StemCell Therapy

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

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Patient dies during procedure

Public release date: 8-Mar-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-351-0896 Genetics Society of America

CHICAGO, IL March 8, 2012 Stem cells provide a recurring topic among the scientific presentations at the Genetics Society of America's 53rd Annual Drosophila Research Conference, March 7-11 at the Sheraton Chicago Hotel & Towers. Specifically, researchers are trying to determine how, within organs, cells specialize while stem cells maintain tissues and enable them to repair damage and respond to stress or aging. Four talks, one on Thursday morning and three on Sunday morning, present variations on this theme.

For a fertilized egg to give rise to an organism made up of billions or trillions of cells, a precise program of cell divisions must unfold. Some divisions are "asymmetric": one of the two daughter cells specializes, yet the other retains the ability to divide. Chris Q. Doe, Ph.D., professor of biology at the University of Oregon, compares this asymmetric cell division to splitting a sundae so that only one half gets the cherry. The "cherries" in cells are the proteins and RNA molecules that make the two cells that descend from one cell different from each other. This collecting of different molecules in different regions of the initial cell before it divides is termed "cell polarity."

Dr. Doe and his team are tracing the cell divisions that form a fly's nervous system. "Producing the right cells at the right time is essential for normal development, yet it's not well understood how an embryonic precursor cell or stem cell generates a characteristic sequence of different cell types," he says. Dr. Doe and his team traced the cell lineages of 30 neuroblasts (stem cell-like neural precursors), each cell division generating a daughter cell bound for specialization as well as a self-renewing neuroblast. The dance of development is a matter of balance. Self-renew too much, and a tumor results; not enough, and the brain shrinks.

Tracing a cell lineage is a little like sketching a family tree of cousins who share a great-grandparent except that the great-grandparent (the neuroblast) continually produces more cousins. "The offspring will change due to the different environments they are born into," says Dr. Doe.

Julie A. Brill, Ph.D., a principal investigator at The Hospital for Sick Children (SickKids) in Toronto, investigates cell polarity in sperm cells. These highly specialized elongated cells begin as more spherical precursor cells. Groups of developing sperm elongate, align, condense their DNA into tight packages, expose enzyme-containing bumps on their tips that will burrow through an egg's outer layers, form moving tails, then detach and swim away.

The Brill lab studies a membrane lipid called PIP2 (phosphatidylinositol 4,5-bisphosphate) that establishes polarity in developing male germ cells in Drosophila. "Reducing levels of PIP2 leads to defects in cell polarity and failure to form mature, motile sperm," Dr. Brill says. These experiments show that localization of the enzyme responsible for PIP2 production in the growing end of elongating sperm tails likely sets up cell polarity. Since loss of this polarity is implicated in the origin and spread of cancer, defects in the regulation of PIP2 distribution may contribute to human cancer progression, she adds.

Stephen DiNardo, Ph.D., professor of cell and developmental biology at the Institute for Regenerative Medicine at the University of Pennsylvania, is investigating how different varieties of stem cells in the developing fly testis give rise to germ cells and epithelial cells that ensheathe the germ cells, as well as being able to self-renew. For each of these roles, stem cells are guided by their environment, known as their "niche."

In the fly testis, we know not only the locations of the two types of stem cells whose actions maintain fertility, but of neighboring cells. "We study how these niche cells are first specified during development, how they assemble, and what signals they use. Elements of what we and others learn about this niche may well apply to more complex niches in our tissues," Dr. DiNardo explains.

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Fly research gives insight into human stem cell development and cancer

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the potential use of the companys cell encapsulation technology with modified stem cells to treat late stage cancers.

Stem cell therapy is not new to physicians dealing with blood and bone cancers, with stem cell transplants being an important treatment for growing new bone marrow since the 1970s. Recent studies have indicated the potential for using stem cells across a much broader range of cancers is becoming a reality, mostly a result of advances in cell and molecular biology techniques.

Traditional chemotherapy works by targeting the fast-growing cells common to cancer tumors. Unfortunately, chemotherapeutics dont differentiate between healthy and cancerous cells. Patients suffering from metastatic cancers, where tumors have spread to multiple areas of the body, often have substantial difficulties with the chemotherapy needed to treat their disease.

In one case, researchers at City of Hope and St. Jude Children's Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used genetically modified stem cells to activate chemotherapeutic drugs at the tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed. The stem cells were designed to produce a specific enzyme that converts the nontoxic prodrug into the chemotherapeutic agent. This method also targets the brain tumor treatment to remain localized within the brain, similar to the pancreatic cancer clinical trial carried out by SG Austria, providing for high dosage chemotherapy without affecting surrounding tissues and avoiding the severe side effects normally associated with cancer therapy.

