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Archive for the ‘Cell Therapy’ Category

Stem Cells May Help Regenerate Heart Muscle

Tuesday, February 14th, 2012

A promising stem cell therapy approach could soon provide a way to regenerate heart muscle damaged by heart attacks.

Researchers at Cedars-Sinai Heart Institute and The Johns Hopkins University harvested stem cells from the hearts of 17 heart attack patients and after prepping the cells, infused them back into the patients' hearts. Their study is published in the current issue of The Lancet.

The patients received the stem cell infusions about three months after their heart attacks.

Researchers found that six months after treatment, patients had significantly less scarring of the heart muscle and also showed a considerable increase the amount of healthy heart muscle, compared to eight post-heart attack patients studied who did not receive the stem cell infusions. One year after, scar size was reduced by about 50 percent.

"The damaged tissue of the heart was replaced by what looks like healthy myocardium," said Dr. Peter Johnston, a study co-author and an assistant professor of medicine at The Johns Hopkins University School of Medicine. "It's functioning better than the damaged myocardium in the control subjects, and there's evidence it's starting to contract and generate electrical signals the way healthy heart tissue does."

While this research is an early study designed to demonstrate that this stem cell therapy is safe, cardiologists say it's an approach that could potentially benefit millions of people who have suffered heart attacks. Damage to the heart muscle is permanent and irreparable, and little can be done to compensate for loss of heart function.

"In the U.S., six million patients have heart failure, and the vast majority have it because of a prior heart attack," said Johnston.

The damaged scar tissue that results from a heart attack diminishes heart function, which can ultimately lead to enlargement of the heart.

At best, Johnston said, there are measures doctors can try to reduce or compensate for the damage, but in many cases, heart failure ultimately sets in, often requiring mechanical support or a transplant.

"This type of therapy can save people's lives and reduce the chances of developing heart failure," he said.

Cardiac Regeneration A Promising Field

Other researchers have also had positive early results in experiments with stem cell therapy using different types of cells, including bone marrow cells and a combination of bone marrow and heart cells.

"It's exciting that studies using a number of different cell types are yielding similar results," said Dr. Joshua Hare, professor of cardiology and director of the University of Miami Interdisciplinary Stem Cell Institute.

The next steps, he said, include determining what the optimal cell types are and how much of the cells are needed to regenerate damaged tissue.

"We also need to move to larger clinical trials and measure whether patients are improving clinically and exhibiting a better quality of life after the therapy."

In an accompanying comment, Drs. Chung-Wah Siu amd Hung-Fat Tse of the University of Hong Kong wrote that given the promising results of these studies, health care providers will hopefully recognize the benefits that cardiac regeneration can offer.

And Hare added that someday, this type of regeneration can possibly offer hope to others who suffered other types of organ damage.

"This stategy might work in other organs," he said. "Maybe this can work in the brain, perhaps for people who had strokes."

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VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates

Tuesday, February 14th, 2012

SOUTH SAN FRANCISCO, CA--(Marketwire -02/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has identified its initial Top 10 drug rescue candidates and plans to launch two formal drug rescue programs by the end of next quarter.

VistaGen's goal for each of its stem cell technology-based drug rescue programs is to generate and license a new, safer variant of a once-promising large market drug candidate previously discontinued by a pharmaceutical company no earlier than late-preclinical development.

"We are now at an advanced stage in our business model," said Shawn Singh, VistaGen's Chief Executive Officer. "After more than a decade of focused investment in pluripotent stem cell research and development, we are now at the threshold where game-changing science becomes therapeutically relevant to patients and commercially relevant to our shareholders. We have positioned our company and our stem cell technology platform to pursue multiple large market opportunities. We plan to launch two drug rescue programs by the end of the next quarter."

Over the past year, VistaGen, working with its network of strategic partners, identified over 525 once-promising new drug candidates that meet the Company's preliminary screening criteria for heart toxicity-focused drug rescue using CardioSafe 3D™, its human heart cell-based bioassay system. After internally narrowing the field to 35 compounds, VistaGen, working together with its external drug rescue advisors, including former senior pharmaceutical industry executives with drug safety and medicinal chemistry expertise, analyzed and carefully narrowed the group of 35 to the current Top 10.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during development due to heart toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.

