StemCell Therapy

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 therapies breaking barriers - Guardian (blog)

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: medical experts call for strict international rules - The Guardian

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

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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Stem cell therapy to treat paralytic dogs draws pet owners from ... - Times of India

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

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."

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

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

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

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

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

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

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."

Explore further: Cardiac stem cells from heart disease patients may be harmful

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Stem cells: the future of medicine - Medical Xpress

A new study at Tel Aviv University shows that stem cell therapy, one of the few treatments available to patients with severe and end-stage heart failure, can actually harm them unless it is done differently.

We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient, said lead researcher Jonathan Leor of the universitys Sackler Faculty of Medicine and Sheba Medical Center.

Doctors use tissue or adult stem cells to replace damaged tissue, which encourages regeneration of blood vessel cells and new heart muscle tissue. But cardiac stem cells from a diseased heart can lead to a toxic interaction via a molecular pathway between the heart and the immune system, the study found.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, Leor said. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

[Read the fully study here (behind paywall)]

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Study says some stem cells dangerous for heart patients

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Stem cell therapy relying on patient's own unhealthy heart may be dangerous - Genetic Literacy Project

Testing stem cell therapies unilaterally?A side-by-side comparison of strength of key muscles may enable scientists to evaluate stem cell therapies for the disease. The approach aims to control for the variability of the disease internally, without historical cohorts and/or the use of a placebo (see Donofrio and Bedlack, 2011; Glass et al., 2016).The biceps and triceps appear to be most reliable muscles to monitor progression in people with ALS according to this analysis (Rushton et al., 2017). [Neural progenitor cells. Courtesy of Nature Cell Biology. Reproduced with permission.]

Motor neurons degenerate in ALS. Why these cells are destroyed remains unclear. Therefore, how to slow or stop this destruction of motor neurons in ALS remains an open question.

In the meantime, a growing number of scientists are turning to stem cells in hopes to promote motor neuron survival in people with ALS and/or reduce their toxicity (see December 2015 conference news). But how to evaluate these strategies in the clinic remains hotly debated.

Now, a research team at Cedar Sinai Medical Center in Los Angeles, California reports that an emerging outcome measure, which involves monitoring muscle strength, may facilitate the evaluation of stem cell therapies for the disease (Rushton et al., 2017). The study, led by Clive Svendsen, found that functional decline of key muscles on the left and right side of people with ALS progressed at a similar rate. The results suggest that at least some stem cell therapies could be evaluated unilaterally by comparing the strength of muscles on the treated and untreated side for each of these muscle groups.

This side-by-side comparison, according to a subsequent power analysis, may enable clinicians to evaluate stem cell therapies for ALS in a smaller sample size without the need for sham surgeries and/or placebo injections.

This unilateral approach is emerging as an alternative to evaluate a growing number of potential neuroprotective strategies for neurodegenerative diseases including ALS (see NCT02943850, NCT02478450; Glass et al., 2016).

The study is published on June 9 in Neurology.

The retrospective analysis, performed in collaboration with Cedar Sinais Robert Baloh, studied the rates of decline of 6 upper and lower muscle groups in nearly 750 people with ALS determined by fixed dynamometry. These longitudinal datasets, previously collected by physical therapist Pat Andres and colleagues, now at Massachusetts General Hospital, capture the decline in strength of key muscles in people with ALS during at least a 16-month period measured by either the TUFTS Quantitative Neuromuscular Exam (TQNE) or more recently, the Accurate Test of Limb Isometric Strength (ATLIS) system (Andres et al., 1986; Shields et al., 1998; Andres et al., 2012.

Analyzing therapies by hand. Meanwhile, Biogen scientists in Cambridge, Massachusetts are turning to hand-held dynamometry to evaluate potential therapies for ALS. The emerging strength-based measure highly correlates with the progressive loss of motor function (ALS-FRS-R) and breathing capacity (FVC) according to a retrospective analysis of 924 people with ALS presented at the 2017 meeting of the American Academy of Neurology (see May 2017 news). And, according to a subsequent side-by-side comparison, these musclesdecline at similar rates. [Image: Douma et al., 2014 under CC BY 2.0 license.]