Nuvilex believes that incorporating Cell-in-a-Box encapsulation with this type of genetically modified stem cell, along with the proprietary cancer treatment being acquired, could significantly aid and improve patient outcomes.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, We are hopeful for the day when late stage cancers can be routinely and safely treated using genetically modified cells like those used in the pancreatic cancer trial, increasing the ability of clinicians to avoid inducing side effects that typically accompany aggressive chemotherapy and/or radiation. Our cell encapsulation technology will enable practitioners to target tumors while preserving the health of the surrounding tissues. We continue to look for leading stem cell and oncology researchers to partner with us as we bring this technology to market.

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 companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

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Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

by Maggie Ruper

WHAS11.com

Posted on March 7, 2012 at 11:50 PM

Updated today at 12:01 AM

LOUISVILLE, Ky. (WHAS11) -- New research published Wed. in the journal Science Translation Medicine, shows organ transplant recipients may not require anti-rejection medication after surgery.

The study, authored by University of Louisville professor Suzanne Ildstad, M.D., suggests bone marrow stem cells are able to trick the recipients immune system into thinking the donated organ is part of the patients natural self. It therefore eliminates the need for patients to take dozens of daily anti-rejection drugs.

Normally, if I have to transplant a kidney into a patient they have to take immunosuppression drugs for their lifetime and that's about 15 to 25 pills a day, said Ildstad.

Louisville native and father of four, Rob Waddell underwent the procedure in 2009 at Northwestern Memorial Hospital. He suffered from Polycystic Kidney Disease since he was 11 years old. His new kidney and the stem cells were donated to him by his next door neighbor.

It was a match and the rest is history. He's what I call my guardian angel," said Wadell.

The results were considered important because the technique worked for patients who did not have well-matched or related donors.

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UofL Professor’s study: Stem cells eliminate need for anti-rejection drugs

ROCKVILLE, Md., March 7, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the second patient to receive stem cells in the cervical (upper back) region of the spine was dosed on February 29th in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 14 is also the first woman to be treated in the trial. Stem cell transplantation into the cervical region of the spinal cord couldsupport breathing, a key function that is lost as ALS progresses. The first twelve patients in the trial received stem cell transplants in the lumbar (lower back) region of the spinal cord only.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"This cohort of patients represents another first for our trial, as we transplant cells directly into the gray matter of the spinal cord in the cervical region," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "We are delighted that the surgeries are progressing in a region that could have a significant impact on the quality of life for ALS patients. With the safe transplantation of our 14th patient, we are well are on our way to demonstrating the safety of our novel procedure."

About the Trial The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts. The trial has now progressed to the final six patients. Each is in the cervical (upper back) region of the spine. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit http://www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, 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 Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

In just two years after going commercial, MediVet Americas headquarters in Nicholasville has seen exponential growth with no sign of slowing down.

The privately owned company is one of a handful of developers and researchers worldwide working on stem-cell regenerative therapy for animals suffering from osteoarthritis, hip dysplasia and other degenerative diseases. MediVet also provides other services such as stem-cell storage and selling stem cell extraction kits to veterinarians around the globe.

Founded as a research company six years ago in Sydney, Australia, MediVet as a whole is now represented in 26 counties and has hubs in 44 American states.

In 2010, there were only two full-time working employees at the office and lab building located in Nicholasville. The headquarters now employs 12 people with more sales, research and manufacturing jobs expected to open up in the next few months.

The Nicholasville lab has seen an increase of 3,000 percent in monetary growth since February 2011, said director of lab services Katherine Wilkie.

A University of Kentucky graduate, Wilkie said the lab has seen tremendous increase in clientele, as well. Currently, the facility banks approximately 600 different animal stem cells that account for more than 2,000 samples from all across the country and Canada.

In September, we received a sample from Alaska, she said. That now gives us an animal from each of the 50 states.

Stem-cell regenerative therapy has been used to treat everything from a mouse to an elephant, and Wilkie said they may soon do the procedure on a dolphin.

The companys blooming success boils down to its devolvement of advanced technologies in extracting, activating and storing stem cells that have cut the cost by one-third of their competitors, CEO Jeremy Delk said.

MediVets research and developments has made the procedures and other services they offer economically viable to the average pet owner, he said.

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Pet stem cell biz booming for MediVet

Approach Could Free Organ Patients From Anti-Rejection Drugs

March 7, 2012 -- New research holds the promise of freeing many organ transplant patients from a lifetime of anti-rejection drugs.

In the first study of its kind, eight kidney transplant patients received stem cells from their kidney donors manipulated to trick their bodies into accepting the foreign organ as its own.

Transplant recipients who are not perfectly matched with their donors typically take several drugs a day for the rest of their lives to keep their bodies from rejecting the new organ and to treat the side effects of those drugs.

