TiGenix : licenses exclusive marketing and distribution rights for ChondroCelect to Sobi

Regulated information 3 April, 2014

TiGenix licenses exclusive marketing and distribution rights for ChondroCelect to Sobi

Sobi to assume responsibility for the commercialisation of ChondroCelect in existing and new markets in Europe and beyond

Sobi's considerable expertise and resources will enhance the availability of ChondroCelect to many more patients in many more countries

TiGenix to focus its resources on developing its pipeline of allogeneic treatments using expanded adipose-derived stem cells (eASC's)

Leuven (BELGIUM) - 3 April, 2014 -TiGenix NV (Euronext Brussels: TIG), the European leader in cell therapy, announced today that it has licensed the marketing and distribution of ChondroCelect, the cell-based medicinal product for the repair of cartilage defects of the knee, to the international specialty healthcare company dedicated to rare diseases, Swedish Orphan Biovitrum AB ('Sobi', NASDAQ OMX Stockholm: SOBI).

ChondroCelect was the first cell-based product to be approved in Europe. It is currently available for patients and reimbursed in Belgium, the Netherlands and Spain. Sales of ChondroCelect in 2013 were Euro 4.3 million, a growth of 25% on a like-for-like basis over 2012.

Sobi will continue to market and distribute the product where it is currently available and has also acquired the exclusive rights to expand the product's availability to patients in multiple additional territories, including the rest of the European Union, Norway, Switzerland, Turkey, and Russia, plus the countries of the Middle East and North Africa.

TiGenix will receive a royalty of 22% of the net sales of ChondroCelect in the first year of the agreement, and 20% of the net sales of ChondroCelect thereafter. There will be no upfront or milestone payments. The agreement will take effect on 1 June 2014, and has a duration of 10 years.

"We are delighted to reach this agreement with Sobi", said Eduardo Bravo, CEO of TiGenix. "With its experience of marketing and distributing specialty products, and with its human and financial resources, Sobi has the ability to bring ChondroCelect to a far greater number of patients in many more countries. This then allows TiGenix to focus its human and financial resources on the development of its platform and pipeline of allogeneic treatments using expanded adipose-derived stem cells (eASC's) for the benefit of patients suffering from a range of inflammatory and immunological conditions."

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TiGenix : licenses exclusive marketing and distribution rights for ChondroCelect to Sobi

Patient stem cells help identify common problem in ALS

PUBLIC RELEASE DATE:

3-Apr-2014

Contact: B.D. Colen bd_colen@harvard.edu 617-413-1224 Harvard University

Harvard stem cell scientists have discovered that a recently approved medication for epilepsy may possibly be a meaningful treatment for amyotrophic lateral sclerosis (ALS)Lou Gehrig's disease, a uniformly fatal neurodegenerative disorder. The researchers are now collaborating with Massachusetts General Hospital to design an initial clinical trial testing the safety of the treatment in ALS patients.

The investigators all caution that a great deal needs to be done to assure the safety and efficacy of the treatment in ALS patients, before physicians should start offering it.

The work, laid out in two related papers in the April 3 online editions of Cell Stem Cell and Cell Reports, is the long-term fruition of studies by Harvard Stem Cell Institute (HSCI) Principal Faculty member Kevin Eggan, PhD, who, in a 2008 Science paper, first raised the possibility of using ALS patient-derived stem cells to better understand the disease and identify therapeutic targets for new drugs.

Now Eggan and HSCI colleague Clifford Woolf, MD, PhD, have found that the many independent mutations that cause ALS may be linked by their ability to trigger abnormally high activity in motor neurons. Using neurons derived from stem cells made from ALS patient skin cells, the two research teams conducted clinical trials of the anti-epilepsy medication on neurons in laboratory dishes, finding that it reduced the hyperexcitability of the cells.

ALS is a devastating and currently untreatable degradation of motor neurons, the long nerve cells that connect the spinal cord to the muscles of the body. While several potential treatments have looked promising in mice, all proved disappointing in the clinic.

