South Africa: Local Scientists in Stem Cell Breakthrough

22 MARCH 2012

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A group of scientists from South Africa's Council for Scientific and Industrial Research (CSIR) have established a groundbreaking biomedical stem cell technology - a first for Africa - which could hold the key to finding cures for some of the contintent's biggest diseases.

The CSIR announced on Tuesday that its gene expression and biophysics group had generated the first induced pluripotent stem cells (iPSCs) in Africa.

"The ability to grow these stem cells, a complex skill currently available at only a handful of institutions in the US, Europe and Japan, has revolutionised the way that researchers are able to investigate and understand diseases," the CSIR said in a statement.

"It also holds enormous promise in what is known as 'regenerative medicine' - growing new tissue to replace diseased tissue in sick individuals.

"With the advances made at the CSIR, Africa is now set to benefit from this new and powerful technology."

Inducing adult cells to revert to stem cells

According to the council, Dr Janine Scholefield, one of the CSIR researchers involved in generating iPSCs, had recorded video footage of rhythmically beating cells through a microscope.

"The beating pattern is distinctive, and easily recognisable as heart muscle cells," the CSIR said. "These cells, however, didn't come from a heart, but were, instead, transformed into heart cells, from skin cells taken from an adult.

"This is the basis of iPSC technology, which induces adult cells (like skin cells) to revert back into stem cells, which are cells at the earliest stage of life. These early stem cells can then be programmed to become any type of adult cell, such as skin, heart, brain and blood cells."

Vast medical possibilities

The medical possibilities of iPSCs are vast, and include growing new tissue for transplanted into people suffering from various diseases.

"It could be used for restoring sight by replacing defective tissue in the eye; transplanting new heart muscle cells into people with serious heart diseases; giving people with anaemia new healthy blood cells; even harnessing brain cells to treat disorders such as Parkinson's disease," the CSIR said.

Another way of harnessing the technology is to create "disease-in-a-dish" models, by growing diseased tissue from the stem cells of sick patients.

"Since stem cells can be made from a patient's own cells, the cells contain the exact same genetic characteristics as the patient these were taken from, meaning that this tissue will be 'sick' in the same way as the patient."

Avoiding ethical controversies

Part of the novelty of the technology lies in the fact that stem cells can be made from almost any individual with almost any disease, simply by taking a skin sample from that person.

Another benefit of using iPSCs is that they bypass the ethical controversy surrounding classical stem cells, which must be taken from embryos.

Scholefield will be collaborating with Professor Susan Kidson at the University of Cape Town Medical School in developing her models, allowing for the testing of possible cures, or understanding the disease, without having to subject a patient to invasive surgery or untested trial medication.

Applying cutting-edge research in Africa

Scholefield spent three years working with international experts at Oxford University in the UK in order to perfect the technique of creating iPSCs. She now forms part of a team of CSIR scientists with expertise in various emerging health technologies, who work to apply this knowledge in an African context.

According to Dr Musa Mhlanga, who heads up the CSIR's gene expression and biophysics group, cutting-edge medical research "is not useful to Africa if knowledge is being created and applied only in the developed world.

"Given the high disease burden in Africa, our aim is to create knowledge, as well as be innovators and expert practitioners, of the newest and best technologies."

Mhlanga's group receives long-term financial support from the Department of Science and Technology.

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In Treatment of Child’s Heart Defect, Doctors Find a Stem-Cell Surprise

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By Ron Winslow

Doctors at Yale University have successfully implanted a biodegradable scaffold seeded with a four-year-old girl’s own bone-marrow cells to help treat a serious heart defect, asWSJ’s Heartbeat column describes.

The tube — about three inches long — is  made of polyester material similar to that used in the manufacture of dissolvable sutures. Six months after Angela Irizarry’s surgery, it had disappeared, replaced by a bioengineered conduit that acts like a normal blood vessel.

The vanishing act for the scaffold was expected, but what happens to the cells, including stem cells, that spawned the new vessel?

Much to the researchers’ surprise, says Chris Breuer, the Yale pediatric surgeon leading the experimental tissue-engineering project, the cells go away too.

Stem cells and certain other bone-marrow cells have building-block properties that make them the foundation for more specialized cells that grow into the body’s various tissues and structures. Researchers have long believed that stem cells transplanted into heart tissue, for instance, would be a primary component of whatever new tissue that grew as a result.

“A lot of people think that when you put cells in, they turn into whatever cells you want them to turn into,” Breuer tells the Health Blog. “We’ve clearly shown that doesn’t happen in our graft.”

