Archive for the ‘Cell Therapy’ Category

ANNAPOLIS, Md. (WJZ)One of the last search and rescue dogs from 9/11 lives here in Maryland. She was suffering from a painful condition until her owner took action with breakthrough technology.

Mary Bubala has the story.

Red is a search and rescue dog from Annapolis, but has traveled across the country. Her missions include Hurricane Katrina, the La Plata tornadoes and the Pentagon after 9/11.

They credit them with finding 70 percent of the human remains so that helped a whole lot of those families actually get closure, said Heather Roche, Reds owner.

Sept. 11 was Reds first search. Today shes one of the last 9/11 search and rescue dogs still alive.

She retired last summer due to severe arthritis.

It would be nice if her arthritis, if she felt better, that she could do those kinds of things that she misses, Reds owner said while fighting back tears. Alright I am going to cry.

Roche did some research and found an animal hospital in northern Virginia that uses breakthrough stem cell therapy to treat arthritis in dogs.

The Burke Animal Clinic is one of just a few across the country that use stem cell therapy.

The vet harvests 1 to 2 ounces of the dogs fatty tissue, activates the stem cells and then injects them back into the troubled areas.

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Stem Cell Therapy Used To Treat 9/11 Search And Rescue Dog

POWAY, CA--(Marketwire -03/22/12)- Vet-Stem announced today the introduction of StemInsure. The StemInsure service provides banked stem cells that can be grown to supply a lifetime of stem cell therapy for dogs. One fat collection, in conjunction with another anesthetized procedure, gives access to a lifetime of stem cells.

Vet-Stem has trained over 3,500 veterinarians, provided stem cells for over 8,000 animals in the US and Canada and currently banks more than 25,000 doses for future therapeutic use. Many veterinarians and their clients have requested a method to collect and store stem cells when a dog is young, before it needs the regenerative cells for therapy. StemInsure was designed to meet this need.

A Vet-Stem credentialed veterinarian can collect as little as 5 grams of fat (about the size of a grape) from a dog or puppy during an anesthetized procedure. Many veterinarians and owners are electing to do this fat collection in conjunction with a spay or neuter. This small amount of fat is processed and stem cells are cryopreserved in Vet-Stem's state-of-the-art facility. The cells can be cultured in the future to provide enough stem cells to last for the lifetime of the dog. More information can be found at http://www.vet-stem.com/steminsure.php.

"Vet-Stem is pleased to provide StemInsure as a solution to the thousands of veterinarians and dog owners who recognize the value of Vet-Stem cell therapy. The ability to store the cells in conjunction with another procedure is a great way to ensure that the dog will have access to a lifetime of cell therapy while reducing the number of anesthetic events," said Dr. Bob Harman, DVM, MPVM, and CEO of Vet-Stem. Dr. Harman continued, "Currently, Vet-Stem Regenerative Cell Therapy is widely used to treat osteoarthritis, and tendon/ligament injuries. It is our expectation that the therapeutic use of adipose derived stem cells will continue to expand and add to the value of a lifetime supply of stem cells for dogs."

About Vet-Stem:In January of 2004, Vet-Stem introduced the first veterinary stem cell service in the United States. Since that time there has been rapid adoption of this technology for treatment of tendon, ligament, and joint injuries by the veterinary community. Studies have shown that mesenchymal stem cells can dramatically improve the healing of injuries and diseases that have had very few treatment options in the past.

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Vet-Stem Announces StemInsure(R): A Small Fat Sample Now, a Lifetime of Stem Cells Later

SOUTH SAN FRANCISCO, CA--(Marketwire -03/21/12)- 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, and Vala Sciences, Inc., a biotechnology company developing and selling next-generation cell image-based instruments, reagents and analysis software tools, have entered into a strategic collaboration. Their goal is to advance drug safety screening methodologies in the most clinically relevant human in vitro bioassay systems available to researchers today.

