human stem cells

Clinical Trial Offers Hope to Restore Limb Function in Man with Complete Cervical Spinal Cord Injury

Physicians at Rush University Medical Center became the first in Illinois to inject AST-OPC1 (oligodendrocyte progenitor cells), an experimental treatment, into the damaged cervical spine of a recently paralyzed man as part of a multicenter clinical trial.

Dr. Richard G. Fessler, professor of neurological surgery at Rush University Medical Center, is principal investigator for the Phase 1/2a, multicenter clinical trial involving AST-OPC1 at Rush, one of six centers in the country currently studying this new approach.

Fessler injected an experimental dose of 10 million AST-OPC1 cells directly into the paralyzed man’s cervical spinal cord in mid-August. These injected cells were derived from human embryonic stem cells. They work by supporting the proper functioning of nerve cells, potentially helping to restore the conductivity of signals from the brain to the upper extremities (hands, arms, fingers) in a recently damaged spinal cord.

Interim research results from the trial were announced at the 55th Annual Scientific Meeting of the International Spinal Cord Society (ISCoS), which was held in Vienna, Austria, on September 14-16, 2016.

“Until now, there have been no new treatment options for the 17,000 new spinal cord injuries that happen each year,” says Fessler. “We may be on the verge of making a major breakthrough after decades of attempts.”

The next phase of the clinical research trial will involve a dose of 20 million oligodendrocyte progenitor cells, which is the highest dose being studied in this study involving patients who have recently suffered a complete cervical spinal cord injury.

“These injuries can be devastating, causing both emotional and physical distress, but there is now hope. In the 20 years of my research, we have now reached a new era where we hope to demonstrate through research that a dose of very specially made human cells delivered directly to the injured site can have an impact on motor or sensory function,” says Fessler. “Generating even modest improvements in motor or sensory function can possibly result in significant improvements in quality of life.”

Early research results from the trial were announced at the 55th Annual Scientific Meeting of the International Spinal Cord Society (ISCoS), which is being held in Vienna, Austria, on September 14-16, 2016.

“Our preliminary results show that we may in fact be getting some regeneration. Some of those who have lost use of their hands are starting to get function back. That’s the first time in history that’s ever been done,” says Fessler. “Just as a journey of a thousand miles is done one step at a time, repairing spinal cord injuries is being done one step at a time. And, now, we can say that we’ve taken that first step.”

The clinical trial is designed to assess safety and effectiveness of escalating doses of the special cells (AST-OPC1) in individuals with a complete cervical spinal cord injury. Thus far, three individuals have been enrolled in the study at Rush.
The trial has involved the testing of three escalating doses of AST-OPC1 in patients with subacute, C5-C7, neurologically-complete cervical spinal cord injury. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 is administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product.

“In the future, this treatment may potentially be used for peripheral nerve injury or other conditions which affect the spinal cord, such as MS,” says Fessler.

For this therapy to work, the cord has to be in continuity and not severed, according to Fessler. The study seeks male and female patients ages 18 to 65 who recently experienced a complete cervical spinal cord injury at the neck that resulted in tetraplegia, the partial or total paralysis of arms, legs and torso. Patients must be able to start screening within 25 days of their injury, and participate in an elective surgical procedure to inject AST-OPC1 14 to 30 days following injury. Participants also must be able to provide consent and commit to a long-term follow-up study.

The study is funded by Asterias Biotherapeutics, which developed the AST-OPC1 (oligodendrocyte progenitor cells) treatment used in the study, and also in part by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM).

AST-OPC1 cells are made from embryonic stem cells by carefully converting them into oligodendrocyte progenitor cells (OPCs), which are cells found in the brain and spinal cord that support the healthy functioning of nerve cells. In previous laboratory studies, AST-OPC1 was shown to produce neurotrophic factors, stimulate vascularization and induce remyelination of denuded axons. All are critical factors in the survival, regrowth and conduction of nerve impulses through axons at the injury site, according to Edward D. Wirth III, MD, PhD, chief medical director of Asterias and lead investigator of the study, dubbed “SCiStar.”

