Press release - Northwestern Memorial News
Thursday, April 26, 2012
Kidney Transplanted Twice in Two Weeks
Press release - Northwestern Memorial News
Monday, February 27, 2012
Secondhand Smoke Causes Transplant Rejection
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Friday, June 24, 2011
FDA approves new drug for kidney transplant immunosuppression
FDA approves Nulojix for kidney transplant patients
The U.S. Food and Drug Administration approved Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant.
The drug is approved for use with other immunosuppressants (medications that suppress the immune system) -- specifically basiliximab, mycophenolate mofetil, and corticosteroids.
Betatacept (Nulojix) is a type of drug called a selective T-cell costimulation blocker. The drug helps to prevent organ rejection after a kidney transplant. Without immunosuppression, the body can reject a transplanted organ because the immune system recognizes the new organ as foreign (transplant rejection).
By preventing rejection, Nulojix, given through 30 minute intravenous infusions, works with other immunosuppressants to keep the new kidney working.
“Nulojix is a new option for kidney transplant patients,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This new medication used in combination with other immunosuppressants helps control the immune system and prevents organ rejection in patients receiving kidney transplants.”
Nulojix was evaluated in two open-label, randomized, multicenter, controlled Phase 3 studies that enrolled more than 1,200 patients and compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine. These trials demonstrated that the recommended Nulojix regimen is safe and effective for the prevention of acute organ rejection.
Nulojix carries a Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a type of cancer where white blood cells grow out of control after an organ transplant. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), the cause of mononucleosis. Transplant patients who have not been exposed to EBV have more difficulty mounting an effective immune response to the virus if they get infected after transplant; typically they get exposed to the virus at time of transplant, as it is carried in around 80 percent of donated organs. Patients should be tested for EBV and should only receive Nulojix if the test shows they have already been exposed to EBV.
Another Boxed Warning on the Nulojix label, as well as labels of other immunosuppressants, warns of an increased risk of serious infections and other cancers.
Common adverse reactions observed in transplant patients in the trials included low red blood count (anemia), constipation, kidney or bladder infection, and swollen legs, ankles, or feet. Any transplant patients, including those receiving Nulojix, should limit the amount of time spent in sunlight because of the risk of skin cancer and should not get live vaccines because of the risk of infection.
Please see accompanying Full Prescribing Information, including Boxed WARNINGS at www.NULOJIX.com or www.bms.com.
More than 89,000 patients are waiting for a kidney transplant in the United States, according to the Organ Procurement and Transplantation Network, which is overseen by HHS’ Health Resources and Services Administration.
Nulojix is marketed by Princeton, N.J.-based Bristol-Myers Squibb Company.
For More Information:
Approved Drugs:Questions and Answers
National Institute of Diabetes and Digestive and Kidney Diseases
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Wednesday, November 24, 2010
Researchers discover reasons for organ rejection
Results of study reveal that two molecules are interacting to create negative immune response
By Sarah Khan UCLA Daily Bruin
For patients whose organs have failed, an organ transplant often means another shot at a healthy life.
But more than 40 percent of organ transplants fail within one year. A patient’s antibodies will sometimes attack the foreign organ, a phenomenon that has been little understood by researchers up to this point, said Elaine Reed, director of the UCLA Immunogenetics Center.
On Tuesday, UCLA researchers published the results of a five-year study that uncovers previously unknown reasons for why organs are rejected by their host body, said Reed, a co-author of the study.
The key lies with two molecules, human leukocyte antigen and integrin beta-4, which depend on each other to incite the organ rejection, she said.
The interaction of human leukocyte antigen and integrin ignites a negative immune response in a patient with an organ transplant, Reed said. The patient’s body then produces antibodies to shut down the functioning organ, often by overgrowing blood vessel cells and restricting the organ’s access to oxygen and other nutrients.
This mechanism may explain why organ rejection is difficult to reverse, Reed said.
“Once the patients start making the antibodies, you can’t stop it,” she said. “Chronic rejection is the major problem.”
Although it is possible to live without an organ like a kidney, there are not many options for a patient whose body rejects a heart, liver or lung. In these cases, retransplant is often the choice for survival, Reed said.
Waiting periods to receive organs can be so long that patients sometimes die on the wait list, said Murray Kwon, a heart transplant surgeon at Ronald Reagan UCLA Medical Center.
The study doesn’t stop at solving the mystery of organ rejection.
The team is also looking at applying the research to cancer prevention and treatment, said Xiaohai Zhang, lead author of the study and a postgraduate researcher in pathology and lab medicine at UCLA.
In the lab, Zhang prevented integrin from combining with human leukocyte antigen and, as a result, noticed that blood cells did not grow as much, he said.
It may be possible to do the same thing to tumors to keep blood vessels from sprouting inside them, he said.
Although the findings are not ready to be developed into drugs or therapies, the findings provide hope for organ transplant and cancer patients who otherwise have few options for a healthy life, Reed said.
“We have to understand the mechanism before we develop the therapy,” she said.