Cardiomyocytes are the muscle cells of the heart that provide the force necessary to pump blood throughout the body, and as such are the targets of most of the drug toxicities that directly affect the heart. Many of these drug toxicities result in either arrhythmia (irregular, often fatal, beating of the heart) or reduced ability of the heart to pump the blood necessary to maintain normal health and vigor.

"Our collaboration with Vala directly supports the core drug rescue applications of our Human Clinical Trials in a Test Tube platform," said Shawn K. Singh, JD, VistaGen's Chief Executive Officer. "Our high quality human cardiomyocytes combined with Vala's high throughput electrophysiological assessment capabilities is yet another example of how we are applying our stem cell technology platform within a strategic ecosystem of complementary leading-edge companies and technologies. We seek to drive our drug rescue programs forward and generate a pipeline of new, cardiosafe drug candidates."

Through the collaboration, Vala will use its Kinetic Image Cytometer platform to demonstrate both the suitability and utility of VistaGen's human pluripotent stem cell derived-cardiomyocytes for screening new drug candidates for potential cardiotoxicity over conventional in vitro screening systems and animal models. VistaGen's validated human cardiomyocyte-based bioassay system, CardioSafe 3D, will permit Vala to demonstrate the quality, resolution, applicability and ease of use of its new instrumentation and analysis software to make information-rich, high throughput measurements and generate fundamentally new insights into heart cell drug responses. Accurate, sensitive and reproducible measurement of electrophysiological responses of stem cell-derived cardiomyocytes to new drug candidates is a key element of VistaGen's CardioSafe 3D drug rescue programs. VistaGen's strategic collaboration with Vala is directed towards this goal.

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 (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. 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, bringing human biology to the front end of the drug development process.

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 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.

About Vala Sciences

Vala Sciences is a San Diego-based biotechnology company that develops and sells cell-image-based instrumentation, reagents and analysis software tools to academic, pharmaceutical and biotechnology scientists. Vala's IC 200 class of instrumentation, and CyteSeer Automated Image Cytometry software convert labor-intensive qualitative observations of biological changes that can take from days to months, into accurate measurements delivered automatically in minutes.

Cautionary Statement Regarding Forward Looking Statements

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VistaGen Therapeutics Enters Strategic Drug Screening Collaboration With Vala Sciences

SAN DIEGO, CA--(Marketwire -03/21/12)- Entest BioMedical Inc. (OTCQB: ENTB.PK - News) (Pinksheets: ENTB.PK - News)

Entest BioMedical Inc. (OTCQB: ENTB.PK - News) (Pinksheets: ENTB.PK - News) and RenovoCyte LLC announced they have treated 8 canine patients of a 10 dog pilot study utilizing Canine Endometrial Regenerative Cells (CERC) licensed from Medistem Inc. (Pinksheets: MEDS.PK - News) in the treatment of canine osteoarthritis.

Previously, Entest announced the treatment of the first canine patient on November 18, 2011. Since that time Entest's McDonald Animal Hospital has treated 8 dogs in its 10 Dog Pilot Study with RenovoCyte. To date, all of the dogs participating in this study have shown dramatic improvement in their mobility and apparent reduction of pain.

Dr. Greg McDonald, Chief Veterinarian at McDonald Animal Hospital, said, "50 million CERC stem cells have been injected intravenously into eight dogs. Each dog selected for this study showed signs of arthritis. Follow-up blood tests, urinalysis and physical exams are now being scheduled for the patients that have already been treated. So far, all these canine patients have shown improvement."

Entest BioMedical Chairman David Koos stated, "Osteoarthritis is considered one of the most common causes of lameness in dogs, occurring in up to 30% of all dogs. It is caused by a deterioration of joint cartilage, followed by pain and loss of range of motion of the joint. We expect this treatment to relieve these animals from the pain associated with arthritis. This has extraordinary possibilities for dogs and may lead the way for human treatment of arthritic pain."

