August 22, 2013

Could Redistricting Shorten The Wait For A Liver Transplant?

By LAURAN NEERGAARD 08/20/13 12:36 PM ET EDT

TRANSPLANT_REGIONS

WASHINGTON — Where you live can affect your chances of getting a liver transplant, and your risk of dying while waiting. The nation's transplant network says it's time to make the system fairer – and it may take a cue from how politicians redraw voting maps.

"Gerrymandering for the public good" is how Johns Hopkins University transplant surgeon Dr. Dorry Segev describes a proposal to change the map that governs how donated livers are distributed around the country.

The problem: Some areas have fewer donated organs, and higher demand for them, than others. The sickest patients go to the top of the waiting list. But the geographic variation means that someone in California, among the toughest places to get a new liver, waits longer and is a lot sicker before getting transplanted than someone in Ohio or Florida – if they survive long enough.

"This should not be happening," Segev said.

Segev is advising the United Network for Organ Sharing, which runs the transplant network, as its liver specialists consider the novel idea of "redistricting" how livers are allocated – redrawing the nation's 11 transplant regions based on the distribution and demand for donated organs, much like lawmakers set political districts based on the party voting histories of different areas.

The ultimate goal: "That your chance of dying without a liver transplant doesn't depend on your ZIP code," said Dr. John Roberts, transplant chief at the University of California, San Francisco.

The geographic disparity adds another hurdle to the already dire shortage of livers. Just 6,256 patients received a liver transplant last year, all but a few hundred from deceased donors. Nearly 16,000 people are awaiting a liver. About 1,500 people die waiting every year.

Desperate patients sometimes travel across the country to get on a shorter waiting list, if they can afford it or even know it's possible. The best-known example is the late Apple CEO Steve Jobs, who lived in California but in 2009 had a transplant in Memphis, Tenn., which at the time had one of the shortest waits. That's harder for the less wealthy to do.

"I could have withered away here," said William Sherbert, 47, who temporarily moved from California to Florida for a faster transplant.

When hepatitis B caused liver failure, Sherbert spent a year awaiting a transplant from a Los Angeles hospital. He was getting steadily sicker, but was nowhere near the top of the transplant list when his frantic partner finally unraveled how the system works.

Patients who have the highest MELD score – a ranking, based on laboratory tests, that predicts their risk of death – move up the waiting list. But it's not a single national list. The 11 transplant regions are subdivided into local areas that form individual waiting lists, and there are wide variations in organ availability within regions as well as between them. Generally livers first are offered to the sickest patients locally and then regionally. Changes that began this summer will allow some of the sickest patients access to livers from other parts of the country, an initial step to address disparities.

United Network for Organ Sharing figures show that in three regions stretching from Michigan and Ohio down to Florida, adults receiving new livers over the past two years had median MELD scores of 22 to 23. But in the region that includes California, recipients were far sicker, with a median score of 33. Nearly as tough were regions that include New York, and the Dakotas and Illinois.

An Internet database, the Scientific Registry of Transplant Recipients, compares transplant center wait times and success rates so people can choose where to go. They can get on more than one waiting list if they meet each hospital's qualifications, and if they can get to that center within a few hours of being notified that an organ is available. Often, that means moving.

"It's really a shame" that people have to consider such a step, Sherbert said. But he's glad he switched to a Florida hospital's list, possible only because his health insurance paid for the transplant plus the couple's airfare and some living expenses during the seven-month wait. Sherbert is feeling well after his May 2012 transplant, and is back home in Garden Grove, Calif.

In a study published last month in the American Journal of Transplantation, Segev's team used computer modeling to redistrict the transplant regions, better balancing local areas' supply and demand. Segev said 28 percent of Americans live in an area where they'd have a high risk of death before getting a new liver, and redistricting could drop that proportion to as little as 6 percent.

The transplant network's liver committee is considering different map options as it debates how to improve fairness without having to fly organs too far around the country. One big challenge will be turf wars, as transplant centers with shorter waits understandably don't want them to lengthen, said committee chairman Dr. David Mulligan of the Mayo Clinic in Phoenix.

"Every doctor wants the best for their patients. The issue becomes stepping back and looking at the big picture and thinking about all the patients," said Mulligan, who hopes to have a proposal ready for public comment within two years. "Yes, your patient waits a little longer, but they can wait a little longer."

