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Archive for the ‘Stem Cell Therapy’ Category

Cell based therapy is gaining momentum : Dr Pradeep V Mahajan – ETHealthworld.com

Saturday, August 26th, 2017

Recently Dr Pradeep V Mahajan was honoured with Paris Appreciation Awards, 2017 for Excellence in stem cell therapy. He is the Chairman and Managing Director of StemRx Bioscience Solutions Pvt Ltd. In an interview with ETHealthworld, Dr Mahajan talks about the latest advancements in stem cell therapy and where it stands in healthcare system today. Edited excerpts :

How well informed are the doctors today about the cellular therapy? Is it time consuming? Where does cellular therapy stand in the Indian Healthcare system today?

For more than four decades, medical fraternity has knowledge about stem cell science and its potential therapeutic applications. However, earlier, clinicians were commonly aware of hematopoietic stem cell therapy, but were relatively uninformed about the advantages of mesenchymal stem cells. This could be attributed to the medical course syllabus which initially did not include topics specifically on cellular therapy.

Despite the technological advances that medical science is witnessing, it is not possible at present to predict the exact time when cellular therapy and regenerative medicine will replace existing forms of pharmacological and surgical treatments. Nonetheless, there is increasing awareness amongst clinicians who now more receptive to and are advising cell based therapy as an effective therapeutic modality for treatment of diseases.

Which are the diseases that can be treated through cellular therapy? What are the latest advancements?

Cellular therapy and regenerative medicine focuses on eliminating the root cause of the problem by use of cells (cytokines, chemokines etc.), growth factors from ones own body. Orthopedic conditions such as avascular necrosis, osteoarthritis, autoimmune conditions such as rheumatoid arthritis, ankylosing spondylitis, neurological conditions such as cerebral palsy, stroke etc., as well as diabetes, liver, genitourinary disorders, dermatological conditions and many more can achieve benefits from cellular therapy. This form of therapy can be further explored in management of organ failure, to overcome rejection following organ transplants, developmental defects, cancer immunotherapy etc.

Research advances pertaining to introducing products with cell and scaffold based technology through tissue engineering are underway. Bioactive scaffolds that are capable of supporting activation and differentiation of host stem cells at the required site are being developed. In the future it will be possible to use human native sites as micro-niche/micro-environment for potentiation of the human body's site-specific response.

Technologically, advances have been made over the years in both diagnostic and therapeutic approaches. Molecular imaging technology (optical imaging, positron emission tomography etc.) has simplified research on disease mechanism and treatment evaluation related to cell based therapy. Several new technologies are being introduced that simplify the process of isolation and characterization of cells. One such example is the Prodigy technology which completely automates the procedure of cell manufacturing from start to finish, thus enabling standardization and GMP compliance. In addition, detection and identification of specific cell populations is now possible through gene labeling techniques. Similarly, advances in microscopy have enabled study of cell behavior with respect to their surroundings.

What is the scope of cellular therapy in the country?

India is a nation with increasing population demands. Our country is seeing an alarmingly rapid rise in occurrence of diseases and conventional treatment modalities are gradually losing potential to cure affected individuals. Being a developing economy, the application and opportunity of cellular therapy and regenerative medicine is different when compared to other countries. A number game exists between diseases (such as cancer, lifestyle related, autoimmune conditions etc.) and finances in our country. The aim of cellular therapy is to enable a diseased person to use his own body cells for treatment thereby addressing the issue of extreme financial burden as seen with conventional treatment modalities. This will drastically benefit our patients and country and will also propagate India towards becoming the leader in cellular therapy and regenerative medicine.

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Trial of Lung Disease Stem Cell Therapy Could Come by Year’s End – Lung Disease News

Saturday, August 26th, 2017

University of North Carolina Health Careresearchers have made strides toward a stem cell treatment for lung diseases such as pulmonary fibrosis, COPD, and cystic fibrosis.

In fact, they are discussing the start of clinical trials with regulatory authorities.

The team discussed its work in two recent studies. One provedthat it is possible to isolate lung stem cells with a relatively non-invasive procedure. The other showed that stem cells reduce fibrosis in rats with pulmonary fibrosis.

The first study, in the journal Respiratory Research, was titledDerivation of therapeutic lung spheroid cells from minimally invasive transbronchial pulmonary biopsies.The second, inStem Cells Translational Medicine, was Safety and Efficacy of Allogeneic Lung Spheroid Cells in a Mismatched Rat Model of Pulmonary Fibrosis.

This is the first time anyone has generated potentially therapeutic lung stem cells from minimally invasive biopsy specimens, Dr. Jason Lobo, director of the universitys lung transplant and interstitial lung disease program,said in a press release. Hewas co-senior author of both studies.

We think the properties of these cells make them potentially therapeutic for a wide range of lung fibrosis diseases, added Dr. Ke Cheng, who led the studies with Lobo. He is anassociate professor in North Carolina State Universitys Department of Molecular Biomedical Sciences.

The research team had previously homed in on stem and support cells they could isolate from a lung tissue sample and grow in a lab. The tissue formed sphere-like structures in a lab dish, prompting the scientists to call them lung spheroid cells.

In 2015, the team showed that these cells had potent regenerative properties in animals with lung diseases. In fact, the stem cells they cultivated outperformed another type called mesenchymal stem cells.

Their latest project involved gathering lung spheroid cells from patients with various lung diseases. They used a procedure calleda transbronchial biopsy thatcan be done in a doctors office.

We snip tiny, seed-sized samples of airway tissue using a bronchoscope, Lobo said. This method involves far less risk to the patient than does a standard, chest-penetrating surgical biopsy of lung tissue.

From this tiny piece of airway, researchers gathered stem cells, then allowed them to multiply because stem cell treatments require infusions of millions of such cells.

When they injected the cells intravenously into mice, the discovered that most found their way into the animals lungs.

These cells are from the lung, and so in a sense theyre happiest, so to speak, living and working in the lung, Cheng said.

The team then tested the treatment in rats exposed to a chemical that triggers lung fibrosis. The lung spheroid cells gave rise to healthy lung cells, reducing both inflammation and fibrosis in the animals lungs.

Also, the treatment was safe and effective whether the lung spheroid cells were derived from the recipients own lungs or from the lungs of an unrelated strain of rats, Lobo said. In other words, even if the donated stem cells were foreign, they did not provoke a harmful immune reaction in the recipient animals, as transplanted tissue normally does.

