Three women suffering from a degenerative eye condition were blindedlikely permanentlyin a clinical trial for stem cell therapy, according to a report published Wednesday in the New England Journal of Medicine.

The women, who were all between the ages of 72 and 88, had a common medical condition called age-related macular degeneration, in which cells in the retina begin to die off, resulting in spotty or blurred vision. Researchers suspected stem cells derived from the patients own body could regenerate some of the cells lost to the disease. So in the clinical trial, which was conducted in 2015, researchers removed some blood and fat from participants anesthetized abdomens, treated the cells in a standardized way to make them revert to stem cells, then injected into their eyes. They were instructed to use an eyedrops antibiotic for a few days. The three patients had found the trial listed on the government web site clinicaltrials.gov, and had each paid $5,000 for the procedure. The informed consent form listed that blindness was possible as a result of the procedure.

A few days after the patients received the injected stem cells, the participants ended up in the hospital with vision loss, detached retinas, and hemorrhage. The patients lost vision; subsequent checkups led doctors to conclude that they would likely never regain their sight.

Despite the fact that the participants found the procedure on clinicaltrials.gov, the informed consent forms do not mention that it is in fact a clinical trial. The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day, the study authors write. Injecting something experimental into both eyes is both not safe and not typical, they continue.

Recently researchers have been testing lots of different medical uses for stem cells, from treating multiple sclerosis to spinal cord injuries. With the passage of the 21st Century Cures Act in December, Congress cleared the way for faster regulatory approval for promising treatments based on stem cells. At least 13 clinical trials were registered to treat AMD alone as of November 2016, the article authors write.

But anecdotes like these bolster those who counsel restraint when it comes to stem cells. Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy, the article authors write.

Jeffrey Goldberg, a professor of ophthalmology at Stanford University and one of the authors of the article, calls this a call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research, according to a press release.

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Three Women Blinded In Stem Cell Clinical Trial - Vocativ

Spinal Cord Stem Cells Comments Off on Three Women Blinded In Stem Cell Clinical Trial – Vocativ | March 16th, 2017

By Isaac GuererroStaff writer

Xue-Jun Li spends her days studying motor neurons, the cells that send signals from the brain to the body's voluntary muscles.

Motor neuron diseases are degenerative, which means that the muscles don't stop working all at once. When the motor neurons begin to fail, one slowly loses control of the arms and legs, the ability to swallow and, eventually, to breathe.

Scientists know very little about the human nervous system and what causes the motor neurons to stop functioning. Li has published more than 37 peer-reviewed manuscripts and has developed human stem cell models for spastic paraplegias and spinal muscular atrophy, which is the leading genetic cause of death for infants.

Li joined the University of Illinois College of Medicine at Rockford as an associate professor in the Biomedical Sciences Department last May. Her research is supported by the National Institute of Health and ALS Association, among others.

I love the satisfaction of new discoveries, new ideas you get from working in the lab, the interaction with students, she said. But any breakthrough you make is a collaboration.

Her stem cell research is concerned with, among other things, an attempt to better understand microtubule defects that disrupt signals from the brain to motor neurons along the spinal cord. Mitochondrial defects the mitochondria are the energy factories of the cells are another focus.

This fall, Li will teach a class that's a first for the university: stem cells and regenerative engineering.

Isaac Guerrero: 815-987-1361; iguerrero@rrstar.com;@isaac_rrs

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Transform 815: Xue Jun-Li's stem cell research in Rockford sheds light on motor neuron diseases - Rockford Register Star

Spinal Cord Stem Cells Comments Off on Transform 815: Xue Jun-Li’s stem cell research in Rockford sheds light on motor neuron diseases – Rockford Register Star | March 16th, 2017

March 09, 2017 07:03 ET | Source: Neuralstem, Inc.

-NSI-566 Achieved Robust Engraftment and Long-Term Survival After Transplantation-

- Data Published in Journal of Neurotrauma-

GERMANTOWN, Md., March 09, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, announced the recent publication of preclinical data on NSI-566 spinal cord-derived neural stem cells in Journal of Neurotrauma. These data showed robust engraftment and long-term survival of NSI-566 post transplantation in a rat model of penetrating ballistic-like brain injury (PBBI). NSI-566 is Neuralstems lead stem cell therapy candidate.

The study entitled, Amelioration of penetrating ballistic-like brain injury induced cognitive deficits after neuronal differentiation of transplanted human neural stem cells," was led by Ross Bullock, M.D., Ph.D., The Miami Project to Cure Paralysis, University of Miami School of Medicine. These are the first data from the 4-year proof-of-concept research program, funded by the United States Department of Defense, for NSI-566 in traumatic brain injury.

These data on NSI-566 are encouraging, particularly since researchers have long been challenged to achieve durable engraftment and survival of neural stem cells after transplantation, said Dr. Bullock. No long-term treatment beyond physical therapy is currently available to restore cognition after a traumatic brain injury. Transplantation of stem cells into the injured brain may allow a unique replacement therapy and fill a significant medical need.

Researchers transplanted NSI-566 into rats 7-10 days after PBBI. The rats were immunosuppressed to enable survival of NSI-566 neural stem cells. Robust engraftment with evidence of prominent neuronal differentiation was observed after 4 months, and axons from grafted cells extended a significant distance from the graft site along host white matter tracts.

These data continue to support our research and development platform. The results provide additional insight into our proprietary regionally specific stem cells and their potential benefits in nervous system disorders, said Karl Johe, Ph.D., Chief Scientific Officer, Neuralstem. We look forward to additional preclinical data from this collaboration with Dr. Bullocks group to support the potential use of NSI-566 in traumatic brain injury.

About Neuralstem Neuralstems patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstems technology enables the discovery of small molecule compounds by systematic screening chemical compounds against its proprietary human hippocampal stem cell line. The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brains capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstems stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China. In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS. Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

Cautionary Statement Regarding Forward Looking Information This news release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as expect, anticipate, intend, plan, believe, seek or will. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstems periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and Form 10-Q for the nine months ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

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Neuralstem Announces Publication of NSI-566 Data in a Rodent Model of Traumatic Brain Injury - GlobeNewswire (press release)

Spinal Cord Stem Cells Comments Off on Neuralstem Announces Publication of NSI-566 Data in a Rodent Model of Traumatic Brain Injury – GlobeNewswire (press release) | March 10th, 2017

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 9, 2017.

GAINERS

1. Ocera Therapeutics Inc. (OCRX)

Gained 71.82% to close Thursday's trading at $1.89.

News: The Company reported additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy.

The initial STOP-HE results, reported in January 2017, had demonstrated highly statistically significant reduction in ammonia levels over placebo, strong evidence of benefit across multiple endpoints with higher doses (15g, 20g), clinical improvement dose trend, increased responder rate with increased dose and superiority over placebo at all doses. OCR-002 was also safe and well-tolerated.

The additional study data revealed on Thursday indicates that IV OCR-002 provided clinical benefit over placebo in other parameters as well, such as the Physician Overall Evaluation, Model for End-Stage Liver Disease (MELD) scores, and in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels.

2. Cymabay Therapeutics Inc. (CBAY)

Gained 20.29% to close Thursday's trading at $4.09.

News: The Company will provide a corporate overview at the 29th Annual ROTH Conference on March 13th and at the Oppenheimer 27th Annual Healthcare Conference on March 21st.

Near-term catalysts:

- The results from phase II study of Cymabay's investigational drug Seladelpar in primary biliary cholangitis are expected in 3Q 2017. - The company's most advanced product candidate is Arhalofenate for treatment of gout, which has completed phase II studies. The drug candidate is licensed to Kowa Pharmaceuticals America, Inc. in the U.S.

Licensing discussions for other territories are underway. Ex-US licensing agreement for Arhalofenate is expected to be inked this year.

3. Neuralstem Inc. (CUR)

Gained 19.64% to close Thursday's trading at $5.30.

News: The preclinical data of the Company's NSI-566 spinal cord-derived neural stem cells in a rodent model of traumatic brain injury shows robust engraftment and long-term survival. The data are published in Journal of Neurotrauma.

NSI-566 is being explored in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

A phase I safety study of NSI-566 for the treatment of paralysis from chronic motor stroke is being conducted at the BaYi Brain Hospital in Beijing, China. In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS. Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits, according to the company.