Lindsay Porter, who was the last of the eight patients enrolled in the new study, had her kidney transplant in the summer of 2010 and was weaned off all anti-rejection drugs within a year.

The Chicago actress and mother says she feels better than she has in 15 years and sometimes has to remind herself that she had a kidney transplant.

I was 45 when I had the surgery, and I knew I would probably need another kidney at some point, she tells WebMD. The opportunity to have a transplant that would last for the rest of my life and to avoid all of those drugs was very appealing.

The ongoing research is the culmination of many years of work by researcher Suzanne Ildstad, MD, of the University of Louisville, and other researchers, including transplant surgeon Joseph Leventhal, MD, PhD, of Chicagos Northwestern University.

The new wrinkle is that organ donors who are not a perfect genetic match with the patient donate blood as well as a kidney for the procedure.

Bone marrow stem cells collected from the blood were processed in an 18-hour procedure to remove cells associated with organ rejection, leaving behind facilitating cells that do not promote rejection, Ildstad says.

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Altered Stem Cells Limit Transplant Rejection

WASHINGTON -- Patients who are lucky enough to get a transplant for a failed organ usually face a lifetime on anti-rejection drugs, which are expensive, dangerous and not always effective.

But in the future, those drugs may not be needed. A new study suggests that patients receiving an organ that's less than a perfect match can be protected against rejection by a second transplant -- this time of the organ donor's imperfectly matched stem cells.

Though preliminary, the new study is being hailed as a potential game-changer in the field of transplantation, a mystifying development that could offer hope to hundreds of thousands of patients who await or have received donor kidneys and depend on a harsh daily regimen of anti-rejection pills.

The small pilot study, reported Wednesday in the journal Science Translational Medicine, describes a novel regimen that combined old-fashioned cancer treatments with 21st century cell therapy to induce five patients' immune systems to accept donor kidneys as their own despite significant incompatibility.

If the technique proves successful in a larger group of people, future transplant patients may need to take anti-rejection drugs only briefly, and some who rely on them now could discontinue them safely. The recipients of kidneys as well as other organs, including heart, lung, liver and pancreas, might also benefit from access to a wider pool of organs.

The strategy could offer hope for

"Few transplant developments in the past half century have been more enticing," wrote pioneer transplant surgeons James Markmann and Tatsuo Kawai of Massachusetts General Hospital, in a commentary accompanying the study. If borne out, they wrote, the findings "may potentially have an enormous, paradigm-shifting impact on solid-organ transplantation."

Link:
Stem cells may aid organ-transplant patients, study finds

Lindsay Porter's kidneys weighed 16 pounds before her transplant.

STORY HIGHLIGHTS

(CNN) -- By the time Lindsay Porter had her kidneys removed two years ago, they were bulging -- covered in cysts -- and together weighed 16 pounds.

Her abdominal area was so distended, "I looked nine months pregnant, and people regularly asked when I was due," Porter said.

As she prepared for a transplant to address her polycystic kidney disease, Porter, 47, had mixed feelings -- relief to have found a donor, tinged with resignation. She was looking forward to both a new kidney, and a lifetime on immune system-suppressing drugs.

"You get this brand new shiny kidney, and then they give you drugs that eventually destroy it," said Porter.

But that scenario may eventually change, if results of a new pilot study are replicated in a larger group of patients. The study, published Wednesday in the journal Science Translational Medicine, describes eight kidney transplant patients, including Porter, who received a stem cell therapy that allowed donor and recipient immune cells to coexist in the same body.

The effect, in a handful of those patients, was to trick the recipient's immune system into recognizing the donated kidney as its own.

When it works, patients become a sort of medical rarity called a chimera.

"Chimerism is a condition wherein two different genetic cell populations are present in the body, and both cell types are tolerated," said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center, who was not involved in the study, via e-mail.

Read more from the original source:
Scientists offer a glimpse of life without immune-suppressing drugs

Lindsay Porter knew she would eventually need a kidney transplant. She was 19 years old when her mother died from polycystic kidney disease -- a genetic condition that Porter had 50/50 odds of inheriting, and did.

"It didn't really affect me much until my early 30s," said Porter, an actress and mother living in Chicago. "And as I got into my 40s, my kidneys started getting very big with multiple cysts. They were huge."

Porter's kidneys weighed 16 pounds, causing an obvious bulge in her tiny frame.

"It was like two full-term babies inside me," she said, adding that people often mistook her for pregnant. "They had to be removed."

In May 2010, doctors removed Porter's overgrown and failing kidneys. Two months later, a friend gave her one of his. But it was no ordinary transplant. Along with the fist-size organ, doctors at Northwestern Memorial Hospital in Chicago transplanted bone marrow stem cells -- an experimental procedure they hoped would eliminate the need for anti-rejection drugs.

