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ReNeuron Group edges further in stem cell therapy research for stroke patients

LONDON (ShareCast) - ReNeuron Group received the green light to complete the final stages of first phase safety testing of its ReN001 stem cell therapy for disabled stroke patients in Scotland, the company announced Tuesday.

The ReN001 stem cell therapy was being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

ReNeuron is now set to proceed with dosing the last three patients after getting clearance from the Data Safety Monitoring Board which reviewed the study.

The first of the three patients was treated with ReN001 and discharged from hospital. The remaining two are scheduled to be treated this March.

Last year, interim data from the first five patients treated in the study were presented by the Glasgow clinical team. Sustained reductions in neurological impairment and spasticity were observed in all patients compared with their stable pre-treatment baseline performance.

Further and longer term data from the study are expected to be presented in scientific conference later this year.

The company has submitted an application to the UK regulatory authority to commence a multi-site phase two clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke. Preparations are underway to begin the trial mid-year.

RD

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ReNeuron Group edges further in stem cell therapy research for stroke patients

Stem cell transplant for sickle cell patients

A possible cure for a debilitating disease. It strikes one in 500 African Americans. Many live day-to-day on heavy painkillers. Now a new take on an old treatment may put an end to their suffering.

Dr. Damiano Rondelli, University of Illinois Hospital Hematologist: Its a social issue. Its not just a medical issue. The cost, the family involvement its a really big deal.

It is sickle cell anemia, an inherited defect of the red blood cells. More rigid than normal round cells, the crescent or sickle-shaped cells get stuck in small vessels, blocked from delivering oxygen to organs, tissues and joints.

Dr. Rondelli: Damage to lungs, kidneys, liver. The major symptom is pain.

Beverly Means, mother: His hand and feet had swollen up, and I took him to the hospital and they were telling me he had sickle cell. Never heard of it in my life.

But it was a disease that would take over Beverly Means life and the lives of two of her sons, Julius and Desmond.

Julius Means, sickle cell patient: Some of my first memories having sickle cell, playing one day and the next day not being able to even walk.

Diagnosed at eight-months-old, Julius has struggled with sickle cell disease for 25 years.

Julius Means: In and out of hospitals all the time. The majority of the pain would hit me in my legs and my back. So being a young kid and not being able to play with the other kids was pretty awful.

Beverly Means, mother: It was mental torture. It was hard. Devastating to watch your kids and you can do nothing.

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Stem cell transplant for sickle cell patients

New Hope for Type I Diabetes Patients

Seattle, Washington (PRWEB) January 29, 2013

Patients report success with stem cell treatment for diabetics. Traveling4Health&Retirement (THR) announces their choice of a stem cell surgeon sponsor in Buenos Aires, a popular South America destination location for overseas retirement and medical travel.

We are pleased to promote Dr. Alejandro Mesples as our medical services sponsor in Buenos Aires, said Ilene Little, CEO of Traveling4Health&Retirement.

Dr. Mesples has published several papers in medical journals on the results of his research and therapy and is widely known and accepted as the authority on stem cell based surgery for diabetes using the patients own stem cells.

Recent results of his ongoing research were published 1/22/13 in the latest issue (Vol.3 No.1,2013) of the SCD medical journal, paper ID 1080044.

The sponsor selection was based on patient-generated reviews, interviews with the company leadership, and the strong support for the potential of the therapy and associated research as expressed in letters received from professors at the University of Padua in Italy and a professor of Endocrinology at Johns Hopkins.

When patients rave about their medical outcomes and a providers customer service, that gets our attention, said Ilene Little, We only promote doctors and accept destination sponsorships from doctors whose patients and professional peers recommend their services.

Download and listen, for free, to the father of a nine year old girl describing her stem cell treatment by Dr. Mesples on the 1/15/13 Know Before You Go Show aired on the Overseas Radio Network.

Lara was 8 years old and had a diagnosis of type 1 (or juvenile) diabetes newly diagnosed (one month prior to my prescribing her treatment plan), said Dr. Mesples, In September, 2011, we performed a liver implant of bone marrow stem cells in order to stop the autoimmune attack to the pancreas.