Additionally, VistaGen's oral small molecule prodrug candidate, AV-101 (4-Cl-KYN), is in Phase 1b development for treatment of neuropathic pain. Unlike other NMDA receptor antagonists developed previously, AV-101 readily crosses the blood-brain barrier and is then efficiently converted into 7-chlorokynurenic acid (7-Cl-KYNA), one of the most potent and specific glycineB site antagonists currently known, and has been shown to reduce seizures and excitotoxic neuronal death. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. The Company anticipates pursuing Phase 2 development for neuropathic pain and other neurological indications, including depression, epilepsy, and/or Parkinson's disease in the event it receives additional non-dilutive development grant funding from the NIH or private foundations.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue activities, ongoing AV-101 clinical studies, its ability to enter into drug rescue collaborations and/or licensing arrangements with respect to one or more drug rescue variants, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variant identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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Dogs who got stem cell therapy are well

Tuesday, February 14th, 2012

WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.

Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.

Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.

This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.

Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.

"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."

Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.

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Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows

Tuesday, February 14th, 2012

February 14, 2012, 12:22 AM EST

By Ryan Flinn

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

--Editors: Angela Zimm, Andrew Pollack

-0- Feb/13/2012 22:32 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Vet offers stem cell therapy for dogs

Tuesday, February 14th, 2012

COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.

Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.

Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.

"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."

But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.

So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"

"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.

Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.

"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."

This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.

"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.

The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.

When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.

"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.

Copyright 2012 WIS. All rights reserved.

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Stem Cell Treatment Might Reverse Heart Attack Damage

Tuesday, February 14th, 2012

MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.

In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."

Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."

It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

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The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell …

Monday, February 13th, 2012

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell, said, "The JV is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor.”

Dr. Margolin continued, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine.”

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The company’s pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers such as leukemia and lymphoma, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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Stem Cells Therapy MS2.mp4 – Video

Friday, February 10th, 2012

09-02-2012 23:02 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 2 of 4

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Stem Cells Therapy MS1.mp4 – Video

Friday, February 10th, 2012

09-02-2012 22:12 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 1 of 4

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Stem Cells Therapy MS3.mp4 – Video

Friday, February 10th, 2012

09-02-2012 23:17 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 3 of 4

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Adult Stem Cell Treatments for COPD -Real patient results, USA Stem Cells- Leon B. Testimonial – Video

Thursday, February 9th, 2012

12-01-2012 07:24 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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Stem Cell Treatment – Video

Tuesday, February 7th, 2012

10-10-2011 16:05 http://www.StemCellTreatment.org is the #1 stem cell treatment and therapy center in the world. We have done over 8000 stem cell treatments. Stars like Danny Glover come to the American Stem Cell and Anti Aging Center. ASCAAC has done stem cell therapy for diabetes, heart disease, spinal injury, multiple sclerosis, autism and many other problems and diseases. Call 480 243 8859 and get your questions and concerns answered about stem cell treatment for whatever condition your need information on!

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Adult Stem Cell Treatments for COPD -Real patient results, USA Stem Cells- Donald W. Testimonial – Video

Tuesday, February 7th, 2012

20-12-2011 09:01 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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Stem Cell Treatment Fibromyalgia – Video

Tuesday, February 7th, 2012

07-11-2011 15:39 http://www.StemCellTreatment.org Salima had stem cell treatment for Fibromyalgia and had very good results. We have had great success with stem cell therapy for Fibromyalgia also known as FMS. Fibromyalgia symptoms include pain and tenderness in the joints, muscles and other soft tissue. Stem cell treatment for fibromyalgia is something that ASCAAC specializes in. Go to our website for more information and fill out the form or give us a call so we can answer your stem cell and fibromyalgia questions!