Near-term catalyst:

-- Data from a phase II trial of NSI-189 for the treatment of major depressive disorder is expected in 3Q 2017.

4. Immunomedics Inc. (IMMU)

Gained 19.48% to close Thursday's trading at $6.01.

News: A global licensing agreement between Seattle Genetics (SGEN) and Immunomedics, worth over $2 billion, has been put on hold by a Delaware judge, following an injunction filed by venBio Select Advisor LLC, the largest shareholder of Immunomedics, to block the deal.

The license agreement between Seattle Genetics and Immunomedics was signed last month, and it involves antibody-drug conjugate, Sacituzumab govitecan, or IMMU-132.

Sacituzumab Govitecan (IMMU-132) is Immunomedics' lead investigational drug. As part of the agreement, Seattle Genetics is responsible for initiating phase III clinical trials of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and will be responsible for submitting the initial Biologics License Application to the FDA for accelerated approval.

VenBio is seeking to thwart the deal saying it undervalues the potential of IMMU-132. Now that a temporary restraining order has been placed on the deal, maybe there is an opportunity for a better deal.

5. Curis Inc. (CRIS)

Gained 20.78% to close Thursday's trading at $3.08.

News: The Company reported Q4 and full-year 2016 financial results and updated the progress of its pipeline.

The net loss for Q4, 2016 narrowed to $11.3 million or $0.08 per share on total revenue of $2.36 million. This compared with a net loss of $13.5 million or $0.10 per share and total revenue of $2.09 million in the year-ago period.

As for its clinical pipeline, the company noted that its phase I trial for CA-170 continues to progress on track through the dose escalation stage, and extension of the CA-170 Phase 1 study is all set to begin with enrollment of immunotherapy-nave patients in Korea and Spain, and with additional trial centers in other European countries projected to open in the second quarter.

A phase II trial of another drug candidate CUDC-907 in patients with relapsed/refractory MYC-altered diffuse large B cell lymphoma, or DLBCL , is expected to complete enrollment within the first half of this year.

6. VIVUS Inc. (VVUS)

Gained 16.35% to close Thursday's trading at $1.21.

News: The Company reported Q4 and full-year 2016 financial results.

VIVUS reversed to profit in the fourth quarter and full year of 2016 from net losses in the comparable year-ago periods.

Net income for the 2016 fourth quarter and full year was $56.6 million or $0.54 per share and $23.3 million or $0.22 per share, respectively, as compared to a net loss of $12.2 million or $0.12 per share and $93.1 million or $0.90 per share in 2015, respectively.

VIVUS had cash, cash equivalents and available-for-sale securities of $269.5 million at December 31, 2016.

The company noted that it will use its strong cash position for the acquisition and development of a new product pipeline to drive value creation for its stockholders while addressing the unmet needs of patients.

7. TG Therapeutics Inc. (TGTX)

Gained 16.26% to close Thursday's trading at $11.80. Shares of TG Therapeutics have been on the rise since announcing positive top line data from its phase III trial of TG-1101 in patients with high risk Chronic Lymphocytic Leukemia, dubbed GENUINE, on March 6, 2017.

News: The Company has priced an underwritten public offering of 5,128,206 shares of its common stock at a price of $9.75 per share.

Anticipated event: Q4 and full-year 2016 financial results and an update on business outlook for 2017 are slated to be presented on March 10, 2017.

LOSERS

1. InspireMD Inc. (NSPR)

Lost 37.56% to close Thursday's trading at $1.23.

News: The Company has priced its public offering of shares of Series C Convertible Preferred Stock, Series B warrants and Series C warrants.

Each share of Series C Convertible Preferred Stock is convertible into 4 shares of common stock at a conversion price equal to $1.60 per share. The Series B warrants have an exercise price of $2.00 per share of common stock and Series C warrants have an exercise price of $1.60 per share of common stock.

The gross proceeds from the offering are estimated to be up to $7.5 million. The offering is expected to close on or about March 14, 2017.

2. Cogentix Medical Inc. (CGNT)

Lost 13.12% to close Thursday's trading at $1.92.

News: The Company reported Q4 and full-year 2016 financial results.

Net loss for Q4 2016 widened to $18.57 million or $0.40 per share on revenue of $13.2 million. This compared with a net loss of $1.09 million or $0.04 per share and revenue of $13.64 million in the year-ago period.

3. BIOLASE Inc. (BIOL)

Lost 12.41% to close Thursday's trading at $1.20.

News: The Company reported Q4 and full-year 2016 financial results

The net loss for the fourth quarter of 2016 widened to $4.4 million or $0.07 per share as revenues declined to $13.8 million. This compared with a net loss of $2.5 million or $0.04 per share and revenue of $14.5 million in the fourth quarter of 2015.

4. Tandem Diabetes Care Inc. (TNDM)

Lost 11.63% to close Thursday's trading at $1.90.

News: The Company reported Q4 and full-year 2016 financial results.

The net loss for the fourth quarter of 2016 widened to $14.82 million or $0.48 per share as sales fell to $28.91 million. This compared with a net loss of $12.09 million or $0.40 per share and sales of $29.12 million in the fourth quarter of 2015. Tandem has also filed a registration statement on Form S-1 with the SEC relating to a proposed follow-on public offering of approximately $50 million of its common stock.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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Gainers & Losers Of Mar.9: CBAY, IMMU, TGTX, NSPR, TNDM... - RTT News

Spinal Cord Stem Cells Comments Off on Gainers & Losers Of Mar.9: CBAY, IMMU, TGTX, NSPR, TNDM… – RTT News | March 10th, 2017

Stem cell therapy is a quickly advancing treatment being used across the country. Now, its becoming more prevalent in eastern North Carolina to those living with chronic pain an alternative to surgery. The minimally invasive procedure is showing results in alleviating back, knee, hip and shoulder pain. Though stem cell therapy is classified by the Food and Drug Administration as experimental, patients say theyre finding relief. Meet New Bern resident and a local endodontist Dr. Donnie Luper. He was skeptical of the procedure at first.

How did you know what those stem cells were going to differentiate into? I mean was I going to grow a foot out of my shoulder or something like that?

Luper tore his rotator cuff 25 years ago during a tubing incident on the Trent River. A subsequent fall during a golf trip in 2015 sent him to a specialist.

I went to see a shoulder surgeon in Richmond. He told me that he didnt think it was a complete tear of my rotator cuff, that I could probably have a minor surgical procedure done and I asked him about stem cell.

After talking with a friend who opted for stem cell treatment for her knee pain, Luper decided to find out more.

My option was if I would have had that shoulder surgery and they had do that bicep tendon repair, I mean I would have been in a sling for six weeks and probably not working for three months.

According to the Food and Drug Administration, stem cells sometimes called the bodys master cells - have the ability to divide and develop into many different cell types. Each new cell has the potential to remain a stem cell or become another type of cell, such as a nerve cell, a skin cell, or a red blood cell. They may also help repair the body by dividing to replenish cells that are damaged by disease, injury or normal wear. Parkinsons disease, spinal cord injuries, damaged organs and cancer could all be possibly treated with the use of stem cells, but more research is needed. Dr. Angelo Tellis is the owner/physician of Aegean Medical, which provides stem cell therapy to patients in Cary, Jacksonville, Morehead City and New Bern.

The adult stem cells we call multipotent stem cells so they can only differentiate into very specific or certain kinds of tissue. Whereas the embryonic stem cells we call pluripotent and can become a variety, almost any tissue. But I only deal with adult stem cells, theyre found to be more useful in clinical applications.

Dr. Tellis says adult stem cells are more responsive to growing tissue in very specific locations. When patients go into Dr. Tellis office for the two hour procedure, he starts by numbing an area of the abdomen and performing liposuction to collect one or two syringes of body fat.

Stem cells can be found in a lot of different tissues throughout the body, but theyre actually in one of the highest concentrations in your own body fat.

The stem cell sample is combined with platelet rich plasma or PRP collected through a blood draw.

That has a lot of the chemical signals and messengers that activate stem cells. So Ill typically combine that with some of the stem cells collected from the body fat and then go under x-ray guidance and put it exactly in the targeted location where we want to create that healing process.