The researchers said that in humans their goal would be to use patients own stem cells to minimize the risk of immune reactions. But because large quantities of cells are needed, it might be necessary to gather cells from healthy volunteers or organ donation networks as well.

Our vision is that we will eventually set up a universal cell donor bank, Cheng said.

The team is in discussions with the U.S. Food and Drug Administration aimed at starting the first human study by years end. The first trial would include a small group of pulmonary fibrosis patients. The team also hopes their spheroid stem cell therapy will help patients with other lung diseases.

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NICE backs Europe’s first stem cell therapy – PMLiVE

Saturday, August 26th, 2017

Chiesi made history two years ago when it claimed the first approval in Europe for a stem cell therapy, and can now celebrate decision by NICE to recommend its product for routine use in England and Wales.

The therapy - called Holoclar - was approved in 2015 for adults with moderate to severe limbal stem cell deficiency (LSCD) caused by physical or chemical burns to the eyes. LSCD is a rare condition that can lead to blindness, and affects just 3.3 out of 100,000 people in the EU.

Corneal cell renewal and repair are dependent upon the cells present in the limbus, which is found in a small area of the eye between the cornea and the conjunctiva. Burns to the eye can destroy the limbus, causing a deficiency of limbal cells. If this happens, the cornea is covered by a different epithelium following an invasion of cells from the conjunctiva. This process renders the cornea opaque and results in subsequent loss of vision, and conventional corneal transplant is ineffective in these cases.

Holoclar takes the form of a sheet of corneal epithelial cells, containing the patient's own stem cells, that can be used to regenerate and repair damaged eye tissue.

The therapy has been approved with some conditions by NICE. Specifically, it can generally only be used to treat one eye, and to be eligible patients must have previously had treatment with a conjunctival limbal autograft (CLAU) - a form of transplant surgery that involves taking tissue from an unaffected eye - or be unsuitable for that procedure.

Patients with two eyes affected by LSCD can only receive the therapy in the context of research if there is not enough tissue available for a CLAU, according to NICE, which said its appraisal committee had agreed that Chiesi had presented evidence to show that Holoclar "offered several advantages over existing treatments".

Chiesi has agreed to supply Holoclar to the NHS at an undisclosed discount to its list price of 80,000 plus VAT for a single treatment for one eye. The company said the decision will reduce the need for external donors and damage to the donor eye.

"We are delighted that NICE has recommended that eligible patients have access to this personalised and regenerative medicine for a rare and seriously debilitating orphan condition," commented Chiesi's UK managing director Tom Delahoyde.

Holoclar - which won the UK Prix Galien award in 2016 - is the first product from Chiesi's nine-year-old rare disease unit to reach the market, although it could shortly be joined by Lamazym/Lamzede (velmanase alfa), used as an enzyme replacement therapy for the genetic disorder alpha-mannosidosis which is currently under review in Europe.

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Stem Cell Therapy for Infections by Resilient Bacteria – Financial Tribune

Saturday, August 26th, 2017

According to data released by the Food and Waterborne Diseases Office of the Health Ministry, an average of 15% of hospital patients suffer from nosocomial infections.A nosocomial infection is an infection acquired in hospital by a patient who was admitted for a reason other than the infection.The severity of hospital-acquired infections depends on the location and type of infection, said Abbasali Imani Fouladi, the scientific secretary of the 18th International Congress of Microbiology, which will be held on Aug. 29-31 at Tehran University of Medical Sciences, ISNA reported. The use of stem cells and their significant role in treatment of the infectionsin particular, antibiotic-resistant infectionsis a key topic that will be discussed by domestic and foreign specialists at the conference.Sometimes ulcers which are resistant to conventional treatment, respond positively and swiftly to stem cell treatments, he explained, adding that officials from Council for Stem Cell Sciences and Technologies (affiliated to Vice-Presidency for Science and Technology) have been invited to the event that will be attended by scientists from Spain, Italy, UK, and France. Four workshops will be held on the sidelines of the meeting.Stating that with resistance to antibiotics becoming more common, there is greater need for alternative treatments, he said, Currently there are 12 strains of bacteria in need of new antibiotics or alternative treatments.The event is co-sponsored by the Health Ministry, TUMS, Pasteur Institute of Iran, Razi Vaccine and Serum Research Institute, and Ilam University of Medical Sciences, according to the congress website (ismcongress.ir).Nosocomial infections occur worldwide and affect both developed and resource-poor countries. Healthcare-associated infections are among the major causes of death and increased morbidity among hospitalized patients. They are a significant burden both for the patient and public health.According to the World Health Organization, HAIs add to functional disability and emotional stress of the patient and may in some cases, lead to disabling conditions that reduce the quality of life. Nosocomial infections are also one of the leading causes of death. The economic costs are considerable. The increased length of hospital stay for infected patients is the greatest contributor to cost.While the prevalence rate of HAIs is 30% in lower-income countries, the average rate is around 6-11% in developed countries, according to Dr. Hossein Masumi-Asl, head of the Food and Waterborne Diseases Office.The most frequent nosocomial infections are infections of surgical wounds, urinary tract infections and lower respiratory tract infections, he said. According to the official, the highest prevalence of nosocomial infections occurs in intensive care units and in acute surgical and orthopedic wards. Infection rates are higher among patients with increased susceptibility because of old age, underlying disease, or chemotherapy.

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Potential stem cell therapy may help promote hair growth – The Indian Express

Tuesday, August 15th, 2017

By: PTI | Los Angeles | Published:August 15, 2017 6:54 pm Understanding the critical role metabolism plays in hair growth and stem cells.

Scientists have discovered a new way to activate the stem cells in the hair follicle, an advance that may pave the way for novel drugs to promote hair growth. Hair follicle stem cells are long-lived cells in the hair follicle; they are present in the skin and produce hair throughout a persons lifetime. They are quiescent, meaning they are normally inactive, but they quickly activate during a new hair cycle, which is when new hair growth occurs.

The quiescence of hair follicle stem cells is regulated by many factors. In certain cases they fail to activate, which is what causes hair loss.

Researchers from University of California, Los Angeles in the US found that hair follicle stem cell metabolism is different from other cells of the skin. Cellular metabolism involves the breakdown of the nutrients needed for cells to divide, make energy and respond to their environment. The process of metabolism uses enzymes that alter these nutrients to produce metabolites.

