RBCC and n3D Aim to Help Bring Stem Cell Treatments to Market Faster

NOKOMIS, Fla.--(BUSINESS WIRE)--

As global demand for innovative new stem-cell therapies grows by the day, Rainbow BioSciences (OTCBB:RBCC.OB - News) new agreement with n3D Biosciences could help to bring these therapies to market faster than ever before.

Stem cell therapies are becoming increasingly important to healthcare advancement around the world. Rising care delivery costs, worldwide population aging, and potential physician shortages are only three of the issues facing world healthcare providers. The cost to bring a new drug to market has soared to $1.3 billion, and there are now half as many drugs seeking approval as there were 15 years ago.

Rising costs and potential shortages have led to a boom in demand for stem cell therapies. These advanced treatments could soon help to ease costs and provide effective disease treatment, potentially improving patient outcomes and reducing health care costs. For that to happen, however, real challenges must be overcome. Translation of these therapies from the lab to the clinic is slow, and widespread implementation could be a decade away or more.

Thanks to n3Ds Bio-Assembler technology, however, the development timeline for many stem cell therapies could potentially be shortened significantly. The Bio-Assembler enables researchers to culture cells in three dimensions faster and more easily than ever before, streamlining testing and research.

On Thursday, RBCC announced the acquisition of an equity interest in n3D, a fully commercialized company with plans to sell the ground-breaking Bio-Assembler to labs and researchers all over the world. RBCC expects n3Ds value to grow considerably as word spreads about the game-changing technology.

For more information on Rainbow BioSciences, please visit http://www.rainbowbiosciences.com/investors.

Rainbow BioSciences will develop new medical and research technology innovations to compete alongside companies such as Celgene Corp. (NASDAQ:CELG),Cardinal Health, Inc.(NYSE:CAH), Abbott Laboratories (NYSE:ABT) andAffymax, Inc.(NASDAQ:AFFY).

Follow us on Twitter atwww.twitter.com/RBCCinfo.

About Rainbow BioSciences

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RBCC and n3D Aim to Help Bring Stem Cell Treatments to Market Faster

Stem cell brain injections ease Parkinson's

MONKEYS with Parkinson's disease-like symptoms have had their suffering eased by an injection of human embryonic stem cells (hESCs) into their brain.

Jun Takahashi of Kyoto University in Japan and colleagues injected these cells into monkeys whose brains had been damaged by a chemical that destroys dopamine-producing neurons and so causes Parkinson's symptoms.

Two monkeys received hESCs that had been matured into an early form of neural cell. Six months later, the monkeys had recovered 20 to 45 per cent of the movement they had lost before treatment. Post-mortems a year after treatment showed that the cells had developed into fully functioning dopamine-secreting neurons. Another monkey that received less-mature neural cells also showed improvements (Stem Cells, DOI: 10.1002/stem.1060).

"Monkeys starting with tremors and rigidity [began] to move smoothly, and animals originally confined to sitting down were able to walk around," says Takahashi.

The team says it will probably be four to six years before clinical trials in humans begin.

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Stem cell brain injections ease Parkinson's

Eastday-Big stem cell breakthrough

A NEW stem cell therapy treatment to develop new bones for patients with bone loss and new skin for recipients of plastic surgery has been developed, doctors from Shanghai No.9 People's Hospital announced yesterday.

In the procedure, medical staff use a special machine to collect stem cells from a patient's blood. The stem cells adhere to a base made of a special biological material.

The stem cells are then transplanted into the patient's body, where they grow into either new bones or skin tissue, while the base is absorbed by the human body.

"So far the practice has been successful in treating patients with bone and skin loss," said Dr Dai Kerong from Shanghai Jiao Tong University's translational medicine institute at Shanghai No.9 hospital. "The stem cell technology will be used to develop corneas for blind people as well as treating heart attack and stroke patients by developing new heart and cerebral tissue."

The technology is patented in China and abroad and will be licensed within one or two years, according to Dai.

China has established 51 translational medicine centers to boost the introduction of laboratory research into clinical use.

The complicated procedures and documentation required often prevent doctors from introducing lab success into clinical practice.

Dai said one reagent developed by No. 9 hospital's doctors for in vitro fertilization received a license in Europe within six months and has been used in clinical practice "while this would take at least five years in China."

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Eastday-Big stem cell breakthrough

Canadian researchers receive grant to test stem-cell therapy for septic shock

OTTAWA A team of Canadian researchers has been awarded $442,000 to test the world's first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream that's notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospital's sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the body's hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

"It's a unique feature of the stem cells," said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. "Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system."

As with other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Canadian researchers receive grant to test stem-cell therapy for septic shock

Suspended doctor disputes DOH claims

LEE COUNTY, FL -

The attorney for a Bonita Springs doctor whose license was suspended last week after a patient's death now says a different doctor was treating the patient and the patient had not received a stem cell treatment.

Dr. Zannos Grekos is under investigation by the Lee County Sheriff's Office, however no criminal charges have been filed against him.

Dr. Grekos' attorney issued a one page statement to our newsroom that says the patient died during a different procedure performed by a different doctor.[Click here to read the statement.]

The attorney did not identify the doctor on the statement, but says the other doctor was performing liposuction on THE MAN, not stem cell treatment.

The family of 77 year old Richard Poling of Indiana said he was being treated for pulmonary fibrosis.

The Department of Health's Emergency Suspension Order stated Poling died from cardiac arrest while at Grekos' office.

Dr Grekos' attorney states that the medical examiner's office has not provided a report linking the patient's death to stem cell treatment.