Soreness and stiffness can be expected immediately following the procedure and for about a week after. Dr. Tellis says the results tend to improve with time, taking about three to six months for full recovery. This was Lupers experience in 2016.

Really didnt have to take any pain medications. The joint was really sore over the weekend just because of the injection of the fluid there and after that, I had a small amount of discomfort, but nothing I really had to take medication for.

After three months, Luper says he felt 90 percent better. But he decided to get a second opinion from a shoulder surgeon.

And he told me he thought the stem cells had done a lot but that I still had one little bone spur that was rubbing against the muscle and constantly tearing the little bit of the muscle.

After surgery, Luper says his left shoulder started feeling significantly better in about a month. He was also able to return to one of his favorite pastimes golf. While surgery helped eliminate all of his pain, Luper believes stem cells helped regenerate tissue that was damaged years ago.

He said my rotator cuff muscle didnt even look like it had been torn. I actually tore that, Im sixty now, and I actually tore that when I was 34, 35 tubing on the river and I had to do physical therapy for about three months, but he said he saw absolutely no evidence that Id ever had a rotator cuff tear.

Even though some have found relief and possibly a cure through stem cell therapy, the Food and Drug Administration has not approved any stem cell-based products for use, other than HEMACORD (HE-muh-cord). According to their website, the use of stem cells raises safety concerns such as excessive cell growth, the development of tumors as well as cells migrating from the site of administration and differentiating into inappropriate cell types. And then, theres the cost of the procedure, which is not covered by insurance. The price for the treatment ranges from $2,500 to $5,000. But for those who want to avoid major surgery and the downtime associated with recovery, the risk and cost may be worth it.

If Id have surgery, my deductible would have been that because I have an out-of-pocket max. And I would want to do anything to avoid surgery, especially something that would keep me out of work for three months.

The FDA recommends that consumers interested in stem cell therapy should start a conversation with their doctor about the potential risk to benefit ratio. In addition to Aegean Medical, Advanced Health and Physical Medicine in Greenville and Regenerative Medicine Clinic of Wilmington also provide stem cell therapy in eastern North Carolina.

More here:
Stem Cell Therapy An Option For ENC Patients | Public Radio East - Public Radio East

Spinal Cord Stem Cells Comments Off on Stem Cell Therapy An Option For ENC Patients | Public Radio East – Public Radio East | March 7th, 2017

A U.S. biotech company is preparing to start experiments using stem cells to try to stimulate 20 brain-dead patients back to life. And no, this isn't an elevator pitch for a sci-fi horror film.

The Mind Unleashed reports the company Bioquark will be trying to use stem cells to regrow and stimulate neurons to bring the patients back from brain death. It works like this: They implant stem cells in the patient's brain while also infusing the spinal cord with chemicals typically used to try and wake up coma patients. Then, hopefully, brain activity is essentially 'jump-started.' The technique is untested, so these experiments will go a long way toward proving (or disproving) the viability of the process.

Bioquark CEO Ira Pastor said they hope to see some results within 2-3 months after treatment begins, with the long-term goal being to develop techniques for brain-dead patients to eventually be able to make a full recovery. Which is certainly a heady, and ethically tricky, goal. You know, and also kind of scary. Ambitious and potentially live-saving, but still a little freaky.

What do you think of the technique? Is this going to revolutionize brain recovery or be the first step toward the T-virus?

(via The Mind Unleashed)

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Scientists moving ahead with research to resurrect the dead with stem cells - Blastr

Spinal Cord Stem Cells Comments Off on Scientists moving ahead with research to resurrect the dead with stem cells – Blastr | March 5th, 2017

Science Times

Suicide Switch for Transplanted Stem Cells The Scientist The team then differentiated the iPSCs into neural stem and progenitor cells, and transplanted them into mice with a spinal cord injury. The mice began to recover some motor function, but as neural tumors and teratomas grew from the transplanted cells ... Stem Cell Assay Market, 2016-2024: By Type, Applications ...QWTJ LIVE One Stop all 17 news articles »

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Suicide Switch for Transplanted Stem Cells - The Scientist

Spinal Cord Stem Cells Comments Off on Suicide Switch for Transplanted Stem Cells – The Scientist | March 2nd, 2017

Notes This is a 7-day-old embryo that scientists kept alive in a laboratory dish. If it developed further, the clusters in green would become cells that shape the body and the red/purple cells would form the placenta.

Ali Brivanlou slides open a glass door at the Rockefeller University in New York to show off his latest experiments probing the mysteries of the human embryo.

"As you can see, all my lab is glass just to make sure there is nothing that happens in some dark rooms that gives people some weird ideas," says Brivanlou, perhaps only half joking.

Brivanlou knows that some of his research makes some people uncomfortable. That's one reason he has agreed to give me a look at what's going on.

His lab and one other discovered how to keep human embryos alive in lab dishes longer than ever before at least 14 days. That has triggered an international debate about a long-standing convention (one that's legally binding in some countries, though not in the U.S.) that prohibits studying human embryos that have developed beyond the two-week stage.

Ali Brivanlou's research team at Rockefeller University in New York was one of two groups internationally that figured out how to keep human embryos alive in lab dishes beyond the 14-day stage of development. Rob Stein/NPR hide caption

And in other experiments, he's using human stem cells to create entities that resemble certain aspects of primitive embryos. Though Brivanlou doesn't think these "embryoids" would be capable of developing into fully formed embryos, their creation has stirred debate about whether embryoids should be subject to the 14-day rule.

Brivanlou says he welcomes these debates. But he hopes society can reach a consensus to permit his work to continue, so he can answer some of humanity's most fundamental questions.

"If I can provide a glimpse of, 'Where did we come from? What happened to us, for us to get here?' I think that, to me, is a strong enough rationale to continue pushing this," he says.

For decades, scientists thought the longest an embryo could survive outside the womb was only about a week. But Brivanlou's lab, and one in Britain, announced last year in the journals Nature and Nature Cell Biology that they had kept human embryos alive for two weeks for the first time.

That enabled the scientists to study living human embryos at a crucial point in their development, a time when they're usually hidden in a woman's womb.

"Women don't even know they are pregnant at that stage. So it has always been a big black box," Brivanlou says.

Gist Croft, a stem cell biologist in Brivanlou's lab, shows me some samples, starting with one that's 12 days old.

"So you can see this with the naked eye," Croft says, pointing to a dish. "In the middle of this well, if you look down, there's a little white speck it looks like a grain of sand or a piece of dust."

Under a microscope, the embryo looks like a fragile ball of overlapping bubbles shimmering in a silvery light with thin hairlike structures extending from all sides.

Croft and Brivanlou explain that those willowy structures are what embryos would normally extend at this stage to search for a place to implant inside the uterus. Scientists used to think embryos could do that only if they were receiving instructions from the mother's body.

"The amazing thing is that it's doing its thing without any information from mom," Brivanlou says. "It just has all the information already in it. That was mind-blowing to me."

The embryos they managed to keep alive in the lab dish beyond seven days of development have also started secreting hormones and organizing themselves to form the cells needed to create all the tissues and organs in the human body.

The two scientists think studying embryos at this and later stages could lead to discoveries that might point to new ways to stop miscarriages, treat infertility and prevent birth defects.

"The only way to understand what goes wrong is to understand what happens normally, or as normally as we can, so we can prevent all of this," Brivanlou says.

The 14-day cutoff

But Brivanlou isn't keeping these embryos alive longer than 14 days because of the rule.

A long-standing rule prohibits scientists from keeping human embryos alive more than two weeks, after which the central nervous system starts to develop. The 14-day rule was developed decades ago to avoid raising too many ethical questions about experimenting on human embryos. It's a law in some countries, and just a guideline in the U.S.

"The decision about pulling the plug was probably the toughest decision I've made in my scientific career," he says. "It was sad for me."

The 14-day rule was developed decades ago to avoid raising too many ethical questions about experimenting on human embryos.

Two weeks is usually the moment when the central nervous system starts to appear in the embryo in a structure known as the "primitive streak."

It's also roughly the stage at which an embryo can no longer split into twins. The idea behind the rule is, that's when an embryo becomes a unique individual.

