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NYSCF scientists make living brain cells from Alzheimer’s patients biobanked brain tissue

By adminJanuary 8, 2014Stem Cell Medical Center

PUBLIC RELEASE DATE:

7-Jan-2014

Contact: David McKeon DMckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (January 7, 2014) Scientists at The New York Stem Cell Foundation (NYSCF) Research Institute, working in collaboration with scientists from Columbia University Medical Center (CUMC), for the first time generated induced pluripotent stem (iPS) cells lines from non-cryoprotected brain tissue of patients with Alzheimer's disease.

These new stem cell lines will allow researchers to "turn back the clock" and observe how Alzheimer's develops in the brain, potentially revealing the onset of the disease at a cellular level long before any symptoms associated with Alzheimer's are displayed. These reconstituted Alzheimer's cells will also provide a platform for drug testing on cells from patients that were definitively diagnosed with the disease. Until now, the only available method to definitively diagnose Alzheimer's disease that has been available to researchers is examining the brain of deceased patients. This discovery will permit scientists for the first time to compare "live" brain cells from Alzheimer's patients to the brain cells of other non-Alzheimer's patients.

NYSCF scientists successfully produced the iPS cells from frozen tissue samples stored for up to eleven years at the New York Brain Bank at Columbia University.

This advance, published today in Acta Neuropathologica Communications , shows that disease-specific iPS cells can be generated from readily available biobanked tissue that has not been cryoprotected, even after they have been frozen for many years. This allows for the generation of iPS cells from brains with confirmed disease pathology as well as allows access to rare patient variants that have been banked. In addition, findings made using iPS cellular models can be cross-validated in the original brain tissue used to generate the cells. The stem cell lines generated for this study included samples from patients with confirmed Alzheimer's disease and four other neurodegenerative diseases.

This important advance opens up critical new avenues of research to study cells affected by disease from patients with definitive diagnoses. This success will leverage existing biobanks to support research in a powerful new way.

iPS cells are typically generated from a skin or blood sample of a patient by turning back the clock of adult cells into pluripotent stem cells, cells that can become any cell type in the body. While valuable, iPS cells are often generated from patients without a clear diagnosis of disease and many neurodegenerative diseases, such as Alzheimer's disease, often lack specific and robust disease classification and severity grading. These diseases and their extent can only be definitively diagnosed by post-mortem brain examinations. For the first time we will now be able to compare cells from living people to cells of patients with definitive diagnoses generated from their banked brain tissue.

Brain bank networks, which combined contain tens of thousands of samples, provide a large and immediate source of tissue including rare disease samples and a conclusive spectrum of disease severity among samples. The challenge to this approach is that the majority of biobanked brain tissue was not meant for growing live cells, and thus was not frozen in the presence of cryoprotectants normally used to protect cells while frozen. NYSCF scientists in collaboration with CUMC scientists have shown that these thousands of samples can now be used to make living human cells for use in disease studies and to develop new drugs or preventative treatments for future patients.

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NYSCF scientists make living brain cells from Alzheimer's patients biobanked brain tissue

Stem Cells Used to Model Disease that Causes Abnormal Bone Growth

By adminJanuary 8, 2014Stem Cell Clinic

Researchers have developed a new way to study bone disorders and bone growth, using stem cells from patients afflicted with a rare, genetic bone disease. The approach, based on Nobel-Prize winning techniques, could illuminate the illness, in which muscles and tendons progressively turn into bone, and addresses the similar destructive process that afflicts a growing number of veterans who have suffered blast injuries including traumatic amputations or injuries to the brain and nervous system. This insidious hardening of tissues also grips some patients following joint replacement or severe bone injuries.

The disease model, described in a new study by a UC San Francisco-led team, involves taking skin cells from patients with the bone disease, reprogramming them in a lab dish to their embryonic state, and deriving stem cells from them.

Edward Hsiao, MD, PhD

Once the team derived the stem cells, they identified a cellular mechanism that drives abnormal bone growth in the thus-far untreatable bone disease, calledfibrodysplasiaossificansprogressiva(FOP). Furthermore, they found that certain chemicals could slow abnormal bone growth in the stem cells, a discovery that might help guide future drug development.