The study builds on previous work, led by Barrow Institutes Jeremy Shefner in Phoenix, Arizona and Biogens Toby Ferguson in Cambridge, Massachusetts, which found that monitoring the strength of key muscles using hand-held dynamometry is a reliable and reproducible approach to measure progression of ALS in a clinical setting and thereby, may facilitate the evaluation of potential therapies (see May 2017 conference news; Shefner et al., 2014).

Now, Svendsens team is gearing up to evaluate their potential stem cell therapy for ALS. The strategy uses genetically engineered neural progenitor cells (NPCs) to deliver GDNF into the CNS in hopes to protect motor neurons in people with the disease (see April 2017 news; Gowing et al., 2014). The approach is at the phase 1 stage. Stay tuned.

Featured Paper

RushtonDJ, Andres PL, Allred P, Baloh RH,SvendsenCN. Patients with ALS show highly correlated progression rates in left and right limb muscles. Neurology. 2017 Jun 9. [PubMed].

References

ShefnerJM, Liu D, Leitner ML, Schoenfeld D, Johns DR, Ferguson T, Cudkowicz M.Quantitativestrengthtesting in ALS clinical trials. Neurology. 2016 Aug 9;87(6):617-24. [PubMed].

Andres PL, Skerry LM, Munsat TL, Thornell BJ, Szymonifka J, Schoenfeld DA, Cudkowicz ME. Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials. Muscle Nerve. 2012 Jan;45(1):81-5. [PubMed].

Andres PL, Hedlund W, Finison L, Conlon T, Felmus M, Munsat TL.Quantitative motor assessment in amyotrophic lateral sclerosis. Neurology. 1986 Jul;36(7):937-41.[PubMed].

Glass JD, Hertzberg VS, Boulis NM, Riley J, Federici T, Polak M, Bordeau J, Fournier C, Johe K, Hazel T, Cudkowicz M, Atassi N, Borges LF, Rutkove SB, Duell J, Patil PG, Goutman SA, Feldman EL. Transplantation of spinal cord-derived neural stem cells forALS: Analysis of phase 1 and 2 trials. Neurology. 2016 Jul 26;87(4):392-400.[PubMed].

Gowing G, Shelley B, Staggenborg K, Hurley A, Avalos P, Victoroff J, Latter J, Garcia L, Svendsen CN. Glial cell line-derived neurotrophic factor-secreting human neural progenitors show long-term survival, maturation into astrocytes, and no tumor formation following transplantation into the spinal cord of immunocompromised rats. Neuroreport.2014 Apr 16;25(6):367-72. [PubMed].

Further Reading

Atassi N, Beghi E, Blanquer M, Boulis NM, Cantello R, Caponnetto C, Chi A, Dunnett SB, Feldman EL, Vescovi A1, Mazzini L; attendees of the International Workshop on Progress in Stem Cells Research for ALS/MND. Intraspinal stem cell transplantation for amyotrophic lateral sclerosis: Ready for efficacy clinical trials? Cytotherapy.2016 Dec;18(12):1471-1475. [PubMed].

Donofrio PD, Bedlack R. Historical controls in ALS trials: a high seas rescue? Neurology. 2011 Sep 6;77(10):936-7. [PubMed].

clinical trial clinical trial design disease-als gdnf neuralstem neuroprotection stem cell topic-clinical topic-randd

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ALS Research Forum | To Evaluate Stem Cell Therapies, Think ... - ALS Research Forum

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Patients with severe and end-stage heart failure have few treatment options available to them apart from transplants and miraculous stem cell therapy. But a new Tel Aviv University study has found that stem cell therapy may in fact harm patients with heart disease.

The research, led by Prof. Jonathan Leor of TAUs Sackler Faculty of Medicine and Sheba Medical Center and conducted by TAUs Dr. Nili Naftali-Shani, explores the current practice of using cells from the host patient to repair tissue and contends that this can prove deleterious or toxic for patients. The study was recently published in the journal Circulation.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, said Prof. Leor. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

Tissue or adult stem cells blank cells that can act as a repair kit for the body by replacing damaged tissue encourage the regeneration of blood vessel cells and new heart muscle tissue. Faced with a worse survival rate than many cancers, a number of patients with heart failure have turned to stem cell therapy as a last resort.