But the rule was initiated when no one thought it would ever be possible to keep embryos growing in a lab beyond two weeks. Brivanlou thinks it's time to rethink the 14-day rule.

"This is the moment," he says.

Scientists, bioethicists and others are debating the issue in the U.S., Britain and other countries. The rule is law in Britain and other countries and incorporated into widely followed guidelines in the United States.

Insoo Hyun, a bioethicist at Case Western Reserve University, advocates revisiting the rule. It would allow more research to be done on embryos that are destined to be destroyed anyway, he says embryos donated by couples who have finished infertility treatment.

"Given that it has to be destroyed," Hyun says, "some would argue that it's best to get as much information as possible scientifically from it before you destroy it."

But others find it morally repugnant to use human embryos for research at any stage of their development and argue that lifting the 14-day rule would make matters worse.

"Pushing it beyond 14 days only aggravates what is the primary problem, which is using human life in its earliest stages solely for experimental purposes," says Dr. Daniel Sulmasy, a Georgetown University bioethicist.

The idea of extending the 14-day rule even makes some people who support embryo research queasy, especially without first finding another clear stopping point.

Hank Greely, a Stanford University bioethicist, worries that going beyond 14 days could "really draws into question whether we're using humans or things that are well along the path to humans purely as guinea pigs and purely as experimental animals."

Embryo alternative: "Embryoids"

So as that debate continues, Brivanlou and his colleagues are trying to develop another approach. The scientists are attempting to coax human embryonic stem cells to organize themselves into entities that resemble human embryos. They are also using induced pluripotent stem (iPS) cells, which are cells that behave like embryonic stem cells, but can be made from any cell in the body.

Embryoids like this one are created from stem cells and resemble very primitive human embryos. Scientists hope to use them to learn more about basic human biology and development. Courtesy of Rockefeller University hide caption

Embryoids like this one are created from stem cells and resemble very primitive human embryos. Scientists hope to use them to learn more about basic human biology and development.

Brivanlou's lab has already shown that these "embryo-like structures" or "embryoids" can create the three fundamental cell types in the human body.

But the scientists have only been able to go so far using flat lab dishes. So the researchers are now trying to grow these embryonic-like structures in three dimensions by placing stem cells in a gel.

"Essentially, we're trying to, in a way, to re-create a human embryo in a dish starting from stem cells," says Mijo Simunovic, another of Brivanlou's colleagues.

In early experiments, Simunovic says, he has been able to get stem cells to "spontaneously" form a ball with a "cavity in its center." That's significant because that's what early human embryos do in the uterus.

Simunovic says it's unclear how close these structures could become to human embryos entities that have the capability to develop into babies.

"At the moment, we don't know. That's something that's very hot for us right now to try to understand," Simunovic says.

Simunovic argues the scientists are not "ethically limited to studying these cells and studying these structures" by the 14-day rule.

There's a debate about that, however.

"At what point is your model of an embryo basically an embryo?" asks Hyun, especially when the model seems to have "almost like this inner, budding life."

"Are we creating life that, in the right circumstances, if you were to transfer this to the womb it would continue its journey?" he asks.

Dr. George Daley, the dean of the Harvard Medical School and a leading stem cell researcher, says scientists have been preparing for the day when stem-cell research might raise such questions.

"I think what prospects people are concerned about are the kinds of dystopian worlds that were written about by Aldous Huxley in Brave New World," Daley says. "Where human reproduction is done on a highly mechanized scale in a petri dish."

Daley stresses scientists are nowhere near that, and may never get there. But science moves quickly. So Daley says it's important scientists move carefully with close ethical scrutiny.

The latest guidelines issued by the International Society for Stem Cell Research call for intensive ethical review, Daley notes.

Brivanlou acknowledges that some of his experiments have produced early signs of the primitive streak. But that's a very long way from being able to develop a spinal cord, or flesh and bones, let alone a brain. He dismisses the notion that the research on embryoids would ever lead to scientists creating humans in a lab dish.

"They will not get up start walking around. I can assure you that," he says, noting that full human embryonic development is a highly complex process that requires just the right mix of the biology, physics, geometry and other factors.

Nevertheless, Brivanlou says all of his experiments go through many layers of review. And he's convinced the research should continue.

"It would be a travesty," he says, "to decide that, somehow, ignorance is bliss."

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Human 'Embryoids' And Other Embryo Research Raises Concern ... - NPR

Spinal Cord Stem Cells Comments Off on Human ‘Embryoids’ And Other Embryo Research Raises Concern … – NPR | March 2nd, 2017

SAN CARLOS, Calif., March 1, 2017 /PRNewswire/ --Natera (NTRA), a leader in genetic testing, today announced the upcoming launch of Evercord; a new offering being made commercially available in the second quarter of 2017 that enables expectant parents to collect, store and potentially retrieve their newborn's cord blood and tissue for therapeutic use in transplantation and regenerative medicine applications. Natera aspires to build a different type of national cord blood company, by combining best-in-class cord blood cryopreservation with the company's ability to provide timely information about genetic disease risk; potentially expanding families' stem cell treatment options in the future. Natera will offer Evercord through its leading direct sales channel in the United States.

The Market Potential of Cord Blood Stem Cells Newborn stem cells sourced from umbilical cord blood are known to contain hematopoietic stem cells (HSCs) that can potentially differentiate and regenerate healthy blood and immune systems. Unfortunately, out of the roughly four million births each year in the United States, more than 95% of the cord blood from those births is currently discarded as waste;1 highlighting a significant opportunity both for families who could benefit from cord blood, and for Natera, as it enters the cord blood and tissue banking market. Published data also suggests that one in three people in the United States, or 128million people, could potentially benefit from regenerative medicine applications which, if proven effective, expands the possible therapeutic use of cord blood stem cells.2 More than 300 studies are currently underway, including clinical trials focused on current and new cord blood stem cell therapies in regenerative medicine.3 These trials hold promise for a growing list of conditions, including Alzheimers disease, cerebral palsy, diabetes (Type I/II), spinal cord injury, cartilage and bone repair, and heart defects. More than 30,000 cord blood stem cell treatments have been conducted worldwide and Natera's prenatal tests, including its carrier test, Horizon, currently screen for 35 of the nearly 80 diseases where cord blood stem cell treatment has been administered. Considering the research advances in stem cells and regenerative medicine, it is anticipated that number will, more than likely, continue to grow.

Introducing EvercordThe launch of Evercord is part of a partnership with Bloodworks Northwest, one of the oldest and most reputable public umbilical cord blood banks in the country. Evercord's service will offer expectant families the opportunity to bank their baby's umbilical cord blood and tissue for potential medical use by the child or related family member. Under the terms of the agreement between Natera and Bloodworks, Bloodworks will perform processing and testing services on cord blood samples submitted by Evercord customers and will cryo-preserve the banked cord blood and tissue at its Seattle, Washington-based best-in-class cord blood cryopreservation storage facility. The companies also plan to build a new facility in anticipation of future growth.

The relationship offers several other competitive advantages. Evercord leverages Bloodworks' 20 years of experience processing and banking cord blood; the lab has a strong track record of successfully releasing nearly 1,000 cord blood samples for transplant, more than other leading private cord blood banks.

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Once Evercord is commercially launched, it will expand Natera's existing portfolio of women's reproductive health products, further diversifying Natera's revenue base and adding a traditionally high yield business into its product mix. Evercord will also be well positioned to immediately take advantage of Natera's well-established commercial capabilities, including: patient and healthcare provider digital services through Natera's Patient Portal and Natera Connect, and a specialized salesforce that already calls on the nation's busiest obstetrics and gynecology offices and fertility centers.

"At Natera, we believe adding cord blood and tissue banking to our product offerings is a natural extension of our commitment to family health and beyond," said Matt Rabinowitz, CEO and founder of Natera. "Evercord builds on our excellence as a genetic testing company and our mission to transform the diagnosis and management of genetic diseases. Cord blood stem cells have demonstrated regenerative capabilities that medicine is just beginning to learn how to harness; offering a unique opportunity to potentially generate complete genetic information on a human being at the moment of birth. Many of the genetic diseases that cord blood treats today are also conditions that our tests screen for, which could enable us to offer a far more extensive service offering in the future than those offered by leading 'storage-only' cord blood banks today."