The federal government announced plans Thursday to lift a moratorium on funding of certain controversial experiments that use human stem cells to create animal embryos that are partly human.

The National Institutes of Health is proposing a new policy to permit scientists to get federal money to make embryos, known as chimeras, under certain carefully monitored conditions.

The NIH imposed a moratorium on funding these experiments in September because they could raise ethical concerns.

One issue is that scientists might inadvertently create animals that have partly human brains, endowing them with some semblance of human consciousness or human thinking abilities. Another is that they could develop into animals with human sperm and eggs and breed, producing human embryos or fetuses inside animals or hybrid creatures.

But scientists have argued that they could take steps to prevent those outcomes and that the embryos provide invaluable tools for medical research.

NIH Plans To Lift Ban On Research Funds For Part-Human, Part-Animal Embryos

Photo: Pablo Ross of the University of California, Davis, inserts human stem cells into a pig embryo as part of experiments to create chimeric embryos. Rob Stein/NPR

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Amy Karle: Bringing Bones to Life from Pier 9 on Vimeo.

Regenerative Reliquary

2016-Present

Leveraging the intelligence of human stem cells, bioartist Amy Karle created this 3D bioprinted scaffold made of a biodegradable hydrogel that disintegrates over time, with the intention that stem cells seeded onto that design will eventually grow into tissue and mineralize into bone along that shape. Karle’s work opens a new form of artwork, as well as expanding opportunities for enhancing our bodies, biomedical applications, and making things that were never possible to create before.

I hope none of you every need an organ transplant or a graft. 

I hope none of you need stem cell therapy

I hope none of you have to fight a disease that requires extensive testing on human tissue.

Because due to the inability of social conservatives to LEAVE PEOPLE ALONE and do what they wish with the contents of their own bodies, your options are going to become fewer and fewer.

Stem Cells Become Beating Heart

Beating cardiac tissue has been coaxed from stem cells in research that could help doctors better understand early human heart development.

Researchers at the University of California, Berkeley and the Gladstone Institutes say they used chemical and physical cues to start the transformation of human stem cells, which can morph into any other type of cell. Once initiated, the differentiating cells started organizing themselves into a more complex arrangement, including tiny chambers like in developing embryonic hearts. Learn more below.

Keep reading

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At 20, Divya Nag dropped out of college and is now revolutionizing the medical industry

In 2001, George W. Bush banned almost all human embryonic stem cell research. scientists were immediately forced to explore other avenues. But with their potential to take on the form of any cell in the body, stem cells had been (and still are) an enormously promising research avenue. So in 2011, Divya Nag started her own company focused on stem cells derived from skin cells. But she wasn’t done there.

A teenager has invented a better and cheaper way to grown hundreds of mini brains

A 16-year-old just built a bioreactor for mini-brains (lab-grown organs made from human stem cells.) Christopher Hadiono and his team of fellow high school students developed the replicator using 3-D printing, which makes it a more affordable option than other devices in the market. The mini brains are crucial in fighting a headline-making, rapidly spreading global disease.

Follow @the-future-now

Scientists grow miniature human stomachs from stem cells

Scientists have grown miniature human stomachs from stem cells as a way of studying gastric diseases such as ulcers and stomach cancer and in the future creating tissue to repair patients’ stomachs.

The mini-stomachs are grown in petri dishes from stem cells. Fully formed, they are the size of a pea and shaped like a rugby ball. They are hollow with an interior lining that is folded into glands and pits like a real stomach.

(source)

Drugs stimulate body’s own stem cells to replace the brain cells lost in multiple sclerosis

A pair of topical medicines already alleviating skin conditions each may prove to have another, even more compelling use: instructing stem cells in the brain to reverse damage caused by multiple sclerosis.

