined in the near future. Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on http://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.
About hESC-derived RPE Cells
The retinal pigment epithelium (RPE) is a highly specialized tissue located between the choroids and the neural retina. RPE cells support, protect and provide nutrition for the light-sensitive photoreceptors. Human embryonic stem cells differentiate into any cell type, including RPE cells, and have a similar expression of RPE-specific genes compared to human RPE cells and demonstrate the full transition from the hESC state.
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.
About Wills Eye Institute
Wills Eye Institute is a global leader in ophthalmology, established in 1832 as the nation’s first hospital specializing in eye care. U.S. News & World Report has consistently ranked Wills Eye as one of America’s top three ophthalmology centers since the survey began in 1990. Wills Eye is a premier training site for all levels of medical education. Its resident and post-graduate training programs are among the most competitive in the country. One of the core strengths of Wills is the close connection between innovative research and advanced patient care. Wills provides the full range of primary and subspecialty eye care for improving and preserving sight, including cataract, cornea, retina, emergency care, glaucoma, neuro-ophthalmology, ocular oncology, oculoplastics, pathology, pediatric ophthalmology and ocular genetics, refractive surgery and retina. Ocular Services include the Wills Laser Correction Center, Low Vision Service, and Diagnostic Center. Its 24/7 Emergency Service is the only one of its kind in the region. Wills Eye also has a network of nine multi-specialty, ambulatory surgery centers throughout the tri-state area. To learn more, please visit http://www.willseye.org.
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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Stem cells – ISWA project – Video
Posted: February 15, 2012 at 1:18 am
14-02-2012 08:13 STEM CELLS The dance of life Recent developments in regenerative medicine and modern biology are going to have an enormous impact on our lives. Also the way itself we face the problem of sickness, aging and death changes as the hope (or the illusion?) grows that we always can fight and delay them. Stem cell research is in fact changing our knowledge of the fundamental mechanisms of life and feeding the idea that we can increasingly contrast the cruel natural selection rules which make us fall ill, grow old and die. A new frontier opens and unpredictable changes in our culture are taking place. People's hopes and fears grow at the same time. The general properties of the stem cells is presented, namely the ability to proliferate and, under certain conditions, to differentiate in other types of cells. In this way they can generate a new tissue replacing a damaged one, and also a new organ (like blood, thrachea, liver, heart, skin, cornea and very recently retina). A stamp is shown, which was emitted by the Japanese government to celebrate the discovery of a university team, which was able to regenerate a cornea and giving the opportunity to a patient to see again. Then the innovative results is presented in applications of the stem cells to orthopedy, muscular dystrophy, cardiology and dentistry. Finally the etherogeneus perspectives is presented offered by stem cell research to treat degenerative disorders, like Alzheimer, Parkinson diseases and Multiple Sclerosis. www ...
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Stem cells - ISWA project - Video
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Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute’s Adipose Cell Technology
Posted: February 15, 2012 at 1:18 am
SUNRISE, Fla., Feb. 14, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has acquired the worldwide exclusive rights to Ageless Regenerative Institute's adipose (fat) derived therapeutic cell technology for use in the cardiac field.
"The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients," said Mike Tomas, President and CEO of Bioheart. "We have successfully treated patients in Mexico and now we are ready to expand into the US."
Adipose tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or LipiCell(TM) in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCell(TM) will be accomplished through endocardial implantations with the MyoStar(TM) Injection Catheter under the guidance of the NOGA(R) cardiac navigation system by Biosense Webster, Inc. -- A Johnson & Johnson Company.
Under the terms of the agreement, Bioheart will have a worldwide exclusive license to all of Ageless technology for use in the heart attack and heart failure markets. The agreement provides for upfront and milestone equity payments to Ageless.
Ageless' President and Chief Executive Officer, Dr. Sharon McQuillan, MD added, "We are excited about this collaboration with Bioheart, a leader in developing cell therapies for cardiovascular disease. Together with Bioheart, we can help to revolutionize cardiovascular medicine and improve the current standard of care for these patients."
About Bioheart, Inc.
Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.
For more information on Bioheart, visit http://www.bioheartinc.com.
About Ageless Regenerative Institute, LLC
The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.
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Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology
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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from …
Posted: February 13, 2012 at 4:13 pm
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
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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...
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Researchers make breakthrough in stem cell research
Posted: February 13, 2012 at 12:05 pm
The research is a collaborative effort involving UQ's Australian Institute for Bioengineering and Nanotechnology (AIBN) and is led by UQ Clinical Research Centre's (UQCCR) Professor Nicholas Fisk.
It revealed a new method to create mesenchymal stem cells (MSCs), which can be used to repair bone and potentially other organs.
“We used a small molecule to induce embryonic stem cells over a 10 day period, which is much faster than other studies reported in the literature,” Professor Fisk said.
“The technique also worked on their less contentious counterparts, induced pluripotent stem cells.