But our findings suggest that stem cells, like any drug, can have adverse effects, said Prof. Leor. We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient.

Hope for improved cardiac stem cell therapy

In addition, the researchers also discovered the molecular pathway involved in the negative interaction between stem cells and the immune system as they isolated stem cells in mouse models of heart disease. After exploring the molecular pathway in mice, the researchers focused on cardiac stem cells in patients with heart disease.

The results could help improve the use of autologous stem cells those drawn from the patients themselves in cardiac therapy, Prof. Leor said.

We showed that the deletion of the gene responsible for this pathway can restore the original therapeutic function of the cells, said Prof. Leor. Our findings determine the potential negative effects of inflammation on stem cell function as theyre currently used. The use of autologous stem cells from patients with heart disease should be modified. Only stem cells from healthy donors or genetically engineered cells should be used in treating cardiac conditions.

The researchers are currently testing a gene editing technique (CRISPER) to inhibit the gene responsible for the negative inflammatory properties of the cardiac stem cells of heart disease patients. We hope our engineered stem cells will be resistant to the negative effects of the immune system, said Prof. Leor.

Meanwhile, for those unable to profit from stem cell therapy, researchers at Ben Gurion University of the Negev (BGU) have developed a revolutionary new drug that may reverse the damage and repair the diseased heart.

The newly developed drug is a polymer which reduces the inflammation in cardiovascular tissue and stops plaque build-up in arteries. Then it goes one step further and removes existing plaque in the heart, leaving healthy tissue behind.

Professor Ayelet David, a researcher at BGU revealed the drug might also help people suffering from diabetes, hypertension and other conditions associated with old age.

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Israeli Scientists: Stem Cell Therapy Not Good for All Heart ... - The Jewish Press - JewishPress.com

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On the cusp of payoffs for patients, stem cell therapy faces threat from unregulated clinics - STAT

AUSTIN, Texas -- The legal battle to get patients access to stem cell therapy in Texas is closer to reality.

Gov. Greg Abbott signed such legislation into law this week, and itmeans some patients will be heading into uncharted medical territory.

Come Sept. 1, patients with terminal illnesses or severe chronic diseases will be allowed to access experimental stem cell treatments in Texas.

MORE |Governor Signs Law to Allow Chronic, Terminally Ill in Texas to Get Stem Cell Treatments

Currently, mostpatients who want stem cell therapy have to travel outside the United States to do it, and stem cell re-injections are only allowed here within a 24-hour window.

"This is going to protect patient health, and provide for the treatments to be done here locally at home," saidMike Byrom, the Chief Science Officer at Austin stem cell bankBioEden.

Byrom said the new lawwill keep patients in the country, and will provide renewed hope for those with serious ailments.

This hope resulted in anemotional fight this session.

Texas State Rep. Drew Springer, R-Gainesville, gave an impassioned speech for the legislation as the deadline to read new bills approached, urging lawmakers to keep it from dying.

"I'll be damned if we don't get the chance tonight to hear the very next bill that opens up the doors of medical science," saidSpringer, whose wife is wheelchair-bound."It might give somebody like my wife a chance to walk."

But not everyone's convinced this is the right way to go.

"We want access for patients to the best drugs, but we think they ought to go through the FDA approval process," saidTexans for Cures Chairman David Bales.

Bales was one of the few people who testified against the bill. While he supports more stem cell research,hearguesthe state should fund it, rather than letting for-profit businesses lead the way.

"You run the risk of medical fraud because a lot of these guys, a lot of these patients, are paying a lot of money, to physicians and drug manufacturers who haven't gone through the right process,"Balessaid.

Patients who will be participating in stem cell therapy procedures will give up their right to take legal action if something goes wrong.

