Anger as Scots patients miss out on ‘breakthrough’ stem cell therapy offered by NHS England – Herald Scotland
By JoanneRUSSELL25
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."
VistaGen Therapeutics Reports Fiscal 2017 Financial Results and Provides Corporate Update – Benzinga
By JoanneRUSSELL25
SOUTH SAN FRANCISCO, CA--(Marketwired - June 29, 2017) - VistaGen Therapeutics Inc. (NASDAQ:VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, today reported its financial results for its fiscal year ended March 31, 2017.
The Company also provided an update on its corporate progress, clinical status and anticipated milestones for AV-101, its orally available CNS prodrug candidate in Phase 2 development, initially as a new generation treatment for major depressive disorder (MDD).
"With a team of industry experts and a focused strategy in place, we have established a strong foundation and embarked on paths to achieve several key catalysts within the next 18 months. We anticipate our first catalyst within the next 9 months as the NIMH completes its AV-101 Phase 2 monotherapy study in MDD, a study being conducted and fully funded by the NIH. Additionally, we are working closely with the FDA and our Principal Investigator, Dr. Maurizio Fava of Harvard University Medical School, on our AV-101 Phase 2 adjunctive treatment study in MDD, which we anticipate will begin enrollment in the first quarter of 2018 and be completed by the end of 2018, with topline results available in the first quarter of 2019," commented Shawn Singh, Chief Executive Officer of VistaGen.
In addition to MDD, AV-101 may have therapeutic potential in several other CNS indications where modulation of NMDA receptors, activation of AMPA pathways and/or active metabolites of AV-101 play a key role, including for treatment of epilepsy, as a non-opioid alternative for management of neuropathic pain, and to address certain symptoms associated with Parkinson's disease and Huntington's disease.
Mr. Singh continued, "Our MDD clinical program is our top priority, and will remain so. Additionally, however, recent peer-reviewed publications suggest that AV-101 may have significant therapeutic potential as a non-opioid treatment alternative for pain management. We are also excited about AV-101's potential to reduce dyskinesia associated with standard levodopa, or L-DOPA, therapy for Parkinson's disease, based on results from previous non-clinical studies. Without diverting our priority focus on MDD, we plan to expand our AV-101 Phase 2 clinical program during the next year to include these important CNS indications with significant unmet need."
"We are also pleased to have advanced our cardiac stem cell program during fiscal 2017, through both our participation in the FDA's CiPA initiative focused on using novel human stem cell models to predict cardiac toxicity of new drug candidates long before animal and human studies, as well as our exclusive sublicense agreement with BlueRock Therapeutics, an emerging force in cardiac regenerative medicine, founded and funded by Bayer AG and Versant Ventures. Our initial revenue-generating milestone with BlueRock Therapeutics was completed during fiscal 2017. We are optimistic about this relationship's potential and the future of cardiac regenerative medicine. We believe these significant events over the past year have positioned us to create substantial value for our stakeholders in fiscal 2018 and beyond."
Potential Near-Term Milestones:
Operational Highlights During Fiscal 2017:Achievements Related to Stem Cell Technologies
Advancement of AV-101 as a Potential, Non-Opioid Treatment Alternative for Chronic Pain
Bolstered Team with Industry Experts
Intellectual Property Accomplishments
Capital Market Highlights
Financial Results for the Fiscal Year Ended March 31, 2017:
Revenue for the fiscal year ended March 31, 2017 totaled $1.25 million and was attributable to a sublicense agreement with BlueRock Therapeutics, for certain rights to the Company's proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.
Research and development expense totaled $5.2 million for the fiscal year ended March 31, 2017, an increase of approximately 33% compared with the $3.9 million incurred for the fiscal year ended March 31, 2016. The increase in year-over-year research and development expense was attributable to increased focus on development of AV-101, including preparations to launch the Phase 2 Adjunctive Treatment Study in MDD.
General and administrative expense decreased to $6.3 million in the fiscal year ended March 31, 2017, from $13.9 million in the fiscal year ended March 31, 2016, primarily as a result of the decrease in non-cash stock compensation expense, partially offset by an increase in non-cash expense related to grants of equity securities in payment of certain professional services during fiscal 2017. Of the amounts reported, non-cash expenses, related primarily to grants or modifications of equity securities, totaled approximately $3.1 million in fiscal 2017 and $11.9 million in fiscal 2016.
Net loss for the fiscal years ended March 31, 2017 and 2016 was approximately $10.3 million and $47.2 million, respectively, the latter amount including a non-recurring, non-cash expense of approximately $26.7 million attributable to the extinguishment of approximately $15.9 million carrying value of prior indebtedness, including then-outstanding Senior Secured Convertible Notes, and conversion of such indebtedness into equity securities between May and September 2015 at a conversion price (stated value of the equity received) of $7.00 per share.
At March 31, 2017, the Company had a cash and cash equivalents balance of $2.9 million. Since late-March 2017, the Company sold units consisting of unregistered common stock and common stock warrants to accredited investors in a self-placed private placement, yielding approximately $1 million in cash proceeds to the Company.
About VistaGen
VistaGen Therapeutics, Inc. (NASDAQ:VTGN) is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen's lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD). AV-101's mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company's Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington's disease, L-Dopa-induced dyskinesia associated with Parkinson's disease and other disorders where modulation of the NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.
VistaStem Therapeutics is VistaGen's wholly owned subsidiary focused on applying human pluripotent stem cell technology, internally and with collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells.
For more information, please visit http://www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful financing, launch, continuation and results of the NIMH's Phase 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and L-DOPA-induced dyskinesia associated with Parkinson's disease, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the Phase 2 clinical development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
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VistaGen Therapeutics Reports Fiscal 2017 Financial Results and Provides Corporate Update - Benzinga
Siberian scientists say stem cells can treat varicose veins – Russia Beyond the Headlines
By JoanneRUSSELL25
Scientists at the Institute of Chemical Biology and Fundamental Medicine (ICBFM) based in Siberia have discovered that stem cells can restore blood flow in veins with clots.
"Quite a lot of pathologies regarding veins still remain unstudied." Source: Getty Images
To help treat varicose veins, scientists need to accelerate the growth of blood vessels, which would be a crucial development for cardiac medicine. A heart attack is caused by damaged arteries, and an ischemic stroke also often results from vascular damage.
"Quite a lot of pathologies regarding veins still remain unstudied," said Igor Mayborodin, a doctor of medical sciences at the stem cell laboratory at ICBFM. "Weve looked into blood flow restoration in situations when there are blood clots. Now were trying to use stem cells to stimulate the growth of veins and bypass the diseased area."
The discovery by Siberian scientists will make it possible to successfully treat diseases of the veins and resulting complications, for example, varicosis, phlebothrombosis (the formation of a blood clot in the vein that leads to its blockage), and even some types of trophic ulcers and cerebral strokes.
Researchers conducted a number of studies on rats, injecting them with stem cells taken from their relatives. The experiment showed that within a week small vessels had formed in the rodents, and in the third week the replacement of the introduced cells with the rodents' own cells began.
The new blood vessels remained in the body but stem cells that formed walls were gradually replaced by those of the rodents. Thus, scientists showed that stem cells can restore blood flow, bypassing damaged veins. Based on the results, a series of articles will be prepared.
Also, scientists witnessed unexpected side effects. "Some of the stem cells die, and then macrophages are attracted to the site, that is, 'ingester' cells capable of actively engulfing and digesting the remains of dead cells," Mayborodin said. "This is what helps a surgical wound be rid of damaged tissue quicker and heal. This is a good result."
The scientists are continuing their state-funded research, and they have obtained a patent for their work. For the time being, however, they cant check the results in clinical tests because Russian law restricts the use of stem cells on humans.
"Wed like to utilize the obtained data in regards to humans, but this is currently not possible," Mayborodin said. "For now were refining the results of the research on cell therapy and clarifying possible complications. But wed like to test our hypothesis at least on a severe case of varicosis in clinical conditions."
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Siberian scientists say stem cells can treat varicose veins - Russia Beyond the Headlines
Bone Therapeutics receives Intent to Grant Notice from European Patent Office for allogeneic bone cell therapy platform – OrthoSpineNews
By JoanneRUSSELL25
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Gosselies, Belgium,26 June 2017; 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that the European Patent Office (EPO) has notified the Company of its intention to grant a key patent covering its first-in-class allogeneic cell therapy technology.
Once granted, the patent titled, Osteogenic differentiation of bone marrow stem cells and mesenchymal stem cells using a combination of growth factors, will provide legal protection to Bone Therapeutics both for the manufacturing methods and for the distinct cell type used in its allogeneic cell therapy technology. Specifically, the patent covers methods to manufacture differentiated and biologically active osteoblastic (bone-forming) cells from bone marrow stem cells, using a specific combination of growth factors, and also covers a new class of osteoblastic cells suitable for allogeneic administration to the patient.
Bone Therapeutics will now validate the patent in several countries in the European Union, potentially allowing IP protection for its allogeneic bone cell therapy platform until 2029. Patents from the same patent family have already been granted in Japan, Australia and Singapore and applications are pending in the USA, Canada, India and South Korea. ALLOB, Bone Therapeutics most advanced allogeneic bone cell therapy product, is currently being evaluated in Phase I/IIA clinical trials for delayed-union fractures and spinal fusion, for which interim results are expected in the third quarter this year.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: This notice from the European Patent Office confirms our allogeneic bone cell therapy technology is both innovative and distinctive. When granted, this European patent will significantly strengthen our IP position in the field of bone cell therapy, giving us further validation for the scientific and commercial development of our cell therapy products whilst also enhancing our position with respect to new partnerships.