About Bloodworks Northwest's Public Cord Blood ProgramBloodworks Northwest partners with hospitals across the region to recover and store umbilical cord blood from new mothers -- an important source of stem cells for use in cancer treatment, metabolic or immune system disorders, and research. Bloodworks Northwest created the first and only public umbilical cord blood bank in the Northwest of the United States and has program partnerships with 15 hospitals across Washington, Oregon and Hawaii providing nearly 50 units per month to the national cord bloodregistry.

About NateraNatera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation software system.

Product offerings include the Spectrum pre-implantation genetic test for embryo selection during IVF; the Anora miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon carrier test to detect inherited mutations; the Panorama non-invasive prenatal test (NIPT) to identify common chromosomal anomalies in a fetus as early as nine weeks of gestation; and Evercord, a cord blood and tissue banking service offered at birth to expectant parents.

Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test.

These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.

Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.

Forward-looking statementsThis release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release.

Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, whether cord blood or cord tissue will be found to be effective in treating additional conditions, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers.

Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's Form 10-Q for the quarter ended September 30, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company's website at http://www.natera.com under the Investor Relations section, and on the SEC's website at http://www.sec.gov.

Contacts:Natera, Inc. Mike Brophy, Chief Financial Officer, 650-249-9091 x1471 mbrophy@natera.com Laura Zobkiw, Corporate and Media Relations, 650-249-9091 x1649 Lzobkiw@natera.com

1https://parentsguidecordblood.org/en/cord-blood-infographic (February 2017). 2 Harris, D., & Rogers, I. (2007). Umbilical Cord Blood: A Unique Source of Pluripotent Stem Cells for Regenerative Medicine.Current Stem Cell Research & Therapy,2(4), 301-309. doi:10.2174/157488807782793790; http://www.mdpi.com/2227-9059/2/1/50/htm 3https://clinicaltrials.gov/ct2/results?term=Umbilical+AND+Stem+Cells (February 2017).

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/natera-inc-announces-launch-of-evercord-cord-blood-and-tissue-banking-service-300415652.html

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Natera, Inc. Announces Launch of Evercord Cord Blood and Tissue Banking Service - Yahoo Finance

Spinal Cord Stem Cells Comments Off on Natera, Inc. Announces Launch of Evercord Cord Blood and Tissue Banking Service – Yahoo Finance | March 1st, 2017

The mystery of what controls the range of developmental clocks in mammals -- from 22 months for an elephant to 12 days for a opossum -- may lie in the strict time-keeping of pluripotent stem cells for each unique species.

Developmental clocks are of high importance to regenerative medicine, since many cells types take long periods to grow to maturity, limiting their usefulness to human therapies. The regenerative biology team at the Morgridge Institute for Research, led by stem cell pioneer and UW-Madison professor James Thomson, is studying whether stem cell differentiation rates can be accelerated in the lab and made available to patients faster.

In a study published in February online editions of the journal Developmental Biology, Morgridge scientists tested the stringency of the developmental clock in human stem cells during neural differentiation. First, they closely compared the differentiation rates of the cells growing in dishes compared to the known growth rates of human cells in utero. Second, they grew the human stem cells within a mouse host, surrounded by factors -- such as blood, growth hormones and signaling molecules -- endemic to a species that grows much more rapidly than humans.

In both cases -- lab dish or different species -- the cells did not waver from their innate timetable for development, without regard to environmental changes.

"What we found remarkable was this very intrinsic process within cells," said lead author Chris Barry, a Morgridge assistant scientist. "They have self-coding clocks that do not require outside stimulus from the mother or the uterus or even neighboring cells to know their pace of development."

While the study suggests that cellular timing is a stubborn process, the Thomson lab is exploring a variety of follow-up studies on potential factors that could help cells alter their pace, Barry said.

One aspect of the study that's immediately valuable across biology is the realization that how stem cells behave in the dish aligns almost precisely with what happens in nature.

"The promising thing is that we can take species of stem cells, put them in tissue culture, and more confidently believe that events we're seeing are probably happening in the wild as well," Barry said. "That is potentially great news for studying embryology in general, understanding what's going on in the womb and disease modeling for when things can go wrong."

It also opens up potential avenues in embryology that would have been inconceivable otherwise -- for example, using stem cells to accurately study the embryology of whales and other species with much longer (or shorter) gestation rates than humans.

In order to accurately compare development timing across species with wildly different gestation rates -- nine months compared to three weeks -- the team used an algorithm called Dynamic Time Warping, originally developed for speech pattern recognition. This algorithm will stretch or compress the time frame of one species to match up with similar gene expression patterns in the other. Using this process, they identified more than 3,000 genes that regulate more rapidly in mice and found none that regulate faster in human cells.

The impact of solving the cell timing puzzle could be enormous, Barry said. For example, cells of the central nervous system take months to develop to a functional state, far too long to make them therapeutically practical. If scientists can shorten that timing to weeks, cells could potentially be grown from individual patients that could counteract grave diseases such as Parkinson's, Multiple Sclerosis, Alzheimer's, Huntington's disease and spinal cord injuries.

"If it turns out these clocks are universal across different cell types," said Barry, "you are looking at broad-spectrum impact across the body."

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Stem Cells Fiercely Abide by Innate Developmental Timing, Study Shows - Bioscience Technology

Spinal Cord Stem Cells Comments Off on Stem Cells Fiercely Abide by Innate Developmental Timing, Study Shows – Bioscience Technology | March 1st, 2017

The mystery of what controls the range of developmental clocks in mammals -- from 22 months for an elephant to 12 days for an opossum -- may lie in the strict time-keeping of pluripotent stem cells for each unique species.

Developmental clocks are of high importance to regenerative medicine, since many cell types take long periods to grow to maturity, limiting their usefulness to human therapies. The regenerative biology team at the Morgridge Institute for Research, led by stem cell pioneer and University of Wisconsin-Madison Professor James Thomson, is studying whether stem cell differentiation rates can be accelerated in the lab and made available to patients faster.

In a study published in February online editions of the journal Developmental Biology, Morgridge scientists tested the stringency of the developmental clock in human stem cells during neural differentiation. First, they closely compared the differentiation rates of the cells growing in dishes compared to the known growth rates of human cells in utero. Second, they grew the human stem cells within a mouse host, surrounded by factors -- such as blood, growth hormones and signaling molecules -- endemic to a species that grows much more rapidly than humans.

In both cases -- lab dish and different species -- the cells did not waver from their innate timetable for development, without regard to environmental changes.

"What we found remarkable was this very intrinsic process within cells," says lead author Chris Barry, a Morgridge assistant scientist. "They have self-coding clocks that do not require outside stimulus from the mother or the uterus or even neighboring cells to know their pace of development."

While the study suggests that cellular timing is a stubborn process, the Thomson lab is exploring a variety of follow-up studies on potential factors that could help cells alter their pace, Barry says.

One aspect of the study that's immediately valuable across biology is the realization that how stem cells behave in the dish aligns almost precisely with what happens in nature.

"The promising thing is that we can take species of stem cells, put them in tissue culture, and more confidently believe that events we're seeing are probably happening in the wild as well," Barry says. "That is potentially great news for studying embryology in general, understanding what's going on in the womb, and disease modeling for when things can go wrong."

It also opens up potential avenues in embryology that would have been inconceivable otherwise -- for example, using stem cells to accurately study the embryology of whales and other species with much longer (or shorter) gestation rates than humans.

In order to accurately compare development timing across species with wildly different gestation rates -- nine months compared to three weeks -- the team used an algorithm called dynamic time warping, originally developed for speech pattern recognition. This algorithm will stretch or compress the time frame of one species to match up with similar gene expression patterns in the other. Using this process, they identified more than 3,000 genes that regulate more rapidly in mice and found none that regulate faster in human cells.

The impact of solving the cell timing puzzle could be enormous, Barry says. For example, cells of the central nervous system take months to develop to a functional state, far too long to make them therapeutically practical. If scientists can shorten that timing to weeks, cells could potentially be grown from individual patients that could counteract grave diseases such as Parkinson's, multiple sclerosis, Alzheimer's disease, Huntington's disease and spinal cord injuries.