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New Law Opens Door for Stem Cell Therapy in Texas - Spectrum News

'Advances made in stem cell therapy in Asia far more than those made in US' The Hindu Indigenously developed therapeutic modules for neuro development disorders like autism have demonstrated a higher rate of recovery and improvement among sufferers, Nandini Gokulchandran, a Mumbai-based researcher in the field of stem cell therapy ...

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'Advances made in stem cell therapy in Asia far more than those made in US' - The Hindu

AUSTIN, Texas -- Gov. Greg Abbott has signed a new law that allows terminally ill or those which chronic diseases receive stem cell treatments in Texas.

Stem cell therapy is the use of stem cells to treat or prevent a disease or condition, and is often patient's last hope for improvement.

Bone marrow transplant is the most widely used stem-cell therapy, and can often help those with multiple sclerosis and other diseases.

House Bill 810, which was introduced by Rep. Tan Parker, R-Flower Mound, passed in both the Texas House and Senate.

"It is easy to fall into the trap of viewing legislation as just words on a piece of paper," said Sen. Paul Bettencourt, R-Houston, the bill's sponsor in the Senate. "But for the many people who are ill with multiple sclerosis and other diseases that stem cell therapy has the hope of solving in our lifetime, I look at this bill, I look at the possibility of what can happen in the 21st Century, with Texas taking the lead on adult stem cell treatments and this bill has the potential to extend lives and make a difference for these patients."

The Texas Medical Board will be responsible for writing the rules for the treatment.

"Everyone has a zest for life. This adult stem cell treatment possibility gets government out of the way to let these new therapies flourish and give these patients hope for a future good quality of life," Bettencourt added.

The legislation takes effect Sept. 1.

-- Value of Stem Cell Therapy --

According to the National Institues of Health, stem cellshave the remarkable potential to develop into many different cell types in the body during early life and growth.

In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive.

When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Doctors say stem cells are important for living organisms for many reasons.

In the 3- to 5-day-old embryo, called ablastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lungs, skin, sperm, eggs and other tissues.

In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.

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Governor Signs Law to Allow Chronic, Terminally Ill in Texas to Get Stem Cell Treatments - Spectrum News

By combining an experimental stem cell treatment with a nanoparticle delivery system, researchers may eventually stop MS and other autoimmune diseases.

An innovative stem cell therapy could change how we treat multiple sclerosis (MS), but are we any closer to a cure?

The work of Dr. Su Metcalfe, founder and chief scientific officer of the biotech company LIFNano, appears to be breathing new life into that hope.

Metcalfe and her team developed a way to fight MS by using the bodys own natural mechanisms but it hasnt been tested in humans yet.

MS is an inflammatory and neurodegenerative autoimmune disease that can result in an array of neurological symptoms including fatigue, muscle spasms, speech problems, and numbness. It is caused by the immune system attacking myelin, the insulating coating that runs along the outside of nerve cells. The result is damage to the brain and central nervous system.

The disease currently affects roughly 2.5 million people worldwide. About 200 new cases are diagnosed each week in the United States.

LIFNano uses a new treatment based on LIF a stem cell protein that forms naturally in the body to signal and regulate the immune systems response to myelin.

LIF, in addition to regulating and protecting us against attack, also plays a major role in keeping the brain and spinal cord healthy, Metcalfe recently told Cambridge News.

In fact it plays a major role in tissue repair generally, turning on stem cells that are naturally occurring in the body, making it a natural regenerative medicine, but also plays a big part in repairing the brain when its been damaged, she said.

Metcalfe has spent years studying LIF, but only recently realized its potential for treatment likening it to an on/off switch for the immune system.

However, once she discovered its potential, there were almost immediate problems in its application. One of the earliest was how quickly LIF breaks down once it is administered into the body.

If you try just to inject it into a patient, it dissipates or disappears in about 20 minutes, Olivier Jarry, CEO of LIFNano, told Healthline.

That makes it unusable in a clinic. You would have to have some kind of pump and inject it continually.

A breakthrough came for Metcalfe when she took findings from her studies of LIF and applied them to nanotechnology. The treatment she is now developing relies on nanospheres derived from a well-established medical polymer known as PLGA, which is already used in materials like stitches. And because it is biodegradable, it can be left to dissolve inside the body.