"The big problem in ALS is that there are more than a hundred mutations in dozens of genes that all cause the disease, but almost all of the therapeutics that have gone forward in the clinic have done so for just one of those mutations, SOD1, which almost everyone studies in mice," said Eggan, a professor in Harvard's Department of Stem and Regenerative Biology.

"And so," he continued, "the key question that we really wanted to address wasare clinical efforts failing because the mouse is taking us on a wild goose chase, or is it simply that people haven't had the opportunity to pre-test whether their ideas are true across lots of forms of ALS?"

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Patient stem cells help identify common problem in ALS

New York Podiatrist Dr. Jeffrey Adler to Be Interviewed April 5 on NewsTalkRadio 77 WABC About the Use of Stem Cell …

New York, New York (PRWEB) April 03, 2014

Dr. Jeffrey Adler, New York podiatrist and Owner/Medical Director of Adler Footcare New York, will be interviewed by radio personality Laura Smith and taking live calls on New York talk show 77 WABC about the use of stem cells to treat chronic foot pain.

Adler Footcare New York uses live birth stem cells to help treat patients with chronic foot problems such as: Plantar fasciitis, Osteoarthritis, Achilles tendonitis and torn soft tissue. The stem cell treatment is proving to be much more effective than traditional treatments like physical therapy or orthotic therapy.

Stem cells have the ability to replicate themselves or change into the cell type that is needed to repair damaged tissue. The therapy works by directly introducing live stem cells into the affected area causing pain. Its approved by the FDA and consistently reviewed by medical professionals to remove the potential of any communicable diseases.

Dr. Adler often travels to other states to share his knowledge with other doctors in his profession. His latest research on stem cell therapy has gained much interest among his peers in the medical industry.

When compared to traditional treatments, stem therapy is proving to be more successful and longer lasting, Dr. Adler said. We are seeing patients heal much quicker and return to their normal activities much sooner.

To learn more about stem cell replacement therapy or to schedule a consultation with a New York podiatrist at Adler Footcare, call (212) 704-4310 or visit http://www.mynycpodiatrist.com.

About Adler Footcare New York Dr. Jeffrey L. Adler, Medical/Surgical Director and owner of Adler Footcare New York has been practicing podiatric medicine since 1979 and has performed thousands of foot and ankle surgeries. Dr. Adler is board certified in Podiatric Surgery and Primary Podiatric Medicine by the American Board of Multiple Specialties in Podiatry. Dr. Adler is also a Professor of Minimally Invasive Foot Surgery for the Academy of Ambulatory Foot and Ankle Surgeons. As one of only several in the country who perform minimally invasive podiatric surgery, Dr. Adlers patients enjoy significantly reduced recovery times.

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New York Podiatrist Dr. Jeffrey Adler to Be Interviewed April 5 on NewsTalkRadio 77 WABC About the Use of Stem Cell ...

Revolutionary stem cell op to repair hearts: Graham read in Good Health about a pioneering way to beat heart failure …

Graham Parker, 41, from County Durham is one of first to benefit from trial Some participants were given stem cells and the rest placebo Stem cells were taken from bone marrow in his hip and injected into heart Years later Graham feels better - but still classed as having heart failure

By Carol Davis

Published: 18:04 EST, 31 March 2014 | Updated: 18:25 EST, 31 March 2014

Graham Parker took part in a trial using stem cells to repair heart damage

A major new trial is using patients' own stem cells to treat heart failure. One of the first to benefit is Graham Parker, 41, an archaeology student from Stanley, County Durham. He tells CAROL DAVIS his story.

Working as a supply teacher a few years ago, I started feeling exhausted. I couldn't walk more than 50 metres without pausing, was constantly breathless and would wake at night coughing.

At first I thought it was a cold or flu, or the stress of a house move. But my mum, a retired nurse, pointed out I'd been ill for two months, and sent me to the doctor.