As hair follicle stem cells consume the nutrient glucose a form of sugar from the bloodstream, they process the glucose to eventually produce a metabolite called pyruvate. The cells then can either send pyruvate to their mitochondria the part of the cell that creates energy or can convert pyruvate into another metabolite called lactate. Our observations about hair follicle stem cell metabolism prompted us to examine whether genetically diminishing the entry of pyruvate into the mitochondria would force hair follicle stem cells to make more lactate, and if that would activate the cells and grow hair more quickly, said Heather Christofk, an associate professor at UCLA.

The research team first blocked the production of lactate genetically in mice and showed that this prevented hair follicle stem cell activation. Conversely, they increased lactate production genetically in the mice and this accelerated hair follicle stem cell activation, increasing the hair cycle. Before this, no one knew that increasing or decreasing the lactate would have an effect on hair follicle stem cells, said William Lowry, a professor at the UCLA.

Once we saw how altering lactate production in the mice influenced hair growth, it led us to look for potential drugs that could be applied to the skin and have the same effect, said Lowry. The team identified two drugs that, when applied to the skin of mice, influenced hair follicle stem cells in distinct ways to promote lactate production.

The first drug, called RCGD423, activates a cellular signalling pathway called JAK-Stat, which transmits information from outside the cell to the nucleus of the cell. The research showed that JAK-Stat activation leads to the increased production of lactate and this in turn drives hair follicle stem cell activation and quicker hair growth. The other drug, called UK5099, blocks pyruvate from entering the mitochondria, which forces the production of lactate in the hair follicle stem cells and accelerates hair growth in mice.

Through this study, we gained a lot of interesting insight into new ways to activate stem cells, said Aimee Flores, first author of the study published in the journal Nature Cell Biology. The idea of using drugs to stimulate hair growth through hair follicle stem cells is very promising given how many millions of people, both men and women, deal with hair loss, said Flores.

I think weve only just begun to understand the critical role metabolism plays in hair growth and stem cells in general; Im looking forward to the potential application of these new findings for hair loss and beyond, she said.

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Stem cell therapy may help knees – News – Citizens’ Voice – Citizens Voice

Tuesday, August 15th, 2017

Q: I read that you can use your own stem cells to rejuvenate worn-out knees. Does this really work?

A: Worn out is a good way to term what happens to the knee joint with prolonged use. Lets look at how this happens, starting with cartilage.

The lower portion of the knee joint (at the tibia) contains shock absorbers called menisci made of cartilage. You have one on the inner portion and another on the outer portion of each knee. The upper portion of the knee joint (at the femur) is lined with cartilage as well. All of this cartilage helps protect the bones at the joint but it doesnt heal or regenerate well due to limited blood supply. When severe, worn cartilage leads to arthritis of the knee. In knee X-rays of people over age 60, 37 percent have shown evidence of arthritis of the knees.

The intriguing thing about stem cells is that they have the ability to become any type of cell that the body needs. The cells used for stem cell injections in the knees are called mesenchymal stem cells, and they can differentiate into bone, fat or cartilage cells. These stem cells can come from the fat cells of your body, from your bone marrow or from the inner lining of your knee joint; theyre then replicated in the laboratory and injected into the knee joint.

Heres what the research shows so far.

In a 2013 study, 32 patients with meniscal tears of the knee were injected with a combination of stem cells, platelet-rich plasma and hyaluronic acid. The study reported improved symptoms and even MRI evidence of meniscal cartilage regeneration.

In a 2014 study, 55 patients who had surgery for meniscal tears of the knees were separated into three groups, with two of the groups receiving stem cell injections. Researchers found that, after six weeks, pain had decreased substantially in the two groups that received stem cell injections and that the decrease was even greater at one and two years after the injection.

In a 2017 study in the British Journal of Sports Medicine, researchers analyzed six studies that used stem cells for osteoarthritis of the knees. In five of the studies, stem cells were given after surgery to the knee; in the other study, stem cells from a donor were administered without surgery. All the studies showed reduced pain and improved knee function. Further, in three of the four trials, MRIs corroborated the cartilage improvements.

There may be benefit to stem cell injections for cartilage loss of the knees, but more data are needed. Id also like to see more data on this type of therapy as a preventive measure for younger patients before their knees are worn out.

ASK THE DOCTORS is written by Robert Ashley, M.D., Eve Glazier, M.D., and Elizabeth Ko, M.D. Send questions to askthedoctors@

mednet.ucla.edu, or write: Ask the Doctors, c/o Media Relations, UCLA Health, 924 Westwood Blvd., Suite 350, Los Angeles, CA, 90095.

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Stem cell therapy for heart failure gets a gold-standard trial – Salon

Tuesday, August 15th, 2017

In the days after a heart attack, surviving patients and their loved ones can breathe a sigh of relief that the immediate danger is over but the scar tissue that forms during the long healing process can inflict lasting damage. Too often it restricts the hearts ability to fill properly between beats, disrupting rhythm and ultimately leading to heart failure. Yet a new possible treatment may help to revitalize an injured ticker.

A cadre of scientists and companies is now trying to prevent or reverse cardiac damage by infusing a cocktail of stem cells into weakened hearts. One company, Melbourne, Australiabased Mesoblast, is already in late-stage clinical trials, treating hundreds of chronic heart failure patients with stem cell precursors drawn from healthy donors hip bones. A randomized trial that includes a placebo group is scheduled to complete enrollment next year.

Mesoblasts earlier-stage trials, published in 2015 inCirculation Research, found that patients who received injections of its cell mixture had no further problems related to heart failure.

Promising results from the new trial would be a major step forward for a field that has long been criticized for studies that are poorly designed, incomplete or lack control-group comparisons, as well as for the peddling of unproved therapies in many clinics worldwide.

Another company, Belgium-based TiGenix, hopes to attack scar tissue before it forms by treating patients with a mixture of heart stem cells within seven days of a heart attack. This approach has just completed phase II trials, but no findings have yet been published.

There are still many unanswered questions about how stem cells typically derived from bones could help heal the heart. Leading theories suggest they may help fight inflammation, revitalize existing heart cells, or drive those cells to divide or promote new blood-vessel growth, says Richard Lee, leader of the cardiovascular program at the Harvard Stem Cell Institute. Other stem cell scientists, including Joshua Hare, who conducted earlier-stage Mesoblast research and directs the Interdisciplinary Stem Cell Institute at the University of Miami, say the cells may work in multiple ways to heal scar tissue. According to Hare, the stem cells could ultimately be a truly regenerative treatment.