Normally this type of diabetes is secondary to antibody-mediated destruction and its evolution is marked by the increase of antibodies levels, low c peptide (low pancreatic function), and early use of insulin in high doses.

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New Hope for Type I Diabetes Patients

TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid

Regulated information january 29, 2013

TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid

Leuven (BELGIUM), Madrid (SPAIN) - January 29, 2013 - TiGenix (Euronext Brussels: TIG), a leader in the field of cell therapy, announced today that further to the cGMP inspection by the Spanish health authorities it has successfully renewed its manufacturing authorization for stem cell products at its manufacturing facility in Madrid, Spain.

"The GMP facility in Madrid performs a vital function within our organization by manufacturing high-quality, clinical grade allogeneic stem cell products to fuel our key clinical programs," said Wilfried Dalemans, CTO of TiGenix. "It is an important stepping stone before we can move to commercial manufacturing at our state-of-the-art, central GMP manufacturing site in Sittard-Geleen, the Netherlands. Our strong cell therapy manufacturing capabilities place us at the forefront of the cell therapy industry."

For more information: Eduardo Bravo Claudia D`Augusta Chief Executive Officer Chief Financial Officer eduardo.bravo@tigenix.com claudia.daugusta@tigenix.com Hans Herklots hans.herklots@tigenix.com +32 16 39 79 73

About TiGenix

TiGenix NV (Euronext Brussels: TIG)is a leading European cell therapy companywith a marketed product for cartilage repair, ChondroCelect, and a strongpipeline with clinical stage allogeneic adult stem cell programsfor the treatment ofautoimmune and inflammatory diseases.TiGenixis based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (theNetherlands). For more information please visitwww.tigenix.com.

Forward-looking information

This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix` control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix` expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

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TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid

Stem cell 'first aid' for rat stroke

27 January 2013 Last updated at 20:06 ET

Stem cells given in the vital period immediately after a stroke may aid recovery, suggest researchers.

Rats injected with stem cells 30 minutes after a stroke had almost normal brain function restored within a fortnight.

The Bolivian research team say the method has potential in human trials.

Current best practice is to treat many patients with "clot-busting" drugs in the "golden hour" after a stroke has taken place.

The research, published in the journal Stem Cell Research and Therapy, adds to others which have found that stem cells could aid stroke patients by boosting the body's ability to repair tissue damage.

Stem cells are the body's "master cells", with the potential to become many different cell types, and theoretically replace cells lost through disease or injury.

Recent tests in humans have show some promise, with stroke symptoms improving after an infusion of stem cells.

Stem cells are an incredibly interesting area of stroke research.

The Bolivian team, from La Paz University Hospital, extracted a certain type of stem cells from fat and bone marrow, then injected them into the blood vessels of rats shortly after they had suffered an artificially-induced stroke.

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Stem cell 'first aid' for rat stroke

Cardiac involvement and treatment-related mortality after non-myeloablative haemopoietic stem-cell transplantation …

Background

Autologous haemopoietic stem-cell transplantation (HSCT) benefits patients with systemic sclerosis but has been associated with significant treatment-related mortality and failure to improve diffusion capacity of carbon monoxide (DLCO). We aimed to assess efficacy of HSCT and use of rigorous cardiac screening in this group.

We assessed patients with diffuse systemic sclerosis or limited systemic sclerosis and interstitial lung disease who were treated with HSCT as part of a study or on a compassionate basis at Northwestern University (Chicago, IL, USA) or the University of So Paulo (Ribeiro Preto, Brazil). Unselected peripheral blood stem cells were harvested with cyclophosphamide (2 g/m2) and filgrastim. The transplant regimen was a non-myeloablative regimen of cyclophosphamide (200 mg/kg) and rabbit anti-thymocyte globulin (rATG; 4565 mg/kg). We followed patients up to 5 years for overall survival, relapse-free survival, modified Rodnan skin score, and pulmonary function tests.