"These drugs are currently an absolute necessity, but they have a downside," said Dr. Joseph Leventhal, Porter's transplant surgeon at Northwestern Memorial Hospital and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine.

Anti-rejection drugs suppress the immune system, preventing it from attacking the donated organ like an infection. But suppressing the immune system makes the body vulnerable to infections and even cancer. And the drugs, which carry toxic side effects, can't ward off rejection forever. "Many individuals will still lose their transplants over time due to chronic rejection," said Leventhal.

To coax Porter's body into recognizing the new kidney as her own, Leventhal and colleagues wiped out part of her immune system and replaced it with the donor's. It took four days of chemotherapy, whole-body irradiation and a bone marrow transplant -- no walk in the park, according to Porter. But over time, the donor bone marrow stem cells gave rise to immune cells that accepted the kidney as if it was Porter's own -- a process called induced immune tolerance.

"At first I was taking 24 pills a day," said Porter, describing the "cocktail" of anti-rejection drugs needed to fend off an attack on her new kidney while the bone marrow stem cells were setting up shop. "And you really can't miss a dose. I had to set my cell phone alarm for every 12 hours every single day to remind me."

After six months, Porter started weaning herself off the drugs. And after a year, she no longer needed them at all.

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New Transplant Approach Changes Lives

(AP) An experimental technique seems to be freeing some kidney transplant patients from having to take anti-rejection drugs.

Researchers transplanted certain cells from the kidney donor's bone marrow along with the new organ. Five of eight transplant recipients who tried the method so far were off immune-suppressing medication up to 2 1/2 years later, the researchers reported Wednesday.

The preliminary results were considered important enough to be published in the journal Science Translational Medicine even though the study still is under way, because the technique worked for patients who didn't have well-matched or related donors.

The idea is that if a sort of twin immune system takes root and lasts, it can allow the patient's body to accept the foreign organ and not attack it, said study co-author Dr. Suzanne Ildstad of the University of Lousville. Scientists call it chimerism.

"The most reliable indicator of really being successful at taking someone off immune-suppressing drugs is durable chimerism," says Ildstad, who teamed with doctors at Chicago's Northwestern Memorial Hospital for the research.

Transplant recipients usually must take multiple immune-suppressing pills for life to prevent rejection of their new organ. Those drugs cause lots of side effects, such as raising the risk of cancer and kidney damage.

Other scientists are attempting to tap bone marrow to induce immune tolerance, with varying success.

Ildstad's approach transfuses a special mix of bone marrow cells including blood-producing stem cells and another type named "facilitating cells" that are thought vital for a successful transplant. She filters out still other cells that can become too aggressive and cause a life-threatening disorder named graft-versus-host disease.

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Transplant recipients had radiation and chemotherapy, not destroying their own bone marrow but tamping it down to make space for the donated cells, explained study co-author Dr. Joseph Leventhal, a Northwestern transplant surgeon. Five patients who had the dual immunity a year later were weaned off all drugs. Two others whose hybrid immunity faded are faring well using a low dose of one anti-rejection drug. One patient needed a repeat transplant after an infection and didn't get to try weaning.

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New treatment for kidney transplant patients may reduce need for anti-rejection drugs

WASHINGTON (AP) An experimental technique seems to be freeing some kidney transplant patients from having to take anti-rejection drugs.

Researchers transplanted certain cells from the kidney donor's bone marrow along with the new organ. Five of eight transplant recipients who tried the method so far were off immune-suppressing medication up to 2 years later, the researchers reported Wednesday.

The preliminary results were considered important enough to be published in the journal Science Translational Medicine even though the study still is under way, because the technique worked for patients who didn't have well-matched or related donors.

The idea is that if a sort of twin immune system takes root and lasts, it can allow the patient's body to accept the foreign organ and not attack it, said study co-author Dr. Suzanne Ildstad of the University of Lousville. Scientists call it chimerism.

"The most reliable indicator of really being successful at taking someone off immune-suppressing drugs is durable chimerism," says Ildstad, who teamed with doctors at Chicago's Northwestern Memorial Hospital for the research.

Transplant recipients usually must take multiple immune-suppressing pills for life to prevent rejection of their new organ. Those drugs cause lots of side effects, such as raising the risk of cancer and kidney damage.

Other scientists are attempting to tap bone marrow to induce immune tolerance, with varying success.

Ildstad's approach transfuses a special mix of bone marrow cells including blood-producing stem cells and another type named "facilitating cells" that are thought vital for a successful transplant. She filters out still other cells that can become too aggressive and cause a life-threatening disorder named graft-versus-host disease.

