StemCell Therapy

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 9:23 PM EST, Thu March 8, 2012

Dr. Zannos Grekos, seen here in 2009, could have his license suspended.

STORY HIGHLIGHTS

(CNN) -- A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

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Florida suspends doctor accused of illegal stem cell therapy

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the potential use of the companys cell encapsulation technology with modified stem cells to treat late stage cancers.

Stem cell therapy is not new to physicians dealing with blood and bone cancers, with stem cell transplants being an important treatment for growing new bone marrow since the 1970s. Recent studies have indicated the potential for using stem cells across a much broader range of cancers is becoming a reality, mostly a result of advances in cell and molecular biology techniques.

Traditional chemotherapy works by targeting the fast-growing cells common to cancer tumors. Unfortunately, chemotherapeutics dont differentiate between healthy and cancerous cells. Patients suffering from metastatic cancers, where tumors have spread to multiple areas of the body, often have substantial difficulties with the chemotherapy needed to treat their disease.

In one case, researchers at City of Hope and St. Jude Children's Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used genetically modified stem cells to activate chemotherapeutic drugs at the tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed. The stem cells were designed to produce a specific enzyme that converts the nontoxic prodrug into the chemotherapeutic agent. This method also targets the brain tumor treatment to remain localized within the brain, similar to the pancreatic cancer clinical trial carried out by SG Austria, providing for high dosage chemotherapy without affecting surrounding tissues and avoiding the severe side effects normally associated with cancer therapy.

Nuvilex believes that incorporating Cell-in-a-Box encapsulation with this type of genetically modified stem cell, along with the proprietary cancer treatment being acquired, could significantly aid and improve patient outcomes.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, We are hopeful for the day when late stage cancers can be routinely and safely treated using genetically modified cells like those used in the pancreatic cancer trial, increasing the ability of clinicians to avoid inducing side effects that typically accompany aggressive chemotherapy and/or radiation. Our cell encapsulation technology will enable practitioners to target tumors while preserving the health of the surrounding tissues. We continue to look for leading stem cell and oncology researchers to partner with us as we bring this technology to market.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

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Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

Lindsay Porter's kidneys weighed 16 pounds before her transplant.

STORY HIGHLIGHTS

(CNN) -- By the time Lindsay Porter had her kidneys removed two years ago, they were bulging -- covered in cysts -- and together weighed 16 pounds.

Her abdominal area was so distended, "I looked nine months pregnant, and people regularly asked when I was due," Porter said.

As she prepared for a transplant to address her polycystic kidney disease, Porter, 47, had mixed feelings -- relief to have found a donor, tinged with resignation. She was looking forward to both a new kidney, and a lifetime on immune system-suppressing drugs.

"You get this brand new shiny kidney, and then they give you drugs that eventually destroy it," said Porter.

But that scenario may eventually change, if results of a new pilot study are replicated in a larger group of patients. The study, published Wednesday in the journal Science Translational Medicine, describes eight kidney transplant patients, including Porter, who received a stem cell therapy that allowed donor and recipient immune cells to coexist in the same body.

The effect, in a handful of those patients, was to trick the recipient's immune system into recognizing the donated kidney as its own.

When it works, patients become a sort of medical rarity called a chimera.

"Chimerism is a condition wherein two different genetic cell populations are present in the body, and both cell types are tolerated," said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center, who was not involved in the study, via e-mail.

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Transplant without lifetime of drugs?

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today pointed out the potential for substantial partnership and licensing opportunities using the companys cell encapsulation technology for applications in stem cell research and medicine. Migration of implanted cells away from the target site and host rejection have been recognized as fundamental challenges faced by the stem cell community regarding their use in therapy, which the companys technology overcomes.

The technology being acquired from associate SG Austria is used to place live stem cells into strong, flexible and permeable capsules. These capsules can then be implanted into animals or humans for specific therapies. Stem cells can then exist at the desired location inside the capsules, prevented from migrating and protected from the immune system that aims to eliminate such foreign cells from the body.

Stem cell therapy is being used by clinicians throughout the world for treating such diverse diseases as spinal cord injury, amyotrophic lateral sclerosis, burns, glioma, multiple myeloma, arthritis, heart disease, stroke, Stargardt's Macular Dystrophy, and age-related macular degeneration, among others, most of which can be found at ClinicalTrials.gov.

Historically, researchers have faced numerous difficulties in succeeding with certain stem cell treatments, because of the problems associated with keeping stem cells alive for significant periods of time, stopping rejection and destruction by the recipients immune system, and keeping stem cells from migrating away from the desired sites. Cells encapsulated in SG Austrias porous beads have been shown to remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and are unable to migrate to other sites in the body.