Five (6%) of 90 patients died from treatment-related causes. Despite standard guidelines that recommend echocardiogram for screening before transplantation, four treatment-related deaths occurred because of cardiovascular complications (one constrictive pericarditis, two right heart failures without underlying infection, and one heart failure during mobilisation), and one death was secondary to sepsis without documented underlying heart disease. Kaplan-Meier analysis showed survival was 78% at 5 years (after eight relapse-related deaths) and relapse-free survival was 70% at 5 years. Compared with baseline, we noted improvements after HSCT in modified Rodnan skin scores at 1 year (58 patients; p<00001), 2 years (42 patients; p<00001), and 3 years (27 patients; p<00001) and forced vital capacity at 1 year (58 patients; p=0009), 2 years (40 patients; p=002), and 3 years (28 patients; p=0004), but total lung capacity and DLCO were not improved significantly after HSCT. Overall mean DLCO was significantly improved in patients with normal baseline echocardiograms (p=0005) or electrocardiographs (p=005).

Autologous HSCT with a non-myeloablative regimen of cyclophosphamide and rATG with a non-selected autograft results in sustained improvement in skin thickness and forced vital capacity. DLCO is affected by baseline cardiac function. Guidelines for cardiac screening of patients with systemic sclerosis to assess treatment-related risk from pulmonary artery hypertension, primary cardiac involvement, or pericardial disease should be reconsidered and updated.

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Cardiac involvement and treatment-related mortality after non-myeloablative haemopoietic stem-cell transplantation ...

Stem Cell Research: Stem Cells Nearly Cure Rats of Stroke Complications

The latest in stem cell research suggests that stem cells given in the vital period immediately after a stroke (known colloquially as the "golden hour") could make major headway in recovery. A research team in Bolivia injected rats with stem cells thirty minutes after a stroke, and discovered that they had almost completely normal brain function restored within two weeks. The team says that this has serious potential in human trials. Their study was led by Dr. Exuperio Diez-Tejedor from La Paz University Hospital, and supports previous studies that point in a similar direction: stem cells can be useful in treating stroke patients because they aid the body's ability to repair tissue damage. The stem cells used in this study were multipotent stromal cells extracted from fat and bone marrow. These are the types of stem cells that people are talking about when they talk of "master cells," the kind that can differentiate into many different cell types. Researchers hope that they will ultimately replace cells that are lost through disease or injury. The Bolivian study was published in the open-access journal Stem Cell Research and Therapy.

The controversy surrounding stem cells, at least in the United States, has been primarily centered around embryonic stem cells; but in this study, Dr. Diez-Tejedor was able to use "allogenic" (foreign) cells from other rats, and stated: "Improved recovery was seen regardless of origin of the stem cells, which may increase the usefulness of this treatment in human trials. Adipose (fat)-derived cells in particular are abundant and easy to collect without invasive surgery." This is outstanding news, as it implies that further research can be done and treatments be created without the destruction of embryos, effectively removing the politics from this branch of medicine. The team seems incredibly optimistic about their results, stating that they believe they might even be able to stop the "chain reaction" of cellular damage that results when the initial injury destroys cells in the surrounding areas. They continued, "From the viewpoint of clinical translation allogenic stem cells are attractive because they can be easily obtained from young healthy donors, amplified, and stored for immediate use when needed after a stroke." This implies that the usage of adult stem cells collected in a similar manner to that of a blood drive could ultimately provide a stroke treatment that would be immediately available to a suffering patient, just like donor blood. As exciting as this is, Dr. Clare Walton of the British organization The Stroke Association put a gentle damper on the enthusiasm, telling BBC News that human trials will not be happening anytime soon: "Stem cells are an incredibly interesting area of stroke research and the results of this study provide further insight into their potential use for stroke recovery. However, we are a long way off these types of treatments being used in humans and a lot more research is needed."

Despite the payoff of studies such as this one being so far in the future, the data suggesting that adult stem cells could be so incredibly useful should be heartening for those who have been disappointed by the political interference in this branch of medical research to date.

Follow Lauren Moccio on Twitter @TheGrottoTweets for more commentary on news, entertainment & politics.