Indeed, in experiments performed to learn how the tubes morphed into blood vessels, Breuer and his colleagues transplanted their scaffold seeded with human cells into mice bred with deficient immune systems to prevent rejection of the cells.  Within a few days, the human cells were gone, replaced within the scaffold by mouse cells, including cells characteristic of those that line the inner wall of blood vessels.

Initially, “I refused to believe it,” Breuer says. “I redid the experiment three different ways and saw the same thing every time.”

The upshot: Transplanted cells that have a quality of stem cells don’t build new parts themselves, he says. ”They cause the body to induce regeneration.”

Whether the same process happens in human patients such as Angela isn’t certain, he says. But the finding is consistent with other research that sheds new light on how the power of stem cells may be marshaled to regenerate tissue and body parts affected by birth defects, injury and disease.

STEM CELL INJECTION

Scientists have developed a new stem cells injection that helps generating a modified immune system in patients undergoing kidney transplants, a breakthrough they say could have a 'major impact' on transplant science.

Early tests of the new injection given to a small number of patients in the US have been successful and researchers claimed it could remove the need for a lifetime of drugs which currently transplant patients take to suppress the immune system, the BBC News reported.

One of the problems associated with organ transplantation is the risk that the body will 'recognise' the new organ as a foreign invader and attack it.

To prevent this, patients take powerful drugs to suppress their immune systems, and will have to do this for life.

The drugs come at a price, preventing organ rejection but increasing the risk of high blood pressure, diabetes and serious infection. But with the new method, published in the journal Science Translational Medicine, the researchers said patients would no longer need anti-rejection medication.

The study, carried out at the University of Louisville and the Northwestern Memorial Hospital in Chicago, involved eight patients whose transplant came from a live donor, who also underwent a procedure to draw stem cells -- the building blocks of their immune system, from the blood.

The transplant recipient's body was prepared using radiotherapy and chemotherapy to suppress their own immune system.

Then the transplant went ahead, with the stem cells put into their body a couple of days later.

Dr. Joseph Leventhal, at Northwestern University Feinberg School of Medicine, said: "The preliminary results from this ongoing study are exciting and may have a major impact on organ transplantation in the future."

He said that, as well as kidney patients, the technique might improve the lives of those receiving other organs.

According to the scientists, the idea is that these will help generate a modified immune system that no longer attacks the organ or its new owner. Although the patients started off with the same anti-rejection drugs, the aim was to reduce these slowly, hopefully withdrawing them completely over time, they said.

Five out of the eight patients involved in the trial managed to do this within a year. While stem cells from organ donors have been used before, this is the first time it has been used for 'mismatched' transplants, in which donors and recipients do not have to be related and immunologically similar, the researchers added.

Stem cell treatment tricks immune system into accepting donor organs, study shows

Reuters  Mar 8, 2012 – 6:26 PM ET

Christopher Furlong/Getty Images

With conventional organ transplants, recipients need to take pills to suppress their immune systems for the rest of their lives. These drugs can cause serious side effects, including high blood pressure, diabetes, infection, heart disease and cancer.

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By Julie Steenhuysen

CHICAGO — Scientists have found a way to trick the immune system into accepting organs from a mismatched, unrelated organ donor, a finding that could help patients avoid a lifetime of drugs to prevent rejection of the donated organ.

Of eight kidney transplant patients who have been treated with this new approach, five have managed to avoid taking anti-rejection drugs a year after their surgery, according to the study published on Wednesday in Science Translational Medicine.

And one patient, 47-year-old Lindsay Porter of Chicago, is completely free of anti-rejection drugs nearly two years after her kidney transplant.

This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients

“I hear about the challenges recipients have to face with their medications and it is significant. It’s almost surreal when I think about it because I feel so healthy and normal,” she said in a statement.

With conventional organ transplants, recipients need to take pills to suppress their immune systems for the rest of their lives. These drugs can cause serious side effects, including high blood pressure, diabetes, infection, heart disease and cancer.

“This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients,” Dr. Suzanne Ildstad, director of theInstitute of Cellular Therapeutics at the University of Louisville in Kentucky, who developed the new approach, said in a statement.

But some experts say the procedure, in which patients undergo a bone marrow transplant from an unmatched organ donor, is too risky, especially given the relative safety of kidney transplants.

We have to think about the risks and benefits. Since the current treatment is so stable, it really has to be safe,” said Dr. Tatsuo Kawai, a transplant surgeon at Harvard Medical School, who wrote a commentary on the new approach in the journal.

PATENTED TECHNOLOGY

The new technique draws on research by Australian immunologist Sir Frank Macfarlane Burnet and Brazilian-born British zoologist Peter Medawar, who won the 1960 Nobel Prize for discovering that the immune system in animals can be trained to acquire tolerance of foreign tissue.

