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Dr. Nikolai Tankovich, President Of Stemedica, Appointed Legate to The Center of Science and Society at The University …

The Board of Trusties of the Centre for Science and Society at Trinity College of the University of Oxford, England has appointed Nikolai Tankovich, MD, PhD, FASLMS as a Legate of the Centre. Dr. Tankovich is President and Chief Medical officer of Stemedica Cell Technologies, Inc. and Chairman of Stemedica International S.A. a manufacturer of ischemic tolerant adult allogeneic stem cells.

(PRWEB) March 15, 2012

Dr. Tankovich has been a frequent lecturer and guest speaker at the Centre for the last several years. The position of Legate recognizes the importance of his continuing role in reporting on the latest worldwide trends in regenerative medicine and biotechnology. Dr Tankovich is a surgical oncologist who holds a Masters Degree in Physics and a PhD in Biophysics. He is a Fellow of the American Society of Laser Medicine and Surgery. Dr. Tankovich is the author of multiple patents in the fields of stem cells and laser science.

Dr. Frank C. Schuller, Director of the Centre for Science and Society at Trinity College said, We are pleased to formalize our valued relationship with Dr. Tankovich by naming him a Legate of the Center. This honor is in recognition of his extensive contributions to advancing scientific understanding at the University of Oxford, and in anticipation of many years of continuing involvement.

Speaking of his lecturing at Trinity College, Dr. Tankovich noted, It is always a pleasure to present the latest medical and scientific information to some of the brightest researchers and scientists in the world. I look forward to working with The Center to explore the boundaries of science and technology to help translate research into meaningful cures for many of the presently chronic diseases and conditions that are prevalent today.

Richard Silcock, Associate Director of the Centre, said, "During recent years, Dr. Tankovich has generously contributed his extensive knowledge and practical expertise to stimulate lively debates at the Centre on stem cell research and its medical or commercial applications. He joins a panel of Legates who have distinguished themselves in their careers. We are honored that Dr. Tankovich will be an ambassador for the Centre to promote discussion of important issues connecting science and society."

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The Company is currently conducting clinical trials for stroke under US IND using ischemic tolerant mesenchymal (itMSC) stem cells. Regulatory pathways for spinal cord injury, diabetic retinopathy, acute myocardial infarct, acute respiratory distress syndrome and wound repair are also underway.

For more information regarding Stemedica Cell Technologies, Inc. contact Dave McGuigan at dmcguigan(at)stemedica(dot)com.

Dave McGuigan Stemedica Cell Technologies Inc (858) 658-0910 Email Information

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Dr. Nikolai Tankovich, President Of Stemedica, Appointed Legate to The Center of Science and Society at The University ...

TiGenix Reports Full Year 2011 Financial Results

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011.

Business highlights

Financial highlights

"TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points."

Business Update

Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash position.

As a result of the merger, the Company's development focus has shifted from early stage preclinical programs towards a number of highly promising clinical stage products for inflammatory and autoimmune disorders of high unmet medical need, each addressing markets in excess of EUR 1 billion. TiGenix product pipeline is based on a proprietary stem cell platform that exploits expanded allogeneic (donor-derived) adult stem cells derived from human adipose (fat) tissue ('eASCs'). The platform has been extensively characterized in line with requirements of the European Medicines Agency (EMA) and is supported by exhaustive preclinical and CMC packages.

Given its focus on cell therapy, TiGenix is in the process of divesting its ChondroMimetic franchise, which is based on a biomaterial platform. To be able to concentrate on its core business and move forward with a clean slate, TiGenix has decided to write-off the intellectual property related to the OrthoMimetics acquisition.

ChondroCelect commercial roll-out progressing with first national reimbursementChondroCelect obtained reimbursement in Belgium in May 2011, and is today available in 22 specialized treatment centers.

TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain under managed access and private insurance schemes, while pursuing national reimbursement in these countries and France.

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TiGenix Reports Full Year 2011 Financial Results

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

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

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

OTTAWA A team of Ottawa researchers has been awarded $442,000 to test the worlds first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream thats 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 hospitals 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 bodys 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.

Its 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.

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

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

Red Blood Cell Growth Linked to Leukemia?

(Ivanhoe Newswire)-- Yale researchers have discovered how megakaryocytes or giant blood cells that produce wound healing platelets grow 10 or more times bigger than other blood cells and how they may cause a form of leukemia.

"A failure of these cells to grow might be an initial trigger for megakaryoblastic leukemias," Diane Krause, senior researcher for the Yale Cancer Center, professor of laboratory medicine, cell biology, and pathology and associate director of the Yale Stem Cell Center, was quoted as saying.

Megakaryocytes grow so large because the DNA within the cell duplicates over and over again but without the cell undergoing cell division. A megakaryoblastic can house more than 120 sets of nuclear DNA before it becomes the biological equivalent of a supernova, undergoing significant changes to break apart into thousands of platelets needed for normal blood clotting.

A Yale team led by postdoctoral associate Yuan Gao discovered that two proteins called guanine exchange factors (GEF-H1) halt endomitosis. They found that without GEF-H1, nuclear DNA couldn't go from two internal nuclei to four. Additional divisions of nuclear DNA within the cell could not occur unless there was reduced expression of ECT2.

The team was intrigued by the results because a gene implicated in malignant leukemias, MKL1, also seems to be necessary to promote normal megakaryocyte maturation. The Krause lab is now studying whether mutant forms of MKL1 may keep levels of GEF-H1 high, therefore, making it impossible for megakaryocytes to undergo endomitosis and building the foundation for development of cancer.

"These findings reveal another important step toward the formation of functional platelets, which are necessary for normal blood clotting," Krause said. "But they also provide a clue regarding what may go away to transform normal megakaryocytes into malignant leukemia cells."

SOURCE: Developmental Cell, March 2012.

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Red Blood Cell Growth Linked to Leukemia?

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

FDA receives complaint about Houston company that stored Gov. Perry's stem cells

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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FDA receives complaint about Houston company that stored Gov. Perry's stem cells

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 ...