The CERC is a "universal donor" stem cell product that does not require matching with the recipient allowing for the generation of standardized products that can be delivered to the office of the veterinarian ready for injection. This is in stark contrast to current stem cell therapies utilized in veterinary applications which require the extraction, manipulation, and subsequent implantation of tissue from the animal being treated. CERC is the canine equivalent of Medistem's Endometrial Regenerative Cell (ERC). Medistem was recently granted approval from the FDA to initiate a clinical trial in human patients using its ERCs.

"We are extremely pleased with our research relationship with Entest BioMedical. This study of canine pets suffering from naturally occurring osteoarthritis is a better test model than laboratory induced disease because it will give us the opportunity for long term follow up of these patients. RenovoCyte sees this study as part of the supporting documentation that will be needed to obtain FDA approval for widespread usage of this therapy," said Shelly Zacharias, DVM, Director of Veterinary Operations, RenovoCyte, LLC.

A spokesperson for Entest noted the Company is also currently conducting a 10 dog safety study on its immune-therapeutic cancer vaccine for dogs, having treated 3 dogs so far.

About Entest BioMedical Inc.:Entest BioMedical Inc. (http://www.entestbio.com) is a veterinary biotechnology company focused on developing therapies that harness the animal's own reparative / immunological mechanisms. The Company's products include an immuno-therapeutic cancer vaccine for canines (ImenVax). ImenVax is less invasive and less traumatic in treating cancer. Additionally, the Company serves as the contract research organization conducting a pilot study on a stem cell based canine osteoarthritis treatment (developed by RenovoCyte LLC) utilizing a 'universal donor' stem cell. Entest is also building a network of veterinary hospitals (with its initial location in Santa Barbara, CA and anticipates acquiring other veterinary hospitals in California) -- which serve as distribution channels for its products.

DisclaimerThis news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

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Entest BioMedical Excited With Progress on 10 Dog Pilot Study of "Universal Donor" Stem Cell Treatment for Canine ...

TUESDAY, March 20 (HealthDay News) -- A novel technique that uses a kidney transplant recipient's own stem cells may someday replace or reduce the initial use of anti-rejection medications, new research suggests.

Six months after receiving a kidney transplant, only about 8 percent of people given their own mesenchymal stem cells experienced rejection compared with almost 22 percent of people on the standard anti-rejection drugs, according to the study.

"Mesenchymal stem cells are stem cells that can be differentiated into a variety of cells," explained Dr. Camillo Ricordi, study senior author and director of the Cell Transplant Center and Diabetes Research Institute at the University of Miami Miller School of Medicine.

"If you infuse mesenchymal stem cells at the time of the transplant, you could replace the use of powerful anti-rejection drugs, and maybe replace immunosuppressants altogether," he said. This technique could be used in the transplantation of islet cells (in the pancreas) for people with type 1 diabetes, and for other organ transplants, such as the liver, he added.

The people given their own stem cells also had improved kidney function earlier after transplant, Ricordi said.

Results of the study appear in the March 21 issue of the Journal of the American Medical Association.

One of the biggest remaining hurdles in organ transplantation remains the need for powerful anti-rejection and immune-suppressing medications after the transplant.

"Basically, the way we prevent kidney rejections is by putting you on very powerful anti-rejection drugs and immunosuppressive agents to prevent your cells from attacking the foreign organ," said Dr. Robert Provenzano, chair of the department of nephrology, hypertension and transplantation at St. John Providence Health System in Detroit. "But, the current standard has some problems, like an increased risk of infections and the possibility of creating a cancer."

The body's immune system sends out surveillance cells to protect the body against foreign invaders, such as a bacteria, virus or, in this case, a new organ, Provenzano said. The current method of preventing these cells from attacking the new organ is essentially to destroy the surveillance cells. But mesenchymal cells can naturally suppress those surveillance cells so they don't attack, he said.

To see if this suppression would be enough to prevent rejection, Ricordi and his colleagues, including researchers from Xiamen University in China, recruited 159 people with serious kidney disease who were on dialysis. They ranged in age from 18 to 61.