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Cell-based Therapy Research – Video

Tuesday, February 7th, 2012

10-01-2012 17:54 Cell-based therapy research at Swedish Heart and Vascular Institute is quintessential to medical advancement. Medical director Dr. Paul P. Huang researches stem cell therapy pertaining to cardiovascular disease. He provides an historical perspective of stem cell research and explains how stem cells can help cardiovascular patients avoid surgery and improve their quality of life. Dr. Huang believes that regenerative medicine is medicine's next frontier. For more information visit http://www.swedish.org

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stem cell therapy mexico, Successfully Results – Video

Friday, February 3rd, 2012

23-11-2011 02:11 For instance, neural cells in the brain and spinal cord that have been damaged can be replaced by stem cells. In the treatment of cancer, cells partially damaged by radiation or chemotherapy can be replaced with new healthy stem cells that adapt to the affected area, whether it be part of the brain, heart, liver, lungs, or wherever. Dead cells of almost any kind, no matter the type of injury or disease, can be replaced with new healthy cells thanks to the amazing flexibility of stem cells.

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CORRECTING and REPLACING Leading Global Cell Therapy Organizations Support U.S. Department of Justice Appeal of Ruling …

Thursday, February 2nd, 2012

MINNEAPOLIS--(BUSINESS WIRE)-- Please replace the release dated January 23, 2012 with the following corrected version due to multiple revisions.

The corrected release reads:

LEADING GLOBAL CELL THERAPY ORGANIZATIONS SUPPORT U.S. DEPARTMENT OF JUSTICE APPEAL OF RULING ON DONOR COMPENSATION

Coalition says PBSC donor compensation poses health risks to patients and donors

A coalition of eight leading international health organizations today issued a statement supporting the U.S. Department of Justice’s appeal of the Ninth Circuit Court ruling that allows certain marrow donors to be compensated. Filed Jan. 17, the Justice Department’s appeal cites the potential for serious health risks to patients and donors if the ruling stands.

Approximately 5,000 patients each year in the United States receive marrow transplants from unrelated donors to treat leukemia, lymphoma and a number of other diseases. The marrow is a source of stem cells that are critical to restoring the immune system for these patients. Two techniques are used to extract these stem cells. The first draws marrow directly from the donor’s hip bone and the second moves the stem cells out of the bone marrow and into the bloodstream using a stimulating hormone, and then collects peripheral blood stem cells (PBSCs) in a procedure similar to the collection of platelets from blood donors.

Since 1984, the National Organ Transplant Act (NOTA) has banned payment for all marrow stem cell donations. However, a Dec. 1, 2011, Ninth Circuit Court of Appeals ruling legalized compensation for PBSC donations, but upheld the ban on compensation for marrow donation through aspiration.

“The world’s leading cell therapy organizations oppose compensating people who sell their stem cells, however collected, and believe the Ninth Circuit made an erroneous distinction between marrow stem cells extracted directly from bone or from blood,” said Jeffrey W. Chell, M.D., chief executive officer of the National Marrow Donor Program® (NMDP), a coalition member that operates the Be The Match Registry®, the world’s largest listing of volunteer marrow donors. “We fully support the Justice Department’s decision to protect patients and their donors by challenging the ruling. Those motivated by self-gain are more likely to withhold health information that would make them unsafe donors. The blood banking experience in the United States shows that this results in donations that are unacceptable from a clinical standpoint.”

The coalition includes the nonprofit NMDP, the World Marrow Donor Association, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society of Histocompatibility and Immunogenetics, International Society of Cellular Therapy and The Transplantation Society. Those seeking to overturn the ban against selling stem cells argue that payment for donors might increase patients’ access to bone marrow; however, the coalition asserts the opposite is true.

Paying for stem cells also would mean the U.S. no longer follows standards recognized throughout developed countries in Europe and Asia, which use volunteer donors in cell therapies. As a result, patients may not be able to use the worldwide search process. These international partnerships are vital to helping increase patients’ access to potential donors. In 2011, nearly half of the transplants facilitated by the NMDP involved either an international donor or patient.