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Medical Tourism Corporation Announces Stem Cell Therapy in Mexico With GIOSTAR – NBC Right Now

Tuesday, August 15th, 2017

The two entities join hands for all-inclusive stem cell treatment in Los Algodones, Tijuana, and Guadalajara. Package includes personalized therapy protocol, travel assistance, and more. GIOSTAR is a global stem cell leader with more than 4,000 people treated.

DALLAS-August 14, 2017- (Newswire.com)

The major medical tourism facilitator has added another much-needed treatment to its comprehensive list of medical services, stem cell treatment in Mexico, as a way of helping people with degenerative, immunological, and blood-based diseases receive alternative healthcare and lead a happy, healthy life.

About GIOSTAR Mexico

Founded by a leading stem cell scientist, Dr. Anand Srivastava who is credited with setting up stem cell research programs in Sal Research Institute, UCSD, UCI and Sanford Burnham Institute, GIOSTAR is a visionary organization in the field. With its headquarters in San Diego and multiple top-notch facilities, offices and hospitals in various locations including India, Mexico, Brazil and Colombia, the venture is expanding its reach and making treatment for several devastating immunological and blood- related diseases accessible for all.

GIOSTAR Mexico offers stem cell therapy in Tijuana, Guadalajara, and Los Algodones. Current treatments include Diabetes Type I and Type II, Lupus, Multiple Sclerosis, Crohn's disease, and Spinal Cord Injuries (SCI), among others. The therapies for Alzheimer's, Autism, Anti-Aging Treatments, Parkinson's disease, Heart and Retinal Degeneration, and many more diseases are being developed by the dedicated and skilled members of the institute.

Some prominent features of GIOSTAR are:

About Medical Tourism Corporation (MTC)

The Texas-based Medical Tourism Corporation is a Better Business Bureau (BBB) accredited health tourism organizer. The corporation aims to connect medical tourists from all over the world to excellent healthcare services without the underlying stress. The most daunting part of the medical tourism process is the lack of information about quality treatments in Mexico, India, and other health tourism hubs. MTC emerges as a helping hand, and assists its customers in planning every little detail of their medical trip and even offers generous post-op services and follow-up care for a safe recovery.

With the introduction of alternative therapies for taxing and draining conditions, such as stem cells for Parkinson's in Mexico, the organization is expanding its arsenal of services and treatments offered.

Medical Tourism Corporation has recently partnered with GIOSTAR with the goal of making quality healthcare come true. The two entities have collaborated to offer personalized protocols for various conditions and injuries, including stem cell therapy for spinal injuries in Mexico.

Aiming to provide exemplary stem cell treatment in Mexico, MTC provides a host of services and features that set the venture apart:

What to Expect?

The National Institutes of Health (NIH) estimates up to 23.5 million Americans suffer from autoimmune diseases. All that is standing between these patients and life-altering medical treatments is a border away.

This timely collaboration between GIOSTAR and MTC is an important step forward in bridging the gap between demand and supply of effective alternative treatments for people suffering from the aforementioned ailments when conventional therapies fail to treat. More information on stem cell therapy in Mexico is available on the official website of Medical Tourism Corporation.

Related LinksStem Cell Treatment for Diabetes Type 1 and 2 in MexicoStem Cell Treatment for Arthritis in Mexico

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Stem Cell Therapy Selectively Targets and Kills Cancerous Tissue – Anti Aging News

Tuesday, August 15th, 2017

Researchers have created a method to kill cancerous tissue without causing the harmful side effects of chemotherapy.

Medical researchers at the University of California, Irvine have created a stem cell-based method to zero in on cancerous tissue. This method kills the cancerous tissue without causing the nasty side effects of chemotherapy. Such side effects are avoided by treating the disease in a more localized manner. The advancement was spearheaded by associate professor of pharmaceutical sciences Weian Zhao. The details of the stem cell therapy were recently published in Science Translational Medicine.

About the new Stem Cell Therapy

Zhao's team programmed stem cells derived from human bone marrow to pinpoint the specific properties of cancerous tissue. They implemented a portion of code to these engineered cells to identify stiff cancerous tissue, lock onto it and implement therapeutics. The researchers safely used this new stem cell therapy in mice to kill metastatic breast cancer that had moved to the lungs. They transplanted these engineered stem cells in order for the teamto pinpoint and settle in the site of the tumor.

Once the stem cells reached the tumor, they released enzymes referred to as cytosine deaminase. The mice were then provided with an inactive chemotherapy known as prodrug 5-flurocytosine. The tumor enzymes stimulated the chemotherapy into action. Zhao stated his team zeroed in on metastatic cancer that occurs when the disease moves to additional parts of the body. Metastatic tumors are especially dangerous. They are responsible for90 percent of all cancer deaths.

Why the new Stem Cell Therapy is Important

Zhao is adamant his stem cell therapy represents an important newparadigm in the context of cancer therapy. Indeed, Zhao has blazed a trail in a new direction that others will likely follow in the years to come. It is possible his new stem cell therapy serves as an alternative and more effective means of treating cancer. This stem cell therapy will serve as an alternative to numerous forms of chemotherapy that typically have nasty side effects. Chemotherapy certainly kills plenty of growing cancer cells yet it can also harm healthy cells. The new type of treatment keys in on metastatic tissue that allows for the avoidance of the undesirable side effects produced by chemotherapy.

Though the published piece describing this stem cell therapy is centered on breast cancer metastases within thelungs, the method will soon be applicable to additional metastases. This is due to the fact that numerous solid tumors are stiffer than regular tissue. The new system does not force scientists to invest time and effort to pinpoint and create a brand new protein or genetic marker for each kind of cancer.

The Next Step

At this point in time, Zhao's team has performed pre-clinical animal studies to show the treatment is effective and safe. They plan to segue to human studies in the coming months and years. Zhao's team is currently expanding to additional types of cells such as cancer tissue-sensing and engineered immune system CAR-T (T cells) to treat metastasizing colon and breast cancers. Their goal is totransform this technology for the treatment of additional diseases ranging from diabetes to fibrosis and beyond.

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Stem cell therapies: medical experts call for strict international rules – The Guardian

Thursday, July 6th, 2017

Stem cells have long been used to treat blood cancers and some immune diseases. But some doctors are offering stem cell treatments for diseases still under clinical trial. Photograph: Mauricio Lima/AFP/Getty Images

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks, the authors wrote.

Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldales death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve comorbidities and that stem cells could move from joints to other parts of the body to improve disease in distant sites including lungs and brain, vision, mentation and pain.

In his report into Drysdales death, the coroner Hugh Dillon wrote that he could not say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale.

But regardless of his motivation, Dr Brights performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdales death.

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australias drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. A TGA spokeswoman said the Administration was still examining the options for changes to the legislation to reflect public and industry views. The TGA currently considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

There is a precedent for international regulation of this industry because regulations already exist around drugs the way they are manufactured, she said.

This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

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Stem cell therapies breaking barriers – Guardian (blog)

Thursday, July 6th, 2017

STEM CELL THERAPIES BREAKING BARRIERSPhysicians all over the world are increasingly employing stem cell therapies for the treatment of chronic diseases including hypertension, diabetes, chronic kidney disease, neurological disorders, asthma, diabetes, rheumatoid arthritis, spinal cord injuries, female and male sexual dysfunction, joint pain and autoimmune disease. INSET is Dr. David Ikudayisi, of the Glory Wellness and Regenerative Centre PHOTO CREDIT: http://theconversation.com

Technology offers groundbreaking new treatment option for chronic diseases to patients Physicians all over the world are increasingly employing stem cell therapies for the treatment of chronic diseases including hypertension, diabetes, chronic kidney disease, neurological disorders, asthma, diabetes, rheumatoid arthritis, spinal cord injuries, female and male sexual dysfunction, joint pain and autoimmune disease.

A study published last week in the FASEB Journal showed that a new therapy developed through stem cell technology holds promise as a treatment for chronic asthma.

Also, researchers have successfully patched up damaged hearts to treat heart failure, using the patients own muscle stem cells but another study published last week in journal Circulation found that the treatment could be more harmful than helpful if cardiac stem cells are involved.

In another study published in the journal Science Translational Medicine, team of investigators has successfully repaired severe limb fractures in laboratory animals with an innovative technique that cues bone to regrow its own tissue. If found to be safe and effective in humans, the pioneering method of combining ultrasound, stem cell and gene therapies could eventually replace grafting as a way to mend severely broken bones.

Using new gene-editing technology, researchers have rewired mouse stem cells to fight inflammation caused by arthritis and other chronic conditions. According to the study published in the journal Stem Cell Reports, such stem cells, known as SMART cells (Stem cells Modified for Autonomous Regenerative Therapy), develop into cartilage cells that produce a biologic anti-inflammatory drug that, ideally, will replace arthritic cartilage and simultaneously protect joints and other tissues from damage that occurs with chronic inflammation.

Scientists have for the first time created a special type of neuron from human stem cells that could potentially repair spinal cord injuries. The study was published in the Proceedings of the National Academy of Sciences.

Also, early results of a clinical trial suggest that stem cell therapy may be a promising treatment for erectile dysfunction, after the procedure was found to restore sexual function in men with the condition.

Meanwhile, the ANOVA IRM Stem Cell Centre has opened its doors in Frankfurt, Germany offering a groundbreaking new treatment option to patients worldwide.

One of the pioneers of stem cell therapy in Nigeria, Dr. David Ikudayisi, of the Glory Wellness and Regenerative Centre, with clinics in Abuja and Lagos, told The Guardian that there are several thousand clinical trials based on autologous (patients own) Mesenchymal Stem Cells (MSCs). He said these type of stem cells are relatively easy to obtain from a patient via bone marrow blood or fat tissue and have been shown to hold vast healing potential.

Ikudayisi is a United States (U.S.) Board Certified Internist with a strong passion for regenerative aesthetic and cosmetic medicine.

Ikudayisi said ASCT and Platelet Rich Plasma Therapy (PRPT) are under a new specialty of medicine known as regenerative medicine, which is a specialist segment of medicine that helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to.

ASCT may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. Adult stem cell therapy with or without PRPT revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related, Ikudayisi said.

He said that ASCT and PRPT are safe as shown by many published research reports and clinical trials done already. He, however, said this does not guarantee that adverse effects cannot occur if physicians that are not properly trained do the treatment.

The US-trained said ASCT has helped a lot of people all over the world to regain their lives back from debilitating ailments and Nigerians are not left behind. He said there are real people in Nigeria that were either wheelchair bound but now walking freely with occasional use of a cane or using a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger.

He said ASCT has helped chronic kidney disease patients in Nigeria that are on haemodialysis to either reduce the frequency of haemodialysis per week or like in a patient that was recommended to have kidney transplant a year ago is now off haemodialysis and off diabetic medications, and remain stable for the last six months.

Ikudayisi said men with erectile dysfunction are now feeling like young men again. He further explained: I would be remiss to mention that the type of treatment protocol, the dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results.

The only groups of patients that will always need more than a couple of transplantation sessions are patients with the neurological disorders. The latest researches and evidence-based studies show the number of treatment session needed to get significant clinical results can decreased by adding Exosomes to the treatment sessions.

Ikudayisi said there are some diseases that conventional treatments have no cure for, but ASCT can reverse the symptoms of those diseases, repair, and regenerate the damaged tissues or organs involved. He explained: In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial Rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like rheumatoid arthritis, lupus, scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like Amyotrophic lateral sclerosis (ALS) and spinal cord injury.

Ikudayisi said ASCT can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and up-regulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of adult stem cells, he said.

Ikudayisi said a procedure called P-Shot for Men uses PRPT to resolve challenges relating to erectile dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery, he said.

Ikudayisi said since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant, but as with any procedure, there is a risk of infection, which can be very minimal or non-existent if done under the right conditions. He said adult stem cells transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease.

The regenerative medicine expert, however, said: Currently, the cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that Health is wealth.

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Stem cell therapy to treat paralytic dogs draws pet owners from … – Times of India

Thursday, July 6th, 2017

Bareilly: Dog owners from across the country, including Delhi and Gujarat, are turning up with their paralytic pets at the Indian Veterinary Research Institute (IVRI) here for stem cell therapy. Scientists treat a paralyzed dog by transplanting stem cells from healthy dogs. IVRI is the second institute in the country to offer this treatment, after Madras Veterinary College, Chennai.

According to scientists, no research has been conducted to determine the number of dogs who suffer from paralysis every year in India. However, the institute receives at least four cases every week of spinal trauma which causes paralysis in dogs. IVRI recorded 143 cases of posterior paralysis in 2016. These were treated with stem cell therapy and medicines.