Transplant recipients had radiation and chemotherapy, not destroying their own bone marrow but tamping it down to make space for the donated cells, explained study co-author Dr. Joseph Leventhal, a Northwestern transplant surgeon. Five patients who had the dual immunity a year later were weaned off all drugs. Two others whose hybrid immunity faded are faring well using a low dose of one anti-rejection drug. One patient needed a repeat transplant after an infection and didn't get to try weaning.

Much more study is needed to find the best approach but "the results are striking," Dr. Tatsuo Kawai of Massachusetts General Hospital wrote in an accompanying editorial. He is part of a team that in 2008 reported the only other success with a small number of mismatched transplants.

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Cells may spare kidney transplant rejection drugs

Donating a kidney may save a person's life - but only if the conditions are precise.

Kidney donors must be related and immunologically matched to their donors and even then, the recipient must take a lifetime of anti-rejection medications, which dont guarantee the organ won't be rejected.

But a new clinical trial from Northwestern Memorial Hospital in Chicago, Ill. has shown how stem cells can be used to trick a recipients immune system into believing the new organ has been part of that persons body all along.

The breakthrough has the potential to eliminate both the risks associated with kidney transplantation and the need for anti-rejection medications within one year after surgery.

Its the holy grail of transplantation, said lead author Dr. Joseph Leventhal, transplant surgeon at Northwestern Memorial Hospital and associate professor of surgery and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine in Chicago, Ill. This notion of being able to achieve tolerance through donor derived cells has been around for more than 50 years, but its translation to the clinic has been quite elusive. This article details the first successful attempt of this in mismatched and unrelated kidney recipients.

The research was published Wednesday in the journal Science Translational Medicine, and it is the first study of its kind in which the donor and recipient were not related and did not have to be immunologically matched. Only 25 percent of siblings are immunologically identical, severely limiting the possibility of being a kidney donor.

The procedure worked by extracting a little bit more from the kidney donor than just their kidney. They also donated part of their immune system. About one month before surgery, bone marrow stem cells were collected from the donor and then enriched with facilitating cells becoming stem cells that will ultimately fool the donors immune system allowing the transplant to succeed.

One day after the kidney transplant occurs, the facilitating cell-enriched stem cells are also transplanted in the recipient, which then prompts the formation of stem cells in the bone marrow. This then causes specialized immune cells similar to the donors immune cells to develop, creating a dual bone marrow system environment, so both the donors immune system and the recipients immune system function inside the persons body.

Leventhal said that the ultimate goal is for the recipient to initially take anti-rejection medications but then slowly wean off of them within a year. According to Leventhal, the drugs come with their own share of negative side effects.

The foundation of clinical transplantation revolves around the use of medicines and suppressive drugs to control the immune system, Leventhal said. These drugs have been very successful in reducing the rates of loss of organs due to acute rejection where side effects include increase risk of infection and cancer, and metabolic side effects, such as the increase risk of hypertension and bone disease. But the drugs themselves are potentially harmful to the organs we transplant. Despite our ability to reduce rates of acute rejection, most individuals go on to lose organs because of chronic (long-term) rejection.

Original post:
Stem cell research allows for mismatched kidney transplants

By Michelle Fay Cortez - Wed Mar 07 19:16:55 GMT 2012

Kidney transplant patients given a mixture of stem cells from their organ donor were able to quit taking anti-rejection medicine in a small study, suggesting that life-long reliance on the toxic drugs may be avoidable.

Five of eight patients treated were able to stop taking about a dozen pills a day to suppress their immune systems. The drugs, which prevent rejection and stop tissue from a donated kidney from attacking the patient, can damage the transplant and cause diabetes, infections, heart disease and cancer.

The breakthrough, reported in the journal Science Translational Medicine, mixed stem cells from the donors infection-fighting immune system with the patients natural immune system. The result enabled tissue from both to co-exist in the transplant patient without either being seen as foreign by the immune system, researchers said.

The results may potentially have an enormous, paradigm- shifting impact on solid-organ transplantation, wrote James Markmann and Tatsuo Kawai from Massachusetts General Hospital in Boston, in an editorial accompanying the study. Although only a taste of things to come, few transplant developments in the past half-century have been more enticing than these that put transplantation tolerance within our grasp.

The findings are particularly striking since the patients werent perfect tissue matches with the living donors. The mismatch traditionally makes it more difficult for the donated organ to survive since the patients immune system perceives the unfamiliar tissue as a threat.

Its been a longstanding goal in transplantation to achieve tolerance, to get the recipient to see the donor organ as part of itself, said Joseph Leventhal, a surgeon at Northwestern Memorial Hospital in Chicago and the lead author. A road to tolerance now exists, he said.

Having two immune systems blend into one is called a chimerism. The long-lasting effect seen in the study may stem from the manipulation of stem cells taken from the donor in advance of the surgery, according to the report.