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Stem Cell Research: Stem Cells Nearly Cure Rats of Stroke Complications

Stem Cell Therapy Helps Stroke Victims Recover in Two Weeks

The rats completely recovered from a stroke within two weeks with stem cell therapy (Wiki Commons)

Stem cell therapy administered shortly after a stroke could significantly increase the sufferer's chance of a complete recovery.

When administered to rats within 30 minutes of suffering a stroke, the rodents made a full recovery within two weeks, a study showed.

The research, published in BioMed Central's open access journalStem Cell Research & Therapy, found that stem cells from the bone marrow of fat can improve the recovery of rats following a stroke.

Researchers at La Paz University Hospital found that treatment improved the amount of brain and nerve repair, as well as the animal's ability to complete tasks.

Rats were treated intravenously with stem cells half an hour after a stroke. In humans, such rapid response is known to dramatically improve the outcome of victims.

The researchers found improvements in the stem cell group within 24 hours of the treatment, compared to the control group.

The FAST response advertising campaign has aimed to increase awareness of symptoms. Facial and arm weakness and speech problems suggest it is time to call emergency services.

Human trials

A delay in treatment can result in death or long-term disabilities. A stroke occurs when the blood supply to part of the brain is cut off.

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Stem Cell Therapy Helps Stroke Victims Recover in Two Weeks

Stem cells aid recovery from stroke

Public release date: 27-Jan-2013 [ | E-mail | Share ]

Contact: Hilary Glover hilary.glover@biomedcentral.com 44-020-319-22370 BioMed Central

Stem cells from bone marrow or fat improve recovery after stroke in rats, finds a study published in BioMed Central's open access journal Stem Cell Research & Therapy. Treatment with stem cells improved the amount of brain and nerve repair and the ability of the animals to complete behavioural tasks.

Stem cell therapy holds promise for patients but there are many questions which need to be answered, regarding treatment protocols and which cell types to use. This research attempts to address some of these questions.

Rats were treated intravenously with stem cells or saline 30 minutes after a stroke. At 24 hours after stroke the stem cell treated rats showed a better functional recovery. By two weeks these animals had near normal scores in the tests. This improvement was seen even though the stem cells did not appear to migrate to the damaged area of brain. The treated rats also had higher levels of biomarkers implicated in brain repair including, the growth factor VEGF.

A positive result was seen for both fat (adipose) and bone-marrow derived stem cells. Dr Exuperio Dez-Tejedor from La Paz University Hospital, explained, "Improved recovery was seen regardless of origin of the stem cells, which may increase the usefulness of this treatment in human trials. Adipose-derived cells in particular are abundant and easy to collect without invasive surgery."

###

Media Contact

Dr Hilary Glover Scientific Press Officer, BioMed Central Mob: 44-778-698-1967

Notes

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Stem cells aid recovery from stroke

Stem cells aid recovery from stroke, study suggests

Jan. 28, 2013 Stem cells from bone marrow or fat improve recovery after stroke in rats, finds a study published in BioMed Central's open access journal Stem Cell Research & Therapy. Treatment with stem cells improved the amount of brain and nerve repair and the ability of the animals to complete behavioural tasks.

Stem cell therapy holds promise for patients but there are many questions which need to be answered, regarding treatment protocols and which cell types to use. This research attempts to address some of these questions.

Rats were treated intravenously with stem cells or saline 30 minutes after a stroke. At 24 hours after stroke the stem cell treated rats showed a better functional recovery. By two weeks these animals had near normal scores in the tests. This improvement was seen even though the stem cells did not appear to migrate to the damaged area of brain. The treated rats also had higher levels of biomarkers implicated in brain repair including, the growth factor VEGF.

A positive result was seen for both fat (adipose) and bone-marrow derived stem cells. Dr Exuperio Dez-Tejedor from La Paz University Hospital, explained, "Improved recovery was seen regardless of origin of the stem cells, which may increase the usefulness of this treatment in human trials. Adipose-derived cells in particular are abundant and easy to collect without invasive surgery."

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Stem cells aid recovery from stroke, study suggests