"If it turns out these clocks are universal across different cell types," says Barry, "you are looking at broad-spectrum impact across the body."

A video highlighting Barry's work can be seen at https://vimeo.com/183526442.

Story Source:

Materials provided by University of Wisconsin-Madison. Original written by Brian Mattmiller. Note: Content may be edited for style and length.

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Stem cells fiercely abide by innate developmental timing, study ... - Science Daily

Spinal Cord Stem Cells Comments Off on Stem cells fiercely abide by innate developmental timing, study … – Science Daily | March 1st, 2017

Former football player raising money for stem cell treatment ... Lexington Herald Leader A Danville native who hopes to be able to walk again is raising money for life-changing treatments. and more »

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Former football player raising money for stem cell treatment ... - Lexington Herald Leader

Spinal Cord Stem Cells Comments Off on Former football player raising money for stem cell treatment … – Lexington Herald Leader | February 27th, 2017

Medical tourism is alive and well in places all over the world. Thailand, Mexico and Colombia are just some of the destinations where people travel in order to get affordable health care. While finances are the main concern of medical tourists, another reason to make the trip is for services that arent provided in a travelers local city or country. Stem Cells are still a controversial topic in many countries and while research is being conducted, people who might benefit from the treatments may not be able to locate a qualified provider. Why travel so far just for stem cell treatment? Well.

They May Be Able To Cure Cancer

Cancer is one of the most prevalent diseases out there without a cure. With so many people falling ill to this disease, the need for a cure is more important than ever. Stem cell studies are being conducted and researchers have found that stem cell therapy can be used to add healthy cells into the system to suppress the disease while stimulating the growth of new and healthy marrow. Hodgkins Lymphoma, breast cancer and ovarian cancer may benefit the most from these treatments.

They Could Be Capable of Treating Blood Disease

According to NSI Stem Cell, stem cell therapy may be able to provide the body with regenerative and healthy blood cells to combat blood disease. With healthy blood cells in the system, diseases like Sickle Cell Anemia, Fanconi Anemia and Thalassemia could be effectively treated.

They Have The Ability To Treat Injuries and Wounds

By increasing blood vessels and improving blood supply, stem cells could treat both chronic and acute wounds, especially in older patients who dont heal as quickly. Specifically, stem cell therapy could help treat surface wounds, limb gangrene and the replacement of jawbone.

Research Is Being Done On a Huge Variety of Treatment Potential

Stem cells are constantly undergoing research to uncover their potential when it comes to medical treatments. Some of the treatments being explored include:

-Auto-immune Disease: These cells may be able to repair and regenerate damaged tissue for people suffering from Rheumatoid Arthritis, Buergers Disease, and Systemic Lupus.

-Neurodegeneration: They could help with diseases such as MS and Parkinsons.

-Brain & Spinal Cord Injuries: The cells could reduce inflammation and help to form healthy, new tissue.

-Heart Conditions: Stem cells are being utilized to create new blood vessels, reverse tissue loss and regenerate heart muscle tissue.

-Tooth & Hair Replacement: They can help grow thinning hair and replace missing teeth.

-Vision Loss: Retinal cells are being injected into the eyes to improve vision.

-Pancreatic Cells: Healthy Beta Cells in the pancreas are being produced by stem cells. These therapies would help diabetic patients and allow them to decrease their dependence on insulin.

-Orthopedics: Stem cells can be utilized to treat arthritis and ligament/tendon injuries.

-HIV/Aids: Researchers are looking into using stem cells to produce an immune system that is resistant to disease.

The Cost of Treatment Will Vary But Can Be Affordable

While it may seem that the cost of stem cell therapy would be extremely high, the truth is that it varies. It all depends on the treatment necessary but the range could be from $1,000 to $100,000. In the future, insurance companies may even cover costs for some treatments.

Stem Cells Come From Multiple Sources

Stem cells come from a whole variety of places including bone marrow, adipose tissue, blood and umbilical cords. In the case of extraction from adipose tissue, they can be harvested and then put back in a patient after only a couple of days. All of the procedures to acquire the stem cells can be done with willing participants and donors.

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Why People Are Traveling For Stem Cell Treatment | The Huffington ... - Huffington Post

Spinal Cord Stem Cells Comments Off on Why People Are Traveling For Stem Cell Treatment | The Huffington … – Huffington Post | February 25th, 2017

NEW DELHI: Private banking of umbilical cord blood is a big business running parallel to childbirth in big hospitals, but is it worth the cost? While companies offering the facility for a few thousand rupees claim it can be used to treat conditions ranging from cerebral palsy to diabetes, health experts and doctors disagree. They say stem cell transplantation for treatment is limited to hereditary or genetic conditions, specifically blood disorders.

In both cases, umbilical cord blood cannot be used to save the donor since it will have the same genetic abnormalities. Its usage for treating the donor's siblings, or other family members, is also rare, as the HLA (a protein) has to match and weight-to-cord-blood ratio with the recipient has to be just right.

The limitations notwithstanding, expecting mothers are flooded with offers to preserve the cord blood. Patients complain that most private hospitals and boutiques for childbirth allow marketing agents from stem cell banking facilities to freely solicit them. "I was inundated with calls from stem cell companies trying to convince me to go for umbilical cord preservation. On each visit to the hospital, representatives from these companies hound you," said Nutan Verma, who is expecting twins.

Geeta Sharma said she went through multiple presentations from executives of stem cell banking companies while waiting in hospital to deliver her baby. "They offered free genetic testing, lifelong storage and other benefits. I chose one of them offering to preserve umbilical cord for 21 years at Rs 50,000. The company representative told me that the contract can be renewed on expiry," she said.

Geeta Jotwani, deputy director general of Indian Council of Medical Research (ICMR), told TOI that private companies offering to preserve umbilical cord blood must be strictly regulated. "Soliciting of patients by selling fake hopes is wrong. There is no evidence of stem cell use from umbilical cord presently, except in blood disorders. Only those having family members with these disorders should store it," she said.

Jotwani said ICMR was working on guidelines for stem cell banking which would be made public soon. "Many private banks are storing cord tissue, dental pulp, menstrual blood and adipose tissue as well for which there is no scientific evidence of any use in treatment as yet," she added.

Dr S P Yadav, paediatric hematologist at Medanta Medicity, Gurgaon, said private stem cell banking companies claimed that umbilical cord blood could be used to treat spinal cord injury, cerebral palsy and even diabetes, though there is no such proven research. "Currently, only five medical conditions can be treated through cord blood stem cell transplant blood cancer, bone marrow failure, thalassaemia and sickle cell anaemia, immune system deficiency since birth and inborn errors of metabolism," he said. "The chances of cord blood being used in the family or by the donor are 0.01%. Still, if somebody wants to preserve it, they should be allowed to. The problem is when poor or middle class families are lured into doing so with false claims about preserved blood being a panacea for all diseases," said Yadav.

On average, private banking of stem cells derived from cord blood costs Rs 50,000 to Rs 70,000. Banks claim to freeze the cells in liquid nitrogen so that it can be used up to 20 years from the date of preservation.

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Umbilical cord blood: Cord blood: Big business, small benefits ... - Times of India

Spinal Cord Stem Cells Comments Off on Umbilical cord blood: Cord blood: Big business, small benefits … – Times of India | February 25th, 2017

GERMANTOWN, Md., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (CUR), a biopharmaceutical company focused on the development of central nervous system therapies based on its neural stem cell technology, today announced that U.S. Patent No. 9572807 was issued by the United States Patent and Trademark Office (USPTO) for NSI-189, the lead compound in Neuralstem's neurogenic small molecule program in development for the treatment of major depressive disorder. US 9,572,807 has claims to protocols for using NSI-189 and related compounds for treatment of major depressive disorder. Counterparts have been filed in Australia, Canada, Europe, Japan, Singapore and South Korea. These patents will expire in June 2035.

The new patent adds to the portfolio of over 20 U.S. and 120 foreign issued and pending patents that are owned or licensed to Neuralstem in the field of regenerative medicine. This includes U.S. Patent No. 9,540,611, issued on January 10, 2017 by the USPTO, covering the treatment of neurodegenerative diseases using NSI-566, the companys proprietary neural stem cell therapy candidate.