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Stem Cell Therapy Could Boost Kidney Transplant Success: Study

Editor's Choice Academic Journal Main Category: Huntingtons Disease Also Included In: Stem Cell Research Article Date: 19 Mar 2012 - 10:00 PDT

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However, according to a study published March 15 in the journal Cell Stem Cell, a special type of brain cell created from stem cells could help restore the muscle coordination deficits that are responsible for uncontrollable spasms, a characteristic of the disease. The researchers demonstrated that movement in mice with a Huntington's-like condition could be restored.

Su-Chun Zhang, a University of Wisconsin-Madison neuroscientist and the senior author of the study, said:

In the study Zhang, who is an expert in creating various types of brain cells from human embryonic or induce pluripotent stem cells, and his team focused on GABA neurons. The degradation of GABA cells causes the breakdown of a vital neural circuit and loss of motor function in individuals suffering from Huntington's disease.

According to Zhang, GABA neurons generate a vital neurotransmitter, a chemical that helps support the communication network in the brain that coordinates movement.

Zhang and his team at the UW-Madison Waisman Center, discovered how to generate large quantities of GABA neurons from human embryonic stem cells. The team's goal was to determine whether these cells would safely integrate into the brain of a mouse model of Huntington's disease.

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Huntington's Disease - Stem Cell Therapy Potential

MOUNTAIN VIEW, Calif., March 20, 2012 /PRNewswire/ -- SanBio Inc. today announced the successful enrollment of the first dose cohort of patients in its Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries. The first 6 patients, of a total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been reported. For details regarding this clinical trial, please refer to http://www.strokeclinicaltrial.org.

SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine", said Keita Mori, SanBio CEO. "We are pleased to learn that the initial dose level was well tolerated."

SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.

"The successful completion of the initial dose cohort is a major step in any first-in-human study", said Dr. Ernest Yankee, SanBio's Vice President of Development. "We are looking forward to initiating the next two dose cohorts and wrapping up the study. The safety findings thus far are very encouraging"

About SB623: SB623 is a proprietary cell therapy product consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.

About SanBio: SanBio is a privately held San Francisco Bay Area biotechnology company focused on the discovery and development of new regenerative cell therapy products.

For more information: http://www.san-bio.com

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SanBio Announces Enrollment of First Cohort of Patients in Its Clinical Trial of Stem Cell Therapy for Chronic Stroke

A special dog used to help people is getting some much-needed help of her own at a Virginia clinic, myFOXdc.com reported.

Red, a 12-year-old black Labrador, is one of the last surviving search and rescue dogs deployed during the 9/11 attacks.

Her handler, Heather Roche, told WTTG-TV that Red was recently certified when Sept. 11, 2001, occurred, and the devastating terror attacks were her first big mission.

Red's job was to find DNA evidence at The Pentagon's north parking lot with 26 other dogs, and according to Roche, she did a "fantastic job."

"I got her as a puppy ... You have to convince [her] everything that she does, whether it's climbing ladders or any kind of search, that it's her idea," Roche told WTTG-TV. "No matter what I've asked her to do, she's done it and she's done it flawlessly."

But in her old age Red developed crippling arthritis, and underwent stem cell regenerative therapy Monday to help ease her pain so she can get back out on the job.

Dr. John Herrity of Burke Animal Clinic in Burke, Va., told WTTG-TV, "Red has a back issue that, after a fall from a ladder has not really been right, and has been living in pain, so we're going to give those stem cells IV [intravenously] and then also inject them along the back to try to help Red's comfort."

"She's had a great career and has made a difference to a lot of families by bringing their loved ones home," Roche said.