Dr. Miguel Forte, Chief Medical Officer of Bone Therapeutics, further noted: Obtaining this patent is an important step in the development of our allogeneic bone cell therapy technology. It will provide a solid IP protection for our current work and for future technological advances, allowing us to continue our efforts to create patient-centric and commercially interesting bone cell therapy solutions.
About Bone Therapeutics
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation. Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into osteoblastic, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery. Our primary clinical focus is ALLOB, an allogeneic off-the-shelf cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB, obtained from patients own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.
Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate coveringnine patent families. Further information is available at: http://www.bonetherapeutics.com.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in thispress release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Josh Sandberg has been an executive search consultant focused exclusively on orthopedic and spine start-ups since 2004. He has had a tremendous impact in helping his clients avoid costly hiring mistakes by his deep industry knowledge and network. In 2010, Josh co-founded Ortho Spine Companies, which is the parent company of Ortho Spine Distributors (OSD), Surg.io and Ortho Sales Partners (OSP). OSD a searchable database that helps ease the frustration of finding orthopedic distributors throughout the country. Surg.io is the ultimate distributor toolkit that offers distributors the tools necessary to build the foundation of a scalable and highly functioning sales organization. OSP is an end-to-end solution that helps companies approach the Global Market in a cost efficient way. Our team has hundreds of years of experience and can help you navigate the many challenges present in bringing new technologies to the market.
Is doubling our life span desirable? – Price Sun Advocate
By JoanneRUSSELL25
The times, they are a-changing.
Since Gregor Mendel unwittingly became the father of genetics by writing down his botanical observations, we have been progressing along swimmingly in our understanding and application of biology.
In the past few years, we ourselves have made some measured leaps forward in the field of biotechnology, some small someless so. Yet with the monumental achievements we have made thus-far from the advent of vaccines to our understanding of how our bodies age and degenerate, we have yet to make that quantum leap forward. That quantum leap may itself not be that far off and if anything is a good indicator of that its observable in the nature of the biotech we are currently developing.
With any huge leap forward, however, come new challenges and a slew of new questions that desperately need to be answered.
This next step in our journey isnt quite like when we eradicated major diseases or began transplanting organs because it isnt about extending human life a mere few additional years. We are taking about a doubling in the years a human may live. Thats right, double.
Now, before you write this off as sci-fi or wishful thinking, let me walk you through exactly what breakthroughs are currently occurring. It all has to do with CRISPR gene-line editing and 3-dimensional printing.
We are at the point where we can take normal somatic cells like the ones from your skin, coax them back into stem cells then re-engineer them into just about any type of cells we want. This means shortly we will be able to take skin cells and make them into heart tissue, or liver, or pancreatic or any number of different ones.
Next, the advances in 3-dimensional printing may shortly be able to take your newly minted cells and print them onto a blank scaffolding in the shape of just about any organ you may need.
Think of that: if you need a new heart it could be as simple as scratching some skin from your arm, reprogramming the cells and then printing you a whole new organ. Not a transplant from a donor, your own cells. This means no rejection and no waitlists. When an organ fails we replace it, again and again and again.
What is to become of a human race that is capable of living seemingly without end? This brings up some serious questions that would have to be answered quickly.
For starters, we see that the current population growth of our species is unsupportable as we resist green energies and advanced farming methods. If humans were to begin to live twice as long or longer we must figure out what we are going to do.
Now the radicals would suggest we simply control the populations but I dont believe that is necessary or even morally right. All we must do is increase our carrying capacity. I must admit that was not my own musing but one my father suggested to me.
If we are able to increase how much food and energy we produce without damaging the planet there is virtually no limit to how many humans can live at once. But the question is, will we resist it as we are now? Will the prospect of living healthily well over a century spur us to begin to accept scientific consensus? Or will we continue down our current path of selfishness and greed? Only time will tell.
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Is doubling our life span desirable? - Price Sun Advocate
Study says some stem cells dangerous for heart patients | The Times … – The Times of Israel
By JoanneRUSSELL25
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.
The findings could suggest a way to make stem cell therapy safer for heart disease patients. The treatment is often a last resort, apart from getting a transplant.
Researchers discovered a molecular pathway involved in the toxic interaction while studying stem cells in mice with heart disease. By deleting the gene that makes the pathway, the cells ability to regenerate healthy tissue can be restored, they found.
The researchers are now testing a gene editing technique to delete the problem gene.
We hope our engineered stem cells will be resistant to the negative effects of the immune system, Leor said.
The study was conducted by TAUs Dr. Nili Naftali-Shani and published in the journal Circulation.
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Study says some stem cells dangerous for heart patients | The Times ... - The Times of Israel
Israeli Scientists: Stem Cell Therapy Not Good for All Heart … – The Jewish Press – JewishPress.com
By JoanneRUSSELL25
Photo Credit: Nati Shohat / Flash 90
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
Probing Psychoses – Harvard Magazine
By JoanneRUSSELL25
Andrew LeClerc knew something was wrong when he heard voices when no one else was around. Some were those of people he knew, others were unfamiliar, but all had the authentic mannerisms of real people, not his imagination. He was in his early twenties, unsure of his direction in life, and had been taking synthetic marijuana to ease stress from past traumas. Disturbed by the voices, he sought help in an emergency room and voluntarily admitted himself to a psychiatric hospital, not realizing he would be kept there for six days. He was diagnosed with psychosis, but had little interaction with a therapist. You mostly sit around with coloring books, he says. It felt like a punishment, when all he wanted was help.
Afterward, he contacted therapists, but many were booked. An online search led him to a research study at Beth Israel Deaconess Medical Center in Boston for people newly diagnosed with psychotic disorders. In January 2014, he entered a two-year study that compared two approaches to psychotherapy to help manage cognitive impairments and other symptoms. He was also prescribed an antipsychotic medication.
Eventually he was diagnosed with schizophrenia. Now, about four years later, at 26, LeClerc is learning to live with the condition. Its hard for a person whos diagnosed with schizophrenia to be told somethings not real when they think its real, he says. He continues to take antipsychotic medications that help control his hallucinations and lives in an apartment below his parents in Middleton, Massachusetts. Hes hoping to start a small business, putting his love of gardening to work as a landscaper.
But more importantly, hes learned to make peace with his mind. He likes to say: I dont hear voices, I hear my own brain. When voices do appear, he recognizes them as a product of an aberrant auditory cortex, and he thinks about engaging his prefrontal cortexthe decision-making part of the brainto help him distinguish fact from fiction. I have tools to pull myself back to the moment, he says.
Not everyone who struggles with schizophrenia is able to find such stability. The illness takes many forms; symptoms may include hallucinations and delusions, lack of motivation, and cognitive problems similar to dementia. It tends to strike in the late teens and early twenties, robbing young people of their mental stability just as theyre entering adulthood, beginning careers, or pursuing a college degree. Some improve, while others experience a long mental decline.
The treatments that we have are useful but not great, says Matcheri Keshavan, Cobb professor of psychiatry at Harvard Medical School (HMS) and the leader of the study that LeClerc participated in. The medications used to treat schizophrenia are decades old, and only ameliorate symptoms. Like other psychiatric illnesses, schizophrenia has suffered from a lack of investment from pharmaceutical companies. Says Keshavan, We need better medications that really address the underlying cause of this illness.
But those causes are still mysterious. What scientists do know is that schizophrenia tends to run in families. About 70 percent to 80 percent of a persons risk of developing the illness, Keshavan says, can be explained by genetic factors. Recently, theres been a surge of effort to capitalize on that fact. Advances in genetics have made it possible to search not only for clues about schizophrenia and other psychiatric illnesses hidden within thousands of human genomesbut also for potential new treatments.
As a result, theres been a renaissance in research on schizophrenia and other psychiatric disorders, and some cautious optimism. Its been possible to make real if still early progress in understanding what genes and molecules influence these illnesses, says Steven McCarroll, Flier associate professor of biomedical science and genetics. At Harvard, the leading force is the Stanley Center for Psychiatric Disease Research at the Broad Institute, which is pouring new funding and resources into amassing data on the genetics of mental illness.
Bringing the power of genomics to psychiatric disease fulfills a long-held goal for the Stanley Centers director, Steven Hyman, professor of stem cell and regenerative biology. An HMS professor of psychiatry before becoming head of the National Institute of Mental Health (NIMH) in 1996, Hyman was frustrated by the sluggish progress on the science of psychiatric disorders, as research on illnesses like cancer, heart disease, and diabetes marched ahead. Schizophrenia in particular is challenging to study because its uniquely human. Scientists can study limited aspects of psychiatric illness in animals if they can measure an observable behavior, such as avoiding social interactions or grooming excessively. But psychosis is a problem of thinking; animals, as far as is known, dont experience it in any way we can measure. Its also challenging because brain tissue is so inaccessible. We were really hampered, Hyman says, and I, frankly, didnt know all that much more when I was at NIMH in the late 1990s than careful observers knew at the turn of the twentieth century.
Steven Hyman, director of the Stanley Center for Psychiatric Disease Research Photograph by Stu Rosner
When he left the position, Hyman was interested in researching psychiatric disease but didnt see a rigorous path to do so; instead, he accepted a position as Harvards provosttaking what he now refers to as a 10-year timeout. During that time, a revolution occurred. Genetic technologies and vastly expanded computer power opened new paths for studying the biological basis of complex diseases.
The Broad Institute launched the Stanley Center in 2007 under inaugural director Edward Scolnick, thanks to an initial $100 million in private funding from philanthropists Ted and Vada Stanley, aiming to bring much-needed innovation to treatments for psychiatric disease by harnessing the power of genomics. (The Stanleys provided another $650 million in 2014, an unprecedented gift for psychiatric research.) Partly as a result, the center has gathered the worlds largest collection of DNA samples for studying not only psychiatric diseasesincluding schizophrenia, autism, ADHD, and bipolar disorderbut also healthy control subjects. The resulting data are freely available to the public.