Led by researchers at Case Western Reserve, a multi-institutional team used a new discovery approach to identify drugs that could activate mouse and human brain stem cells in the laboratory. The two most potent drugs – one that currently treats athlete’s foot, and the other, eczema – were capable of stimulating the regeneration of damaged brain cells and reversing paralysis when administered systemically to animal models of multiple sclerosis. The results are published online Monday, April 20, in the scientific journal Nature.

“We know that there are stem cells throughout the adult nervous system that are capable of repairing the damage caused by multiple sclerosis, but until now, we had no way to direct them to act,” said Paul Tesar, PhD, the Dr. Donald and Ruth Weber Goodman Professor of Innovative Therapeutics, and associate professor in the Department of Genetics & Genome Sciences at the Case Western Reserve School of Medicine. “Our approach was to find drugs that could catalyze the body’s own stem cells to replace the cells lost in multiple sclerosis.”

The findings mark the most promising developments to date in efforts to help the millions of people around the world who suffer from multiple sclerosis. The disease is the most common chronic neurological disorder among young adults, and results from aberrant immune cells destroying the protective coating, called myelin, around nerve cells in the brain and spinal cord.

Without myelin, neural signals cannot be transmitted properly along nerves; over time, a patient’s ability to walk, hold a cup or even see is inexorably eroded. Current multiple sclerosis therapies aim to slow further myelin destruction by the immune system, but the Case Western Reserve team used a new approach to create new myelin within the nervous system. Their work offers great promise of developing therapies that reverse disabilities caused by multiple sclerosis or similar neurological disorders.

“To replace damaged cells, much of the stem cell field has focused on direct transplantation of stem cell-derived tissues for regenerative medicine, and that approach is likely to provide enormous benefit down the road,” said Tesar, also a New York Stem Cell Foundation Robertson Investigator and member of the National Center for Regenerative Medicine. “But here we asked if we could find a faster and less invasive approach by using drugs to activate native stem cells already in the adult nervous system and direct them to form new myelin. Our ultimate goal was to enhance the body’s ability to repair itself.”

Tesar emphasized that much work remains before multiple sclerosis patients might benefit from the promising approach. Scientists still must find ways to transform the topical medications for internal use and determine their long-term efficacy and potential side effects. That said, using existing, federally approved drugs enhances the likelihood that the compounds can be made safe for human use.

Tesar and his colleagues could zero in on the two catalyzing medications only because of a breakthrough that his laboratory achieved in 2011. Specifically, the researchers developed a unique process to create massive quantities of a special type of stem cell called an oligodendrocyte progenitor cell (OPC). These OPCs are normally found throughout the adult brain and spinal cord, and therefore inaccessible to study. But once Tesar and his team could produce billions of the OPCs with relative ease, they could begin to test different existing drug formulations to determine which, if any, induced the OPCs to form new myelinating cells.

Using a state-of-the-art imaging microscope, the investigators quantified the effects of 727 previously known drugs, all of which have a history of use in patients, on OPCs in the laboratory. The most promising medications fell into two specific chemical classes. From there, the researchers found that miconazole and clobetasol performed best within the respective classes. Miconazole is found in an array of over-the-counter antifungal lotions and powders, including those to treat athlete’s foot. Clobetasol, meanwhile, is typically available by prescription to treat scalp and other skin conditions such as dermatitis. Neither had been previously considered as a therapeutic for multiple sclerosis, but testing revealed each had an ability to stimulate OPCs to form new myelinating cells. When administered systemically to lab mice afflicted with a multiple sclerosis-like disease, both drugs prompted native OPCs to regenerate new myelin.

“It was a striking reversal of disease severity in the mice,” said Robert Miller, PhD, a member of the neurosciences faculty at Case Western Reserve who, with Tesar, is a co-senior author of the Nature paper. The two collaborated on this project while Miller also served as Vice President for Research at Case Western Reserve; since June his primary appointments are at the George Washington University School of Medicine and Health Sciences, where he is Senior Associate Dean for Research and Vivian Gill Distinguished Research Chair. “The drugs that we identified are able to enhance the regenerative capacity of stem cells in the adult nervous system. This truly represents a paradigm shift in how we think about restoring function to multiple sclerosis patients.”