If dogs are treated only with medicines, recovery is witnessed only in a few cases, said Amarpal (who goes by his first name), head and principal scientist, division of surgery, IVRI. On an average, 17% recovery rate was noted among dogs administered only medicines.

However, the best response was recorded among severely affected dogs when they were treated using stem cells, where almost all the patients responded to treatment to variable extent, said the scientist. Though we have cases where recovery was 100%, the average recovery rate is about 50%. The experiment proved the efficacy of stem cell therapy in cases of paralysis due to spinal trauma, said Amarpal.

The paralytic dog is first administered anesthesia before the stem cells are injected into its spinal cord. It takes only one session for a dog to undergo the therapy and it is discharged the same day.. After this, the owner has to bring his pet for check-ups for two or more times so that vets can monitor how the animal is responding to the treatment and if it is suffering from any reaction, said Amarpal.

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Photo-responsive protein hydrogels as agent for controlled stem cell/protein release – Phys.Org

Thursday, July 6th, 2017

July 6, 2017 Material design empowered by protein sequence space. Credit: Department of Chemical and Biological Engineering, HKUST

Hydrogels, noted for their biomimetic properties, are the leading materials for biomedical applications, such as drug delivery and stem cell therapy. Traditional hydrogels made up of either synthetic polymers or natural biomolecules often serve as passive scaffolds for molecular or cellular species, which render these materials unable to fully recapitulate the dynamic signaling involved in biological processes, such as cell/tissue development.

Photo-responsive hydrogels are of particular interest to material scientists, because light is regarded as an ideal tool to control molecules or cell behavior with high spatiotemporal precision and little invasiveness. The major challenge for scientist is how to assemble these complex globular proteins into supramolecular architectures efficiently while preserving their function.

In a recent research, a group of scientists from The Hong Kong University of Science and Technology created a B12-dependent light-sensing hydrogel by covalently stitching together the photoreceptor C-terminal adenosylcobalamin binding domain (CarHC) proteins under mild conditions. This direct assembly of stimuli-responsive proteins into hydrogels represents a versatile solution for designing "smart" materials and opens up enormous opportunities for future material biology.

The findings were published in the journal PNAS on June 6, 2017.

"In our research, we were able to create an entirely recombinant protein-based light-sensitive hydrogels by covalently assembling the CarHC photoreceptor proteins using genetically encoded SpyTag-SpyCatcher chemistry," said Fei Sun, author of the paper and assistant professor at HKUST's department of chemical and biomolecular engineering. "The AdoB12-dependent CarHC tetramerization has been shown to be essential for the formation of an elastic hydrogel in the dark, which can undergo a rapid gel-sol transition caused by light-induced CarHC disassembly."

"The resulting hydrogel composed of physically self-assembled CarHC polymers exhibited a rapid gel-sol transition on light exposure, which enabled the facile release/recovery of 3T3 fibroblasts and human mesenchymal stem cells (hMSCs) from 3D cultures while maintaining their viability." Sun added. "Given the growing demand for creating stimuli-responsive "smart" hydrogels, the direct assembly of stimuli-responsive proteins into hydrogels represents a versatile strategy for designing dynamically tunable materials."

Explore further: Investigating folding stability and dynamics of proteins

More information: Ri Wang et al, B12-dependent photoresponsive protein hydrogels for controlled stem cell/protein release, Proceedings of the National Academy of Sciences (2017). DOI: 10.1073/pnas.1621350114

Journal reference: Proceedings of the National Academy of Sciences

Provided by: Hong Kong University of Science and Technology

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Is stem cell therapy approved in Singapore? – The Straits Times

Saturday, July 1st, 2017

Reader Charles Wang wrote to ask if stem cell therapy - the use of stem cells to treat various medical conditions - is approved in Singapore. Mr Wang also asked where one could seek this treatment if it is available. Health reporter Linette Lai answered.

Any new treatment must be backed up by sufficient scientific evidence to ensure that it is safe and effective. However, there is still not enough scientific evidence available for stem cell therapy to be approved as a mainstream treatment in Singapore.

A Ministry of Health spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments, and it is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it would have to be conducted within the context of clinical trials."

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Anger as Scots patients miss out on ‘breakthrough’ stem cell therapy … – Herald Scotland

Saturday, July 1st, 2017

LUCY Clarke was facing a downhill spiral when she flew to Russia to undergo a cutting edge stem cell transplant.

Two years on she says the procedure not only halted her illness in its tracks, but reversed much of the damage inflicted by multiple sclerosis.

The 41-year-old from Inverness is now backing crowdfunding efforts so that her friend and neighbour, Rona Tynan, can receive the same life-changing operation in Mexico before she becomes too ill to qualify.

Mrs Tynan, 50, has until the end of August to raise the 60,000 needed.

However, both are angry at a cross-border divide which means that a small number of MS patients in England can undergo the treatment for free on the NHS, while in Scotland despite having some of the highest rates of MS in the world the health service has refused patients' funding and no clinical trials are planned.

Mrs Clarke, a chemistry graduate and acupuncturist, began investigating AHSCT (autologous haematopoietic stem cell transplantation) in 2014 after her condition progressed from relapsing-remitting to secondary progressive MS. At the time her son was three and she feared ending up in a wheelchair.

Although the treatment has been available overseas for decades, it has never been routinely available on the NHS and is considered unproven by many neurologists.

It is also a highly aggressive therapy, using intensive chemotherapy to strip out sufferers faulty immune systems before replenishing it with stem cells harvested from their own bone marrow or donor tissue. Despite the risks, many patients including Mrs Clarke credit it with transforming their lives.

She underwent the procedure in Moscow over a period of four weeks in April and May 2015. She said: From when my son was three to when I had the transplant, my walking had deteriorated, I needed to use a walking stick all the time, I had very poor balance, debilitating fatigue, I had brain fog, I used to slur my words.

"Im left-handed and my left hand was really weak so my writing was bad. Other things would come and go numbness in my legs, tingling, cramps in my calves, sore and painful legs. The majority of them have gone since the transplant.

I noticed quite quick improvements in things like balance. The biggest thing is not really having fatigue, and the brain fog completely went. I stopped slurring my words quite quickly after treatment. I was more alert. I had more concentration, more focus. Within six months the shaking in my left arm had gone. Ive still got drop foot in my right leg and I still use a walking stick, but once youve got to the stage of secondary progressive it all gets a bit scary. Things are going downhill and youre told theres nothing that can be done, so really my goal from treatment was just to halt the progression to know I wasnt getting any worse. Thankfully, and luckily, I have seen lots of benefits.