Clinically, the genetic and trauma-caused conditions are very similar, with bone formation in muscle leading to pain and restricted movement, according to the leader of the new study, Edward Hsiao, MD, PhD, an endocrinologist who cares for patients with rare and unusual bone diseases at the UCSF Metabolic Bone Clinic in the Division of Endocrinology and Metabolism.

The human cell-based disease model is expected to lead to a better understanding of these disorders and other illnesses, Hsiao said.

The new FOP model already has shed light on the disease process in FOP by showing that the mutated gene can affect different steps of bone formation, Hsiao said. These different stages represent potential targets for limiting or stopping the progression of the disease, and may also be useful for blocking abnormal bone formation in other conditions besides FOP. The human stem-cell lines we developed will be useful for identifying drugs that target the bone-formation process in humans."

The teams development of, and experimentation with, the human stem-cell disease model for FOP, published in the December issue of theOrphanetJournal of Rare Diseases, is a realization of the promise of research using stem cells of the type known as induced pluripotent stem (iPS) cells, immortal cells of nearly limitless potential, derived not from embryos, but from adult tissues.

Shinya Yamanaka, MD, PhD, a UCSF professor of anatomy and a senior investigator with the UCSF-affiliated Gladstone Institutes, as well as the director of the Center foriPSCell Research and Application (CiRA) and a principal investigator at Kyoto University, shared the Nobel Prize in 2012 for discovering how to makeiPScells from skin cells using a handful of protein factors. These factors guide a reprogramming process that reverts the cells to an embryonic state, in which they have the potential to become virtually any type of cell.

Leaked files slam stem-cell therapy

By adminJanuary 8, 2014Stem Cell Treatment

Massimo Valicchia/NurPhoto/Corbis

Potential patients have offered vocal support for Staminas stem-cell treatment in Italy.

A series of damning documents seen by Nature expose deep concerns over the safety and efficacy of the controversial stem-cell therapy promoted by Italys Stamina Foundation. The leaked papers reveal the true nature of the processes involved, long withheld by Staminas president, Davide Vannoni. Other disclosures show that the successes claimed by Stamina for its treatments have been over-stated. And, in an unexpected twist, top Italian scientists are dissociating themselves from an influential Miami-based clinician over his apparent support for the foundation.

Stamina, based in Brescia, claims that it successfully treated more than 80 patients, mostly children, for a wide range of conditions, from Parkinsons disease to muscular dystrophy, before the health authorities halted its operations in August 2012. A clinical trial to assess the treatment formally was approved by the Italian government last May, and an expert committee was convened by the health ministry to study Staminas method and to recommend which illnesses the trial should target.

Stamina says that its technique involves extracting mesenchymal stem cells from a patients bone marrow, culturing them so that they turn into nerve cells, and then injecting them back into the same patient. But full details of the method have never been revealed, and Vannoni provided the full protocol to the expert committee only in August.

In October, the committees report prompted health minister Beatrice Lorenzin to halt plans for the clinical trial. That led to public protests in support of Stamina, and, after an appeal by Vannoni, a court ruled in early December that the expert committee was unlawfully biased. Some members had previously expressed negative opinions of the method, the ruling said. As a result, Lorenzin appointed a new committee on 28December, reopening the possibility of a clinical trial.

Staminas protocol, together with the original committees report, was leaked to the press on 20 December (Nature has also been shown transcripts of the committees deliberations). The leaked papers reveal that the original expert committee identified serious flaws and omissions in Staminas clinical protocol. It did not apply legally required Good Manufacturing Practice standards, the committee says. The protocol exposed an apparent ignorance of stem-cell biology and relevant clinical expertise, the report argues, as well as flawed methods and therapeutic rationale (see Protocol opinion).

What the expert committee said on Staminas methods.

The report of the original expert committee tasked with looking at Staminas clinical protocol includes the following opinions:

The protocol contains no method for screening for pathogens such as prions or viruses, even though the culture medium used could contain them.