The coalition cites the following reasons in its position against donor compensation:

Protecting Recipient and Donor Safety
A complete and truthful health history is critical to ensure that individuals are eligible to donate and that donated cells are free from infectious diseases. There is substantial scientific evidence that people wanting to sell their blood or body parts are more likely to withhold medical details and information that could harm patients. Ensuring Physicians’ Ability to Provide Quality Care
The decision of whether the donation occurs through the traditional method of bone marrow extraction or PBSC donation should be based on the best clinical judgment of the patient’s physician and will vary from patient to patient. While the donor always has the last say on whether and how to donate, PBSCs may not be in the best interests of the patient in many cases. Paying for PBSCs may cause donors to choose this method instead of a marrow extraction recommended by the recipient’s physician. Maintaining Altruistic Motivations
Compensating donors could deter those who are willing to donate for purely altruistic reasons. The more than 9.5 million members of the Be The Match Registry, as well as an additional 9 million potential donors available on international registries, are proof positive that people do not need financial incentive to save a life. Avoiding the Creation of Markets in Marrow Donation
Patients may promote donor drives with the promise of compensation, appealing to those with financial need, and not fully disclose the risks associated with the donation. For profit organizations also have an incentive to exploit their donors over a patient’s unique needs. In addition, markets put physicians in the morally dubious position of carrying out medical procedures solely for monetary profit.

For these reasons, the members of the coalition remain opposed to the selling of stem cells.

About the Coalition
The coalition includes the NMDP, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society for Histocompatibility and Immunogenetics, International Society of Cellular Therapy, The Transplantation Society, and the World Marrow Donor Association.

About the National Marrow Donor Program®(NMDP)
The National Marrow Donor Program (NMDP) is the global leader in providing marrow and umbilical cord blood transplants to patients with leukemia, lymphoma and other diseases. The nonprofit organization matches patients with donors, educates health care professionals and conducts research so more lives can be saved. The NMDP also operates Be The Match®, which provides support for patients, and enlists others in the community to join the Be The Match Registry® – the world’s largest listing of potential marrow donors and donated cord blood units – contribute financially and volunteer. For more information, visit marrow.org or call 1 (800) MARROW-2.

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BioRestorative Therapies to Present at 7th International Conference on Cell Therapy for Cardiovascular Disease

Saturday, January 28th, 2012

JUPITER, Fla., Jan. 23, 2012 /PRNewswire/
-- BioRestorative Therapies, Inc. (OTCQB: BRTX.PK[1] -
News[2])
("BRT") today announced that it will be presenting at the
Seventh International Conference on Cell Therapy for
Cardiovascular Disease. The event, being held at the New
York-Presbyterian Hospital/Columbia University Medical Center,
is a two-and-a-half-day conference dedicated to the evolving
field of cell-based therapies for the repair and regeneration
of cardiac and vascular disease.

Dr. Amit Patel, Director of Clinical Regenerative Medicine and
Tissue Engineering at the University of Utah and a member of
the BRT Scientific Advisory Board, will be presenting his
findings relating to brown fat stem cells and metabolic
disorders (one of BRT's stem cell initiatives). His talk,
entitled "Metabolic Syndrome: A Role For Cell Therapy,"
will be on Wednesday, January 25th at 1:50 PM.

Mark Weinreb, Chairman and CEO of BRT, has also been selected
to serve on an industry panel and will discuss BRT's
ThermoStem™ Program and the use of brown fat stem cells
as potential therapeutics.  The session will be held on
Thursday, January 26th from 3:15-4:15 PM.

BRT is involved in a research initiative focusing on the use of
Brown Fat stem cells to potentially treat metabolic disorders
and obesity that may lead to heart disease, diabetes,
hypertension, kidney disease and other diseases and disorders.