The GP suspected asthma, and gave me an inhaler. But within a week it was worse and I couldn't walk more than a few yards without retching.

So I saw a second GP. She didn't say what she thought it was - she called an ambulance instead. I was admitted to the Queen Elizabeth Hospital in Gateshead, then transferred to the Freeman Hospital in Newcastle while they ran several tests, including an ECG (electrocardiogram) and MRI (magnetic resonance imaging) scan.

Doctors explained I had heart failure: part of my heart muscle was damaged and the lower pumping chamber had become flabby so couldn't pump blood round my body properly. This was why I was so exhausted.

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Revolutionary stem cell op to repair hearts: Graham read in Good Health about a pioneering way to beat heart failure ...

Researchers discover ancient virus DNA remnants necessary for pluripotency in humans

Mar 31, 2014 by Bob Yirka Human embryonic stem cells in cell culture. Credit: Wikipedia.

(Phys.org) A team of Canadian and Singaporean researchers has discovered that remnants of ancient viral DNA in human DNA must be present for pluripotency to occur in human stem cells. In their paper published in the journal Nature Structural and Molecular Biology, the team describes how they disabled a viral remnant in stem cell samples and discovered that doing so prevented the stem cell from being able to grow into all but one type of human cell.

All of the cells in the human body start out as stem cellsthe ability of such cells to do so is known as pluripotency. Scientists don't really understand how individual stem cells know which type to become but are working hard to find outit could lead to the development of cures for many diseases or the regeneration of lost limbs. In this new effort, the researchers wondered about the role of remnant viral DNA in stem cell DNA and pluripotency in general.

Scientists have known for some time that viral DNA exists in human DNA, the result of retrovirus infections millions of years ago. Retroviruses reproduce by injecting their own DNA into the DNA of a hostif it occurs in sperm or egg cells, the virus DNA can end up in the DNA of the host. Until now, scientists have thought that remnant viral DNA was simply "junk" DNAmeaning it didn't do anything at all. Now it appears clear that at least one type of such DNAHERV-Hactually plays a very important role in pluripotency.

The researchers treated some human stem cells with a small amount of RNA designed to suppress HERV-H. Doing so, they found, removed the stem cell's ability to develop into any human cellinstead they would only grow into cells that resembled fibroblastscells normally found in connective tissue. A closer look revealed that suppressing HERV-H also suppressed the production of proteins necessary for pluripotency. Thus, at least in humans, the remnant viral DNA appears to be necessary for normal human developmentwithout it, human life would be impossible.

Because of the role HERV-H plays in pluripotency, its possible other remnant viral DNA plays a role in human development as well, thus it's very likely that other research efforts will focus on testing each to see if they are more than just junk left over from infections over the course of human evolution.

Explore further: Critical factor (BRG1) identified for maintaining stem cell pluripotency

More information: The retrovirus HERVH is a long noncoding RNA required for human embryonic stem cell identity, Nature Structural & Molecular Biology (2014) DOI: 10.1038/nsmb.2799

Abstract Human endogenous retrovirus subfamily H (HERVH) is a class of transposable elements expressed preferentially in human embryonic stem cells (hESCs). Here, we report that the long terminal repeats of HERVH function as enhancers and that HERVH is a nuclear long noncoding RNA required to maintain hESC identity. Furthermore, HERVH is associated with OCT4, coactivators and Mediator subunits. Together, these results uncover a new role of species-specific transposable elements in hESCs.

2014 Phys.org

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Researchers discover ancient virus DNA remnants necessary for pluripotency in humans

Oklahoma Medical and Cosmetic Center Introduces Xcell to the State

Oklahoma City, OK (PRWEB) April 02, 2014

Vitality Medical and Cosmetic Center is excited to announce that they have added Xcell Therapy, a revolutionary stem cell therapy process, as a service for its patients. This will mark Vitality Medical and Cosmetic Center as the only facility in Oklahoma state to offer Xcell. The process is used to improve the look of scars, stimulate hair growth, ease joint discomfort, combat certain degenerative cell diseases, and provide an overall revitalizing effect on the skin.