The human genome has started to give us a really powerful way into the problem, Steven McCarroll explains, because the key source of scientific leverage that we have is we know that schizophrenia and other psychiatric illnesses are heritablethey aggregate in families. Their molecular secrets are almost certainly hidden in the way our genomes vary from person to person.
Much of the research on genetics and disease has focused on what McCarroll calls genetic sledgehammersgenes that when mutated would almost certainly make you sick. But schizophrenia, like most common diseases, is genetically complex. The hereditary component of the disease may be a product of tens to hundreds of genetic nudges, variations that dont cause disease by themselves, but together make people vulnerable to illness.
Studying genetic nudges requires amassing large numbers of DNA samples to achieve the statistical power to find subtle variations that may contribute to disease, a project thats taken enormous collaborative effort by many scientists and institutions around the world. The Psychiatric Genomics Consortiumthe largest scientific collaboration involving psychiatric diseaseformed in 2007 and comprises hundreds of investigators in 38 countries and nearly a million genetic samples. The Stanley Center has served as the hub for data sharing, aggregation, and analysis to further the consortiums discoveries.
One of the key tools for uncovering the genetic basis of disease is the genome-wide association study (GWAS)a way of quickly sorting through the common variations in genomes to find those that are more common in people with a given trait or disease than in those without. Associate professor of medicine Mark Daly, who leads the analytic hub of the consortium, says that scientists originally thought such studies might uncover a handful or two of DNA variants that could be statistically correlated with schizophrenia. But rather than identifying a few standouts, the consortiums Schizophrenia Working Group found a crowd of genetic associations, each contributing just a tiny amount of risk. A landmark paper published in 2014 in the journal Nature, led by Michael ODonovan of Cardiff University, described 108 different locations in the genome that harbored variants associated with schizophrenia.
GWAS studies can identify only stretches of DNA: like flags on a zoomed-out map of a city, they provide a neighborhood, not the exact address. We know where the variants are, one of which is likely to be the causal variant, but cant say for sure which one, says assistant professor of medicine Ben Neale, who is developing methods to analyze genomic data. Another approach is to sift through genomes in finer-grained detail by directly reading each letter of the DNA sequence. Such work is time-consuming, but it can help uncover rare genetic differences that are linked to disease, many of which have a stronger effect than common variants. Work by the consortium has also analyzed areas of DNA that are deleted or duplicated, called copy number variations. People with schizophrenia tend to have more such variations overall, and the genes they affect can provide clues to the diseases origins.
Meanwhile, the Stanley Center and other institutions are working to collect thousands more DNA samples from people with schizophrenia and other psychiatric disorders, hoping to identify even more genetic associations of risk. Hyman doesnt see such data-gathering as an endless project. We should kill this problem, he says, meaning in some reasonable number of yearsseven to 10we should have proceeded so far in the genetics of schizophrenia, bipolar disorders, autism, perhaps some other disorders, that weve reached diminishing returns in terms of biological information.
But so far, the picture is still incomplete. The vast majority of genetic samples, for instance, come from people of European ancestry. From a purely scientific point of view, it means were missing a large proportion of the worlds genetic diversity, says Karesten Koenen, professor of psychiatric epidemiology at the Harvard T.H. Chan School of Public Health. Most of that diversity is in Africa: There is much more diversity in African genomes than in those of people from other parts of the world.
Koenen is leading an effort through the Stanley Center to launch genetic research on psychiatric disease in Ethiopia, Uganda, Kenya, and South Africa. Their researchers are partnering with researchers and academic and clinical institutions in those countries and will be gathering DNA samples and clinical information from people diagnosed with schizophrenia. We really want to build local capacity, she says, and develop sustainable research programs that can be led by local scientists and clinicians. The center also plans to extend the effort to Latin America, beginning in Mexico.
This effort will help fill in the genetic picture of psychiatric illness, and will also help correct a vast imbalance. Geneticists are beginning to use data to classify patients based on their risk of developing complex diseases, including schizophrenia. But these risk profiles, Koenen says, lose accuracy when applied to people of African descent. As this kind of profiling makes its way into medicine, she says, Theres a risk that if we dont extend this research to Africa, the health disparity and treatment gap will widen.
What will all this data amount to? Theres a misconception, McCarroll says, that the goal of this research is to conjure up a crystal ball genetic test that will give people personalized treatments based on their unique portfolio of genes. Thats not the aim. Our goal, he says, is to understand the core biological processes in the illnesses, so that innovative treatments can be developed that can treat anyone. Scientists hope that the dizzying array of schizophrenia-related genes will converge onto a few basic processes in the brain, once the function of those genes is understood.
But even as scientists have made dramatic leaps in discovering genetic risk factors of complex diseases, the task of understanding how those genes work is a different, and slower, task.
Researchers from Harvard and the Broad Institute have grown human brain organoids, three-dimensional organ models cultured from stem cells, to study the genetics of psychiatric illness. This series shows (clockwise from upper left) growth at 1, 3, 6, and 9 months, with development of synapses indicated in green. Quadrato et al./Nature 2017
McCarroll was lead author of a study making one of the strongest links between a specific genetic variant and its role in schizophrenia. Working with Aswin Sekar (then a graduate student, now a research fellow), he focused on the most powerful signal of risk in GWAS studies to date, a stretch of DNA in chromosome 6 that was known to harbor many genes involved in the immune system. They focused on one called C4, which has a high degree of variability in humans: each of its different forms may be present in multiple copies in one individual. By using both genetic data and postmortem brain tissue, they found that people with schizophrenia are more likely to have variants of the C4 gene that lead to higher levels of one gene product, C4A, in brain cells.
C4A is one of several proteins involved in a type of immunity called the complement pathway, which helps clear damaged cells and harmful microbes from the body. As part of their study, McCarroll and Sekar collaborated with associate professor of neurology Beth Stevens, whose previous research with mice clarified an ingenious connection between the complement pathway and the brain. Scientists know that as the brain develops, it churns out new cells, which form billions of connections called synapses. In adolescence and early adulthood, some of these connections are pared back, a process called synaptic pruning. In mice, Stevens has found, this pruning is mediated by the complement pathway, which triggers immune cells called microglia to attack neural connections: literally nibbling at synapses.
Sekar, McCarroll, and Stevens also worked with professor of pediatrics Michael Carroll, who had developed mice with varying copies of the C4 gene, and showed that too much C4 activity in the animals can lead to excess pruning. Its too much of a good thing, Stevens says. Their finding suggests that schizophrenia, in some cases, may be caused by loss of synapses in adolescencean especially promising result because it supports clinical observations: synaptic pruning coincides with the age when schizophrenia typically emerges, and brain imaging shows that many people with schizophrenia experience a thinning of the prefrontal cortex in the early stages of disease.
Steven McCarroll, Flier associate professor of biomedical science and genetics Photograph by Stu Rosner
McCarroll emphasizes that the C4A variation contributes only a small amount of risk of disease, but may collude with other variants to tip the brain past a threshold. There are a lot of genetic findings that map to synapses, says Hyman, so some of those other variants may contribute to a larger disruption in how synapses are formed and maintained. But other processes are likely at work in schizophrenia as well. Some genetic risk variants relate to a chemical signal in the brain called glutamate, and others to ion channels, proteins that determine how electrical signals propagate in brain cells. There are also others, Hyman adds, that, frankly, just have us scratching our heads.
The work on C4 offers an example of how genetics is beginning to help neuroscience move forward. Its opened up a ton of new directions and strategies for our group, says Stevens. Across Harvard and the Stanley Center, a growing community is launching collaborative projects with the goal of taking psychiatric disease research into new territories.
One priority is developing new models for teasing out the role of genes in the brain. Scientists have been able to study some behaviors that relate to mental illness in animals, but there is no animal model for schizophrenia. Michael Carroll is now working to extend the C4 study by creating humanized mice that carry human C4 genes, which may make it possible to study their function in a living brain.
Other researchers are trying to develop new ways to study psychiatric disease in humans. Paola Arlotta, professor of stem cell and regenerative biology, explains that when scientists are able to get samples of human brain tissuefrom patients undergoing surgery, postmortem donations, or even tissue from fetusesthe cells die quickly. They cant be propagated and studied in a laboratory, so there is no renewable source of the actual endogenous tissue.
Stem cells have emerged as a way around that problem. Scientists can now take cells from the skin or hair and transform them into induced pluripotent stem (iPS) cells that are capable of becoming other cell types, including brain cells. (At the Stanley Center, Arlotta and other scientists are exploring how to transform iPS cells into specific types of brain cells.) The iPS cells allow scientists to study how cells derived from a person of one genetic background differ from those of another person. Scientists can also use the genome-editing tool CRISPR-Cas9 to introduce specific genetic changes and study their effects.
But theres very little that can be learned about psychiatric disease from isolated cells: brain activity depends on the constant chatter of many cells that are intricately connected. Arlotta has been investigating whether neural stem cells can be spun into something that behaves more like human brain tissue. So-called organoidsclusters of millions of cells up to a few millimeters in diametercan be formed from growing stem cells in a nutrient-rich solution. Organoids have already been used to study events that happen in early development: last year, a team of researchers used them to study the effects of the Zika virus on developing brains.
But since psychiatric diseases like schizophrenia emerge later in life, Arlotta wants to make organoids grow larger and live longer, and to understand whether they can mimic some of the properties of an older brain. This is a new tissue were making, she says, and so the questions that we want to answer are: can we develop them for a very long time, can we understand the cellular composition, can we see if these organoids make actual networks and communicate with each other?