We are excited to be bringing forward therapeutic options that could make a tremendous difference in the lives of those who suffer from nervous system disorders and conditions, said Rich Daly, Chairman and CEO, Neuralstem. We will continue to aggressively establish a broad portfolio of intellectual property to protect our research and development efforts.

About Neuralstem

Neuralstems patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstems technology enables the generation of small molecule compounds by screening hippocampal stem cell lines with its proprietary systematic chemical screening process. The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brains capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstems stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China. In addition, NSI-566 is being evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS. Patients from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

Cautionary Statement Regarding Forward Looking Information

This news release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as expect, anticipate, intend, plan, believe, seek or will. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstems periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and Form 10-Q for the nine months ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

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Neuralstem Announces Issuance of US Patent Covering NSI-189 - Yahoo Finance

Spinal Cord Stem Cells Comments Off on Neuralstem Announces Issuance of US Patent Covering NSI-189 – Yahoo Finance | February 22nd, 2017

Severely hyperbranched vascular network surrounding the spinal cord (red dotted box) of zebrafish embryo blood vessels in white.

A team of researchers at Karlsruhe Institute of Technology (KIT) shake at the foundations of a dogma of cell biology. By detailed series of experiments, they proved that blood vessel growth is modulated by neurons and not, as assumed so far, through a control mechanism of the vessel cells among each other. The results are groundbreaking for research into and treatment of vascular diseases, tumors, and neurodegenerative diseases. The study will be published in the journal Nature Communications.

Our work is pure basic research, Professor Ferdinand le Noble of KITs Zoological Institute says, but provides a completely new perspective on how blood vessels grow, branch out, or are inhibited in their growth. For decades, researchers have been looking for ways to promote or impede the formation of new blood vessels. Whereas heart attack and stroke patients would profit from new arteries, cancer patients would benefit from tumor starving by putting a stop to ingrowing blood vessels.

The key figures in the newly discovered extremely finely balanced process are signaling molecules: the brake on growth soluble FMS-like tyrosine kinase-1, referred to as 1sFlt1, and the vascular endothelial growth factor, referred to as VEGF. Even though, so far, it has been largely unknown how VEGF is regulated by the body, inhibition of this growth factor has been applied for years already in the treatment of cancer patients and of certain eye diseases. The therapy, however, is successful only in part of the patients and has several undesired side effects.

So far, research assumed the blood vessels to more or less regulate their own growth, explains le Noble. In case of oxygen deficiency, he points out, tissue, among others, releases the growth factor VEGF, thus attracting the blood vessels carrying VEGF receptors on their surfaces. We wanted to know how this blood vessel growth is regulated at the time of a creatures birth. The team around le Noble hence studied the continuous growth of nerve tracts and circulatory vessels in zebrafish model organisms. The eggs of zebrafish are transparent and develop outside of the mothers body, allowing researchers to watch and observe the development of organs or even individual cells without injuring the growing animal.

By means of fluorescent dyes, postgraduate Raphael Wild in a first step documented colonization of neuronal stem cells and subsequent vascular budding in the vertebral canal of zebrafish. To understand the exact process, the team started a detailed biochemical and genetic analysis.

The researchers proved that at different development stages, the nerve cells of the spinal cord produce more or less sFlt1 and VEGF and, in this way, modulate the development of blood vessels. At the early development stage, neuronal sFlt1 brakes blood vessel growth by binding and inactivating the growth factor VEGF. In the spinal cord, this creates an environment poor in oxygen, which is essential to the early development of the neuronal stem cells. With increasing nerve cell differentiation, concentration of the soluble sFlt1 decreases continuously, and the brake on vascular growth is loosened because more active VEGF is now available. Subsequently, blood vessels grow into the young spinal cord to provide it with oxygen and nutrients.

In addition, Raphael Wild and his colleague Alina Klems show that the concentration of the growth factor is crucial as regards the density of the developing blood vessel network. Whereas, when the brake sFlt1 in nerve cells was switched off completely, a dense network of blood vessels formed which even grew into the vertebral canal, the growth of blood vessels was suppressed when sFIt1 was increased. Even small variations in substance concentration thus led to severe vascular developmental disorders.

Since vascular cells also have own forms of sFlt1 and VEGF, the question arose as to whether blood vessel growth may, to a certain degree, regulate itself. To find out, the researchers applied the still young and extremely elegant CRISPR/Cas method: Whereas there was no effect when sFlt1 was switched off only in vascular cells, an intensive growth of blood vessels was observed when the production of sFlt1 was switched off in the nerve cells only.

From the results we conclude that by a fine modulation of sFlt1 and VEGF, nerve cells very dynamically regulate the density of their blood vessel network according to requirements or according to the respective development stage, le Noble points out. The previous assumption that growing blood vessel cells control the succeeding vascular cells is a cell biology dogma whose foundations are being shaken.

Please note: The content above may have been edited to ensure it is in keeping with Technology Networks style and length guidelines.

References:Wild, R., Klems, A., Takamiya, M., Hayashi, Y., Strhle, U., Ando, K., Mochizuki, N., van Impel, A., Schulte-Merker, S., Krueger, J., Preau, L. and le Noble, F. (2017) Neuronal sFlt1 and Vegfaa determine venous sprouting and spinal cord vascularization, Nature Communications, 8, p. 13991. doi: 10.1038/ncomms13991.

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Neurons Signal Spinal Cord Vascularisation - Technology Networks (press release) (registration) (blog)

Spinal Cord Stem Cells Comments Off on Neurons Signal Spinal Cord Vascularisation – Technology Networks (press release) (registration) (blog) | February 21st, 2017

The Register's editorial 5:32 p.m. CT Feb. 20, 2017

A tray of vials containing cerebral spinal fluid in Baltimore used to analyze both adult and fetal tissue in cancer research.(Photo: AP)

Among the threats to scientific advances are politicians who do not understand science. Unfortunately, too many of these politicians land jobs in the Iowa Legislature. They send a message this state is the last place a medical researcher should locate.

In 2002, lawmakers with an unfounded fear of scientists cloning babies passed a bill banning the creation of stem cells through a process called somatic cell nuclear transfer. Researchers useembryos, left over from in vitro fertilization, that would otherwise be discarded. After the vote banning the process, lawmakers were crying, hugging and carrying on about how life begins at conception.

Their emotion was pathetically misguided, as there was nothing pro-life about the measure. In fact, the law jeopardized life-saving research. It also prompted a cell biologist at the University of Iowa to pack up, move to Illinois and take her team and millions of federal dollars for cancer research with her.

Now here we go again. Lawmakers who apparently lack anunderstanding of laboratory research and the history of medical advancementsare pushing Senate File 52 in yet another effort to meddle in the work of real scientists. The bill, recently approved by a GOP-led Senate subcommittee,would ban acquiring, providing, receiving, otherwise transferring or using fetal tissue in this state. Fetal tissue, extracted during legal, voluntary abortions, can be discarded or used in medical research.

Lawmakers apparently would rather it be discarded. Committee chair Sen. Jake Chapman, R-Adel, said he didn't want to hinder research, but we also need to understand there is a moral responsibility, as well, to ensure that baby body parts arent being sold.

The same way no one was cloning babies in Iowa more than a decade ago, no one is selling "baby parts" today.

But inflammatory rhetoric is what people resortto when they don't want to acknowledge facts. Federal law already prohibits profiting from selling fetal tissue. Planned Parenthood of the Heartland says its Iowa affiliate does not even donate it. If the bill becomes law, anyone using fetal tissue namely researchers could land in the slammer for up to 10 years.

The Iowa Board of Regents registered opposition to the legislation, along with lobbyists representing the medical industry, churches and others. The board, which oversees state universities, requested an exemption that would allow research on certain fetal cells and proposed language to enable medical donations and permit the diagnosis of diseases.

Lawmakers did not immediately amend the bill, even thoughUI has been one of dozens of institutions across the country that has used fetal tissue in medical research. In recent years, the National Eye Institute provided the school more than $1 million for glaucoma research that used the tissue, according to data compiled by the Associated Press in 2015.