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9/11 search and rescue dog receives stem cell therapy

GOLDEN, Colo., March 20, 2012 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (OTCQB:VODG.PK - News), dba Vitro Biopharma, has recently received approval for its presentation entitled "GMP Cell Culture Media for Expansion of MSCS Prior to Allogeneic or Autologous Transplantation." The Company recently expanded its stem cell media products to include clinical grade MSC-Gro(TM) media for use in clinical trials of stem cells. The Company will present its current findings at the annual meeting of the International Society of Cellular Therapy (ISCT) in Seattle, Washington this coming June. To get more information regarding the International Society of Cellular Therapy visit http://www.celltherapysociety.org/

Vitro Biopharma has developed a series of products to support clinical application of adult stem cells known as mesenchymal stem cells (MSCs) that are completely divorced and different from ethically contentious embryonic stem cells. MSCs are derived from numerous adult tissue sources including bone marrow, blood, adipose tissue, teeth, etc and show considerable promise in clinical applications especially for treatment of injury and diseases affecting joints, bone, ligaments and tendons. There are over 200 ongoing clinical trials of MSCs to study potential treatment of diabetes, Parkinson's disease, organ transplant rejection, osteoarthritis, MS, spinal cord injury, stroke, myocardial infarction, cardiovascular disease, liver degeneration, COPD and other medical conditions.

Vitro Biopharma will present the current status of its clinical grade MSC-Gro(TM) Brand of culture medium for growth and differentiation of MSCs at the ISCT meeting. Through its extensive research and experience with cell culture media, Vitro Biopharma has developed highly competitive media that is suitable for clinical applications. Critical characteristics are that they are serum-free, chemically-defined and free from animal-derived components. Furthermore, it is essential that serum-free media perform the same as formulations containing contain blood serum, a complex mixture of biologically active components with intrinsic variability from batch to batch and safety issues regarding potential infectious agents. Vitro will present its results regarding each of these points and the status of FDA approval of its clinical products.

Dr. Jim Musick, Vitro's President & CEO, said, "We are very pleased to be approved for presentation at the ISCT Annual Meeting. It is apparent from the reported widespread efficacy of MSCs in clinical trials and the low incidence of adverse effects that there is potential to achieve regulatory approval for advanced treatment of many diseases, injuries and cellular degenerative conditions. Our new clinical products expand our offering of tools to support stem cell research by providing highly competitive new products for clinical studies including our serum-free, animal-free and chemically defined MSC-Gro(TM) Brand of media formulations optimized for human MSC self-renewal & lineage-specific differentiation, together with LUMENESC(TM) high performance assays of stem cell quality, potency and response to toxic agents. We intend to leverage our current advances in human medical MSC-based treatments to offer products for treatment of horses, dogs and cats. The results of MSC therapy in animals may also provide safety and efficacy data to support human clinical studies."

About Vitro Diagnostics, Inc.

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG.PK - News) (http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, MSC-Gro(TM) optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix(R), Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute LUMENESC(TM) and LumiSTEM(TM) quantitative assays for determination of stem cell quality, potency and response to toxic agents.

The Vitro Biopharma logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12086

Safe Harbor Statement

Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.

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Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy

NEW YORK, March 20, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company") is a leader in the cell therapy industry, developing cell based therapeutics supported by the Company's expertise in contract manufacturing. This strategic combination and depth of experience in cell therapy development and manufacturing provide NeoStem with unique capabilities to develop its own cell therapies and that sets the Company apart from others in the cell therapy landscape. 2011 represented a major year of strategic transition for NeoStem, and the Company plans to build upon that in 2012 and in the years ahead.

NeoStem reported its audited results for 2011. Consolidated revenues for the year ended December 31, 2011 were $73.7 million compared to $69.8 million for 2010. The Company's consolidated net loss for 2011 was $56.6 million, which included $10.3 million of non-cash equity-based compensation expense, $19.4 million of goodwill impairment charges and $9.0 million of depreciation and amortization. Overall, the Company's consolidated cash loss for 2011 was $15.5 million (see reconciliation below). Net loss attributable to NeoStem common shareholder interests for 2011 was $47.8 million, or $0.54 per share.

As of December 31, 2011, the Company had consolidated cash and cash equivalents of $12.7 million, and an additional $2.5 million in cash held in escrow (classified in Other Assets).