To better characterize these cell-based models, Arlotta and her colleague Kevin Eggan, a fellow professor of stem cell and regenerative biology, are collaborating with McCarroll to apply a technology his lab developedDropSeqthat makes it possible to analyze gene activity in individual cells. The technology will provide a detailed, cell-by-cell understanding of what these models may reveal. In a Nature paper published in April, Arlottas team demonstrated that its possible to cultivate human brain organoids for nine months or more. Analysis revealed that the organoids are filled with a diverse mix of brain-cell types, and that these cells actually form interconnected networks, suggesting they may begin to function in ways that brains do.
But how much meaningful information about psychiatric disorders can be gleaned by studying individual cells or clusters of artificial tissue remains unclear. And an even bigger question is how to use these models to study the effects of genetic nudges. Disease genetics, typically, has been studied by altering or removing genes, one at a time, in an animal. Studying a whole suite of subtle genetic variations in a model system is a completely new idea.
There is no playbook, says Hyman. He acknowledges that the work is risky; many of these projects are possible only because the Stanley Centers open-ended funding makes it easier for labs to work together to pursue new ideas. We spend many tens of millions of dollars a year, and were accountable only at the end of the year to our scientific advisory board, and we tell them our strategy, he says. It gives us enormous flexibility, but its an enormous responsibility.
Some scientists and clinicians believe that gathering genetic data and studying cells is a misguided strategy for alleviating psychiatric illness. They see it as reductionist, and argue that it emphasizes the inborn biological origins of illnesses rather than other factorslike abuse, trauma, drug use, and emotional stressthat are known to play a role in their development. Hyman answers, Genes are not fate, but genes have an awful lot to say. Genetics and the environment both undoubtedly contribute to disease, but both ultimately must act on the brainand genetics happens to be a more tractable way to study whats happening in the brain.
Genetics is already providing insights that could help alter the way psychiatric disorders are defined. People have studied disorders with a box around them, says Elise Robinson, assistant professor of epidemiology, who has analyzed genetic differences within and between disorders such as schizophrenia, bipolar disorder, depression, and autism, which are usually defined by clinical categories outlined in the Diagnostic and Statistical Manual of Mental Disorders. But Robinson says the idea of distinct boundaries separating these disorders is not necessarily consistent with biology. Genetically, psychiatric disorders look more like Venn diagrams with large overlaps. People with schizophrenia share 60 percent to 70 percent of genome-wide variation with those who suffer bipolar disorder, and about 25 percent with autism.
Similarly, there is no simple dividing line between people who have a psychiatric illness and those who dont. Genetic risk for schizophrenia is not something you either have or dont have, she says. Theres a little bit of risk in all of us. Natural variations in many different genes, she explains, have been shown to relate to the way people perform on tests of cognitive or emotional skills. Schizophrenia may emerge from some combination of factors that are part of normal variation in the development and functioning of the human brain. This is true for other complex diseases and many normal traits, she adds: height, for instance, is largely determined by genetics, but theres no single geneor even handful of genesthat controls it. Its a quality that emerges from many genetic inputs.
Robinson believes that scientists could learn more about these disorders by cutting across diagnostic boxes and studying genetic variants that are linked to multiple traits and disorders. Only by understanding how these variants affect the brain can researchers begin to understand how they contribute both to normal brain function and to the risk of disease.
Such research could help demystify the experiences of people like Andrew LeClerc. He has learned to talk about his schizophrenia as something he struggles with, not something that defines him. He describes his condition as a mental difference.
LeClerc also appreciates that not all the voices in his head are negative: he sometimes hears words of encouragement or helpful warnings. As he speaks, his thoughts dont always follow the linear paths of normal conversation, but they can take him into deeper places; he has a keen understanding of how humans brains create their own realities. He sees an analogy to his condition in the once-expensive glass pieces he has begun collecting from his local dump. Glass that seems like trash, he says, can be reused or recycled, so it isnt really broken. He describes himself the same way: Im fragile, not broken.
It may take decades before genetic research on schizophrenia yields new treatments for people like LeClerc, but clues about the biological underpinnings of schizophrenia could help in other ways. Patients with psychiatric disorders get blamed for those disorders in our culture in a way that people with diseases in other organs dont, says McCarroll. If this research can provide a firmer biological understanding of whats happening in the brain, he says, I would hope that we could generate more empathy.
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Probing Psychoses - Harvard Magazine
Banks targets embryonic stem cell research funding – Fort Wayne Journal Gazette
By JoanneRUSSELL25
Rep. Jim Banks, R-3rd, introduced legislation Thursday that would prevent the use of federal funds for stem cell research involving human embryos.
Banks' bill would direct the U.S. Department of Health and Human Services to give priority to medical research with the greatest potential for near-term clinical benefit in human patients and that does not use stem cells from destroyed, discarded or created embryos.
Scientists say embryonic stem cells show potential for transforming into other cells that might repair tissue damaged by disease or injury. Human embryonic stem cells used in research come from donated, unused fertilized eggs developed for in vitro fertilization procedures.
Adult blood stem cells are used to treat leukemia, and adult neural stem cells have been tested for brain disorders and spinal cord injuries.
This bipartisan bill prioritizes stem cell research that has a real impact on patients suffering right now while ensuring that research is conducted ethically without destroying human embryos, Banks, a freshman lawmaker from Columbia City, said in a statement.
Rep. Dan Lipinski, D-Ill., co-sponsored Banks' bill, which is called the Patients First Act of 2017.
The Dickey-Wicker Amendment of 1996 prohibited HHS from funding research using created or destroyed human embryos. But a federal court ruled in 2011 that Dickey-Wicker was ambiguous and did not ban research using stem cells from in vitro fertilization.
The Alliance for Regenerative Medicine, a coalition of medical companies, research institutions and patient advocacy groups that support embryonic stem cell research, had little to say Thursday about Banks' legislation.
As an organization representing the broader global regenerative medicine sector, our position is that we are in favor of government funds supporting the best science in an effort to speed safe and efficacious products to patients in need, Lyndsey Scull, senior communications director for ARM, said in an email.
Scull said ARM would monitor Banks' bill in the legislative process.
Banks' proposal states it would promote the derivation of pluripotent stem cell lines without the creation of human embryos for research purposes and without the destruction or discarding of, or risk of injury to, a human embryo.
The National Institutes of Health defines pluripotent stem cells as those that can give rise to any type of cell in the body except those needed to support and develop a fetus in the womb. They come from embryos and fetal tissue, although induced pluripotent stem cells are genetically reprogrammed cells taken from adult tissues.
In May, Banks led a letter signed by 40 other Republican House members that asked President Donald Trump to replace Dr. Francis Collins as the director of the NIH because of Collins' support for human embryonic stem cell research. Trump announced last week that he is retaining Collins, a geneticist nominated for NIH chief by President Barack Obama and confirmed by unanimous consent by the Senate in 2009.
The NIH is an HHS agency.
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Banks targets embryonic stem cell research funding - Fort Wayne Journal Gazette
Eva Feldman steps down as Taubman Institute director – The Detroit News
By JoanneRUSSELL25
Eva Feldman, M.D., Ph.D.(Photo: Detroit News file photo)
World-renowned researcher Dr. Eva Feldman is stepping down as director of the University of Michigans A. Alfred Taubman Medical Research Institute, an organization that supports research for cures for debilitating and deadly diseases.
Feldman was the founding director of the institute launched by philanthropist and businessman A. Alfred Taubman, who died in 2015 at age 91. Feldman spent the last 10 years at the helm as the institute developed new drugs, surgeries and therapies for diseases such as adult and childhood cancer, diabetes, cardiovascular disease and, Feldmans research interest, amyotrophic lateral sclerosis.
When Alfred and I began the institute 10 years ago together, we had a vision of creating an institute where clinician scientists would take their most novel discoveries from their laboratory and translate that into patient clinical trials, said Feldman, adding that the team of four has grown to over 200. Weve really been able to realize that vision.
Feldman, 65, said Thursday that she raised the institute from its infancy.
Its now time for the next person to take it through its adolescence, because its still growing, she said. So it just seemed the perfect time to pass the baton to someone to have the next 10 best years of their life the way I just had the 10 best years of my life.
The institute will select the next director soon, Feldman said.
A Russell N. DeJong Professor of Neurology, Feldman will continue to run the ALS clinic at UM and her own laboratory, Program for Neurology Research & Discovery. Her team of 30 scientists have spent years working on human clinical trials that may lead to a treatment for ALS, a neurological disease also known as Lou Gehrigs disease. Most ALS patients lose the ability to walk and talk, and death may occur within three to five years of diagnosis.
In 2010, Feldman started the first human clinical trial approved by the U.S. Food and Drug Administration to use stem cells to treat ALS. The FDA recently approved Feldman to move onto the final, nationwide phase of the trial that involves injecting stem cells into the spinal cord of ALS patients. If approved, the drug could be marketed to patients.
Besides focusing on the trial, Feldman said shell have more time to do a deep dive into why people with diabetes get neurological complications.
She also was elected to the National Academy of Medicine and plans to use her position to help others understand the value of philanthropy.
Philanthropy can be a game changer Al Taubman showed us that and one of my goals is to help other clinician scientists throughout the country understand the process, she said.
Feldman said shes much closer to a cure for ALS, but were not there yet. For now, she wants to press the pause button on the disease.
When the patient comes to me, I want to be able to offer them a therapy so they will stay right where they are the first day I see them, she said. I dont think that stem cells will necessarily make people go back to where they are before they got ill, but if we can stop the disease in its tracks, my patients will be happy and I will be happy.
Feldman was named a 2011 Detroit News Michiganian of the Year. Shes served as the president of the American Neurological Association, the third woman to hold the position in 130 years, and was named one of Americas Top Doctors in 2016.
