Children Undergoing Bone Marrow Transplant Remain At Risk For Premature Death

MedicalResearch.com Interview with:

Smita Bhatia, MD, MPH Gay and Bew White Endowed Chair in Pediatric Oncology Professor, Pediatric Oncology Vice Chair for Outcomes Research, Dept of Pediatrics Director, Institute for Cancer Outcomes and Survivorship School of Medicine University of Alabama at Birmingham Associate Director for Outcomes Research UAB Comprehensive Cancer Center 

Dr. Bhatia

Smita Bhatia, MD, MPH
Gay and Bew White Endowed Chair in Pediatric Oncology
Professor, Pediatric Oncology
Vice Chair for Outcomes Research, Dept of Pediatrics
Director, Institute for Cancer Outcomes and Survivorship
School of Medicine
University of Alabama at Birmingham
Associate Director for Outcomes Research
UAB Comprehensive Cancer Center 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Allogeneic bone marrow transplantation BMT is used with a curative intent for life-threatening malignant and non-malignant diseases of childhood.

In this observational study, we describe the late mortality experienced by children undergoing BMT over the past 3 decades. Our cohort included 1388 BMT recipients who had undergone allogeneic BMT between 1974 and 2010 and survived 2 or more years.

We found that, conditional on surviving the first 2 years after bone marrow transplantation, the probability of surviving an additional 20 years approached 80%. Risk of dying from non-relapse-related causes exceeded the risk of dying from relapse-related causes.

The leading non-relapse-related causes of death were infection (with or without graft vs. host disease) and new cancers. Overall, the cohort was at a 14-fold greater risk of dying as compared with the general population (of similar age and sex). Further, this excess risk remained elevated even among those who had survived 25 years.

On a positive note, the risk of late mortality has continued to decline over the past 3 decades. 

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Hepatitis C Treatment After Kidney Transplant May Extend Lives and Decrease Costs

MedicalResearch.com Interview with:

Mark H. Eckman, MD Posey Professor of Clinical Medicine Director, Division of General Internal Medicine Director, Center for Clinical Effectiveness University of Cincinnati Medical Center Cincinnati, OH

Dr. Eckman

Mark H. Eckman, MD
Posey Professor of Clinical Medicine
Director, Division of General Internal Medicine
Director, Center for Clinical Effectiveness
University of Cincinnati Medical Center
Cincinnati, OH 

MedicalResearch.com: What is the background for this study?

Response: People who are infected with hepatitis C virus and have kidney failure need a kidney transplant.

Recent studies have found that it is possible to transplant kidneys from donors who are infected with hepatitis C virus into patients who need a transplant and are already infected with the virus. In addition, drugs are available to cure most patients of hepatitis C virus, including those who have kidney failure. Infected patients who need a kidney transplant have 2 options. One option is to receive an infected kidney and then use drugs after the transplant to cure themselves and the transplanted kidney of the virus. Another option is to use the drugs first to get rid of the virus and then to receive a kidney from a donor who does not have hepatitis C virus infection.

For the more than 500,000 patients receiving dialysis for end-stage renal disease (ESRD), less than 4% receive kidney transplants. Because of the limited organ availability, hemodialysis is the final treatment for most patients with ESRD. Of the 10% or so of U.S. patients receiving dialysis who are infected with the hepatitis C virus (HCV), some are willing to accept HCV-infected kidneys, in part, because the wait times for such kidneys are shorter than those for HCV-uninfected kidneys. Because the yearly mortality rate for patients receiving hemodialysis is so high, between 4% and 16%, reducing the time to kidney transplant can have a dramatic effect on both survival and quality of life.

Because it may not be possible to do this type of research with actual people, we created a model that allowed us to estimate possible outcomes without using actual people.

The model was a computer program that combined the best available information to approximate what might happen to participants in a real-world clinical trial. Continue reading

Organ Transplant Recipients Require Vigilant Sun Protection

MedicalResearch.com Interview with:
“Sunscreen” by Tom Newby is licensed under CC BY 2.0Rebecca Ivy Hartman, M.D
Instructor in Dermatology
Brigham and Women’s Hospital
Boston MA 02115

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Organ transplant recipients (OTR) are at 100-fold higher risk to develop certain skin cancers compared to the general population due to immunosuppression, and thus preventing skin cancer in this population is critical.

Our study found that in a high-risk Australian OTR population, only half of patients practiced multiple measures of sun protection regularly.

However, after participating in a research study that required dermatology visits, patients were over 4-times more likely to report using multiple measures of sun protection regularly. Patients were more likely to have a positive behavioral change if they did not already undergo annual skin cancer screening prior to study participation.

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Early Study Demonstrates Airways Can Be Transplanted from Aortic Templates

MedicalResearch.com Interview with:
Emmanuel Martinod MD PhD
Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Chirurgie Thoracique et Vasculaire, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny,
Université Paris Descartes, Fondation Alain Carpentier, Laboratoire de Recherche Bio-chirurgicale, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou
Paris, France 

MedicalResearch.com: What is the background for this exciting new technology and study? What are the main findings? 