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Leaked files slam stem-cell therapy

Stem cells on the road to specialization

By adminJanuary 8, 2014Stem Cell Treatment

PUBLIC RELEASE DATE:

7-Jan-2014

Contact: Joshua Brickmann joshua.brickman@sund.ku.dk 45-51-68-04-38 University of Copenhagen

Scientists at the University of Copenhagen have gained new insight into how both early embryonic cells and embryonic stem cells are directed into becoming specialised cell types, like pancreatic and liver cells. The results have just been published in the scientific journal eLife.

This latest research from the Danish Stem Cell Center (Danstem) at the University of Copenhagen, helps identify how stem cells create so called pathways and roads supporting their own specialisation. This understanding is an important step towards stem cell-based cell therapies for conditions like diabetes and liver diseases.

"The new insight that we have gained into the impact of the physical environment on cell development is highly valuable," says Professor Joshua Brickman from DanStem, "It enables us to create the optimal physical environment in the laboratory for stem cells and progenitor cells to develop into specific, mature cells."

On the road

Developing cells constantly move and while moving around, they organise and build a physical environment very much like a small city with pathways and roads. The new research published in the scientific journal eLife shows two important things. Firstly the embryonic cells receive signals from other cells that actually instruct them in how to organise and build the road leading the cells towards early stages of pancreas and liver cells.

Professor Brickman and his team also found that they could isolate these roads from the developing stem cells and literally freeze them. The saved roads were then used in a separate experiment which showed that in the absence of an important cell signal, the road alone can be used to improve the cells' development and differentiation towards mature cells.

"Apart from gaining new important insight into cell development, our work also suggests that some of the current approaches to human embryonic stem cells specialisation towards both pancreatic and liver cells may not have been effective, because the important role of these roads, the so called extra-cellular matrix, was ignored," says Joshua Brickman.

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Stem cells on the road to specialization

StemGenex® Offers New Options to Diabetes Patients through Cutting-Edge Stem Cell Therapy

By adminJanuary 8, 2014Stem Cell Treatment

http://www.StemGenex.com. This image must be used in conjunction with the news release with which it was originally distributed.(PRNewsFoto/StemGenex/Rafe Swan/Cultura/Getty Images)

LA JOLLA, Calif., Jan. 7, 2014 /PRNewswire/ -- According to The American Diabetes Association there are over 25 million people in the US living with diabetes. These patients are suffering from complications such as heart disease, stroke, high blood pressure, blindness, kidney disease, neuropathy and amputation. Since adult stem cells have the ability to differentiate into many different types of cells, such as those required for proper pancreatic functioning, StemGenex believes there is hope for these patients.

StemGenex is currently studying ways to regenerate insulin producing cells within the pancreas by using adult stem cells. By harvesting adipose derived stem cells through a mini-liposuction procedure, the doctors can then minimally manipulate the stem cells in an on-site lab before reintroducing them back into the patient's body, the very same day. Once the stem cells are reintroduced, StemGenex believes they may differentiate into insulin producing cells of the pancreas. StemGenex is studying outcomes such as better glycemic control, decreases in insulin requirement, as well as reductions in HBA1C and triglyceride levels.

Stem cell treatment studies are currently being offered by StemGenex to patients diagnosed with Diabetes as well as degenerative neurological diseases. StemGenex takes a unique approach of compassion and empowerment while providing access to the latest stem cell therapies for diseases including Parkinson's, Alzheimer's, Diabetes, stroke recovery, COPD and others. Rita Alexander, founder of StemGenex and the company's first stem cell patient, insists that all patients be treated like they are one of our loved ones. "Hope, compassion, and the relentless pursuit for an end to these diseases are our primary focus."

StemGenex is extremely proud of its reputation as a leader in the stem cell industry as well as its dedication to putting patients first. StemGenex actively tracks and posts its patient satisfaction rates on its website in multiple categories as a way to share with the public how patients have been positively affected through these stem cell studies. These statistics are updated monthly and can be found here: StemGenex Patient Satisfaction Ratings

To find out more about stem cell therapy, contactStemGenexeither by phone at (800) 609-7795 or email Contact@stemgenex.com.