The cells were sent to Suzanne Ildstad, director of the Institute of Cellular Therapeutics at the University of Louisville in Kentucky. There facilitating cells that help transplants take hold were identified and used to enrich the mixture, which was given to the patient the day after surgery.

The researchers didnt provide details on how they crafted the stem cell mix, which may make it difficult for other investigators to confirm the findings, Markmann and Kawai wrote.

The rest is here:
Stem Cells Help Kidney-Transplant Patients Skip Rejection Drugs in Study

By Robert Langreth - Thu Mar 08 05:00:01 GMT 2012

Radiating one tumor can trigger the immune system to wipe out tumors in other parts of the body and may boost the effectiveness of Bristol-Myers Squibb Co. (BMY)s cancer drug Yervoy, doctors have shown.

Researchers at Memorial Sloan-Kettering Cancer Center are reporting on the case of a 41-year-old woman with advanced melanoma who took Yervoy, a drug that stimulates the immune system to fight cancer cells, in a clinical trial. She didnt respond to the medicine until she got a radiation treatment to shrink a tumor on her lung that was pressing on a nerve and causing severe back pain.

Soon, all the other tumors in her body started shrinking, according to the results published in the New England Journal of Medicine. The case is the best demonstration to date of a rare phenomenon called the abscopal effect, in which radiation to just one tumor causes other tumors all over the body to regress, said Charles Drake, a medical oncologist at the Johns Hopkins University School of Medicine not involved with the study.

It is a really amazing finding, Drake said in a phone interview. It confirms that this effect can occur.

The broad tumor shrinkage was associated with changes in the immune system that occurred after the radiation treatment, according to the report.

Harnessing the effect may enable researchers to boost the response rate to Yervoy, said Memorial Sloan-Ketterings Jedd Wolchok, an oncologist and senior author on the case study. The radiation-linked response may occur because the radiation creates cellular debris that the immune system recognizes as dangerous, he said.

Yervoy for melanoma is the first in a new class of drugs that removes molecular brakes on immune system cells that prevent them from attacking cancer. While it improves survival by four months, the drug causes major tumor shrinkage in 10 to 15 percent of melanoma patients. Doctors are looking for a way to improve on this.

Valerie Esposito, the radiation patient in the study, started getting Yervoy in September 2009 and didnt clearly benefit at first. She was definitely getting worse until she got the radiation in December 2010, said Wolchok.

Yet when doctors performed a scan a few months after the radiation, six tumors in her spleen and two more in her lymph nodes that had not been radiated shrank dramatically, he said.

Continued here:
Radiation Blast May Turbocharge Bristol-Myers Melanoma Drug, Report Shows

WEDNESDAY, March 7 (HealthDay News) -- Researchers report that they were able to create a kind of hybrid immune system in patients who received kidney transplants, a process that appeared to allow the recipients' bodies to accept a foreign organ instead of trying to reject it.

There are caveats. The research is preliminary and only involved a tiny number of patients. Also, the required procedure is expensive and its long-term effects aren't known.

But if it works, the process -- which involves transferring bone marrow cells from the kidney donor to the patient -- could allow organ transplant recipients to avoid a lifetime of taking dozens of pills a day. "It's a huge step forward," said Dr. Suzanne Ildstad, director of the University of Louisville's Institute for Cellular Therapeutics, and co-author of the study published in the March 7 issue of Science Translational Medicine.

The immune system's job is to keep invaders out of the body, but it can do its work too well when a patient needs an organ transplant. "People think that once you get your transplant, everything is simple, but it's really far from that," Ildstad said.

Patients often have to take 15 to 25 pills a day to dampen their immune system, she said, and that can lead to complications such as infections, diabetes, high blood pressure and cancer.

"Even if you're perfect and take your drugs every day, every year there's a certain number of transplants lost to chronic rejection," Ildstad explained.

One way to get the immune system under control is to make it think like the immune system in the person who's donating the organ. That immune system of the donor would recognize the transplanted organ and not try to get rid of it.

In the new procedure, the researchers removed stem cells from the bone marrow of the kidney donors, put them through a special process designed to give them a boost, then inserted them into the organ recipients.

Essentially, the goal is to create a hybrid immune system -- part donor, part recipient -- in the bone marrow of the recipient. The marrow then creates cells in the immune system.

Of eight patients, five have not required any medications to suppress their immune systems, Ildstad said. Two of the patients take the medications at a low dose; one patient experienced complications related to blood poisoning and a blood clot in an artery to the kidneys.