Published November 24, 2010 in News, Science & Health
Monday, October 25, 2010
Vitamin D Deficiency Linked To Lung Transplant Rejection
Maywood, IL– eNews Park Forest (ENEWSPF)– Vitamin D deficiency is associated with a significant increase in lung transplant rejection, according to research conducted at Loyola University Health System (LUHS). These data were presented Monday at The American Society for Bone and Mineral Research 2010 annual meeting in Toronto, Ontario.
"Vitamin D deficiency is prevalent among lung transplant recipients," said Pauline Camacho, MD, study investigator and director of the Loyola University Osteoporosis and Metabolic Bone Disease Center. "This study shed greater light on the serious impact that this deficiency has on lung transplant patients."
Patients who undergo lung transplants are at risk for rejecting the organ, and 77 percent of these patients are vitamin D deficient. Researchers believe that vitamin D helps the immune system tolerate the organ. Thus optimal levels of this supplement are critical for positive outcomes.
This study evaluated 122 patients who underwent a lung transplant at Loyola between January 2005 and June 2008. Sixty-four patients were male and 58 were female with an average age of 49.2 years. Vitamin D levels were checked following the transplants. Of the 122 patients, 50 percent were vitamin D deficient, 18 percent were not deficient and 32 percent were unknown. Vitamin D deficiency was associated with a significant increase in rejection for 51.7 percent of patients during the first year following transplant. Vitamin D deficiency also showed a trend toward increased airway inflammation in 16.7 percent of patients.
The health benefits of vitamin D are widespread and range from warding off cancer, osteoporosis, heart disease, diabetes and depression. Researchers speculate that vitamin D also may improve the health of lung transplant patients. Further studies will evaluate the effect of vitamin D therapy on short- and long-term lung transplant rejection rates, lung function and long-term survival.
Thomas Cascino, third-year medical student at Loyola University Chicago Stritch School of Medicine (Stritch); Charles Alex, MD, FCCP, program director for lung transplant at LUHS; and Ramon Durazo, PhD, assistant professor of preventive medicine and epidemiology at Stritch, also were study investigators.
For more information, visit http://www.loyolahealth.org
Thursday, February 04, 2010
Experimental Organ Transplant Drug Keeps Immune System in Check
In lab tests, it fights rejection and reduces need for immunosuppressive meds, study finds
By Amanda Gardner
HealthDay Reporter
(HealthDay News) -- Adding a new drug to the heavy regimen of immunosuppressant drugs given to organ transplant recipients not only prevented rejection of the new organ but also cut down on the amount of immunosuppressant drugs needed, a new study finds.
Researchers hope the experimental drug will eventually preclude the need for any immunosuppressant drugs after an organ transplant.
"Current drugs are quite toxic when it comes to long-term survival. There are side effects, and organs suffer because of the drugs," said Dr. Mohanram Narayanan, associate professor of internal medicine at Texas A&M Health Science Center College of Medicine in Temple and chief of clinical transplantation at Scott & White Healthcare. "This is a definite step in the right direction."
"The hope is that this will translate into a new treatment to prevent organ rejection in transplant patients," added Agnes Azimzadeh, second author of a study published Feb. 3 in Science Translational Medicine.
"The other long-term goal is not only to prevent the rejection of organs more efficiently than is done currently but also to induce tolerance to the graft itself," added Azimzadeh, an assistant professor of surgery at the University of Maryland School of Medicine in Baltimore.
"That means that we modulate, we tweak, we educate the immune system of the transplant recipient so it recognizes the graft as [its own] cells rather than recognizing it as foreign. We would educate the immune system so well that at some point we could stop or decrease significantly immunosuppressive drugs that the patient has to take."
Organ transplantation is the only hope for many patients experiencing kidney, heart or other organ failure, but the body's innate immune system perceives the new organ as a threat and sends out immune soldiers to attack it.
As a result, transplant recipients must take immunosuppressive drugs with major toxic side effects for the rest of their lives.
And the organ will eventually be rejected anyway, said the study authors.
Existing drugs aim at the immune system's T cells which, by attacking or not attacking a new organ, can make or break the transplant.
T cells are controlled by two pathways that can activate or inhibit release of the cells.
Current immunosuppressive drugs target both pathways, meaning that T cells can't do their regular job of clearing legitimate threats to the system, making organ recipients vulnerable to infection.
These scientists blocked only one pathway with a more specific antibody, leaving the immune system less reactive to the body's new resident.
None of the monkeys who were given either heart or kidney transplants with the usual immunosuppressive drugs plus the CD28 blocker had rejected their organs three months after receiving the drug.
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Wednesday, January 21, 2009
New hope for organ recipients
By Danny Rose, Medical Writer theage.com.au
Australian scientists have stumbled across a "weird" effect within the immune system that offers hope of a new treatment to help transplant recipients accept their donor organs.
Researchers at Sydney's Garvan Institute set out to investigate how inflammation works in transplants with an experiment using the immune system's most powerful "activator" - a hormone called B cell activating factor or BAFF.