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Eva Feldman steps down as Taubman Institute director - The Detroit News
Bone marrow mesenchymal stem cell repair of cyclophosphamide-induced ovarian insufficiency in a mouse model – Dove Medical Press
By JoanneRUSSELL25
Back to Browse Journals International Journal of Women's Health Volume 9
Ahmed Badawy,1 Mohamed A Sobh,2 Mohamed Ahdy,3 Mohamed Sayed Abdelhafez1
1Department of Obstetrics and Gynecology, 2Department of Internal Medicine, 3Department of Clinical Pharmacology, Mansoura University, Mansoura, Egypt
Objective: Attempting in vivo healing of cyclophosphamide-induced ovarian insufficiency in a mouse model using bone marrow mesenchymal stem cells (BMMSCs). Methods: Female BALB/c white mice were used to prepare a model for premature ovarian failure by single intraperitoneal injection of cyclophosphamide (80 mg/kg). Ten mice were injected with BMMSCs and then sacrificed after 21 days for morphometric evaluation of the ovaries. Hormonal profile was evaluated while mice were being sacrificed. Another 10 mice were left for natural breeding with male mice, and 5 of these were injected with BMMSCs. Oocyte-like structures were obtained from 3 mice and were subjected to in vitro fertilization/intracytoplasmic sperm injection. Results: Morphometric analysis of the ovaries demonstrated the presence of newly formed primordial follicles. Contribution of MSCs to the formation of these follicles was proven by a labeling technique. There was a drop in estradiol and rise in follicle-stimulating hormone levels, followed by resumption of the hormonal levels to near normal 21 days after MSCs therapy. The 5 mice that were injected with MSCs became pregnant after natural breeding. Fertilization and further division was reported in 5 oocytes subjected to intracytoplasmic sperm injection, but division did not continue. Conclusion: From this proof-of-concept trial, we can say that healing of damaged ovaries after chemotherapy in mice is possible using in vivo therapy with BMMSCs. This should open the gate for a series of animal studies that test the possibility of in vitro maturation of germinal epithelium of the ovary into mature oocytes.
Keywords: cyclophosphamide, stem cell, POF, ovarian insufficiency
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UVA Honored as Center of Excellence for Bone Marrow Cancer – NBC 29 News
By JoanneRUSSELL25
Release from the University of Virginia Health System:
CHARLOTTESVILLE, Va., June 14, 2017 - University of Virginia Cancer Center has earned recognition as a national center of excellence for its care of patients with myelodysplastic syndrome (MDS), a cancer of the bone marrow that often leads to leukemia.
UVA is the only center in Virginia to receive this designation from the MDS Foundation for the treatment of this condition, which UVA hematologist Michael Keng, MD, said is often referred to as a bone marrow failure disorder.
Bone marrow produces stem cells that make white blood cells, red blood cells and platelets. In patients with MDS, the marrow does not produce enough healthy cells. When there are not enough healthy cells, there is an increased risk of infection, bleeding, easy bruising and anemia. Approximately 30 percent of patients diagnosed with MDS will progress to a diagnosis of acute myeloid leukemia.
According to the MDS Foundation website, centers of excellence have:
UVA provides tailored care for each MDS patient through a multidisciplinary team. UVAs care team includes medical oncologists/hematologists, pharmacists, care coordinators, nurses, infectious diseases specialists, clinical trial coordinators, and support services such as social workers, case workers, and therapists.
UVA is devoted to providing support, research, treatment and education around MDS to all patients, caregivers, physicians, nurses and other healthcare providers, Keng said.
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UVA Honored as Center of Excellence for Bone Marrow Cancer - NBC 29 News
Transplants using iPS cells put Riken specialist at forefront of regenerative medicine research – The Japan Times
By JoanneRUSSELL25
When she entered medicine in the mid-1980s, Masayo Takahashi chose ophthalmology as her specialty, she said, because she wanted to have a family and thought the discipline would spare her from sudden work calls in the middle of the night, helping her best balance work and life.
Three decades later, the 55-year-old mother of two grown-up daughters is at the forefront of the nations even the worlds research into regenerative medicine.
In September 2014, she offered a ray of hope to scores of patients suffering from a severe eye condition when her team at the Riken institutes Center for Developmental Biology in Kobe succeeded in a world-first transplanting of cells made from induced pluripotent stem (iPS) cells into a human body.
The operation, conducted as a clinical study, involved creating a retinal sheet from iPS cells, which were developed by Shinya Yamanaka, a researcher at Kyoto University. His 2006 discovery of iPS cells, which can grow into any kind of tissue in the body, won him a Nobel Prize in 2012.
During the 2014 procedure, the retinal sheet was transplanted into a female patient in her 70s with age-related macular degeneration (AMD), an eye disorder that blurs the central field of vision and can lead to blindness. The research team used iPS cells made from the patients own skin cells.
Takahashi made history again in March when she and her team carried out the worlds first transplant of retina cells created from donor iPS cells stocked at Kyoto University. The time and cost necessary for the procedure has been significantly reduced by using the cells, which are made from super-donors, people with special white blood cell types that arent rejected by the immune systems of receiving patients.
Takahashi was in Tokyo last week to speak at the Foreign Press Center and later with The Japan Times. She recounted the highlights of her 25-year research and the numerous legal and other challenges she has overcome.
Takahashi points to the day she led that first iPS transplant surgery Sept. 12, 2014 as the high point of her career so far. Because she worked so hard leading up to the surgery to confirm the safety of the retinal cells, she said that when the operation was over, she was relieved and slept very well.
It wasnt the same for Yamanaka, who provided the stem cells to Takahashi, she said, chuckling. Yamanaka-sensei couldnt sleep well after the surgery because he didnt know about the safety of the cells very well. I should have convinced him.
Some researchers have expressed concern that iPS cell-derived cells have a higher risk of developing cancer. But Takahashi said she knew from the outset that the type her team was making, retinal pigment epithelium (RPE) cells, are extremely unlikely to cause tumors. RPE cells make up the pigmented layer of tissue that supports the light-sensitive cells of the retina.
People in the world think iPS cells are very dangerous because we modify the genes, she said. The retinal pigment epithelium cell is very safe. We knew it from the beginning because we have never seen a metastatic tumor from this cell. Ophthalmologists know very well that this cell is very safe and very good.
The Osaka native said she learned of and became fascinated by the possibility of using stem cells for eye diseases in the mid-1990s, when she took a year off from clinical practice at Kyoto University to work as a researcher at the Salk Institute in San Diego. She moved to Riken in 2006.
More than 2 years have passed since that first iPS surgery, but the transplanted cells remain intact. According to Takahashi, it was not the goal of the research from the outset to improve the eyesight of the patient, who suffered from a very severe case of AMD. Before the surgery, the patient required injections of drugs into her eyeball every two months, but her visual acuity was declining. After the surgery, her acuity stabilized, and more importantly, she is happy, feeling that her vision has brightened and widened, Takahashi said.
Many challenges remain, however, to advance the technology and make it commercially available. One of the issues is cost, Takahashi said, adding that it will take until around 2019 before the cost of the iPS treatment for AMD will fall below 10 million. The first surgery in 2014 cost about 100 million in total, much of which was spent to maintain the clean room and culture the cells.
Still, Takahashi sees a huge potential for iPS cell therapy in her field and beyond.
Every disease has potential to be treated by iPS cell-derived cells or ES (embryonic stem) cell-derived cells in the future, she said, responding to a question on the chances of iPS cells being used to treat ALS, a rare, degenerative neurological disease for which there is currently no cure.
She said she has learned through her experience that some patients are very happy with small improvements.
For ALS, at first, I thought, its a systemic, whole-body disease, so I didnt know how they can fix it, she said. But a doctor (who specializes in ALS) said, its OK, if one finger moves, its (still) OK. So I realized that some benefit will come from cell therapy.
A Matter of Health is a weekly series on the latest health research, technology or policy issues in Japan. It appears on Thursdays.
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Transplants using iPS cells put Riken specialist at forefront of regenerative medicine research - The Japan Times
Stem Cell Therapy Offers Hope for Multiple Sclerosis Remission – Healthline
By JoanneRUSSELL25
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.
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Stem Cell Therapy Offers Hope for Multiple Sclerosis Remission - Healthline
Exercise Can Help Reduce Fat Found In Bone Marrow – Huffington Post Canada
By JoanneRUSSELL25
Fat doesn't just sit on top of your bones according to recent research it can also be found inside of your bone marrow too, and running can help shrink it.
According to Dr. Maya Styner, the study's lead researcher and an assistant professor of endocrinology and metabolism at the University of North Carolina at Chapel Hill, exercise has the ability to improve bone quality, particularly in obese mice.
Though the research on mice is not directly translated to human results, Styner says, "The kinds of stem cells that produce bone and fat in mice are the same kind that produce bone and fat in humans."
Marrow is the spongy tissue found inside some of your bones and is comprised of stem cells, nerves, blood vessels and fat. In healthy adults, bone marrow is half red and half yellow.
The yellow portion of bone marrow is used to store fats and provide sustenance required for bone function. In the event of severe blood loss or fever, yellow marrow can turn red.
Styner's study suggests that, like other types of body fat, marrow fat can be used as a source of energy.
"There's been intense interest in marrow fat because it's highly associated with states of low bone density, but scientists still haven't understood its physiologic purpose," said Styner. "We know that exercise has a profound effect on fat elsewhere in the body, and we wanted to use exercise as a tool to understand the fat in the marrow."
The study, which looked at the marrow fat in mice, found after six weeks obese mice who ran on a wheel had a significant reduction in the size of their fat cells, and in some cases appeared identical to lean mice.