Response: What is the background for this exciting new technology and study? What are the main findings?

Response:  The background is 10 years of research at laboratory followed by 10 years of academic clinical research.

We demonstrated the feasability of airway bioengeenring using stented aortic matrices for complex tracheal or bronchial reconstruction.  Continue reading

Pre-Emptive Therapy of CMV in Allogeneic Hematopoietic Cell Transplant

MedicalResearch.com Interview with:

 Dr-Roy F. Chemaly

Dr. Chemaly

Roy F. Chemaly, MD, MPH F.A.C.P., F.I.D.S.A.
Department of Infectious Diseases
Infection Control and Employee Health
Division of Internal Medicine
MD Anderson Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: CytomegalovirusCMV infection is a common cause of morbidity and mortality in allo-HCT recipients. Evidence suggests that CMV infection has not only an enormous clinical burden, but a substantial economic burden as well.

We conducted this study at MD Anderson to determine the economic and clinical burden of preemptive therapy (PET) for CMV infection. Between 2012 and 2015, 100 consecutive patients hospitalized at our institution for allo-HCT who experienced reactivation of CMV and were treated pre-emptively, were enrolled.

The majority of patients were men (55%), who had underlying leukemia (73%), and underwent matched unrelated donor transplant (59%). At the time of hospitalization, most patients had acute GvHD (62%), and were on steroids (58%) within 30 days of CMV reactivation which occurred at a median of 32 days post-HCT (2 -174). A total of 192 episodes of PET occurred in the 100 allo-HCT recipients within 1 year post-HCT. PET consisted of ganciclovir (41%), foscarnet (40%), and valganciclovir (38%). IVIG was also used as adjunct therapy in 20% of episodes.

Progression to Cytomegalovirus disease occurred in 4 patients (4%) and mainly affected the GI tract. Mean length of stay for patients treated with ganciclovir or foscarnet was 32 days (2-141) and 41 days (1-177), respectively. The average direct cost per patient admitted for PET was $126,038 ($7,866-$641,841) and the mean cost of CMV antiviral drug per hospitalization was $6,096 for IVIG, $2,410 for foscarnet, $836 for ganciclovir, and $780 for valganciclovir.

Serious side effects from PET were observed in 35% of patients on ganciclovir and 12% of patients on foscarnet. Total direct cost per encounter was significantly higher in patients who had serious side effects from foscarnet. All-cause mortality was 59% at 1 year post-transplant.

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Electronic Pillbox May Improve Adherence To Complicated Medication Regime

MedicalResearch.com Interview with:

Bethany J. Foster, MD MSCE Montreal Children’s Hospital Department of Pediatrics,  Department of Epidemiology, Biostatistics, and Occupational Health McGill University, Montreal, QC, Canada

Dr. Foster

Bethany J. Foster, MD MSCE
Montreal Children’s Hospital
Department of Pediatrics,
Department of Epidemiology, Biostatistics, and Occupational Health
McGill University, Montreal, QC, Canada

MedicalResearch.com: What is the background for this study?

Response: Adolescent and young adult kidney transplant recipients have the highest risk of graft loss of any age group. One of the main reasons for this is not taking their anti-rejection medications as prescribed. Our study had the goal of testing an intervention to try to improve young patients’ adherence to their strict medication schedule. The intervention included feedback of how well they were taking their medications (which was monitored electronically), text message reminders for medication doses, and individualized coaching to address their personal barriers to taking their medications.

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Investigational Imaging Test Can Help Determine Success or Failure of Bone Marrow Transplant

MedicalResearch.com Interview with:

Kirsten Williams, M.D. Blood and marrow transplant specialist Children’s National Health System

Dr. Williams

Kirsten Williams, M.D.
Blood and marrow transplant specialist
Children’s National Health System 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: This study addressed a life-threatening complication of bone marrow transplantation called bone marrow failure. Bone marrow transplantation has provided a cure for patients with aggressive leukemias or acquired or genetic marrow dysfunction. The process of bone marrow transplantation involves giving chemotherapy and/or radiation, which removes the diseased blood cells from the bone marrow. After this, new bone marrow stem cells are infused from a healthy individual. They travel to the bone marrow and start the slow process of remaking the blood system. Because these new cells start from infancy, it takes upwards of four to five weeks for new mature healthy cells to emerge into the blood, where they can be identified. Historically, there has been no timely way to determine if the new cells have successfully repopulated unless they can be seen in the blood compartment. This condition of bone marrow failure is life-threatening, because patients don’t have white blood cells to protect them from infection. Once bone marrow failure is diagnosed, a second new set of stem cells are infused, often after more chemotherapy is given. However, for many individuals this re-transplantation is too late, because severe infections can be fatal while waiting cells to recover.