Eighteen months on, MRI brain scans show no signs of disease progression and while Mrs Clarke stresses that the treatment is neither a magic bullet nor a walk in the park, she is supporting Rona Tynans bid to undergo the same surgery in October.

Mrs Tynan, a retired Metropolitan police sergeant and mother-of-two from Inverness, also has secondary progressive MS. She is already in a wheelchair and fears that unless she undergoes the treatment soon she will become too ill. She said: Im a 7.5 out of 10 on the disease progression scale, where 10 is death. Most clinics stop taking you at seven, but Mexico just raised it to 8.5. Thats brilliant for people like myself, but I cant afford to get any more ill.

So far, Mrs Tynans fundraising page on JustGiving has raised nearly 4000, but she is frustrated that more is not being done to help Scottish patients. In England, clinical trials are ongoing in London and Sheffield but a small number of patients with relapsing-remitting MS can be referred for the treatment off-trial, for free, on the NHS. In Scotland, however, eligible patients have been turned down for NHS funding.

Mrs Tynan said: It seems crazy to me that Brits are going to Chicago and Mexico and Russia for a treatment that in the long-run could save the NHS loads of money. Scotland is one of the worst places in the world for MS yet in England you can get this treatment for free. Why arent we fighting in Scotland to get this?

Mrs Clarke added: Its very unfair. It just seems a no brainer to me why they wouldnt make it available not for all patients but for some. The Scottish Government said referral decisions were "for clinicians".

A spokesman said: "Whilst the vast majority of healthcare provided by NHS Scotland is delivered in Scotland, NHS boards can commission treatment in other countries on an ad hoc basis, particularly where highly specialised treatment is involved. Decisions to refer patients are for clinicians, based on agreed guidelines, which ensure best practice, equity of access and consistency of treatment for all patients.

"HSCT is not currently widely available anywhere on the NHS, but people from Scotland can participate in trials held in other centres across the UK, where clinically determined appropriate and beneficial."

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Anger as Scots patients miss out on 'breakthrough' stem cell therapy ... - Herald Scotland

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askST: Is stem cell therapy available in Singapore? – The Straits Times

Wednesday, June 28th, 2017

Reader Charles Wang wrote in to ask if stem cell therapy is approved for use in Singapore. Stem cell therapy refers to the use of stem cells to treat various medical conditions. Mr Wang also asked if it is available, and where one can seek this treatment.

Health reporter Linette Lai answered.

Any new treatment must be backed by sufficient scientific evidence to ensure that it is safe and effective. However, there is not enough scientific evidence yet for stem cell therapy to be approved as a mainstream treatment in Singapore.

There is not enough scientific evidence yet to ensure that stem cell therapy is safe and effective for it to be approved as a mainstream treatment in Singapore. PHOTO: ST FILE

A Health Ministry spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments and is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it will have to be conducted within the context of clinical trials."

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askST: Is stem cell therapy available in Singapore? - The Straits Times

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Stem Cell Procedures: Know Before You Buy – KUTV 2News

Tuesday, June 27th, 2017

SALT LAKE CITY (KUTV) Today on Fresh Living were talking about Stem Cell Therapy.

Dr. Steven Warren from Intermountain Health and Wellness joined the show to share information with Casey & Kari about what patients need to know:

Before a patient commits to having a stem cell injection the patient should:

1. That an MRI or CT of the joint has shown the destruction of the tissue and Stem cells are needed to repair the damaged tissue.

2. Confirm that they will be getting a certificate that verifies that the injection will contain, live viable stem cells and at least a cell count of 1 million for most joints in the body.

3. That the doctor has been thoroughly trained in joint injections using guided imaging injections. Such as a C-arm fluoroscopy or Ultrasound.

4. Ensure the procedure will be performed under a strict sterile environment. To reduce the risk of a joint infection.

Intermountain Health and Wellness has a deal for Fresh Living viewers: call in NOW for a consultation to find out what stem cells can do for YOU! First 25 callers will receive a FREE MRI with the procedure. phone (801) 981-8795

For more information, visit: IntermountainStemCells.com

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Takeda prepping to take over EU production of stem cell therapy from 2021 – BioPharma-Reporter.com

Friday, June 23rd, 2017

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohns disease stem cell therapy licensed from TiGenix.

Following its acceptance for review by the European Medicines Agency (EMA), Takeda and TiGenix announced this week Swissmedic has accepted for review the file for compound Cx601, an allogeneic expanded adipose-derived stem cell (eASC) therapy for the treatment of complex perianal fistulas in patients with Crohns disease.

The therapy is being made from TiGenix site in Madrid, Spain but CEO Eduardo Bravo told Biopharma-Reporter its partner Takeda which holds the rights for Cx601 in non-US markets following a licensing agreement inked last year will take responsibility for its manufacture from 2021 from a purpose built manufacturing facility in Europe.

Takeda spokesman Luke Willats told this publication: After a transition period for technology transfer during which TiGenix will manufacture Cx601, Takeda will assume responsibility for manufacturing the compound.

But while Willats added the firm is exploring how itcan best meet manufacturing responsibilities for Cx601 following a potential European Commission (EC) approval decision for the compound in 2017, he could not comment further on specific plans or CAPEX investments.

The Japanese pharma firm has its European headquarters in Switzerland, with production sites in Austria, Belgium, Denmark, Estonia, Germany, Ireland, Italy, Norway, Poland and Russia.

Fat chance

Cx601 is produced by TiGenix in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons, Bravo told us.

The fat gets sent to our facility in Madrid and is processed to extract the stem cells, which account for about 2% of the material. These are placed in plastic flasks with serum to multiply the number. This is repeated until there is a large population and then the cells are frozen, creating the master cell bank (MCB).

According to Bravo, one liposuction when expanded produces upwards of 360 billion cells, enough to treat 2,400 patients.

While TiGenix is considering using bioreactors for its future pipeline, it will continue making the product as it does now due to not needing to increase volume and the challenges of making production changes in the middle or end of development.

For cell therapies, the process defines the product. Anything you change could change the cells themselves, effectively changing the product.

US deal with Lonza

TiGenix holds the US rights to Cx601 and is discussing with the US Food and Drug Administration (FDA) whether it can file using EMA data, something Bravo said would be decided in the next six-to-eight months.