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Transplant Procedure Creates 'Hybrid' Immune System to Combat Rejection

Public release date: 6-Mar-2012 [ | E-mail | Share ]

Contact: Mary Wade mwade@aao.org 415-447-0221 American Academy of Ophthalmology

SAN FRANCISCO March 6, 2012 A new paradigm to explain glaucoma is rapidly emerging, and it is generating brain-based treatment advances that may ultimately vanquish the disease known as the "sneak thief of sight." A review now available in Ophthalmology, the journal of the American Academy of Ophthalmology, reports that some top researchers no longer think of glaucoma solely as an eye disease. Instead, they view it as a neurologic disorder that causes nerve cells in the brain to degenerate and die, similar to what occurs in Parkinson disease and in Alzheimer's. The review, led by Jeffrey L Goldberg, M.D., Ph.D., assistant professor of ophthalmology at the Bascom Palmer Eye Institute and Interdisciplinary Stem Cell Institute, describes treatment advances that are either being tested in patients or are scheduled to begin clinical trials soon.

Glaucoma is the most common cause of irreversible blindness worldwide. For many years, the prevailing theory was that vision damage in glaucoma patients was caused by abnormally high pressure inside the eye, known as intraocular pressure (IOP). As a result, lowering IOP was the only goal of those who developed surgical techniques and medications to treat glaucoma. Creating tests and instruments to measure and track IOP was crucial to that effort. Today, a patient's IOP is no longer the only measurement an ophthalmologist uses to diagnose glaucoma, although it is still a key part of deciding how to care for the patient. IOP-lowering medications and surgical techniques continue to be effective ways to protect glaucoma patients' eyes and vision. Tracking changes in IOP over time informs the doctor whether the treatment plan is working.

But even when surgery or medication successfully lowers IOP, vision loss continues in some glaucoma patients. Also, some patients find it difficult to use eye drop medications as prescribed by their physicians. These significant shortcomings spurred researchers to look beyond IOP as a cause of glaucoma and focus of treatment.

The new research paradigm focuses on the damage that occurs in a type of nerve cell called retinal ganglion cells (RGCs), which are vital to the ability to see. These cells connect the eye to the brain through the optic nerve.

RGC-targeted glaucoma treatments now in clinical trials include: medications injected into the eye that deliver survival and growth factors to RGCs; medications known to be useful for stroke and Alzheimer's, such as cytidine-5-diphosphocholine; and electrical stimulation of RGCs, delivered via tiny electrodes implanted in contact lenses or other external devices. Human trials of stem cell therapies are in the planning stages.

"As researchers turn their attention to the mechanisms that cause retinal ganglion cells to degenerate and die, they are discovering ways to protect, enhance and even regenerate these vital cells," said Dr. Goldberg. "Understanding how to prevent damage and improve healthy function in these neurons may ultimately lead to sight-saving treatments for glaucoma and other degenerative eye diseases."

If this neurologically-based research succeeds, future glaucoma treatments may not only prevent glaucoma from stealing patients' eyesight, but may actually restore vision. Scientists also hope that their in-depth exploration of RGCs will help them determine what factors, such as genetics, make some people more vulnerable to glaucoma.

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New research characterizes glaucoma as neurologic disorder rather than eye disease

7 March 2012 Last updated at 11:47 ET By James Gallagher Health and science reporter, BBC News

Stem cells taken from the back of a human eye have restored some vision to blind rats, according to researchers.

They say the findings could help treat blindness, caused by glaucoma, if similar results can be repeated in humans.

The study, published in the journal Stem Cells Translational Medicine, used the cells to form new nerves in the eye.

These hooked up with the existing nerves, restoring sight.

Glaucoma can lead to blindness and is caused by a build-up of pressure within the eye. This kills retinal ganglion cells, the nerves which take information from the retina and pass it onto the brain.

Researchers at University College London and Moorfields Eye Hospital believe they have regenerated the retinal ganglion cells using human stem cells.

With permission from families, cell samples were taken from eyes which had been donated for cornea transplants.

It is a significant step towards our ultimate goal of finding a cure for glaucoma and other related conditions

Very rare cells in the eye, Muller glia stem cells, were collected. These were grown in the laboratory and converted into retinal ganglion cells.

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Human stem cells 'help blind rat'

Public release date: 7-Mar-2012 [ | E-mail | Share ]

Contact: Colleen Sheehan csheehan@nmh.org 312-926-7769 Northwestern Memorial Hospital

CHICAGO New ongoing research published today in the journal Science Translational Medicine suggests organ transplant recipients may not require anti-rejection medication in the future thanks to the power of stem cells, which may prove to be able to be manipulated in mismatched kidney donor and recipient pairs to allow for successful transplantation without immunosuppressive drugs. Northwestern Medicine and University of Louisville researchers are partnering on a clinical trial to study the use of donor stem cell infusions that have been specially engineered to "trick" the recipients' immune system into thinking the donated organ is part of the patient's natural self, thus gradually eliminating or reducing the need for anti-rejection medication.