Xcell Therapy was developed by Florida based research clinician Robert Brandt and has been introduced to Vitality Medical and Cosmetic Center by its CEO, Ron Nerad. The process involves utilizing a patients blood and repurposing the blood to act as a catalyst for the healing process. This is done by drawing blood from the patient, then manipulating the blood in order to remove the red and white blood cells from the patients blood plasma. Whats left is a concentration of super-rich growth factors that Nerad refers to as a golden serum. The serum is then applied topically or injected into the affected area.

The golden serum is full of activated platelets that have released healing proteins called growth factors. These growth factors will excite the recovery process for patients, said Nerad. It is the next generation PRP and we are excited to introduce Xcell and all of its benefits to Oklahoma City and beyond.

PRP, or rather platelet rich plasma, has been used extensively in sports medicine to relieve and accelerate the healing process with athletes who have suffered muscle tears or joint discomfort. The new generation of PRP is referred to as CRP, cytokine rich plasma. The Xcell process falls under the CRP category, the advanced and purer form of PRP, and therefore acts more efficiently than its PRP counterpart.

Nerad combines the healing power of the CRP process of Xcell Therapy with his in-house staffs medical experience to create the perfect environment for healing. Jennifer Collins, the Centers Medical Physician, is responsible for applying the Xcell treatment onto the patient, while chiropractor physician Darren Risley, specializing in soft tissue injuries, gets the body working together in alignment to expedite the recovery process.

While this treatment is still considered experimental it is safe because your healing capable cells are utilized. Non-surgical cortisone injections alleviate pain and inflammation for a short time and can cause side effects like calcification of ligaments and tendons. This regenerative procedure restores and heals the injured cells enabling rehabilitation sooner. The whole process, from consultation to application, takes about an hour.

Along with Xcell Therapy, Vitality Medical and Cosmetic Center offers an array of treatments including spa and laser treatments such as Micro-Needling, Laser Skin Resurfacing treatments, and Botox Cosmetic. To learn more about the medical staff and their work, visit http://www.vitalitymcc.com.

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About Vitality Medical and Cosmetic Center Vitality Medical and Cosmetic Center offers the latest technology and best in class products and procedures at a price that is affordable and offers tremendous value. Vitality offers procedures for skin care & wellness that not only meets but exceeds patient expectations raising the bar in terms of quality and patient experience.

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Oklahoma Medical and Cosmetic Center Introduces Xcell to the State

Big Breakthrough In Stem Cell Manufacturing Technology

April 1, 2014

University of Nottingham

Scientists at The University of Nottingham have developed a new substance which could simplify the manufacture of cell therapy in the pioneering world of regenerative medicine.

Cell therapy is an exciting and rapidly developing area of medicine in which stem cells have the potential to repair human tissue and maintain organ function in chronic disease and age-related illnesses. But a major problem with translating current successful research into actual products and treatments is how to mass-produce such a complex living material.

There are two distinct phases in the production of stem cell products; proliferation (making enough cells to form large tissue) and differentiation (turning the basic stem cells into functional cells). The material environment required for these two phases are different and up to now a single substance that does both jobs has not been available.

Now a multi-disciplinary team of researchers at Nottingham has created a new stem cell micro-environment which they have found has allowed both the self-renewal of cells and then their evolution into cardiomyocyte (heart) cells. The material is a hydrogel containing two polymers an alginate-rich environment which allows proliferation of cells with a simple chemical switch to render the environment collagen-rich when the cell population is large enough. This change triggers the next stage of cell growth when cells develop a specific purpose.