But it has been a long road to bring this about in people, says Dr. Joseph Leventhal, a transplant surgeon at Northwestern Memorial Hospital in Chicago, where the transplants took place.

To get transplant recipients to accept the donor organ, the team needs to condition” them by suppressing their body’s bone marrow with chemotherapy and radiation before transplanting the donor’s bone marrow, the soft fatty tissue inside bones. Bone marrow contains immature blood-forming stem cells that give rise to all blood cells, including immune system cells.

“The idea here is to try to use donor-derived stem cells to achieve engraftment, a state we call chimerism,” Leventhal, a co-author of the study, said in a telephone interview. “Here what we are trying to do is get donor and recipient cells to peacefully coexist in the transplant recipient.”

Here what we are trying to do is get donor and recipient cells to peacefully coexist in the transplant recipient

About a month before transplant surgery, kidney donors must inject themselves with a medication for several days that forces stem cells and other key cells called “facilitating cells” into their bloodstream, from where they can be collected and sent off to the University of Louisville for processing.

Leventhal said these “facilitating cells” are naturally occurring cells that help create a more favorable environment for the stem cells and allow engraftment to occur safely.

Ildstad has developed a process for enriching these cells and formed a company called Regenerex LLC, which is developing the patented technology.

Meanwhile, the transplant recipient is given radiation and chemotherapy to suppress the immune system, a process intended to prepare them for accepting the donor’s stem cells.

The patient then undergoes a kidney transplant, and a day later gets transplanted with the enriched mix of the donor’s stem cells and facilitating cells with the hope of forming two bone marrow systems that can exist and function in one person.

Following those procedures, the recipient starts off taking anti-rejection drugs but is gradually weaned off them with the goal of stopping entirely a year after the transplant.

In the study, five out of eight patients reached this one-year goal. Two patients had a partial response and have been placed on a reduced dose of immunosuppressive drugs.

One patient developed sepsis and lost the new kidney, but has since received a conventional kidney transplant.

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The study is the first to try to create chimeric tolerance in patients using the facilitating cells created by Regenerex.

“By use of this stem cell product, we have been able to show we can safely achieve engraftment of donor stem cells,” Leventhal said.

He said patients developed tolerance to the graft, eliminating the need for anti-rejection drugs, even when donors and recipients were mismatched and unrelated.

Kawai of Harvard called the results “amazing,” but he said it is hard to tell from the study how much of a difference the facilitating cells made because there was no control arm, in which patients underwent the procedure without getting the enriched facilitating cells.

And because these cells are not fully described in the paper, he said it is impossible for other labs to replicate the results.

At Harvard, Kawai and colleagues achieved temporary chimeric tolerance — in which two immune systems coexisted in one body — in a separate study published in 2008 in the New England Journal of Medicine.

Patients in that study did not have their immune systems suppressed by chemotherapy and radiation, and the donor immune system cells died off after a few weeks. But at least one patient still has a working donor organ 10 years after the procedure and does not need to take anti-rejection medications.

Kawai worries that patients in the recent trial are taking too much risk. “Their approach is to totally destroy the host immune system by medication and radiation,” he said.

Kawai said he would like to see the approach tested first in patients with blood cancers or other disorders who would need a bone marrow transplant — patients for whom there are no other options, and therefore in whom this harsh treatment is justified.

Leventhal said the team is still enrolling patients in the clinical trial, which aims to include as many as 40 subjects.

To qualify, donors and recipients need to have compatible blood types and a negative cross-match, which means the recipient does not have antibodies in the blood that could cause rejection of the kidney.

© Thomson Reuters 2012

Nuvilex Announces Major Breakthrough in Stem Cell Research

As Highlighted in Goldman Research Report Nuvilex Stem Cell Technology Allows for Replication Without Rejection or Migration from Targeted Site

March 05, 2012 09:36 AM Eastern Time 

SILVER SPRING, Md.--(EON: Enhanced Online News)--Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, released information today about the company’s cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapy—host rejection and migration of implanted cells away from the target site.

Stem cell therapy is believed by many medical researchers as holding a key to treating cancer, Type 1 diabetes mellitus, Parkinson's disease, Huntington's disease, Celiac Disease, cardiac failure, muscle damage, neurological disorders, and other chronic, debilitating diseases. There are presently >1,400 registered trials using stem cells that are recruiting patients (ClinicalTrials.gov). The encapsulation technology being advanced allows live stem cells to be implanted into robust, flexible and permeable capsules where they can replicate inside the capsules at the target site free from attack by the body’s immune system and free to undergo natural changes to become the appropriate cell type needed.