“To make the pluripotent mature stem cells useful in the clinic, they have to be told what type of cell they need to become (pre-differentiated), before being administered to an injured organ, or otherwise they could form tumours.
“Because only small numbers of MSCs exist in the bone marrow and harvesting bone marrow from a healthy donor is an invasive procedure, the ability to make our own MSCs in large number in the laboratory is an exciting step in the future widespread clinical use of MSCs.
“We were able to show these new forms of stem cells exhibited all the characteristics of bone marrow stem cells and we are currently examining their bone repair capability."
AIBN Associate Professor and Co-Investigator on the project, Ernst Wolvetang said the new protocol had overcome a significant barrier in the translation of stem cell-based therapy.
“We are very excited by this research, which has brought together stem cell researchers from two of the major UQ research hubs UQCCR and AIBN,” Associate Professor Wolvetang said.
The research is published in the February edition of the STEM CELLS Translational Medicine journal.
Provided by University of Queensland (news : web)
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Researchers make breakthrough in stem cell research
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Stem cell injection successfully treats urinary incontinence
Posted: February 13, 2012 at 8:19 am
It started when Deborah Bishop was still in her 20s.
Always athletic -- she had participated in field hockey, speed skating and baseball -- Ms. Bishop was doing jumping jacks when she noticed to her embarrassment that she had leaked urine.
As the weeks wore on, the Canadian woman began to have more and more of these accidents. It wasn't just strenuous exercise that caused them, but also being tickled or coughing or sneezing.
The condition is known as stress urinary incontinence, and researchers say it may affect hundreds of millions of people around the world, primarily women, who are more susceptible because of their anatomy.
Today, Ms. Bishop, 54, is "90 percent" normal on her urinary leakage, she said -- all because of an injection of her own stem cells that she received three years ago.
The cells, known officially as autologous muscle-derived cells, were taken out of her thigh, multiplied several times over in the lab, and then injected into the muscles around her urethra, the opening at the neck of the bladder.
While many people still associate the phrase "stem cells" with ethical debates over using embryos, these stem cells have nothing to do with that.
All of us have stem cells in various parts of our bodies that can develop into mature cells and are used to repair muscle, nerve and tissue damage.
In this case, researcher Johnny Huard at the University of Pittsburgh developed a technique for finding stem cells in muscle tissue and then purifying and multiplying them. The biomedical firm Cook MyoSite Inc. bought the licensing rights to his technique and is overseeing the current tests on treating stress urinary incontinence.
The idea is that the stem cells will create new cells that will strengthen the muscles that control urination. Even though the initial trials were focused on testing the safety of the procedure, 60 to 70 percent of the women have shown a significant decrease in their urinary leakage, said Ryan Pruchnic, Cook MyoSite's director of operations.
Lesley Carr, Ms. Bishop's physician and a urologist at Sunnybrook Health Sciences Centre in Toronto, said there is no medication that helps with this most prevalent form of incontinence. Up to now, the primary last-resort therapy has been surgical insertion of a mesh sling around the urethra.
The surgery is effective, Dr. Carr said, but "there are rare but recognized complications," including pain and infections, and women face up to six weeks of restricted activity after the operation.
That was a big obstacle for Ms. Bishop, not only because she is so physically active, but because she was in the middle of a house renovation when she sought help for her condition.
"I told Dr. Carr I couldn't afford to be out of commission for six weeks," she recalled, "and that's when she must have mentioned the stem cell trial to me."
In July 2009, she had a piece of her outer thigh muscle removed under local anesthesia, a procedure she admits left her feeling "like I'd been kicked by a horse" for about a week.
Researchers then located and multiplied the stem cells in her muscle tissue, and the following September, she had them injected into the muscles around her urethra. The entire injection took about five minutes, she said, and she felt nothing.
The improvement was gradual after that. "I noticed a difference in a couple months," she said, "and a significant difference in four or five months. I thought what made it really unique was that it was using my own muscle cells."
The procedure means that today, she can do her strenuous morning exercises of standing broad jumps and stride jumps without having to wear heavy pads to absorb leakage.
The latest trials with the stem cells are the first to enroll women who will either get real stem cells or placebo injections. Cook MyoSite hopes to have solid results and be able to bring the procedure to market by 2015, Mr. Pruchnic said.
The company has also begun initial tests of the muscle stem cells in people who have had heart attacks or are experiencing chronic heart failure, in hopes they will restore the strength and flexibility of cardiac muscle.
By using a person's own cells, Dr. Carr noted, there is no need for patients to take immunosuppressive medications. She believes such regenerative medicine "will be the wave of the future in most fields" of health care.
Ms. Bishop is certainly sold.
"I've got a girlfriend who's had three children and is very physically active, and she's struggling with stress incontinence now, and so I'm an advocate for this.
"It was an excellent experience for me, and I would highly recommend it to anyone."
Mark Roth: mroth@post-gazette.com or 412-263-1130.
First published on February 13, 2012 at 12:00 am
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Stem cell injection successfully treats urinary incontinence
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