NeoStem believes that the opportunities that exist today in cell therapy are robust and growing despite a persistently difficult financial environment, making this an opportunistic time to pursue the monetization of the Company's 51% ownership of Suzhou Erye Pharmaceutical Co., Ltd. and bolster its cell therapy business. In June 2011, the Company engaged a financial advisor to lead the effort to pursue the possible divestiture of the Company's interest in Erye. Marketing efforts are underway and have generated interest from both financial and strategic buyers.

On the therapeutics side of the business NeoStem now has a pipeline of assets that includes Amorcyte (Phase 2 trial for preservation of heart function after a heart attack), Athelos (physician sponsored Phase 1 trials for a range of auto-immune conditions) and pre-clinical development work on its VSEL(TM) technology. The Company's most advanced asset is AMR-001 for the treatment of acute myocardial infarction for which enrollment for a Phase 2 study in the United States commenced in January. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction ("STEMI") with ejection fraction less than or equal to 48%. The study will include 160 subjects, age 18 and older, randomized 1:1 between treatment and control. The manufacturing, product supply, and logistics for the trial will be supported by Progenitor Cell Therapy, LLC, NeoStem's contract manufacturing company.

Amorcyte currently has ten activated clinical trial sites for its Phase 2 AMI clinical trial with the initial patients enrolled. Trial enrollment is expected to be completed in approximately one year with data read out six months following the last treated patient. The Amorcyte franchise is supported by a strong patent portfolio which includes both composition of matter and methods of treatment around use of these hematopoietic stem cells for treatment of cardiac ischemia and other ischemic tissue that result from vascular insufficiency. The Company sees Amorcyte as a pipeline of therapeutics with potential in multiple indications from STEMI to congestive heart failure and other related vascular insufficiencies. The Amorcyte product addresses both an unmet medical need and a large potential market.

"One of the most important attributes of AMR-001 is that it's 'natural.' We are enhancing the body's normal and natural response to ischemic injury," said Dr. Robin Smith, CEO of NeoStem. "Ample historical evidence, published literature and our own compelling Phase 1 data give us confidence that this product will ultimately make it to the marketplace. Our next most advanced asset is held by Athelos Corporation, (a NeoStem company, partnered with Becton, Dickinson and Company) which is developing a novel T-cell platform for immunological disorders. The Athelos T-cell technology represents an innovative approach to restoring immune balance with potential applications in graft vs. host disease (GvHD), solid organ transplant (SOT) and autoimmune diseases, such as asthma and diabetes. Multiple physician sponsored phase 1 studies are expected to report results that will be used to determine the direction of clinical development.

"NeoStem is also developing pre-clinical assets, including its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today. These activities have received awards in excess of $2.5 million which funds support the work of prestigious researchers who are pioneering this science with NeoStem.

"Behind the development of these therapeutic assets is the NeoStem cell therapy contract manufacturing business (PCT) which itself continues to grow. New clients have engaged PCT to assist them in the development of their products, including a global, diversified healthcare company who recently selected PCT to provide stem cell processing in our two GMP manufacturing facilities in the United States (California and New Jersey). PCT's prominence in the marketplace continues to grow and that is reflected by both client satisfaction and the revenues the company generates.

"As we look to the year ahead, we are excited on multiple fronts. Our capital preservation efforts are now bearing fruit as our cash burn rate is in-line with our peers. We expect to continue to carefully invest our capital in projects that meet our internal rate of return hurdle and risk parameters. We believe the PCT and Amorcyte acquisitions have created true value for our shareholders and we look forward to demonstrating that as these assets reach their respective value inflection points. We see the unmet medical need in cardiology and the treatment burden associated with chronic diseases as representing a significant challenge to modern society. We believe that cell therapy holds many of the solutions to the health crisis that societies face and have the potential to create real pharmacoeconomic benefit as well as shareholder value for our company.

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NeoStem Provides Updates and Reports Year End Results

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

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Box encapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Box technology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our companys ultimate clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilexs ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena

(MENAFN - Arab Times) Ministry of Health (MoH) employees holding PhD degrees announced that they will participate in the sit-in demonstration carried out by the Labor Union of Health Ministry, reports Al-Seyassah daily.