"The preliminary results from this ongoing study are exciting and may have a major impact on organ transplantation in the future," said Joseph Leventhal, MD, PhD, transplant surgeon at Northwestern Memorial Hospital and associate professor of surgery and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine. "With refinement, this approach may prove to be applicable to the majority of patients receiving the full spectrum of solid organ transplants."

Leventhal authored the study along with Suzanne Ildstad, MD, director of the Institute of Cellular Therapeutics at the University of Louisville. It is the first study of its kind where the donor and recipient do not have to be related and do not have to be immunologically matched. Previous studies involving stem cell transplants for organ recipients have included donors and recipients who are siblings and are immunologically identical, something that only occurs in about 25 percent of sibling pairs.

"Being a transplant recipient is not easy. In order to prevent rejection, current transplant recipients must take multiple pills a day for the rest of their lives. These immunosuppressive medications come with serious side effects with prolonged use including high blood pressure, diabetes, infection, heart disease and cancer, as well as direct damaging effects to the organ transplant," said Ildstad. "This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients."

In a standard kidney transplant, the donor agrees to donate their kidney. In the approach being studied, the individual is asked to donate part of their immune system as well. The process begins about one month before the kidney transplant, when bone marrow stem cells are collected from the blood of the kidney donor using a process called apheresis. The donor cells are then sent to the University of Louisville to be processed, where researchers enrich for "facilitating cells" believed to help transplants succeed. During the same time period, the recipient undergoes pre-transplant "conditioning," which includes radiation and chemotherapy to suppress the bone marrow so the donor's stem cells have more space to grow in the recipient's body.

Once the facilitating cell-enriched stem cell product has been prepared, it is transported back to Northwestern, where the recipient undergoes a kidney transplant. The donor stem cells are then transplanted one day later and prompt stem cells to form in the marrow from which other specialized blood cells, like immune cells, develop. The goal is to create an environment where two bone marrow systems exist and function in one person. Following transplantation, the recipient takes anti-rejection drugs which are decreased over time with the goal to stop a year after the transplant.

"This is something I have worked for my entire life," said Ildstad, who pioneered the approach and is known for her discovery of the "facilitating" cell.

Less than two years after her successful kidney transplant, 47-year-old mother and actress Lindsay Porter of Chicago, is living a life that most transplant recipients dream of she is currently free of anti-rejection medications and says at times, she has to remind herself that she had a kidney transplant. "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." Doctors are hopeful that Porter will not need immunosuppressive drugs long-term, given her progress thus far.

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New transplant method may allow kidney recipients to live life free of anti-rejection medication

Los Angeles Times

Patients who are lucky enough to get a transplant for a failed organ usually face a lifetime on anti-rejection drugs, which are expensive, dangerous and not always effective.

But in the future, those drugs may not be needed. A new study suggests that patients receiving an organ that's less than a perfect match can be protected against rejection by a second transplant this time of the organ donor's imperfectly matched stem cells.

Though preliminary, the new study is being hailed as a potential game-changer in the field of transplantation, a mystifying development that could offer hope to hundreds of thousands of patients who await or have received donor kidneys and depend on a harsh regimen of daily anti-rejection pills.

The small pilot study, reported Wednesday in the journal Science Translational Medicine, describes a novel regimen that combined old-fashioned cancer treatments with 21st century cell therapy to induce five patients' immune systems to accept donor kidneys as their own despite significant incompatibility.

If the technique proves successful in a larger group of people, future transplant patients may need to take anti-rejection drugs only briefly, and some who rely on them now could discontinue them safely. The recipients of kidneys as well as other organs, including heart, lung, liver and pancreas, might also benefit from access to a wider pool of organs.

The strategy could offer hope, too, for patients receiving bone marrow transplants to treat blood cancers, speeding the process of finding a donor by allowing physicians to use stem cells that today would be rejected as incompatible.

"Few transplant developments in the past half century have been more enticing," wrote pioneer transplant surgeons James F. Markmann and Tatsuo Kawai of Massachusetts General Hospital, in a commentary accompanying the study. If borne out, they wrote, the findings "may potentially have an enormous, paradigm-shifting impact on solid-organ transplantation."

In an interview, Markmann said that the greatest benefit of techniques described in the new research would be to greatly improve the lives of transplant patients by freeing them of a lifetime reliance on anti-rejection drugs.

But it might also ease the shortage of transplantable organs somewhat by reducing the number lost to rejection, he said. According to the National Kidney Foundation, 4,573 U.S. patients died in 2008 awaiting a kidney transplant due to a donor shortage.

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Study suggests breakthrough in organ transplants