"One of the main clinical implications of this research is that exercise is not just good, but amazing for bone health," said Styner. "With obesity, it seems that you get even more bone formation from exercise. Our studies of bone biomechanics show that the quality and the strength of the bone is significantly increased with exercise and even more so in the obese exercisers."
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Exercise Can Help Reduce Fat Found In Bone Marrow - Huffington Post Canada
New technology uses body fat to help relieve joint pain – DunyaNews Pakistan
By JoanneRUSSELL25
Last Updated On 10 June,201705:37 pm
Stem cells can be harvested from certain parts of the human body.
(Online) - The Lipogems technology has great promise, but experts say itll take time to assess how successful the new procedure isThe technology is ideal for patients with certain orthopedic conditions, such as painful joints including the knee, ankle, or shoulder with limited range of motion. Additionally, it can be used in soft tissue defects located in tendons, ligaments, and/or muscles to improve the biologic environment, said Dr. Brian Cole, professor of orthopedic surgery, and section head of the Rush Cartilage Restoration Center, in a press release.
They are believed to help the natural regenerative processes in the body.
Hence they have earned the nickname as mini drug stores based on their ability to secrete a spectrum of bioactive molecules and support the natural regeneration of focal injuries.
Stem cells can be harvested from certain parts of the human body, most notably bone marrow and adipose tissue (fat).
Harvesting bone marrow stem cells is a significantly more invasive and time-consuming procedure that is performed using general anesthesia.
Lipogems offers a novel approach to orthopedic stem cell treatments by using a persons own fat.
The procedure uses a small incision into an area of subcutaneous fat, from which a quantity of fat tissue is harvested and processed by the Lipogems apparatus.
The technology itself, which really is the device that processes the fat, creates a concentration of fat that has been cleansed of all the extraneous things like red blood cells and fibrous tissues, Cole told Healthline.
The concentrated stem cells within that fat tissue are then applied to the problematic joint or bone area.
Lipogems offers a streamlined procedure for stem cell treatment, but there is nothing new about the science itself.
The use of stem cells to treat a variety of conditions has been ongoing for some time now.
What were lacking is really good data at this point in the clinical setting, Cole said. There is substantial data in the laboratory suggesting that these cells may function in the way Ive described: reducing inflammation and so forth. But, we really dont have yet much in the way of good solid clinical data saying that definitively this is making a difference.
Instead, he would like those seeking orthopedic treatment to understand that Lipogems is just one part of a much larger and more complex suite of tools used by physicians.
It has to be taken into context of all the other possible treatment options, from simply icing down a swollen ankle, to changing your daily activity, to surgery.
The unfortunate thing is that people think, well this is the solution that can be used instead of, say, a joint replacement and no longer do we need to do surgery, said Cole.
Nothing could be further from the truth.
Nonetheless, Cole and his team are still excited about the possibilities of the Lipogems procedure.
Using a readily available and easily accessible substance like fat as a source of stem cells could have far-reaching implications for procedures in the future.
Were optimistic and intuitively there is a good argument to be made that this is as good or better than any other source of stem cells, said Cole.
Go here to read the rest:
New technology uses body fat to help relieve joint pain - DunyaNews Pakistan
Stem Cell Therapy: Repair and Regenerate Our Bodies – Live Trading News
By JoanneRUSSELL25
Stem Cell Therapy: Repair and Regenerate Our Bodies
$USRM
Stem Cells 101: The primary purpose of stem cells is to maintain, heal and regenerate tissues wherever they reside in the body. This is a continuous process that occurs inside the body throughout life. If we did not have stem cells, our lifespan would be about 1 hour, because there would be nothing to replace exhausted cells or damaged tissue.
Notably: any time the body is exposed to any sort of toxin, the inflammatory process causes stem cells to swarm the area to repair the damage.
While it is easy to think of stem cell therapy as some sort of magic, it is wise to implement strategies that nourish and optimize the stem cells we already have in your body.
Dr. Kristin Comella, a notable Stem Cell innovator, writes: You have to create an appropriate environment for these cells to function in. If you are putting garbage into your body and youre constantly burdening your body with toxins, your stem cells are getting too distracted trying to fight off those toxins. By creating an appropriate environment, optimizing your diet and reducing exposure to toxins, that will allow the stem cells that were putting in to really home in and focus on the true issue that were trying to treat.
The other thing weve discovered over the years is that [stem cell therapy] is not the type of thing where you take one dose and youre cured forever. Your tissues are constantly getting damaged Youre going to have to repeat-dose and use those stem cells to your advantage.
When you think about a lizard that loses its tail, it takes two years to grow back the tail. Why would we put unrealistic expectations on the stem cells that were trying to apply to repair or replace damaged tissue? This is a very slow process. This is something that will occur over months and may require repeat dosing.
Stem cells historically were isolated from bone marrow, and have been used for bone marrow transplants for cancer patients since the 1930s. However, we can get stem cells from just about any tissue in the body, every tissue contains stem cells.
Actually our marrow has very low amounts of mesenchymal stem cells, which are now believed to be the most important, from a therapeutic perspective.
Mesenchymal stem cells help trigger an immunomodulatory response or a paracrine effect, which means they send signals out to the rest of the body, calling cells to the area to help promote healing.
What weve discovered in more recent years is that a more plentiful source of stem cells is actually your fat tissue. [Body] fat can contain up to 500 times more cells than your bone marrow, as far as these mesenchymal type stem cells go.
One thing thats also critically important when youre talking about isolating the cells is the number of other cells that are going to be part of that population. When youre isolating a bone marrow sample, this actually is very high in white blood cells, which are pro-inflammatory, Ms. Comella writes.
White blood cells are part of the human immune response.
When an injury occurs, or a foreign body enters our system, white blood cells will attack. Unfortunately, white blood cells do not discriminate, and can create quite a bit of damage as they clean the area out.
Stem cells, in particular the mesenchymal cells, quiet down the white blood cells and then start the regeneration phase, which leads to new tissue. Bone marrow tends to be very high in white blood cells and low in the mesenchymal cells.
So, isolating stem cells from fat tissue is preferred not only because its easier on the patient, but fat also contains a higher population of mesenchymal cells and fewer white blood cells.
The benefit also of isolating [stem cells from] fat is that its a relatively simple procedure. Theres typically no shortage of fat tissue, especially in Americans, Dr.. Comella says. Also, as you age, your bone marrow declines with regards to the number of cells in it, whereas the fat tissue maintains a pretty high number of stem cells, even in older individuals.
Fat can be successfully harvested from just about anyone, regardless of their age or how thin they are. The procedure is done under local anesthesia, meaning that the patient stays awake. We can harvest as few as 15 cubic centimeters of fat, which is a very small amount of fat, and still get a very high number of stem cells.
A stem cell procedure can cost anywhere from $5,000 15,000, depending on what one is having done, and rarely if ever will insurance cover it.
Still, when compared it to the cost of long-term medications or the out-of-pocket cost of getting a knee replacement, stem cell therapy may still be a less expensive alternative.
Also, a single extraction will typically yield enough stem cells for 20 to 25 future treatments, should one decide to store his/her stem cells for future needs.
I think its accessible for patients, Dr.. Comella says. Its an out-patient procedure. You plan to be in clinic for about two hours; no real limitations afterwards, just no submerging in water, no alcohol, no smoking for a week. But other than that, patients can resume their normal activities and go about their regular daily lives.
She notes that patients who eat a very healthy diet, focusing on Organic and grass fed foods, have body fat that is very hearty and almost sticky, yielding high amounts of very healthy stem cells.
We can grow much better and faster stem cells from that fat than [the fat from] somebody who eats a grain-based diet or is exposed to a lot of toxins in their diet, she says. Their fat tends to be very fluffy, buttery yellow. The cells that come out of that are not necessarily as good a quality. Its just been very interesting. And of note, patients that are cigarette smokers, their fat is actually gray-tinged in color. The stem cells do not grow well at all.
What has been described above is whats called an autologous donation, meaning a person is getting the stem cells from oneself. A number of companies provide non-autologous donations using cells harvested from other people, typically women, like amniotic or embryonic mesenchymal cells.
This is an important distinction.
There are now just a couple of studies that have been published comparing an autologous source, meaning cells from you own body, to an allogeneic source, meaning cells from someone else.
So far, what has been discovered is that the autologous cells will outperform somebody elses cells inside ones body. This is not fully understood yet. It may be that the environment that ones own cells function in, and that they used to that environment. They recognize it. It is the same DNA and they can function well there.
But, once the culture is expanded and a pure population of these mesenchymal cells, not necessarily the sample thats coming right off of the liposuction, but a sample that has been taken to the lab and grown, those cells will not elicit an immune response if you use them in someone else. You could scientifically and medically use those in an unmatched person. However, there are some regulatory aspects of that with regards to the FDA.
In the US, there are a variety of new stem cell products available, referred to as amniotic, cord blood products or placenta products, which are prepared at a tissue bank. Such facilities must be registered with the FDA, and the products must undergo additional processing.
For example, they must be morselized, or snap frozen or blended in some way. Such processing typically breaks the membrane, releasing growth factors, and the resulting products are called acellular, meaning there are no living cells remaining in the sample.
The amniotic products available in the US are not so much stem cell products as they are growth factor products.
Dr. Comella notes: They can be useful in creating an immunomodulatory response, which can help to promote healing, but that still differs from the living stem cell procedures that can be done by either isolating cells from your fat or bone marrow. As a general rule, you do not achieve the clinical benefits when using an amniotic product, primarily because they do not contain living stem cells.
I want to contrast that to what are called embryonic stem cells, Dr. Comella adds. The products obtained from cord blood, from women who are having babies, are not embryonic stem cells. Embryonic stem cells are when you are first bringing the egg and sperm together. Three days after that, you can isolate what is called an inner cell mass. This inner cell mass can be used to then grow cells in culture, or that inner cell mass could eventually lead to the formation of a baby.