Image with caption: "www.StemGenex.com". Image available at: http://photos.prnewswire.com/prnh/20140107/LA41524-a

Image with caption: "www.StemGenex.com". Image available at: http://photos.prnewswire.com/prnh/20140107/LA41524-b

Image with caption: "www.StemGenex.com". Image available at: http://photos.prnewswire.com/prnh/20140107/LA41524-c

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StemGenex® Offers New Options to Diabetes Patients through Cutting-Edge Stem Cell Therapy

Exclusive: Doctors Skirt FDA To Provide Human Stem Cell …

By adminJanuary 6, 2014Stem Cell Doctors

The FDA has yet to approve stem cell therapies for general use in medicine, but that hasnt stopped doctors in Colorado from providing them anyway. Chris Centeno and John Schultz have boldly formed Regenerative Sciences Inc. in Broomfield, Colorado. RSI provides its patients with the Regenexx procedure, an adult stem cell transplant that uses your own cells (autologous) to treat joint injuries and bone damage. Theres no surgery needed. A needle extracts bone marrow, RSI isolates the stem cells and cultures them in your own blood, and then these cells are injected into the area where they are needed. Theyve treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSIs own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they havent been able to in years. Weve seen these kinds of results from stem cell treatments before, but only in horses and dogs. Thats because human stem cell therapies like this one arent approved by the FDA. How can Centeno and Schultz flaunt the lack of federal approval? They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado, and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles. I had a chance to talk with Dr. Centeno over the phone and learn more about Regenexx and RSI. For hundreds of patients, he and his team are providing a remarkable hope. Theyve brought lab-cultured medical stem cell therapies to the US. Finally.

Stem cells have been a focal point for hype and hope for years now. Besides healing horses and dogs, they have promising effects on diabetes, corneal blindness, even HIV. Its pretty clear that theyre also the future of organ transplants. Just the news of a stem cell related development or patent will cause a biotech companys stocks to soar. The FDA, which regulates all interstate drug sales and related clinical trials is not trying to keep Americans from these miraculous cures, its simply trying to make sure they are safe first. Apparently, thats taking too long. Medical tourism agencies are starting to cater to those seeking stem cell treatments. Whether or not they are ready for widespread medical use, stem cell therapies are in high demand, not just in the US but around the world. Its no longer a question of when we will have access to these treatments, its a question of how.

Patients interested in the Regenexx procedure face what seems to be a fairly standard experience for autologous stem cell transplants. It takes 20-40 minutes to extract the cells from hip bone marrow with limited anesthesia, and blood is also taken. Over a month RSIs lab will isolate mesenchymal (multipotent) adult stem cells and multiply them until they have 1 to 10 million. Typically, a patient will receive an injection into the treated area once a month for three months. Positive results are sometimes seen quickly (in 1 to 3 months) but will hopefully develop within 6 to 9 months. Importantly, theres no down time as a result of the procedure. Patients can leave the clinic and go home after each injection. A round of Regenexx (extraction, cultivation, and 3 injections) costs $7000-$8500. Those who produce exceptional numbers of stem cells can use subsequent injections (even in other parts of the body) for around $3500. Most insurances will not cover the treatment.

The fact that RSI isolates and cultures (multiplies) the cells is a big difference from other clinics that offer stem cell therapies. That process allows the lab to create enough mesenchymal stem cells to really have an effect on the area in which they are injected. Many clinics around the world will take blood, marrow, or tissue and then spin out the stem cells in a centrifuge, injecting them back in on the same day. That style of therapy could possibly be effective, but it is far less likely than with a dose of millions of multipotent stem cells. There are several doctors around the US that will provide such single-visit stem cell therapies, but as far as I know RSI is the only that offers the lab cultured mesenchymal therapy in the US. Dr. Centeno has confirmed that hes the only one, that he knows of, openly using this particular procedure in the US.