The Conference will take place January 25-27 at the Vivien and
Seymour Milstein Family Heart Center, Myrna L. Daniels
Auditorium, NYPH/Columbia University Medical Center, 173 Fort
Washington Avenue, First Floor, New York City.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc.'s goal is to become a medical
center of excellence using cell and tissue protocols, primarily
involving a patient's own (autologous) adult stem cells
(non-embryonic), allowing patients to undergo cellular-based
treatments. In June 2011, the Company launched a technology
that involves the use of a brown fat cell-based
therapeutic/aesthetic program, known as the ThermoStem™
Program
.  The ThermoStem™ Program will focus on
treatments for obesity, weight loss, diabetes, hypertension,
other metabolic disorders and cardiac deficiencies and will
involve the study of stem cells, several genes, proteins and/or
mechanisms that are related to these diseases and disorders. As
more and more cellular therapies become standard of care, the
Company believes its strength will be its focus on the unity of
medical and scientific explanations for clinical procedures and
outcomes for future personal medical applications.  The
Company also plans to offer and sell facial creams and products
under the Stem Pearls™ brand.

This press release contains "forward-looking statements" within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of
1934, as amended, and such forward-looking statements are made
pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. You are cautioned
that such statements are subject to a multitude of risks and
uncertainties that could cause future circumstances, events or
results to differ materially from those projected in the
forward-looking statements as a result of various factors and
other risks, including those set forth in the Company's Form
10, as amended, filed with the Securities and Exchange
Commission. You should consider these factors in evaluating the
forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in
this release are made as of the date hereof and the Company
undertakes no obligation to update such statements.

CONTACT:
Mark Weinreb
CEO
Tel: (561) 904-6070
Fax: (561) 429-5684

References

  1. ^ BRTX.PK
    (finance.yahoo.com)
  2. ^ News
    (finance.yahoo.com)

Read the rest here:
BioRestorative Therapies to Present at 7th International Conference on Cell Therapy for Cardiovascular Disease

Read More...

Senior Management of NeoStem and Its Subsidiaries Invited to Speak at Seventh International Conference on Cell Therapy …

Saturday, January 28th, 2012

NEW YORK, Jan. 23, 2012 /PRNewswire/ -- NeoStem,
Inc.
[1] (NYSE Amex:
NBS) ("NeoStem" or the "Company"), an international
biopharmaceutical company with a focus on cell-based
therapeutic development, today announced that its Chief Medical
Officer, the lead investigator for its PreSERVE Phase
2 clinical trial
[2] for AMR-001
for preservation of heart function in post acute myocardial
infarction patients, and the President of its subsidiary,
Progenitor Cell
Therapy, LLC
[3], have been
invited to present at the Seventh International Conference on
Cell Therapy for Cardiovascular Disease held from January
25-27, 2012 in New York City. The event is being organized by
the Cardiovascular Research Foundation and will be held at the
Myrna L. Daniels Auditorium in the Vivien and Seymour Milstein
Family Heart Center at NYPH/Columbia University Medical Center.

According to the conference, the program will be dedicated to
the evolving field of cell-based therapies being developed for
the repair and regeneration of cardiac and vascular disease, as
well as related diseases such as diabetes and stroke. This
year's conference will focus on preclinical and clinical
studies on the path to commercialization, highlighting the
status of molecular, cell, and tissue products in addition to
delivery systems. Leaders from the international community will
convene to present their work, experiences, observations, and
opinions on the benefits and unmet challenges of cell-based
therapies.

  • At 4:30 PM on Wednesday, January 25, Andrew L. Pecora, MD,
    FACP, Chief Medical Officer of NeoStem, will speak on an
    industry session entitled "Focus on Acute Injury Technologies."
  • At 9:20 AM on Thursday, January 26, Arshed A. Quyyumi, MD,
    FRCP, FACC, principal investigator of the PreSERVE AMI Phase
    2 trial
    [4] and
    Professor of Medicine and Cardiology at Emory University,
    will speak on a panel entitled "Early and Next Phase Studies"
    within a session entitled "Acute Injury: STEMI and NSTEMI".
  • From 7:30 to 8:30 AM on Friday, January 27, Robert A.
    Preti, PhD, President of Progenitor Cell
    Therapy
    [5] will
    speak as part of Industry Session III entitled "Focus on
    Procedure, Systems Management, and Advanced Technologies."