Those are embryonic stem cells, and those are pluripotential, meaning that they have the ability to form an entire being, versus adult stem cells or stem cells that are present in amniotic tissue, [which] are multipotential, which only have the ability to form subsets of tissue.
When youre dealing with different diseases or damaged tissue or inflammation, mostly you want to repair tissue. If somebody has damage in their knee, they dont necessarily need embryonic cells because they dont need a baby in their knee. They need new cartilage in their knee.
A common question is whether stem cells can cause overgrowth, leading to cancer or tumor formation.
As noted by Dr. Comella, this is a problem associated with embryonic stem cells, which tend to grow very rapidly and can form a teratoma because of the rapid cell growth. Adult stem cells, the cells obtained from ones own body, have growth inhibitions and will not form teratomas.
The theoretical concern that has been addressed in animal models or in petri dishes is that if you take cancer cells that are growing in a dish and apply stem cells, it may make those cancer cells grow more rapidly. But this does not translate in-vivo to humans.
If there was truly an issue with applying stem cells to a patient who has cancer, we would know about it by now, because weve been dosing cancer patients with stem cells since the 1930s. The safety profile is strong and there are tens of thousands of patients documented with these treatments, Dr. Comella says.
Another useful therapy is platelet-rich plasma (PRP).
Our peripheral blood contains platelets, which act as 1st responders when theres an injury. They come in and start the clotting mechanism, thereby preventing one from bleeding to death. They also give marching orders to other cells.
For example: platelets can command stem cells to multiply and grow, or to differentiate and form new tissue.
These platelets also have many different growth factors associated with them, which can help to promote healing and stop inflammation. PRP involves taking a blood sample and then spinning the blood in a centrifuge to isolate the platelets. The platelet-rich plasma is then injected back into the area that is inflamed.
One of the most common uses of platelet-rich plasma or PRP is in a joint. Now, platelets are going to be most successful in something that is rich in stem cells [such as] an acute or a very recent injury.
If you just hurt your knee, the first thing you should do is get PRP, because its going to help promote healing, and those platelets will attach to the surface receptors of the stem cells that are already going to the area to promote healing. It would be like putting fertilizer on your seed, which are the stem cells.
If you have something more chronic, this tends to be a stem cell-poor environment. In other words, you have osteoarthritis or youve got knee pain thats 5 years old and its been there for a long time; just putting PRP in it would be like putting fertilizer on dirt without planting a seed first.
The beauty of stem cell therapy is that it mimics a process that is ongoing in the human body all the time. Our stem cells are continuously promoting healing, and they do not have to be manipulated in any way. The stem cells naturally know how to home in on areas of inflammation and how to repair damaged tissue.
All were doing is harnessing the cells from one location where theyre sitting dormant and relocating them to exactly where we want them and we need them to work, Dr. Comella says. Basically, anything inside your body that is inflamed, that is damaged in some way, that is lacking blood supply, the [stem] cells can successfully treat.
That means orthopedics, knee injections, shoulder injections, osteoarthritis, acute injuries, anterior cruciate ligament tears in the back, back pain associated with degenerative disc disease or damaged tendons or ligaments, herniated and bulging discs. You can also use it in systemic issues, everything from diabetes, to cardiac, to lungs, any tissue organ inside your body that has been damaged.
Autoimmune diseases can also be treated. The stem cells are naturally immunosuppressant, meaning they can help quiet down an over reactive immune system and help the immune system function in a more normal way. Neurological diseases, traumatic brain injury, amyotrophic lateral sclerosis, Parkinsons. All of these have to do with tissue thats not functioning properly. The cells can be used to address that.
It is very impressive, the list of different diseases that could benefit from this intervention.
Again, it is not magic, but one can dramatically improve the benefits of this intervention by combining it with other healthy lifestyle factors that optimize mitochondrial function, such as eating a healthy Real food diet, exercising, sleeping well, avoiding toxins and detoxifying from toxic influences.
Stem Cells for Anti-Aging: Stem cells can also be used as part of an anti-aging program.
Dr. Comella has used stem cells on herself for several years, and report feeling better now than she did 10 year ago.
She writes,The ability to reduce inflammation inside your body is basically making yourself live longer. Inflammation is what kills us all. Its what makes our telomeres shrink. Its what causes us pain and discomfort. Its what makes the tissues start to die. The ability to dose yourself with stem cells and bring down your inflammation, which is most likely caused by any sort of toxin that youve been exposed to, breathing air is exposure to toxins, this is going to lengthen your lifespan.
I typically will do a dose every six to 12 months, regardless of whats going on. If I have anything that is bothering me, if I tweak my knee at the gym, then I absolutely will come in and do an injection in my knee. I want to keep my tissue healthy for as long as possible.
I want to stay strong. I dont want to wait until something is wrong with me. I think that this is the future of medicine. This is what were going to start to see. People will begin to get their regular doses of [their own] stem cells and itll just be common practice.
Keep in mind theres a gradual and progressive decline in the quality and the number of stem cells as we age, so if considering this approach, it would be to your advantage to extract and bank your stem cells as early on as possible. US Stem Cell provides a stem cell bank service, so one can store them until a later date when you might need them.
Your stem cells are never as young as they are right now. Every minute that you live, your telomeres are shrinking. The ability to lock in the youth of your cells today can be very beneficial for you going forward, and for your health going forward. God forbid something happens. What if you have a heart attack? Youre not going to get clearance to get a mini-lipo aspirate procedure.
If you have your cells waiting in the bank, ready for you, it becomes very easy to pull a dose and do an IV delivery of cells. Its almost criminal that were not doing this for every single one of our cardiac patients. This should be standard practice. We should be having every single patient bank their stem cells at a young age and have them waiting, ready and available. The technology is there. We have it. Im not sure why this technology is not being made available to everyone, she says.
I think stem cell therapy is very different than traditional medicine. Stem cell therapy may actually make it so that you dont have to be dependent on pharmaceutical medications. You can actually repair the tissue and thats it. This is a very different way of viewing medicine.
For a Physician in your area providing the service, you can go there. US Stem Cell can help you locate a qualified doctor.
Eat healthy, Be healthy, Live lively
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Paul A. Ebeling, polymath, excels in diverse fields of knowledge. Pattern Recognition Analyst in Equities, Commodities and Foreign Exchange and author of The Red Roadmasters Technical Report on the US Major Market Indices, a highly regarded, weekly financial market letter, he is also a philosopher, issuing insights on a wide range of subjects to a following of over 250,000 cohorts. An international audience of opinion makers, business leaders, and global organizations recognizes Ebeling as an expert.
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Stem Cell Therapy: Repair and Regenerate Our Bodies - Live Trading News
New Technology Uses Body Fat to Help Relieve Joint Pain – Healthline
By JoanneRUSSELL25
The Lipogems technology has great promise, but experts say itll take time to assess how successful the new procedure is.
What if you could put that little bit of body fat around your midsection to good use?
A procedure called Lipogems utilizes a persons body fat as a source of stem cells to help treat arthritis and joint conditions.
At least thats the promise.
Lipogems was approved for widespread use by the Food and Drug Administration (FDA) in November 2016, and its already garnering a lot of attention.
Rush University Medical Center recently became the first sports medicine specialists in the Midwest to offer treatment with the device.
The technology is ideal for patients with certain orthopedic conditions, such as painful joints including the knee, ankle, or shoulder with limited range of motion. Additionally, it can be used in soft tissue defects located in tendons, ligaments, and/or muscles to improve the biologic environment, said Dr. Brian Cole, professor of orthopedic surgery, and section head of the Rush Cartilage Restoration Center, in a press release.
Read more: Stem cell therapies offering hope for MS patients
Stem cells work by growing and differentiating themselves into different cells in the body based on the site of injection.
They are believed to help the natural regenerative processes in the body.
Hence they have earned the nickname as mini drug stores based on their ability to secrete a spectrum of bioactive molecules and support the natural regeneration of focal injuries.
Stem cells can be harvested from certain parts of the human body, most notably bone marrow and adipose tissue (fat).
Harvesting bone marrow stem cells is a significantly more invasive and time-consuming procedure that is performed using general anesthesia.
Lipogems offers a novel approach to orthopedic stem cell treatments by using a persons own fat.
The procedure uses a small incision into an area of subcutaneous fat, from which a quantity of fat tissue is harvested and processed by the Lipogems apparatus.
The technology itself, which really is the device that processes the fat, creates a concentration of fat that has been cleansed of all the extraneous things like red blood cells and fibrous tissues, Cole told Healthline.
The concentrated stem cells within that fat tissue are then applied to the problematic joint or bone area.
The procedure can be completed in under 30 minutes.
Read more: Stem cell therapy a possible treatment for rheumatoid arthritis
Lipogems offers a streamlined procedure for stem cell treatment, but there is nothing new about the science itself.
The use of stem cells to treat a variety of conditions has been ongoing for some time now.
As Healthline reported earlier this year, stem cells have been touted as a breakthrough treatment for some time, but real proof of efficacy is still being researched.
The same is true for Lipogems.
What were lacking is really good data at this point in the clinical setting, Cole said. There is substantial data in the laboratory suggesting that these cells may function in the way Ive described: reducing inflammation and so forth. But, we really dont have yet much in the way of good solid clinical data saying that definitively this is making a difference.
He further cautions individuals thinking that the new procedure, or that stem cells in general, are a panacea.
Read more: Unproven stem cell treatments offer hope but also risks
Instead, he would like those seeking orthopedic treatment to understand that Lipogems is just one part of a much larger and more complex suite of tools used by physicians.
It has to be taken into context of all the other possible treatment options, from simply icing down a swollen ankle, to changing your daily activity, to surgery.