In the past, I have been very skeptical of stem cell treatment centers in other countries. Id like to turn that same critical eye to Regenexx. Its only fair. First, lets look at the success RSI is selling. Autologous transplants are offered in the hands, hips, knees, shoulders, back (non-spinal cord injury), ankles, and bone fractures. For each of these procedures you can find many ardent and exceptionally encouraging patient testimonials on their website, or their YouTube channel, along with a flood of supportive media. Heres a clip from a local news Channel which is pretty indicative of the rest:

Overall, RSI is claiming around 80% patient satisfaction according to its own surveys. Thats incredible, especially when you see some of their patients walking and running again on joints that have experienced years of chronic damage. It also seems Centeno and Schultz have the documented evidence to back up the claims for Regenexxs success. RSI provides case studies for each of its treatments as well as published scientific research. According to my conversation with Centeno, RSI is currently working on a comprehensive statistical analysis of their more popular treatments so they can publish quantitative results in a peer review journal. In other words, theyll soon publish the hard numbers X% of patients feel Y% better Z months after the procedure.

Importantly, RSI seems to be upfront with patients about the limits of their own technique. The website FAQ clearly states that not all results will be like the testimonials, and they even have a dedicated page explaining that stem cell therapies wont work for everyone. Furthermore, RSI has published the largest study of risks and complications associated with stem cell treatments yet produced in the US (N=227). That paper demonstrates the very low harm associated with stem cell therapies much lower than the alternative surgery(published in Current Stem Cell Research & Therapy). Centeno told me that if were really worried that autologous stem cell therapies are going to hurt someone, this paper pretty much shows they wont.

The concerns most people have with RSI are not medical, theyre political. Many applaud Centeno and Schultz for supplying the public with the cutting edge technology they demand, but worry about the manner in which it has been accomplished. Skirting FDA approval for a technique through the arguments they use opens the gate to a host of problems. If RSI can provide Regenexx because it is a doctors procedure not involved in interstate commerce, does that mean someone else can do the same for another treatment? What are the limits of such procedures? How does a patient know if a doctors therapy is safe, or effective, if it hasnt undergone peer review and government inspection?

Patients endorse key stem cell research

By adminJanuary 6, 2014Stem Cell Medicine

Despite some ethical concerns, most patients are now broadly endorsing stem cell research.

In the case of induced pluripotent stem cells (iPSCs), which are stem cells made from skin or other tissues, researchers at the Johns Hopkins University found patients were largely in favour of participating in iPSC research even if personal benefit was unlikely.

The patients, however, raised concerns about consent, privacy and transparency.

"Bioethicists as well as stem cell researchers and policy-makers have discussed ethical issues at length but till date, we didn't have any systematic information about what patients think about these issues," said Jeremy Sugarman, the Harvey M. Meyerhoff professor of bioethics and medicine at Johns Hopkins Berman Institute of Bioethics.

Unlike human embryonic stem cells, iPSCs are derived without destroying a human embryo. Research with human iPSCs is valuable for developing new drugs, studying disease, and perhaps developing medical treatments, said the study published in the journal Cell Stem Cell.

According to the study, consent was highly important for patients. Some patients even suggested that proper informed consent could compensate for other concerns they had about privacy, the "immortalisation" of cells and the commercialisation of stem cells.

There was a "strong desire among participants to have full disclosure of the anticipated uses, with some participants wanting to be able to veto certain uses of their cells", the study added.

"The idea that donated cells would potentially live forever was unnerving to some participants," the report stated.

"This study is a first step in getting crucial information about what values are factored into a decision to participate in iPSC research, and what those participants expect from the experience," said Sugarman.

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Patients endorse key stem cell research

Patients now endorsing key stem cell research

By adminJanuary 6, 2014Stem Cell Medicine

New York, Jan 6 : Despite some ethical concerns, most patients are now broadly endorsing stem cell research.

The patients, however, raised concerns about consent, privacy and transparency.

There was a "strong desire among participants to have full disclosure of the anticipated uses, with some participants wanting to be able to veto certain uses of their cells", the study added.

"The idea that donated cells would potentially live forever was unnerving to some participants," the report stated.

--IANS (Posted on 06-01-2014)

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Patients now endorsing key stem cell research

Stanford gets $90 million cancer study grant

By adminJanuary 6, 2014Stem Cell Medicine

By Lisa M. Krieger lkrieger@mercurynews.com

Stanford has received a vast sum of money to study a tiny population of deadly cancer cells, a gift that could help combat the heartbreak of phoenixlike disease recurrence.

The $90 million from the New York City-based Ludwig Fund will boost research at the Ludwig Center for Cancer Stem Cell Research and Medicine at Stanford's School of Medicine, where scientists are studying cancer stem cells for ways to tear out the roots of tumors.