Dr. Pecora said, "As a presenter at the first industry
session, I look forward to informing industry leaders about the
PreSERVE Phase 2 clinical trial for AMI which is now open for
enrollment and may provide data readout 18 months from the
first patient enrollment, as well as discussing the recent
patent issued to use the Amorcyte technology beyond
cardiovascular disease." 

Dr. Robin L. Smith, Chairman and CEO of NeoStem, said, "This
conference represents validation that the development of
cell therapies for diseases outside of bone marrow
transplantation is progressing as represented by their current
clinical data. Our acquisition of Amorcyte last year has
positioned NeoStem to be a leader in the cell therapy
cardiovascular space. We are excited to be a part of the
developing science represented by this important conference and
share our expertise represented by the progress with Amorcyte
and our capabilities to assist the field with the manufacturing
services of PCT."

About the Cardiovascular Research Foundation

According to the Cardiovascular Research Foundation, their role
in interventional cardiovascular medicine is unique: conducting
research on therapies, pharmacology, and devices during the
earliest stages of development, confirming safety and efficacy
in human clinical trials, and educating the medical community
regarding appropriate use of these new procedures and
technologies. By providing research, evaluation, and education
under one roof, CRF has a unique ability to generate important
research questions, test and refine groundbreaking new
therapies, and ensure that these treatments are available to
patients at the earliest opportunity. For more information,
please visit http://www.celltherapy.crf.org[6].

About NeoStem, Inc. and Amorcyte, LLC, a NeoStem company

NeoStem, Inc. ("NeoStem") is a leader in the development and
manufacture of cell therapies. NeoStem has a strategic
combination of revenues, including that which is derived from
the contract manufacturing services performed by Progenitor
Cell Therapy, LLC, a NeoStem company. That manufacturing base
is one of the few cGMP facilities available for contracting in
the burgeoning cell therapy industry, and it is the combination
of PCT's core expertise in manufacturing and NeoStem's
extensive research capabilities that positions the company as a
leader in cell therapy development. Amorcyte, LLC, also a
NeoStem company, is developing a cell therapy for the treatment
of cardiovascular disease. Amorcyte's lead compound, AMR-001,
represents NeoStem's most clinically advanced therapeutic and
is open for enrollment in a Phase 2 trial for the preservation
of heart function after a heart attack.  Amorcyte expects
to begin a Phase 1 clinical trial in 2012 for AMR-001 for the
treatment of patients with congestive heart failure. Athelos
Corporation, also a NeoStem company, is developing a T-cell
therapy for a range of autoimmune conditions with our partner
Becton-Dickinson.  NeoStem's pre-clinical assets include
its VSEL™ Technology platform for regenerative medicine, which
NeoStem believes to be an endogenous, pluripotent,
non-embryonic stem cell that has the potential to change the
paradigm of cell therapy as we know it today.

For more information on NeoStem and Amorcyte, please visit
http://www.neostem.com[7] and
http://www.amorcyte.com[8].

Forward-Looking Statements

This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements reflect management's current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. Forward looking statements
include statements herein with respect to the successful
execution of the Company's business and medical strategy,
including with respect to the successful development of AMR-001
and other cell therapies, about which no assurance can be
given. The Company's actual results could differ materially
from those anticipated in these forward- looking statements as
a result of various factors. Factors that could cause future
results to materially differ from the recent results or those
projected in forward-looking statements include the "Risk
Factors" described in the Company's definitive proxy statement
filed with the Securities and Exchange Commission on September
16, 2011 and in the Company's periodic filings with the
Securities and Exchange Commission. The Company's further
development is highly dependent on future medical and research
developments and market acceptance, which is outside its
control.

For more information, please
contact:

 

 

 

Trout Group

NeoStem, Inc.