Major priority

Professor of Advanced Drug Delivery and Tissue Engineering, Kevin Shakesheff, said:

Our new combination of hydrogels is a first. It allows dense tissue structures to be produced from human pluripotent stem cells (HPSC) in a single step process never achieved before. The discovery has important implications for the future of manufacturing in regenerative medicine. This field of healthcare is a major priority for the UK and we are seeing increasing investment in future manufacturing processes to ensure we are ready to deliver real treatments to patients when HPSC products and treatments go to trial and become standard.

The research, Combined hydrogels that switch human pluripotent stem cells from self-renewal to differentiation, is published in the Proceedings of the National Academy of Sciences (PNAS).

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Big Breakthrough In Stem Cell Manufacturing Technology

Stem Cells May Rejuvenate Failing Hearts, Study Suggests

By Dennis Thompson HealthDay Reporter

MONDAY, March 31, 2014 (HealthDay News) -- Stem cells injected directly into heart muscle can help patients suffering from severe heart failure by improving an ailing heart's ability to pump blood, a new Danish trial indicates.

Doctors drew stem cells from patients' own bone marrow, and then injected those cells into portions of the heart where scar tissue seemed to interfere with heart function, explained lead researcher Dr. Anders Bruun Mathiasen. He is a research fellow in the Cardiac Catheterization Lab at Rigshospitalet University Hospital Copenhagen.

Within six months of treatment, patients who received stem cell injections had improved heart pumping function compared to patients receiving a placebo, according to findings that were to be presented Monday at the American Academy of Cardiology's annual meeting in Washington, D.C.

"We know these stem cells can initiate the growth of new blood vessels and heart muscle tissue," Mathiasen said. "That's what we think has happened."

If larger follow-up trials prove the treatment's effectiveness, it could provide hope for people suffering from untreatable heart failure.

"Heart failure is one of the biggest causes of death. If you can save lives or improve their symptoms, then a treatment like this would be extremely beneficial," said Dr. Cindy Grines, a cardiologist with the Detroit Medical Center and a spokeswoman for the American College of Cardiology.

The treatment could delay the need for a heart transplant and extend the lives of people who can't qualify for a transplant, Grines added.

This new clinical trial included 59 patients with severe heart failure who were considered untreatable. It is the largest randomized trial to test the potential of stem cell injections in treating heart disease, the researchers said.

In the trial, 39 patients received injections of stem cells into their heart muscle through a catheter inserted in the groin. The procedure required only local anesthesia, Mathiasen said. The other 20 received saline injections.

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Stem Cells May Rejuvenate Failing Hearts, Study Suggests

Brescia hospitals suspend Stamina treatments

Stem-cell treatment discredited in government probes

(ANSA) - Rome, April 2 - Hospitals in Italy that used a discredited stem-cell treatment announced Wednesday they have suspended the program. "Our clinics have decided to suspend Stamina treatments indefinitely," Ezio Belleri, extraordinary commissioner of the civic hospital system in Brescia, told the parliament health committee. Italy's health ministry announced in October that the Stamina Foundation - the nonprofit foundation that developed the treatment - would not be allowed to test it on humans. The foundation was also stripped of its non-profit status after a study found its treatment was "ignorant of stem-cell biology". The head of the foundation, Davide Vannoni, a former psychology lecturer, was indicted earlier this year for alleged attempted fraud against the Piedmont Region. The Stamina Foundation had asked for 500,000 euros of funding to develop a stem-cell laboratory, a request prosecutors argue was fraudulent because the efficacy of the treatment has been "completely disproved". The Stamina treatment involves extracting bone-marrow stem cells from a patient, turning them into neurons by exposing them to retinoic acid for two hours, and injecting them back into the patient. Supporters of the therapy thought it could be a cure for fatal degenerative nerve diseases such as spinal muscular atrophy, while detractors said it was devoid of scientific merit. A panel of experts appointed by Italy's health ministry said in January it found the therapy seriously lacking in both premise and practice. Their report cited "serious imperfections and omissions in the Stamina protocol, including conceptual errors and an apparent ignorance of stem-cell biology".

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Brescia hospitals suspend Stamina treatments