The Goldman Small Cap Research report, issued February 29, 2012, noted some inherent difficulties encountered in stem cell treatments, such as keeping stem cells alive for significant periods of time, potential rejection of the cells and subsequent destruction by the recipient’s immune system, and the migration of the stem cells away from the critical treatment site, while making a distinction that the Company’s cell encapsulation technology overcomes these concerns.

The report also accurately recognized, “Cells encapsulated in SG Austria’s porous beads remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the body’s immune system. Furthermore, encapsulated cells remain within the beads and do not migrate out of the beads to other sites in the body.”

In assessing the overall importance of this technology to Nuvilex’s overall business model, Goldman pointed out, “The Company’s acquisition of the Cell-in-a-Box® approach along with the expertise of SG Austria could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, in addition to being used to target cancer cells, thus making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.”

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, “There is a broad range of expanding research supporting the use of stem cells to treat a variety of human diseases and conditions. Our technology allows for precise maintenance and localization of stem cells, preventing their loss from the critical area of need, that will enable us to potentially create miniature organs at specific sites and as a result we believe greater utilization of those stem cells at the site for their intended purpose, once implanted. As stem cell treatments advance, we expect Nuvilex to be at the forefront of developing new, significant, life changing therapies.”

For a detailed review of the research report and valuation methodology, investors are directed to the Goldman Research Report.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the company’s industry-leading live-cell encapsulation technology.

Safe Harbor Statement

The information provided may contain forward-looking statements and involve risks and uncertainties. Results, events and performances could vary from those contemplated. These statements involve risks and uncertainties which may cause actual results, expressed or implied, to differ from predicted outcomes. Risks and uncertainties include product demand, market competition, and Nuvilex’s ability to meet current or future plans. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

Contacts

Investor Relations Contact:
Marmel Communications, LLC
Marlin Molinaro, 702-434-8692
mmolinarofc@aol.com

TEENAGER IS LOOKING FOR MORE STEM CELL DONORS

Leicester teenage cancer patient Bethany Mickleburgh has welcomed a new drive to get more people to sign up to a register that helps to save lives.

The 14-year-old is recovering in hospital after undergoing a transplant of healthy stem cells which, it is hoped, will help her fight leukaemia.

1. ​
   Bethany Mickleburgh

The healthy stem cells were taken from a woman in Germany who had signed up to a register of potential donors, and then found to be match for the teenager.

Bethany has already inspired thousands of people in Leicestershire to join the donor register.

Later this month, Leicester City Council is hosting an event, inspired by Bethany and fellow stem cell recipient Rik Basra, to encourage more people to sign up.

The event has been organised by deputy city mayor Councillor Rory Palmer.

In a letter written from her hospital bed Bethany, from Western Park, Leicester, said: "I am still recovering in hospital in Birmingham following my treatment, having received donor cells.

"I'm very pleased to have someone as influential as the deputy city mayor of Leicester following our campaign to help people that need transplants.

"Five years ago doctors could not find a good enough match for me and I had to have a different treatment that only worked for so long.

"Over the last few months an extra 3,000 good people have joined the register to try to help. I always knew it might not be possible, even with that number, but I was lucky.

"It's difficult to explain what this meant to me."

Bethany said she was pleased to hear that an event at the Leicester Tigers stadium last year where nearly 2,000 people signed up to the donor register had resulted in another leukaemia patient finding a stem cell match.

She said: "I have just heard that a young man who registered at the main clinic at the Tigers ground has been shown to be a match for someone and was overcome with emotion at the thought of being able to save a life.

"Hopefully this will be repeated many times with the people of Leicester that are now coming forward."

Leukaemia damages the body's stem cells, which in turn affects its ability to create healthy blood and to build an effective immune system, so the cancer spreads.

The point of the transplant is to give the recipient's body healthy stem cells so it can build an effective immune system that can fight the cancer.

The city council event for people to join the register, which is run by the Anthony Nolan Trust in the UK, will take place between 11am and 3pm on Wednesday, March 21, at the Town Hall.

Potential donors merely provide a saliva sample.

They might then be called on to donate blood stem cells if they prove a match for someone fighting leukaemia.

Both Rik, 53, and Bethany were diagnosed with leukaemia last year and told that a stem cell transplant was their last chance of survival.

Rik, a Leicestershire police inspector, had a blood stem cell transplant on Christmas Eve.

Coun Palmer said: "The whole city has been touched by the stories of Rik and Bethany and we share the families' delight that matching donors have now been found."

www.anthonynolan.org