We did reach out to the Department of Heath for comment, but have not heard back from them yet.

We also reached out to Poling's sister who lives in Bonita Springs. She is respecting her family's wishes and is not speaking to the media.

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Suspended doctor disputes DOH claims

Stem-cell breakthrough could mean treatment for Huntington’s

A research report published earlier this week suggests a possible connection between the use of stem cells and a treatment for Huntingtons disease.

Su-Chun Zhang, a UW-Madison professor, is the senior author of the new study, which shows embryonic stem cells may be used to reinstate the neural circuit needed for motor control that is destroyed in Huntingtons patients.

There is no cure for Huntingtons, a terminal disease in which patients lose control of muscle coordination.

The key to the study is the use of GABA neurons, which are responsible for creating the network the brain uses to coordinate motor function, but are reduced in Huntingtons patients. According to the report, researchers found a way to manufacture large quantities of GABA neurons from embryonic stem cells, which they implanted in mice to test how well they would integrate in to the mouses brain.

The cells not only integrated in the mouses brain, but also projected to the corresponding target and reestablished the neural circuit, which restored muscle coordination.

This result suggests a possible treatment for a previously incurable disease, as well as discovering that the human brain may be more resilient than originally thought.

While the findings are optimistic, researchers said in a statement that the technology will not be ready for human trials until further research is completed.

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Stem-cell breakthrough could mean treatment for Huntington’s

Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Grekos' attorney: Another physician treated patient who died

Interview with Dr. Zannos Grekos Grekos contests that his office has done ...

LEE COUNTY A week after Dr. Zannos Grekos was accused of performing a stem cell treatment on a patient who died, his attorney said another physician was treating the patient at the Bonita Springs practice.

And there was no stem cell treatment performed, only liposuction, said Richard Ozelie, the Boca Raton attorney representing Grekos.

Ozelie does not identify the other doctor but said in a statement Wednesday that the Lee County Sheriffs Office and the Lee County Medical Examiners Office both have that information.

The patient, identified by state authorities through the initials R.P., did have liposuction at the Regenocyte medical facility in Bonita Springs, Ozelie said in the statement. The Sheriffs Office later identified the man who died as Richard Poling , 77, of Newburgh, Ind.

The attorney issued the one-page statement because of concerns with the accuracy of media coverage after the state Department of Health suspended Grekos license March 7. The case has received some national media attention.

The next day, the Sheriffs Office launched a criminal investigation into Grekos practice, Regenocyte, 9500 Bonita Beach Road, Suite 310.

Sheriffs Office spokesman Lt. Larry King had no comment Wednesday and said the agencys investigation is continuing.

In the suspension order, the state health department said Grekos infused or directed that the patient have concentrated stem cells infused into his blood stream. The state order said the patient suffered cardiac arrest and died.

The emergency suspension was issued because Grekos violated a license restriction from February, 2011, not to do anything with autologous stem cell treatment or bone marrow aspirate, according to the state order.

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Grekos' attorney: Another physician treated patient who died

Epigenetic signatures direct the repair potential of reprogrammed cells

When skin cells are reprogrammed, many of their cellular properties are recalibrated as they aquire stem cell properties and then are induced to become skin cells again. In order for these "induced" stem cells to be viable in treatment for humans (tissue regeneration, personalized wound healing therapies, etc.), researchers need to understand how they retain or even improve their characteristics after they are reprogrammed.

Since the initial discovery of reprogramming, scientists have struggled with the unpredictability of the cells due to the many changes that occur during the reprogramming process. Classifying specific epigenetic signatures, as this study did, allows researchers to anticipate ways to produce cell types with optimal properties for tissue repair while minimizing unintended cellular abnormalities.

The researchers used reprogrammed cells to generate three-dimensional connective tissue that mimics an in vivo wound repair environment. To verify the role of the protein (PDGFRbeta) in tissue regeneration and maintenance, the team blocked its cellular expression, which impaired the cells' ability to build tissue.

"We determined that successful tissue generation is associated with the expression of PDGFRbeta. Theoretically, by identifying the epigenetic signatures that indicate its expression, we can determine the reprogrammed cells' potential for maintaining normal cellular characteristics throughout development," said first author Kyle Hewitt, PhD, a graduate of the cell, molecular & developmental biology program at the Sackler School of Graduate Biomedical Sciences, and postdoctoral associate in the Garlick laboratory at Tufts University School of Dental Medicine (TUSDM).

"The ability to generate patient-specific cells from the reprogrammed skin cells may allow for improved, individualized, cell-based therapies for wound healing. Potentially, these reprogrammed cells could be used as a tool for drug development, modeling of disease, and transplantation medicine without the ethical issues associated with embryonic stem cells," said senior author Jonathan Garlick, DDS, PhD, a professor in the department of oral and maxillofacial pathology and director of the division of tissue engineering and cancer biology at TUSDM.

Jonathan Garlick is also a member of the cell, molecular & developmental biology program faculty at the Sackler School and the director of the Center for Integrated Tissue Engineering (CITE) at TUSDM.

More information: Hewitt KJ, Shamis Y, Knight E, Smith A, Maione A, Alt-Holland A, Garlick JA. Journal of Cell Science. "PDGFRbeta Expression and Function in Fibroblasts Derived from Pluripotent Cells is Linked to DNA Demethylation" Published online February 17, 2012, doi: 10.1242/jcs.099192

Provided by Tufts University

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Epigenetic signatures direct the repair potential of reprogrammed cells

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

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 ...