Gitanjali Jain Ogawa, Vice
President

Robin Smith, CEO

Phone: +1-646-378-2949

Phone: +1-212-584-4174

Email: gogawa@troutgroup.com[9]
 

Email: rsmith@neostem.com[10]

 

References

  1. ^ NeoStem, Inc.
    (us.lrd.yahoo.com)
  2. ^ PreSERVE Phase 2 clinical
    trial
    (us.lrd.yahoo.com)
  3. ^ Progenitor Cell Therapy, LLC
    (us.lrd.yahoo.com)
  4. ^ PreSERVE AMI Phase 2 trial
    (us.lrd.yahoo.com)
  5. ^ Progenitor Cell Therapy
    (us.lrd.yahoo.com)
  6. ^ http://www.celltherapy.crf.org
    (us.lrd.yahoo.com)
  7. ^ http://www.neostem.com
    (us.lrd.yahoo.com)
  8. ^ http://www.amorcyte.com
    (us.lrd.yahoo.com)
  9. ^ gogawa@troutgroup.com
    (finance.yahoo.com)
  10. ^ rsmith@neostem.com
    (finance.yahoo.com)

Read this article:
Senior Management of NeoStem and Its Subsidiaries Invited to Speak at Seventh International Conference on Cell Therapy ...

Read More...

Islet Sciences, Inc. Selects NeoStem’s Manufacturing Subsidiary Progenitor Cell Therapy for Product Manufacturing

Saturday, January 28th, 2012

ALLENDALE, N.J., Jan. 12, 2012 /PRNewswire/ -- NeoStem's cell
therapy manufacturing division, Progenitor Cell Therapy
("PCT"), a NeoStem, Inc. company (NYSE Amex: NBS) ("NeoStem" or
the "Company"), announced today an agreement whereby PCT will
provide contract manufacturing and regulatory services related
to the development of Islet Sciences – PTM, which will be an
injectable suspension of microencapsulated insulin-producing,
pancreatic islet cells which are harvested from designated
pathogen free pigs. As part of this arrangement, PCT will
perform microencapsulation for parsing beta pancreatic islets
for xenotransplantation using piglet pancreata. Islet Sciences,
Inc. ("Islet") is a biotechnology company engaged in the
research, development and commercialization of patented
technologies in the field of transplantation therapy for
patients with diabetes and is a wholly-owned subsidiary of One
E-Commerce Corporation (OTCBB: ONCE.OB[1] -
News[2]). 

A 2010 study by the CDC found that approximately 25.8 million
Americans, more than 8% of the population, were affected by
diabetes. 5% of this number, approximately 1.3 million, have
type 1 diabetes. Type 1 diabetes is estimated to cost the US
$14.4 billion total annually.

"Given the robust market opportunity and the potential for cell
therapy to alter the disease paradigm, NeoStem has agreed to
this novel arrangement whereby PCT will subsidize manufacturing
margin related to current services for Islet Sciences – PTM
product in exchange for royalties on future sales, exclusive
manufacturing rights for both clinical trial and commercial
manufacturing and an equity stake in Islet's parent. We
recognize that PCT's track record of developing cell therapies
cost efficiently for cell therapy companies makes this a truly
compelling opportunity in the industry," said John Steel, CEO of Islet Sciences.

"Our team looks forward to applying its process and assay
expertise, in partnership with the scientific expertise of Dr.
Jonathan Lakey, scientific
advisor to Islet, and his team, towards the development of this
novel and creative cellular therapeutic for the treatment of
type 1 diabetes," said Robert A.
Preti
, PhD, President of PCT. "We are honored that
Islet Sciences has enlisted PCT to provide manufacturing and
development support as it advances this important product
through clinical development."  

Dr. Robin L. Smith, Chairman and
CEO of NeoStem, added, "We are excited to begin using our
manufacturing currency at PCT to support important technologies
with promise by providing manufacturing and regulatory support
at a reduced profit margin in exchange for participation in
future royalties, equity as well as a commitment for clinical
trial and commercial manufacturing exclusivity."