In the February 29, 2012 research report, Goldman Small Cap Research stated, The Cell-in-a-Box approach could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, discussed the value for licensing the companys stem cell therapy, adding, By overcoming traditional barriers to effective stem cell therapy, namely viability, migration, and host rejection, we believe these new advances in medical science utilizing stem cells and encapsulation will enable us to take quantum leaps forward now and in the future. As a result of challenges SG Austria has overcome, new advances will be surprisingly close at hand and are part of the driving force behind our desire to work with a number of companies in this endeavor. Our primary goal has been and remains to use our technology to bring life changing treatments to patients on an expedited basis.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

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Nuvilex Forecasts Vast Partnership Opportunities Using Breakthrough Stem Cell Technology

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, released information today about the companys cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapyhost rejection and migration of implanted cells away from the target site.

Stem cell therapy is believed by many medical researchers as holding a key to treating cancer, Type 1 diabetes mellitus, Parkinson's disease, Huntington's disease, Celiac Disease, cardiac failure, muscle damage, neurological disorders, and other chronic, debilitating diseases. There are presently >1,400 registered trials using stem cells that are recruiting patients (ClinicalTrials.gov). The encapsulation technology being advanced allows live stem cells to be implanted into robust, flexible and permeable capsules where they can replicate inside the capsules at the target site free from attack by the bodys immune system and free to undergo natural changes to become the appropriate cell type needed.

The Goldman Small Cap Research report, issued February 29, 2012, noted some inherent difficulties encountered in stem cell treatments, such as keeping stem cells alive for significant periods of time, potential rejection of the cells and subsequent destruction by the recipients immune system, and the migration of the stem cells away from the critical treatment site, while making a distinction that the Companys cell encapsulation technology overcomes these concerns.

The report also accurately recognized, Cells encapsulated in SG Austrias porous beads remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and do not migrate out of the beads to other sites in the body.

In assessing the overall importance of this technology to Nuvilexs overall business model, Goldman pointed out, The Companys acquisition of the Cell-in-a-Box approach along with the expertise of SG Austria could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, in addition to being used to target cancer cells, thus making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, There is a broad range of expanding research supporting the use of stem cells to treat a variety of human diseases and conditions. Our technology allows for precise maintenance and localization of stem cells, preventing their loss from the critical area of need, that will enable us to potentially create miniature organs at specific sites and as a result we believe greater utilization of those stem cells at the site for their intended purpose, once implanted. As stem cell treatments advance, we expect Nuvilex to be at the forefront of developing new, significant, life changing therapies.

For a detailed review of the research report and valuation methodology, investors are directed to the Goldman Research Report.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

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Nuvilex Announces Major Breakthrough in Stem Cell Research

Jason Bell

BONITA SPRINGS Jimmy and Jennifer Bell were scrambling to save their 5-year-old-son, Jason, last fall.

Shell-shocked with a diagnosis that their youngest child had primary pulmonary hypertension, a rare lung disorder, they decided to take a chance. If not, a heart-lung transplant would be their son's only chance.

They put their trust in a Southwest Florida cardiologist, Dr. Zannos Grekos, more than 1,000 miles from their Texas home. They learned Grekos performs an experimental stem cell therapy that possibly could help. That's despite a lack of clinical studies and scientific papers.

The U.S. Food and Drug Administration hasn't approved stem cell therapy despite a buzz of optimism of its potential for repairing damaged tissue.

"I was willing to do anything to give my son a fighting chance," said Jimmy Bell, 43, who owns a landscaping company in Keller, a suburb of Fort Worth. "When you are given no other option, you've got to try something."

The treatment would involve a trip to Bonita Springs where Grekos has his practice, Regenocyte; a trip to the Dominican Republic where the treatment would be done, and an up-front payment of $57,000.

"They looked at his medical records first. They didn't know if they could treat him," Bell said. "Once they agreed to treat him, I talked to Grekos. It was the greatest news in my life. I broke down. I just knew this was going to be the miracle to save his life."

* * * * *

The family wired the money in late October 2011 to a Regenocyte account in the Dominican Republic, according to a copy of the paid invoice furnished to the Daily News.

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Texas family turned to Bonita stem cell doctor, but 5-year-old died before 'miracle'

28-02-2012 16:16 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

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

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

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

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

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

11-01-2012 23:04 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- Shirlen M. Testimonial - 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

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.

Read more from the original source:
Cytomedix to Showcase Aldagen's Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings

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.

Read more:
Pathfinder to Present at New York Stem Cell Summit

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."

View post:
Bone gives 'some' heart healing

Public release date: 14-Feb-2012
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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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Read more:
Stem cell treatments improve heart function after heart attack

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

More:
Scarred Hearts Can Be Mended With Stem Cell Therapy

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.

Link:
Dog Receives First-Ever Stem Cell Therapy in Kansas City