Fetal tissue has been successfully used for decades in medical research. It was critical in creating a vaccine for polio, a disease that crippled, paralyzed and sometimes killed its victims. Scientistsinfected fetal kidney cellsto produce mass quantities of the virus that were collected, purified and used for inoculations. They won a Nobel Prize for Medicine in 1954.

Research using human fetal cells shows promise in treatments for spinal cord injuries, eye disease, strokes and Parkinson's disease. But some Iowa lawmakers appear uninterested in saving and improvinglives.They are, however, interested in catering to theanti-abortion crowd with a bill that would not prevent a single abortion.

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Editorial: Fetal tissue bill is anti-life, anti-science - DesMoinesRegister.com

Spinal Cord Stem Cells Comments Off on Editorial: Fetal tissue bill is anti-life, anti-science – DesMoinesRegister.com | February 20th, 2017

Asterias Biotherapeutics (AST) continues to generate excitement and buzz around its stem cell treatment for catastrophic spinal cord injury (SCI). I wrote about this historic event back in September. Thats when the company first released results about this transformative medical breakthrough.

Asterias has now released follow-up data. This was gathered at six and nine months after six quadriplegics received treatment. All six continue to show improvement in motor function and sensation. This is truly wonderful news for those with SCI.

There are also broader medical implications and these should be of great interest to investors.

The difference between this stem cell therapy and traditional drug therapies is huge. Drug therapies have specific and mechanistic impacts. But stem cells derived from embryonic cells work a different way. They draw on the massive DNA databanks in their nuclei. They then use these genetic programs to interact with their surroundings and repair damaged structures.

The Asterias oligodendrocyte progenitor cells were derived from a single unused embryo (from an IVF procedure in the late 1990s). Such embryos are often discarded. But this one was donated to create an unlimited number of therapeutic cells. Both the Bush and Obama Administrations approved the cell line.

When injected into the site of a spinal cord injury, these cells create healthy new spinal cord structures. They restore myelin sheaths (which are like an insulating material on nerves) and repair the lesions caused by injury. They send chemical signals that stimulate the growth of nerve cells. They also generate blood vessels that deliver oxygen and nutrients (and clear out toxic substances).

In works of science fiction, you may have read about nanobots. These are theoretical nanomachines that can fix profound biological damage. But the truth is that we all have this type of device in our bodies at the embryonic stage of development. Each uses the complex repair systems that can be found in the human genome.

These are the cells (AST-OPC1) that were given to patients in the SCI trial. The result is that patients who could not breathe on their own can now perform complex physical tasks. We have seen them lift weights, text, and type 35 words a minute and they continue to improve.

Most people assume this therapy must be the most modern of biotechnologies. In truth, its quite old in modern scientific terms. Dr. Michael West oversaw the creation of this therapy over two decades ago as Gerons chief science officer.

When that company stumbled, he brought the clinical trial and Gerons IP into BioTime (*see disclosure below) as Asterias Biotherapeutics. When I spoke to Asterias CEO Steve Cartt, his excitement was palpable. Heres why.

Each year, about 17,000 people experience the kind of spinal cord injuries targeted by the current trial. AST-OPC1 would be the only approved treatment for this condition.

Cartt is now considering plans to extend clinical trials to those who have suffered less serious spinal cord injuries. This means the patient population for AST-OPC1 cells would expand a great deal.

These cells might also be used to treat other neurological diseases. Multiple sclerosis, for example, also involves the deterioration of the myelin nerve sheath. But this is just the tip of iceberg for pluripotent stem cell therapies. Many of our worst diseases can be addressed by these biological nanobots.

If spinal cords can be repaired, so can the connective tissue deterioration that leads to arthritis and joint failures. Im convinced we will see simple injections of stem cells to repair hip, knee, and other joints in the future.

BioTime has also done extensive research into stem cell therapies for heart muscle and cardiovascular repair. In fact, Dr. West has converted some of my cells to embryonic status. He then engineered them to become my heart muscle cells. There have been animal studies as well. The results indicate that these types of cells will repair the damage done by heart attacks.

Next up, though, is blindness. A BioTime subsidiary in Israel, Cell Cure Neurosciences, is in a phase 1/2a trial to treat dry age-related macular degeneration (dry-AMD). Israeli government grants have helped fund this project.

Based on animal trials, it seems that the companys retinal pigment epithelial cells will be successful in treating the leading cause of adult blindness. Dry-AMD is an attractive target because there is no effective treatment. From what Ive learned, I think that these cells will treat the wet form of macular degeneration and other causes of blindness as well.

This is the real importance of the Asterias SCI trial. Right now, were seeing the proof of concept for a biotechnology that will disrupt the entire healthcare market. I've written about this extensively in Tech Digest (subscribe here for free).

This change will happen sooner than you think. Japan has already revised its Pharmaceutical Affairs Act to speed up the approval of stem cell therapies. And on the home front, several of President Trump's candidates for FDA chief have endorsed similar reforms.

(*Disclosure: The editors or principals of Mauldin Economics have a position in BioTime (BTX) which has significant ownership of Asterias stock. They have no plans to sell their position at this time. There is an ethics policy in place that specifies subscribers must receive advance notice should the editors or principals intend to sell.)

This weekly newsletter by biotech expert Patrick Cox highlights research that is much more advanced than most people know, and the profit potential for investors is vast. Read about the latest breakthroughsfrom new, non-invasive cancer treatments to age-reversing nutraceuticals and vaccines that kill any virusas well as the innovative companies that work on them. Get Tech Digest free in your inbox every Monday.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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A Breakthrough in Stem Cell Treatment? - Equities.com

Spinal Cord Stem Cells Comments Off on A Breakthrough in Stem Cell Treatment? – Equities.com | February 18th, 2017

Stem cell therapy treatment gives new lease of life to 5-year-old Jamshedpur February 17, 2017 , by Desk 1

Ranchi : Till very recently, it was believed that brain damage is irreversible. However, now with emerging research; we understand that it is possible to repair the damaged brain tissue using cell therapy.

Again, today there are still many people in India who have not preserved their stem cells through cord blood banks. For all those patients, who have lost their hopes in finding a new treatment for neurological related disorders, adult stem cell therapy offers a new hope for such kind of patients.

Dr Alok Sharma, Director, NeuroGen Brain and Spine Institute, Professor and Head of Neurosurgery, LTMG Hospital & LTM Medical College, Sion said Stem cell therapy is emerging as one of the newer treatment options for conditions like Autism, Cerebral Palsy, Mental retardation, Muscular Dytrophy, Spinal Cord Injury, Paralysis, Brain Stroke, Cerebellar Ataxia and Other Neurological Disorders. This treatment has the potential to repair the damaged neural tissue at molecular, structural and functional level.

Dr. NandiniGokulchandran, Deputy Director, Neurogen Brain and Spine Institute saidStem Cell Therapy (SCT) done at NeuroGen Brain and Spine Institute is a very simple and safe procedure. Stem Cells are taken from patients own bone marrow with the help of one needle and are injected back in their Spinal Fluid after processing.

Since they are taken from the patients own body there is no rejection, no side effects, hence making SCT a completely safe procedure.

Today, we are presenting a case study of Ranchi based 5 yrs old Master Dhairya Singh. He is a known case of brain damage due to lack of oxygen but not during birth. Dhairya was born in a normal manner, cried immediately after birth also his birth weight was appropriate.

There were no immediate post-natal complications reported. Dhariya was a normal child till the age of one and half years old. Then one day he suffered from an episode of pneumonia for which he was hospitalized for 6 days.

Last updated:Friday, February 17, 2017

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Stem cell therapy treatment gives new lease of life to 5-year-old - Avenue Mail

Spinal Cord Stem Cells Comments Off on Stem cell therapy treatment gives new lease of life to 5-year-old – Avenue Mail | February 16th, 2017

Belleville News-Democrat

A baby's first act, saving a life Belleville News-Democrat Currently, stem cells are being researched to try to find cures or ways to treat autism, spinal cord injury, stroke recovery and Alzheimer's disease. Doll-Pollard said that it is incredibly important for the family to weigh these options before a ...

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A baby's first act, saving a life - Belleville News-Democrat

Spinal Cord Stem Cells Comments Off on A baby’s first act, saving a life – Belleville News-Democrat | February 15th, 2017