In the press release, they said they are protesting against the fact that they are receiving the same salary scale and benefits as any other ministry employee with lower qualifications and if necessary, they are ready to even burn their PhD certificates at the sit-in to get the benefits they deserve according to their qualifications.

The sit-in will be carried out in front of Health Ministry headquarters in Sulaibikhat at 10 am on Tuesday, March 20, 2012.

The number of PhD holders has exceeded 100 considering the participation of PhD holders from other ministries as well.

Meanwhile, the MoH has banned stem cell therapy in the country until the committee tasked to set the standards for the treatment completes its work, reports Al-Anba daily quoting Director of Health License Department Dr Marzouq Al-Bader.

Al-Bader disclosed the ministry had earlier formed the committee to ensure the stem cell procedures are carried out in an appropriate manner to protect the patients. He added the ministry will also issue a decision soon to regulate the use of antibiotics in the private health sector.

Meanwhile, Al-Bader confirmed the ministry has endorsed around 51,000 female doctors in private hospitals and health centers. He said the ministry closely monitors the performance of female doctors and those found to have violated the law will be referred to the Medical Council for the necessary action.

On the issuance of licenses through the Internet, Al-Bader revealed his department has asked the ministry to activate the e-link system for this purpose.

He said the ministry has asked the Kuwait Municipality to issue permit for the construction of a building fit for the department's operations.

Meanwhile, the Medical Emergency Department at the Ministry of Health has affirmed its readiness to deal with emergency cases that may arise due to a series of dust storms engulfing the country.

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Stem cell therapy banned in Kuwait

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

EDMONDS, Wash., March 14, 2012 /PRNewswire/ --Washington Center for Pain Management is participating in a nationwide FDA-cleared adult stem cell study testing novel treatment for chronic low back pain and has enrolled its first patient. The study will test the use of Mesenchymal Precursor Cells (MPCs) adult stem cells derived from bone marrow that will be directly injected into the lumbar disc. The minimally invasive procedure may offer an alternative to back surgery for eligible patients with chronic pain from degenerative discs.

An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

Most patients with low-back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion -- removal of the degenerated discs and the fusion of the bones of the spine -- is necessary. However, these surgeries often are not entirely effective.

"Millions of Americans are debilitated by chronic low back pain," says Dr Hyun Joong Hong MD, the lead investigator at The Washington Center for Pain Management. "This promising therapy is at the cutting edge of medical science and has the potential to create a paradigm shift in our approach to minimally invasive solutions to this disease."

Researchers will enroll approximately 100 study participants. About fifteen participants will be enrolled at The Washington Center for Pain Management and the rest at 11 other medical centers throughout the United States. The trial is scheduled to last for three years.

Washington Center for Pain Management is enrolling study participants suffering from moderate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

Once enrolled, patients are randomly assigned to one of four treatment groups:

Patients will receive a single injection of their assigned test agent directly into the center of the target discs within their spine and will be monitored for safety. Patients will also be monitored using imaging to identify any changes in their disease condition or disease progression. Use of pain medications, self-reports of pain, subsequent surgical interventions and assessments of disability, quality of life, productivity and activity will be evaluated. Repair of the disc and reduction of chronic back pain will be assessed in each patient.

Promising results have been observed in prior research using animal models when stem cells were investigated for the repair of damaged spine discs. The cells were well tolerated in these study animals.

This study is sponsored by Mesoblast Limited, a world leader in the development of biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). The MPCs are derived from young adult donors' bone marrow and are immune tolerant.

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Washington Center for Pain Management Begins Enrollment in United States Stem Cell Therapy Study in Subjects With ...

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law.

In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.

"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."

An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.

Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients.

Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back surgery in July.

The plan by Celltex and Perry to make Texas a leader in the therapy have been controversial since details about the governor's procedure became known last summer. The therapy, drawing on the ability of adult stem cells to replenish dying cells, is promising but thought by most medical researchers to need much more clinical study before it is commercialized.