About Type 1 Diabetes

According to the American Diabetes Association, type 1
diabetes, previously called insulin-dependent diabetes mellitus
(IDDM) or juvenile diabetes, is an autoimmune disease
characterized by insulin deficiency resulting from destruction
of beta-cells in the pancreas, ultimately resulting in the
body's inability to convert consumed sugar and starches into
energy. This form of diabetes usually affects children and
young adults, but it can occur at any age. Although insulin
therapy and other treatments can be used to manage the
condition, the condition is currently incurable.  

About NeoStem, Inc.

NeoStem, Inc. ("NeoStem") is a leader in the development and
manufacture of cell therapies. NeoStem has a strategic
combination of revenues, including that which is derived from
the contract manufacturing services performed by Progenitor
Cell Therapy, LLC, a NeoStem company. That manufacturing base
is one of the few cGMP facilities available for contracting in
the burgeoning cell therapy industry, and it is the combination
of PCT's core expertise in manufacturing and NeoStem's
extensive research capabilities that positions the company as a
leader in cell therapy development. Amorcyte, Inc., also a
NeoStem company, is developing a cell therapy for the treatment
of cardiovascular disease. Amorcyte's lead compound, AMR-001,
represents NeoStem's most clinically advanced therapeutic
and  has commenced enrollment in a Phase 2 trial for the
preservation of heart function after a heart attack.
 Amorcyte expects to begin a Phase 1 clinical trial in
2012 for AMR-001 for the treatment of patients with congestive
heart failure. Athelos Corporation, also a NeoStem company, is
developing a T-cell therapy for a range of autoimmune
conditions with its partner Becton-Dickinson.  NeoStem's
pre-clinical assets include its VSEL™ Technology platform for
regenerative medicine, which NeoStem believes to be an
endogenous, pluripotent, non-embryonic stem cell that has the
potential to change the paradigm of cell therapy as we know it
today.

For more information on NeoStem, please visit http://www.neostem.com[3].

About Islet Sciences, Inc.

Islet Sciences is a development-stage biotechnology company
with patented technologies focused on transplantation therapy
for people with insulin-dependent diabetes. Islet's
transplantation technology includes methods for the culturing,
isolation, maturation, and immunoprotection
(microencapsulation) of islet cells. Islet's mission includes
the introduction of commercial products with applications to
cell-based replacement therapy in the healthcare marketplace.

Forward-Looking Statements

This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements for NeoStem, PCT and Islet
Sciences reflect their respective managements' current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. Forward looking statements
include statements herein with respect to the companies'
successful execution of their  respective business
strategies, including with respect to the successful
development of cell therapeutics, including with respect to
Islet Sciences – PTM, as well as the future of the cell
therapeutics industry. Actual results could differ materially
from those anticipated in these forward- looking statements as
a result of various factors. Factors that could cause future
results to materially differ from the recent results or those
projected in forward-looking statements for NeoStem and PCT
include the "Risk Factors" described in NeoStem's prospectus
supplement filed with the Securities and Exchange Commission
("SEC") on September 30, 2011 and
for Islet include the risks described in the One E-Commerce
Corporation Form 8-K filed with the Securities and Exchange
Commission on December 30, 2011.
The companies' further development is highly dependent on
future medical and research developments and market acceptance,
which is outside their control.

For more information, please
contact:

 

 

 

Trout Group

NeoStem, Inc.

Gitanjali Jain Ogawa, Vice
President

Robin Smith, CEO

Phone: +1-646-378-2949

Phone: +1-212-584-4174

Email: gogawa@troutgroup.com[4]

Email: rsmith@neostem.com[5]

References

  1. ^ ONCE.OB
    (finance.yahoo.com)
  2. ^ News
    (finance.yahoo.com)
  3. ^ http://www.neostem.com
    (us.lrd.yahoo.com)
  4. ^ gogawa@troutgroup.com
    (finance.yahoo.com)
  5. ^ rsmith@neostem.com
    (finance.yahoo.com)

Here is the original post:
Islet Sciences, Inc. Selects NeoStem's Manufacturing Subsidiary Progenitor Cell Therapy for Product Manufacturing

Read More...

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