US trial material will be produced by TiGenixs contract manufacturing organisation (CMO) Lonza , which is undergoing tech transfer at its site in Maryland.

But looking ahead to commercialisation, Bravo said it is not yet decided whether we continue using a CMO or build our own [US] facility.

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Patient with severe burns treated using stem cell therapy | Business … – Business Standard

Friday, June 23rd, 2017

IANS | Mumbai June 23, 2017 Last Updated at 00:16 IST

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

--IANS

rup/nir

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

--IANS

rup/nir

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

IANS

http://bsmedia.business-standard.com/_media/bs/wap/images/bs_logo_amp.png 177 22

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Patient with severe burns treated using stem cell therapy | Business ... - Business Standard

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Stem cells: the future of medicine – Medical Xpress

Friday, June 23rd, 2017

June 23, 2017

Imagine being able to take cells from your skin, transform them into other types of cells, such as lung, brain, heart or muscle cells, and use those to cure your ailments, from diabetes to heart disease or macular degeneration. To realise this, however, challenges still remain, Professor Janet Rossant, a pioneer in the field, says.

All across the world, scientists have begun clinical trials to try and do just that, by making use of the incredible power and versatility of stem cells, which are special cells that can make endless copies of themselves and transform into every other type of cell.

While human embryos contain embryonic stem cells, which help them to develop, the use of those cells has been controversial. The scientists are using induced pluripotent stem cells instead, which are other cells that have been reprogrammed to behave like stem cells.

"There are still significant challenges that we need to overcome, but in the long run we might even be able to create organs from stem cells taken from patients. That would enable rejection-free transplants," said Professor Janet Rossant, a pioneer in the field.

The mouse that changed everything

A speaker at the recent Commonwealth Science Conference 2017 held in Singapore and organised by Britain's Royal Society and Singapore's National Research Foundation, Prof Rossant gave an overview of stem cells' origins, history, uses and potential.

Now a senior scientist at The Hospital for Sick Children (also known as Sick Kids) in Toronto, Canada, after a decade as its chief of research, she was the first scientist to demonstrate the full power of stem cells in mice.

In the early 1990s, scientists believed that stem cells could only become certain types of cells and carry out limited functions. Based on her own research and that of others, however, Prof Rossant believed that they were capable of far more.

Working with other scientists, she created an entire mouse out of stem cells in 1992, upending the conventional wisdom. "We went on to create many baby mice that were completely normal, and completely derived from stem cells grown in a petri dish," she said.

"That was an amazing experiment, and it was instrumental in making people believe that human embryonic stem cells could have the full potential to make every cell type in the body," she added.

When scientists learned how to remove stem cells from human embryos in 1998, however, controversy ensued. Many lobbied against the cells' use in medical research and treatment due to the moral implications of destroying even unwanted embryos to gain the cells.

In Canada, Prof Rossant chaired the working group of the Canadian Institutes of Health Research on Stem Cell Research, establishing guidelines for the field. These guidelines helped to keep the field alive in Canada, and were influential well beyond the country's borders.

In 2006, Japanese researchers succeeded in taking skin cells from adult mice and reprogramming them to behave like embryonic stem cells. These revolutionary, induced pluripotent stem (IPS) cells allowed scientists to sidestep the ongoing controversy.

The challenges in the way

While stem cells have been used for medical treatment in some cases bone marrow transplants, for example, are a form of stem cell therapy there are several challenges that need to be overcome before they can be used more widely to treat diseases and injuries.

"We need to get better at turning stem cells into the fully mature cells that you need for therapy. That's going to take more work. Another issue is that of scale-up. If you're going to treat a patient, you need to be able to grow millions of cells," said Prof Rossant.

She added: "Safety is another concern. One of the most exciting things about pluripotent stem cells is that they can divide indefinitely in the culture dish. But that's also one of the most scary things about them, because that's also how cancer works.

"Furthermore, because we need to genetically manipulate cells to get IPS cells, it's very hard to know whether we've got completely normal cells at the end of the day. These are all issues that need to be resolved."

She noted that some scientists are working on making "failsafe" IPS cells, which have a built-in self-destruct option if they become dangerous. "Bringing stem cells into regenerative medicine is going to require interdisciplinary, international collaboration," she said.

In the meantime, stem cells have been a boon to medical research, as scientists can use them to create an endless supply of different cells to study diseases and injuries, and test drugs. "That's the biggest use of IPS cells right now," Prof Rossant said.

Sick kids and how to help them

At SickKids, which is Canada's largest paediatric research hospital, she has been using stem cells to study cystic fibrosis, a frequently fatal genetic disorder that causes mucus to build up and clog some organs such as the lungs. It affects primarily children and young adults.

SickKids discovered the CFTR gene that, when mutated, causes the disease. It was also the first to produce mature lung cells, from stem cells, that can be used to study the disease and test drugs against it.

Even better, Prof Rossant and her team were able to turn skin cells from cystic fibrosis patients into IPS cells and then into lung cells with the genetic mutation specific to each of them. This is critical to personalising treatment for each patient.

"Drugs for cystic fibrosis are extraordinarily expensive, and patients can have the same mutation and yet respond differently to the same drug," Prof Rossant explained. "With our work, we can make sure that each patient gets the right drug at the right time."

In 1998, Prof Rossant also discovered a new type of stem cell in mice, now called the trophoblast stem cell. These surround an embryo and attach it to the uterine wall, eventually becoming the placenta. She is using such cells to study placenta defects and pregnancy problems.

By using IPS cells to create heart cells and other cells, pharmaceutical companies can also test their new drugs' effectiveness and uncover potential side effects, as well as develop personalised medicines.

"There are still huge amounts of opportunities in pluripotent stem cells," said Prof Rossant, who has won numerous awards for her research, including the Companion of the Order of Canada and the 2016 Friesen International Prize in Health Research.

She is also president and scientific director of the Toronto-based Gairdner Foundation, which recognises outstanding biomedical research worldwide, and a professor at the University of Toronto's molecular genetics, obstetrics and gynaecology departments.

"Meetings like the Commonwealth Science Conference are a fantastic opportunity for scientists to come together, learn about each other's work and establish new relationships, which will help to push science forward, including in stem cell research," she said.

She noted: "The world of science is becoming increasingly interdisciplinary, so this kind of meeting of minds across nations, cultures and scientific fields is really the way of the future."

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