Smaller disparities exist for some other transplants, including kidneys, but the transplant network is focusing first on livers. It wouldn't be a problem if there were more organ donors, Mulligan noted, encouraging people to register: "It's the last chance we have to be a hero in our lives."

Source

The American Journal of Medicine
Volume 126, Issue 8 , Pages 718-722, August 2013

Emily McGibbon, MPH, Katherine Bornschlegel, MPH, Sharon Balter, MD

New York City Department of Health and Mental Hygiene, Long Island City, NY

published online 19 June 2013.

Abstract

Background

Recent guidelines recommend testing all individuals born during 1945-1965 for hepatitis C virus (HCV) antibody. For antibody-positive patients, subsequent RNA testing is necessary to determine current infection status. This study aimed to assess whether clinicians order HCV RNA tests as recommended for antibody-positive patients and to identify barriers to such testing.

Methods

We sampled individuals newly reported to the New York City Department of Health and Mental Hygiene's HCV surveillance system and collected information from clinicians. For patients without RNA test results, we asked the reason an RNA test was not ordered and requested that the clinician order the test.

Results

Of 245 antibody-positive patients, 67% were tested for HCV RNA (for 21% of these, the test was ordered only after our request); 33% had no RNA testing despite our request. Patients without RNA testing were seen in medical facilities (47%), detox facilities (30%), and jail/prison (15%). Reasons RNA testing was not done were that the patient did not return for follow-up (35%), the facility does not do RNA testing (22%), and the patient was tested in jail (15%).

Conclusions

In our study, one third of patients did not get complete testing for accurate diagnosis of HCV, which is essential for medical management. Additional education for clinicians about the importance of RNA testing may help. However, with improved antiviral treatments now available for HCV, it is time for reflex HCV RNA testing for positive antibody tests to become routine, just as reflex Western blot testing is standard for human immunodeficiency virus.

Keywords: Hepatitis C, Surveillance, Testing

Funding: This work was supported in part by an Emerging Infections Program grant for hepatitis surveillance from the Centers for Disease Control and Prevention.

Conflict of Interest: None.

Authorship: All authors had access to the data and a role in writing the manuscript.

PII: S0002-9343(13)00228-3

doi:10.1016/j.amjmed.2013.01.031

© 2013 Elsevier Inc. All rights reserved.

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Tuesday, 20-08-2013

Until now, surgeons have had to memorize the precise location of important blood vessels in organs and where tumors could likely be found and need to be removed. A new app for tablet computers developed by Fraunhofer MEVIS in Bremen could support surgeons in the future and help them reduce the rate of complications during operations. The system has recently been tested for the first time in Germany. On August 15, the surgical team at the Asklepios Klinik Barmbek in Hamburg successfully tested the app during a liver operation.

A liver cancer operation usually lasts many hours because the organ is difficult to operate. It hosts a branching vessel structure through which one and a half liters of blood flow every minute. If a surgeon makes a cut in an inappropriate place, this puts the patient at risk of severe blood loss. In addition, doctors must ensure that the patient retains enough organ volume for survival and that this volume is sufficiently supplied with blood. To accomplish this, doctors need to know as accurately as possible both before and during an operation where blood vessels inside the organ are located.

The new tablet app from the Fraunhofer Institute for Medical Image Computing MEVIS in Bremen promises to deliver this support. It is based on the established MEVIS software for liver operation planning that is employed in clinics worldwide and has been used for more than 6000 patients. Based on 3D x-ray images, the software can reconstruct the locations of blood vessels in the liver for each patient. Before an operation, surgeons can then precisely plan how and where to place the scalpel to most effectively remove a tumor.

However, there are limitations: doctors usually have little opportunity to view the software images during surgery and compare the surgical situation with planning data. Some surgeons even print out images to take into the operating room. "With our app, the entire set of planning data can be shown directly on the operating table" said MEVIS computer scientist Alexander Köhn.

At the intervention in Hamburg, the clinicians used a further feature of the new app. With the integrated camera, the tablet could film the liver during the operation. The app then superimposed the planning data - a branched network showing the vessel system in different colors. "Using this function, we can virtually look into the organ and make the tumor and vessel structures visible" said Prof. Dr. Karl Oldhafer, Chief of the Department of Surgery at the Asklepios Klinik Barmbek in Hamburg. This simplifies comparison to determine whether the intervention has gone according to plan. "With this new technology, we are able to better implement computer-supported operation planning for tumor removal" remarked Oldhafer. "The method has great potential. We imagine using it for operations on other organs, such as the pancreas."