While the drugs proved to have extraordinary effects on mice, their impact on human patients will not be known fully until actual clinical trials. Nevertheless, Tesar and his team already have added reason for optimism; in addition to the tests with animal cells, they also tested the drugs on human stem cells – and saw the medication prompt a similar response as seen in the mouse cells. Both medications worked well, with miconazole demonstrating the more potent effects.

“We have pioneered technologies that enable us to generate both mouse and human OPCs in our laboratory,” said Fadi Najm, MBA, the first author of the study and Research Scientist in the Department of Genetics & Genome Sciences at the Case Western Reserve School of Medicine. “This uniquely positioned us to test if these drugs could also stimulate human OPCs to generate new myelinating cells.”

Tesar, who recently received the 2015 International Society for Stem Cell Research Outstanding Young Investigator Award, said investigators next will work to deepen their understanding of the mechanism by which these drugs act. Once these details are clear, researchers will modify the drugs to increase their effectiveness in people.

The team is enthusiastic that optimized versions of these two drugs can be advanced to clinical testing for multiple sclerosis in the future, but Tesar emphasized the danger of trying to use current versions for systemic human administration.

“We appreciate that some patients or their families feel they cannot wait for the development of specific approved medications,” Tesar said, “but off-label use of the current forms of these drugs is more likely to increase other health concerns than alleviate multiple sclerosis symptoms. We are working tirelessly to ready a safe and effective drug for clinical use.”

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Embryology policy: Revisit the 14-day rule

This week, two groups report that they have sustained human embryos in vitro for 12–13 days1, 2, 3. Embryos normally implant in the wall of the uterus at around day seven. Until now, no one had reported culturing human embryos in vitro beyond nine days4, and rarely have they been sustained for more than seven.

This latest advance comes only 21 months after the researchers at the Rockefeller University in New York City (some of whom are involved in the latest embryo-culturing work) announced that, under certain conditions, individual human embryonic stem cells can self-organize into structures akin to the developmental stages of embryos soon after implantation5, 6 (see ‘Two advances in human developmental biology’). The cells were obtained from pre-existing stem-cell lines (derived from 4–5-day-old embryos donated through fertility clinics).

In principle, these two lines of research could lead to scientists being able to study all aspects of early human development with unprecedented precision. Yet these advances also put human developmental biology on a collision course with the ’14-day rule’ — a legal and regulatory line in the sand that has for decades limited in vitro human-embryo research to the period before the ’primitive streak’ appears. This is a faint band of cells marking the beginning of an embryo’s head-to-tail axis.

The 14-day rule has been effective for permitting embryo research within strict constraints — partly because it has been technologically challenging for scientists to break it. Now that the culturing of human embryos beyond 14 days seems feasible, more clarity as to how the rule applies to different types of embryo research in different jurisdictions is crucial. Moreover, in light of the evolving science and its potential benefits, it is important that regulators and concerned citizens reflect on the nature of the restriction and re-evaluate its pros and cons.

A human embryo 12 days after fertilisation in vitro, with different cell types marked by separate colours. Photograph: Gist Croft, Alessia Deglincerti,/AP

Human embryonic stem cells form self-organized spatial patterns.

Talk about the fascinating implications of ghouls being able to restore issue that is non-regenerative in humans with me.

  • Do the mutative properties of RC cells make them act like human stem cells since in most medical trials stem cells are the only thing shown o be able to restore non-regenerative tissue?
  • May in ROS patients they go haywire and create random constructions sort of like cancerous tumors (or more like Teratoma)?
  • Do RC cells adapt to the consumers DNA to be able to replicate need cells/kagune as soon as they enter a ghoul’s body?
  • DNA is probably why the CCG can track ghoul’s through RC secretions then?