Mice were genetically engineered to produce large amounts of BAFF, in the expectation studies would show how their boosted immune systems would rapidly reject any foreign tissue.
But the exact opposite happened, as the mice accepted their tissue transplants without the need for conventional treatment to suppress the immune system.
"I went to my boss and said `Hey, look at this. This is really weird'," Garvan Institute masters student Stacey Walters said of the moment she made the discovery.
Dr Shane Grey, of the institute's Immunology and Inflammation Program, said he and fellow scientists were "floored".
"Trolling through the scientific literature would make you think `Wow, this BAFF molecule is a very powerful activator of the immune system'," he said.
"To come out with a finding to say that having more of it prevents inflammation, and stops T cells from destroying tissues, at the outset it seems so surprising."
T cells are white blood cells that play a direct role in killing off foreign tissue, and Dr Grey said it seemed the extra BAFF - which led to a higher number of regulating B cells in the blood - had increased T cell tolerance.
The surprise discovery could lead to a targeted treatment for organ transplant recipients, as conventional methods suppress the whole immune system and place already sick people at risk of further illness.
"What we'd like to be able to do is say here's your organ graft and here's some therapies that actually modulate the immune system that is attacking (it)," Dr Grey said.
"But everything else is still working fine - you still have a viral response, you're still making antibodies, you can still clear other infections.
"This provides a lot of hope to say these strategies will happen."
The findings are published in the Journal of Immunology.
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Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network
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Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves
Friday, August 08, 2008
Treatment may reduce organ recipients' need for drugs
Scientists have developed a new treatment for organ transplant patients that may eliminate the need for long-term drug therapy to stop their bodies from rejecting the new organ.
German researchers have found that a cocktail of infection-fighting white blood cells from the transplant recipient and cells from the donor reduced or eradicated the need for immune-suppressing drugs.
In the study, researchers injected the cocktail of the transplant acceptance-inducing cells (TAICs) into organ recipients prior to or after the transplant procedure.
The findings are published in the August edition of the journal Transplant International.
The researchers said that transplant recipients have always been required to take a number of drugs to prevent their immune systems from rejecting the new organ.
However, those drugs don't always prevent rejection of the organ over a long-term period, and they can cause severe side effects.
"That is why our use of transplant acceptance-inducing cells (TAICs) in kidney transplant patients is such an exciting development, as it could eventually offer patients who have had transplant surgery a much higher quality of life, free from complex drug regimes," lead study author Dr. James A. Hutchinson, from the University of Schleswig-Holstein in Kiel, Germany, said in a statement.
"Although our use of TAICs is still in the preliminary stages, the results of our clinical trials on 17 kidney transplant patients are promising."
The study had two phases.
In the first phase, researchers gave 12 kidney transplant patients TAICs as well as conventional drug therapy to reduce the likelihood of organ rejection after their surgery.
Ten of the 12 patients were weaned off the conventional drugs over an eight-week period, with six of them being weaned down to tacrolimus monotherapy, a low-dose drug regime that has fewer side effects.
In the second phase, five kidney transplant patients received TAICs before their operations.
One of the patients went eight months without any conventional anti-rejection drugs, while three others were weaned to the tacrolimus montherapy.
The patients in both phases did not report any major side effects.
"Our research clearly shows that infusing TAICs into patients before they have a kidney transplant, or after the procedure has been carried out, is a practical and safe clinical option," Hutchinson said.
"Although this procedure is still being developed and refined, it poses an exciting possibility for clinicians and patients alike."
(Read a related article about a U.S. study in ScienceDaily)
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Tuesday, June 17, 2008
Immune Molecule That Plays A Powerful Role In Avoiding Organ Rejection Identified
From Science Daily:
When a mouse's immune system is deciding whether to reject a skin graft, one powerful member of a molecular family designed to provoke such a response can effectively reduce the visibility of the mouse's own cells and help the graft survive, researchers say.
"This is a molecule with huge potential to regulate immune response," Dr. Anatolij Horuzsko, reproductive immunologist at the Medical College of Georgia Center for Molecular Chaperone/Radiobiology and Cancer Virology, says of HLA-G dimer.
Dimer appears to be the most powerful among several known forms of HLA-G at inhibiting the immune response, researchers have found. Fetuses use this natural mechanism to hide from the mother's immune system and it's at work in some transplant patients as well.
Now that the scientists know which HLA-G is best at down-regulating the immune response and how it works, they believe the molecule's action can be augmented in people with organ transplants and autoimmune disease and turned down to help fight a tumor. Measuring endogenous levels of HLA-G dimer may also help physicians identify which transplant patients require little, if any, immune suppression. Read the complete article.
“You Have the Power to Save Lives – Sign Your Donor Card & Tell Your Loved Ones of Your Decision”
Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network
For other Canadian provinces click here
In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov
Your generosity can save up to eight lives through organ donation and enhance another 50 through cornea and tissue donation