Alexander Köhn developed the first version of the app with doctors at the Yokohama City University Hospital. The app was tested there at the end of 2012 for the first time during an operation. "The Japanese surgeons were very impressed by the capabilities of the system" said Köhn. "They hope that the app will help reduce complication rates and shorten hospital stays." For future interventions, the app offers the following capabilities:

  • By simply marking the touchscreen, doctors can measure the length of a vessel to be removed. This helps the doctor estimate whether the remaining ends can be sewn together or whether a new piece of vessel must be inserted.
  • After the surgeon removes certain vessels, he can remove them on the app screen with a virtual 'eraser'. The separated vessels disappear from the screen and let the doctor view underlying structures.
  • If, during the operation, a tumor is judged to be larger than at first thought, surgeons must make snap decisions. The MEVIS app can also help here. If additional vessels must be removed, the app calculates which parts of the liver will no longer be sufficiently supplied with blood. This lets the surgeon better estimate whether the remaining organ volume is large enough for the patient to survive.

For many years, Fraunhofer MEVIS has developed procedures to bring image-based planning information into the operating room and make them directly accessible to surgeons. The challenge is that a large amount of data must be efficiently reduced so that the surgeon is always supplied with the most recent and most important information. To allow doctors to request data quickly and selectively, researchers are developing novel interaction strategies. Tablet computers such as the iPad are only one way to implement these ideas. Other MEVIS teams are working to develop navigation systems similar to those found in cars, to project planning data directly on the organ or surgical drapes, and to use gestures to recall desired information.

Source

PRESS RELEASE August 22, 2013, 11:54 a.m. ET

PALO ALTO, Calif., Aug. 22, 2013 /PRNewswire/ -- Cellular Biomedicine Group (OTCQB: CBMG) today announced that it has completed patient enrollment for its Phase I trial to evaluate the safety and preliminary efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.

The Phase I clinical trial for TC-DC therapy for HCC is an open label clinical trial conducted with Shanghai's PLA 85 Hospital, which is a Liver Disease Center. The trial will evaluate the safety and efficacy in lowering the incidence of tumor recurrence and metastasis by means of autologous immune cell therapy in primary HCC patients following standard tumor resection and TACE chemotherapy.

Dr. Cheng Xiang (Chase) Dai, Cellular Biomedicine Group's VP and GM of the Autologous Products Business Unit, said, "We are pleased with this important achievement in the advancement of our therapy for liver cancer, and are on schedule to complete the Phase I trial in Q4 of this year."

About Hepatocellular Carcinoma

Forty-five percent of the world's HCC patients are in China, with over 300,000 new patients diagnosed every year. The therapies commonly offered to most patients are surgery and local chemotherapy, with a 2-year recurrence rate of 51% and median survival time of 13 months.

About TC-DC Therapy for Hepatocellular Carcinoma

TC-DC therapy takes a sample of the patient's own dendritic cells, which are the 'trainer' cells of effecter immune cells, and a sample of the patient's tumor stem cells, and co-cultures them together in the lab. The dendritic cells will learn the characteristics of the patient's own tumor stem cells, and are reintroduced to the patient's body as a vaccine, where they can 'train' the immune system to fight and destroy the tumor stem cells, which are the root cause of tumor recurrence and metastasis.

"One of the primary difficulties in administering effective cancer therapy is in the uniqueness of the disease; no two cancers are the same, " explained Dr. William Cao, President of CBMG, "Therefore, we source both immune and cancer stem cells directly from the patient so that each treatment is specific to each individual. In addition, rather than break down the cancer stem cell and use a portion of it, we use the whole cancer stem cell as the antigen source to stimulate the patient's own dendritic cells."

About Cellular Biomedicine Group

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com

Forward-Looking Statements

Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

Contact:

Jeff Ramson

Investor Relations

ProActive Capital Group

+1 646-863-6341

Sarah Kelly

Director of Corporate Communications, CBMG

+1 650 566 5064

sarah.kelly@CellBioMedGroup.com 

SOURCE Cellular Biomedicine Group

/Web site: http://www.cellbiomedgroup.com

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