The unfortunate thing is that people think, well this is the solution that can be used instead of, say, a joint replacement and no longer do we need to do surgery, said Cole.
Nothing could be further from the truth.
Nonetheless, Cole and his team are still excited about the possibilities of the Lipogems procedure.
Using a readily available and easily accessible substance like fat as a source of stem cells could have far-reaching implications for procedures in the future.
Were optimistic and intuitively there is a good argument to be made that this is as good or better than any other source of stem cells, said Cole.
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New Technology Uses Body Fat to Help Relieve Joint Pain - Healthline
John Theurer Cancer Center and MedStar Georgetown University Hospital Announce 100th Blood Stem Cell Transplant – PR Newswire (press release)
By JoanneRUSSELL25
The BMT program at MedStar Georgetown is a joint effort with specialists from John Theurer Cancer Center and a key component of the Lombardi Comprehensive Cancer Center, the only cancer program in the Washington, D.C. region designated by the National Cancer Institute (NCI) as a comprehensive cancer center.
"Once considered experimental, BMT is today's established gold standard for treating patients with a number of malignant and other non-malignant diseases of the immune system, blood, and bone marrow, including multiple myeloma, lymphoma, and acute and chronic leukemia. For some conditions, blood stem cell transplant can provide a cure in patients who have failed conventional therapies," says Scott Rowley, M.D., chief of the BMT program at MedStar Georgetown as well as a member of the John Theurer Cancer Center's Blood and Marrow Stem Cell Transplantation. "For some conditions, it can actually be a cure; for others, it prolongs survival and improves quality of life. Having performed 100 BMTs at MedStar Georgetown including allogenic transplantation illustrates the strength and maturity of our program achieved in rather short time."
MedStar Georgetown's program is also the only comprehensive BMT center within Washington, D.C. and southern Maryland with accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) for adult autologous procedures, where the patient donates his or her own cells.
The BMT program at John Theurer Cancer Center is one of the top 10 transplant programs in the United States, with more than 400 transplants performed annually.
A BMT involves a two-step process: first, collecting bone marrow stem cells from the patient and storing them for future use. Then, a week or so later, patients receive high dose chemotherapy to eliminate their disease. The previously stored cells are reinfused back into the bloodstream, where after reaching the bone marrow, they begin repopulating and allow the patient to recover their blood counts over the following 2 weeks.
"Even though BMT is considered standard therapy for myeloma worldwide, in the United States fewer than 50 percent of the patients who could benefit from BMT are referred for evaluation," says David H. Vesole, M.D., Ph.D., co- chief and director of Research of John Theurer Cancer Center's Multiple Myeloma division and director of MedStar Georgetown's Multiple Myeloma Program.
"That's mostly due to physicians' concerns that a patient is too old or compromised from other health conditions like diabetes, cardiac disease or renal failure. But new techniques and better supportive care have improved both patient outcomes and the entire transplant process, extending BMT to more patients than ever before."
The MedStar Georgetown/Georgetown Lombardi Blood and Marrow Stem Cell Transplant Program is part of a collaborative cancer research agenda and multi-year plan to form an NCI-recognized cancer consortium. This recognition would support the scientific excellence of the two centers and highlight their capability to integrate multidisciplinary, collaborative research approaches to focus on all the aspects of cancer.
The research areas include expansion of clinical bone marrow transplant research; clinical study of "haplo" transplants use of half-matched stem cell donor cells; re-engineering the function and focus of key immune cells; and the investigation of "immune checkpoint" blocking antibodies that unleash a sustained immune response against cancer cells.
"In this partnership, we've combined John Theurer's strength in clinical care with Georgetown Lombardi's strong research base that significantly contributes to clinical excellence at MedStar Georgetown. By working together, we have broadened our cancer research to offer more effective treatment options for tomorrow's patients," says Andrew Pecora, M.D., FACP, CPE, president of the Physician Enterprise and chief innovations officer, Hackensack Meridian Health. "This is one of many clinical and research areas that have been enhanced by this affiliation."
"Our teams are pursuing specific joint research projects we feel are of the utmost importance and significance in oncology particularly around immuno-oncology as well as precision medicine," says Andr Goy, M.D., MS, chairman of the John Theurer Cancer Center and director of the division chief of Lymphoma; chief science officer and director of Research and Innovation, RCCA; professor of medicine, Georgetown University. "Together our institutions have a tremendous opportunity to transform the delivery of cancer care for our patient populations and beyond."
ABOUT THE JOHN THEURER CANCER CENTER AT HACKENSACK UNIVERSITY MEDICAL CENTER John Theurer Cancer Center at Hackensack University Medical Center is New Jersey's largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 14 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, the John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish the John Theurer Cancer Center from other facilities.www.jtcancercenter.org.
ABOUT MEDSTAR GEORGETOWN UNIVERSITY HOSPITAL MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital with 609 beds located in Northwest Washington, D.C. Founded in the Jesuit principle of cura personaliscaring for the whole personMedStar Georgetown is committed to offering a variety of innovative diagnostic and treatment options within a trusting and compassionate environment. MedStar Georgetown's centers of excellence include neurosciences, transplant, cancer and gastroenterology. Along with Magnet nurses, internationally recognized physicians, advanced research and cutting-edge technologies, MedStar Georgetown's healthcare professionals have a reputation for medical excellence and leadership. For more information please visit: medstargeorgetown.org/bmsct
ABOUT HACKENSACK MERIDIAN HEALTH HACKENSACK UNIVERSITY MEDICAL CENTER Hackensack Meridian Health Hackensack University Medical Center, a 775-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the county's first hospital, it is now part of one of the largest networks in the state comprised of 28,000 team members and more than 6,000 physicians. Hackensack University Medical Center was listed as the number one hospital in New Jersey in U.S. News & World Report's 2016-17 Best Hospital rankings - maintaining its place atop the NJ rankings since the rating system was introduced. It was also named one of the top four New York Metro Area hospitals. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades America's 50 Best Hospitals Award for five or more years in a row. Becker's Hospital Review recognized Hackensack University Medical Center as one of the 100 Great Hospitals in America 2017. The medical center is one of the top 25 green hospitals in the country according to Practice Greenhealth, and received 25 Gold Seals of Approval by The Joint Commission more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet recognized hospital for nursing excellence; receiving its fifth consecutive designation in 2014. Hackensack University Medical Center has created an entire campus of award-winning care, including: the John Theurer Cancer Center; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women's and Children's Pavilion, which houses the Joseph M. Sanzari Children's Hospital and Donna A. Sanzari Women's Hospital, which was designed with The Deirdre Imus Environmental Health Center and listed on the Green Guide's list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to The Northern Trust PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Children's Cancer Institute housed at the Joseph M. Sanzari Children's Hospital. To learn more, visit http://www.HackensackUMC.org.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/john-theurer-cancer-center-and-medstar-georgetown-university-hospital-announce-100th-blood-stem-cell-transplant-300471445.html
SOURCE Hackensack Meridian Health
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John Theurer Cancer Center and MedStar Georgetown University Hospital Announce 100th Blood Stem Cell Transplant - PR Newswire (press release)
Human heart tissue grown from stem cells improves drug testing – Medical Xpress
By JoanneRUSSELL25
June 8, 2017 This image shows human heart muscle cells growing in the 3D tissue structure. The cells have been stained with fluorescent molecules to identify the nuclei in blue, and cardiac-specific protein, in green. Credit: Agency for Science, Technology and Research (A*STAR), Singapore
Researchers at the Institute of Bioengineering and Nanotechnology (IBN) of A*STAR have engineered a three-dimensional heart tissue from human stem cells to test the safety and efficacy of new drugs on the heart.
"Cardiotoxicity, which can lead to heart failure and even death, is a major cause of drug withdrawal from the market. Antibiotics, anticancer and antidiabetic medications can have unanticipated side effects for the heart. So it is important to test as early as possible whether a newly developed drug is safe for human use. However, cardiotoxicity is difficult to predict in the early stages of drug development," said Professor Jackie Y. Ying, Executive Director at IBN.
A big part of the problem is the use of animals or animal-derived cells in preclinical cardiotoxicity studies due to the limited availability of human heart muscle cells. Substantial genetic and cardiac differences exist between animals and humans. There have been a large number of cases whereby the tests failed to detect cardiovascular toxicity when moving from animal studies to human clinical trials.
Existing screening methods based on 2-D cardiac structure cannot accurately predict drug toxicity, while the currently available 3-D structures for screening are difficult to fabricate in the quantities needed for commercial application.
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To solve this problem, the IBN research team fabricated their 3-D heart tissue from cellular self-assembly of heart muscle cells grown from human induced pluripotent stem cells. They also developed a fluorescence labelling technology to monitor changes in beating rate using a real-time video recording system. The new heart tissue exhibited more cardiac-specific genes, stronger contraction and higher beating rate compared to cells in a 2-D structure.
"Using the 3-D heart tissue, we were able to correctly predict cardiotoxic effects based on changes in the beating rate, even when these were not detected by conventional tests. The method is simple and suitable for large-scale assessment of drug side effects. It could also be used to design personalized therapy using a patient's own cells," said lead researcher Dr Andrew Wan, who is Team Leader and Principal Research Scientist at IBN.
The researchers have filed a patent on their human heart tissue model, and hope to work with clinicians and pharmaceutical companies to bring this technology to market.
This finding was reported recently in the Biofabrication journal.
Explore further: Stem cell-based screening methods may predict heart-related side effects of drugs
More information: Hong Fang Lu et al. Engineering a functional three-dimensional human cardiac tissue model for drug toxicity screening, Biofabrication (2017). DOI: 10.1088/1758-5090/aa6c3a
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Human heart tissue grown from stem cells improves drug testing - Medical Xpress