Storing LIF inside these PLGA nanospheres before administering them into the bloodstream allows for a sustained dose over the course of several days.

The process differs significantly from the current drugs used to treat MS. These treatments most often fall under the category of drugs known as immunosuppressors, which inhibit the bodys overall immune system response.

LIF is theoretically much more precise than immunosuppressors, and should keep the immune system functioning against harmful infections and disease.

Were not using any drugs, said Metcalfe. Were simply switching on the bodys own systems of self-tolerance and repair. There arent any side effects because all were doing is tipping the balance. Autoimmunity happens when that balance has gone awry slightly, and we simply reset that.

The team cautions that LIF therapy is still several years away.

While some outlets have run wild with Metcalfes research, announcing that a cure for MS is right around the corner, those headlines are speculative.

Some MS advocacy groups have even made public statements calling coverage of her work premature and irresponsible.

Jarry told Healthline that LIFNano is expecting to enter FDA phase I trials in 2020. This would be the first time that it is used in human subjects. But even if the treatment proves to be safe and effective, the soonest it could be on the market is 2023, he estimated.

The main focus of LIF therapy is now on MS. But it has potential for treating other autoimmune diseases including psoriasis and lupus.

We are optimistic in the sense that we may provide a long-term remission for patients with MS, said Jarry.

Is it a cure? Wed love at some point to use the term cure, but we are very cautious.

Link:
Stem Cell Therapy Offers Hope for Multiple Sclerosis Remission - Healthline

"At StemGenex, we are committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells," said Alexander. "Specifically, we use adipose-derived adult stem cell therapy for patients battling conditions such as Multiple Sclerosis, Parkinson's disease, COPD, Rheumatoid Arthritis and Osteoarthritis. We are also committed to the science of stem cell therapy and sponsor five clinical outcome studiesregistered with theNational Institute of Health (NIH) for these diseases."

"What I personally witnessed before the start of StemGenex were patients who had exhausted conventional medical treatments but wanted to try alternative therapies. I was one of them, suffering from severe Rheumatoid Arthritis. Ihad only three options; I could seek a clinical trial, travel to outside of the U.S. to try alternative therapies such as stem cell treatment or petition the FDA for access to drugs under the agency's "expanded access," or "compassionate use" program. Now, new state laws like the one just passed in Texas, built on model legislation from the Goldwater Institute in Arizona, will allow doctors and patients to make their own informed decisions on treatments that have cleared the safety phase of FDA testing."

Last year, in a move that was seen by some as a response to "Right to Try" laws, the 21st Century Cures Act, a landmark piece of legislation focused on medical innovation and medical research, was signed into law by President Obama. This Act provides the FDA with the flexibility to accelerate how it evaluates regenerative medicine treatments, such as stem cell therapies, while maintaining its high standards of safety and efficacy.

"We're on the cusp of a major change on how patients can access stem cell therapy," saidAlexander. "Today, new treatments and advances in research are giving new hope to people affected by a wide range of autoimmune and degenerative illnesses," said Alexander. "StemGenex Medical Group is proud to offer the highest quality of care and to potentially help those with unmet clinical needs improve their quality of life."

ABOUT StemGenex Medical Group

StemGenex Medical Group is committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells. StemGenex provides stem cell therapy options for individuals suffering with inflammatory and degenerative illnesses. Committed to the science and innovation of stem cell treatment,StemGenex sponsors five clinical outcome studiesregistered with theNational Institutes of Health (NIH) for Multiple Sclerosis, Parkinson's Disease, Rheumatoid Arthritis, Chronic Obstructive Pulmonary Disease (COPD) and Osteoarthritis. These have been established to formally document and evaluate the quality of life changes in individuals following adipose-derived stem cell treatment.

Contact: Jamie Schubert, Director of Media & Community Relations jschubert@StemGenex.com, (858) 242-4243

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stem-cell-therapy-becomes-law-in-texas-300472809.html

SOURCE StemGenex Medical Group

http://www.stemgenex.com

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Stem Cell Therapy Becomes Law in Texas - PR Newswire (press release)