Stanford is one of six institutions to share in Ludwig's $540 million contribution to the field of cancer research, announced Monday. Endowed by the late billionaire Daniel K. Ludwig, a self-made American shipping and real estate magnate who died in 1992, the fund supports cancer research that might be otherwise dependent on the whims of government or corporate support.

"This extraordinary gift will spur innovation well into the future," said Stanford president John Hennessy, calling it "a tremendous vote of confidence."

Billions of dollars have been spent on cancer research since President Richard M. Nixon declared war on the disease in 1971. Yet the fight is going slower than most had hoped, with small changes in the death rate over the decades since.

Part of the problem, scientists think, it that some cancers are driven by hidden cancer stem cells -- which remain tenacious even after treatment, reasserting themselves and continuing to grow. Their discovery by Canadian scientist John Dick in 1994 profoundly altered our concept of cancer biology.

If such cells are proven to be the determinant of relapse, the implication for cancer therapy is enormous. Any treatment that leaves behind residual cancer stem cells would inevitably lead to a relapse.

"These are the subset of cells that self-renew -- they're the dangerous one," said Dr. Irving Weissman, who directs Stanford's Ludwig Center, the only cancer stem cell center of its kind.

Weissman and Dr. Michael Clarke have isolated these cells in many different types of cancers and identified ways they might be vulnerable.

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Stanford gets $90 million cancer study grant

Cedars-Sinai researchers target cancer stem cells in malignant brain tumors

By adminJanuary 6, 2014Stem Cell Medical Center

PUBLIC RELEASE DATE:

6-Jan-2014

Contact: Sandy Van sandy@prpacific.com 808-526-1708 Cedars-Sinai Medical Center

LOS ANGELES (Jan. 6, 2014) Researchers at the Cedars-Sinai Maxine Dunitz Neurosurgical Institute and Department of Neurosurgery identified immune system targets on cancer stem cells cells from which malignant brain tumors are believed to originate and regenerate and created an experimental vaccine to attack them.

Results of laboratory and animal studies are published in the online edition of Stem Cells Translational Medicine, and will appear in the March 2014 print edition. A Phase I safety study in human volunteers with recurrent glioblastoma multiforme, the most common and aggressive brain tumor in adults, is underway.

Like normal stem cells, cancer stem cells have the ability to self-renew and generate new cells, but instead of producing healthy cells, they create cancer cells. In theory, if the cancer stem cells can be destroyed, a tumor may not be able to sustain itself, but if the cancer originators are not removed or destroyed, a tumor will continue to return despite the use of existing cancer-killing therapies.

The researchers identified certain fragments of a protein CD133 that is found on cancer stem cells of some brain tumors and other cancers. In the laboratory, they cultured the proteins with dendritic cells, the immune system's most powerful antigen-presenting cells, which are responsible for helping the immune system recognize and attack invaders.

Studies in lab mice showed that the resulting vaccine was able to stimulate an immune response against the CD133 proteins without causing side effects such as an autoimmune reaction against normal cells or organs.

"CD133 is one of several proteins made at high levels in the cancer stem cells of glioblastoma multiforme. Because this protein appears to be associated with resistance of the cancer stem cells to treatment with radiation or chemotherapy or both, we see it as an ideal target for immunotherapy. We have found at least two fragments of the protein that can be targeted to trigger an immune response to kill tumor cells. We don't know yet if the response would be strong enough to prevent a tumor from coming back, but we now have a human clinical trial underway to assess safety for further study," said John Yu, MD, vice chair of the Department of Neurosurgery, director of surgical neuro-oncology, medical director of the Brain Tumor Center and neurosurgical director of the Gamma Knife Program at Cedars-Sinai. He is senior author of the journal article.

With standard care, which includes surgery, radiation treatment and chemotherapy, median length of survival is 15 months for patients diagnosed with glioblastoma multiforme. Cedars-Sinai researchers have studied dendritic cell immunotherapy since 1997, with the first patient human clinical trial launched in 1998.

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Cedars-Sinai researchers target cancer stem cells in malignant brain tumors