Stem cells are a kind of medicine known as biologics, therapy involving living cells rather than chemicals. Most medical experts say that adult stem-cell therapy involves more than the "minimal manipulation" the agency allows without its oversight because the cells are isolated, cultured in a laboratory and stored for some period of time before being reinjected.

The FDA has recently stepped up enforcement of unregulated adult stem cell activity, though legal experts interviewed last fall by the Chronicle said it was unclear whether the agency would look into Perry's procedure because he seemed fully informed and unharmed by it.

The Texas Medical Board is currently considering a policy that would require providers of stem cells and other experimental drugs to use them only with the permission of independent review committees that assess trials for patient safety. The policy comes up for final approval in April.

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Perry's stem-cell firm draws FDA scrutiny

12-03-2012 17:41 Dr.Mark Newkirk is once again on the cutting edge of medicine. Newkirk Family Veterinarians now offer STEM CELL THERAPY for pets. Dr. Mark Newkirk combines traditional medicine and surgery with Holistic Alternatives to access the best of both worlds. As a Veterinarian, Dr. Newkirk has been serving Southern New Jersey for over 25 years. He is extensively trained in medicine and surgery and also is skilled in the care of exotic pets such as reptiles and birds. Dr. Newkirk is also one of only 5 doctors in the country currently undergoing training by the nationally renowned Dr. Martin Goldstein, the author of "The Nature of Animal Healing", and founder of immuno-augmentative therapy for animals, a true alternative cancer therapy. Dr. Newkirk is a member of American Holistic Veterinary Medical Society, the American Veterinary Medical Association, New Jersey Veterinary Medical Association and the Colorado Veterinary Medical Association. For more information check out Stem Cell Therapy on The Animal Planet's dogs 101 http://www.youtube.com

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Stem Cell Therapy at Newkirk Family Veterinarians - Hunter's Story - Video

12-03-2012 21:11 by:www.medicaltourism.hk

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Chia medical tourism--stroke--stem cell therapy 3.flv - Video

12-03-2012 20:48 by:www.medicaltourism.hk

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Chia medical tourism--stroke--stem cell therapy 1.flv - Video

(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.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

Originally posted here:
Patient dies during procedure

(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.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

See original here:
Doctor accused of illegal stem cell therapy suspended

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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Kidney transplant without a lifetime of drugs?

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 1:34 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 treatment on an elderly patient who died during the procedure.

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

According to the license suspension order, Grekos performed a stem cell treatment earlier 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's activities in 2009 and, at that time, he said he was using stem cell therapy for a company he 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 claimed would help heal crippling diseases, mostly associated with lung problems.

See the article here:
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 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

WASHINGTON, DC--(Marketwire -03/05/12)- The Alliance for Regenerative Medicine issued the following statement today: "An article about stem cell treatments taking place in Texas published by Nature last week is extremely troubling. The article suggests that patients are being administered stem cell treatments that have not been systematically demonstrated to be safe and effective therapies through the established FDA regulatory process.

"Cell therapy treatments, including those using adult stem cells, hold the promise of providing patients with treatments and cures for numerous diseases and disabilities. However, FDA regulation is key to ensuring that the treatments available to patients are safe and effective.

"The Alliance for Regenerative Medicine (ARM), a non-profit organization whose mission is to promote increased funding and development of regenerative medicine products, believes cell therapy and regenerative medicine products, including autologous cell therapy products, must go through the rigorous safety testing that is part of the FDA regulatory process before they can be marketed to the public. These regulations are designed to promote safe collection, manufacture, storage, and use of human cells, and cellular and tissue based products. ARM members comply with these rules because they know that FDA oversight helps to prevent patients from exposure to potentially unsafe products.

"We urge all companies developing stem cell treatments to follow FDA rules governing research and product development. ARM remains committed to working with all stakeholders to ensure that safe and effective products reach patients as soon as possible."

About The Alliance for Regenerative Medicine (ARM) The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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The Alliance for Regenerative Medicine Statement on Use of Cell Therapies Not Approved by the Federal Drug ...