We were the first group to use a new imaging test to understand how the newly infused bone marrow cells develop inside the patient. We have recently published a way to detect the new bone marrow cell growth as early as five days after the cells are given. We used an investigational nuclear medicine test to reveal this early cell growth, which could be detected weeks before the cells appear in the blood. This radiology test is safe, does not cause any problems and is not invasive. It is called FLT (18F-fluorothymidine) and the contrast is taken up by dividing hematopoietic stem cells. The patients could even see the growth of their new cells inside the bone marrow (which they very much enjoyed while waiting to see recovery of the cells in their blood). We could use the brightness of the image (called SUV) to determine approximately how many weeks remained before the cells were visible in the blood.

Finally, we actually could see where the new cells went after they were infused, tracking their settling in various organs and bones. Through this, we could see that cells did not travel directly to all of the bones right away as was previously thought, but rather first went to the liver and spleen, then to the mid-spine (thorax), then to the remainder of the spine and breastplate, and finally to the arms and legs. This pattern of bone marrow development is seen in healthy developing fetuses. In this case, it occurs in a similar pattern in adults undergoing bone marrow transplant.

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Umbilical Cord Blood Stem Cells May Improve Symptoms in Children with Autism

MedicalResearch.com Interview with:

Michael G. Chez, M.D. Director of Pediatric Neurology Sutter Memorial Hospital Director of the Pediatric Epilepsy and Autism Programs Sutter Neuroscience Group 

Dr. Michael Chez

Michael G. Chez, M.D.
Director of Pediatric Neurology Sutter Memorial Hospital
Director of the Pediatric Epilepsy and Autism Programs
Sutter Neuroscience Group 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The study looked at possible use of autologous cord blood as a source of stem cells in patients with autism. The patients had to have fairly good genetic screening per protocol and had confirmation of autism to participate.

The use of cord blood was a pilot cross over double blind study with hypothesis that a post natal factor or immune dysregulation may add to the autism clinical phenotype.

Cord blood ( the baby’s own from birth) is a safe source of mixed stem cell types and should be safe from rejection or autoimmune reaction in theory.

Infusion /placebo or placebo/infusion was randomized and observed and tested every 3 months with switch to other wing of treatment at 0 and 6 months. Total observation was over 1 year.

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Potentially Cancerous Genital Lesions Common in Transplant Population

MedicalResearch.com Interview with:

Dr. Christina Lee Chung, MD Associate Professor Department of Dermatology Drexel University

Dr. Chung

Dr. Christina Lee Chung, MD
Associate Professor
Department of Dermatology
Drexel University

MedicalResearch.com:  What is the background for this study?  What are the main findings?

Response: In early 2016, five years after the inception of our specialty medical-surgical transplant dermatology center, we realized our nonwhite transplant patients were developing skin cancer at higher rates and found interesting trends. These data were published in a previous manuscript. One of the more striking findings was that these patients were developing a high proportion of skin cancer in non-sun-exposed areas such as the genital region. There are no standard guidelines regarding genital skin evaluation and it is unclear how often it is performed in any capacity amongst dermatologists, including practitioners in our center, quite frankly. Our group was concerned that we could be missing skin cancers in this “hidden” area in our high-risk organ transplant population so we launched a quality improvement initiative that incorporated thorough genital skin evaluation as a standard part of post-transplant skin cancer screening.   

Fifteen months after we started this modified screening process, we decided to evaluate the results. To account for any variation in examination, we looked at the findings of a single practitioner.

We found that genital lesions are common in the transplant population and include high rates of genital warts and skin cancer. However, patient awareness of the presence of genital lesions was alarmingly low. Nonwhite transplant patients, Black transplant recipients in particular, were disproportionately affected by both genital warts and genital skin cancer in our cohort. Similar to cervical cancer, high-risk HPV types were closely associated with genital squamous cell carcinoma development in our transplant population. Continue reading

What Are The Health Risks To Living Kidney Donors?

Emanuele Di Angelantonio MPhl Department of Public Health and Primary Care School of Clinical Medicine University of Cambridge 

Emanuele Di Angelantonio

MedicalResearch.com Interview with:
Emanuele Di Angelantonio MPhl

Department of Public Health and Primary Care
School of Clinical Medicine
University of Cambridge 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: This systematic review supports and expands previous research suggesting that living kidney donors have no increased risk for several major chronic diseases, with the exception of end stage renal disease. Female donors seem to be at increased risk for preeclampsia. Furthermore, there was no evidence that living kidney donors had higher risk for mortality, cardiovascular disease, or type 2 diabetes, or reduced quality of life. –

MedicalResearch.com: What should readers take away from your report?

Response: This study highlights the low but real risks of living kidney donation and emphasise the importance of careful assessment and counseling for all living kidney donors. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: While this systematic review and meta-analysis provide some important answers, the field is still a long way from offering precise risk estimates to prospective donors.  

No disclosures 

Citations:

O’Keeffe LM, Ramond A, Oliver-Williams C, Willeit P, Paige E, Trotter P, et al. Mid- and Long-Term Health Risks in Living Kidney DonorsA Systematic Review and Meta-analysis. Ann Intern Med. [Epub ahead of print 30 January 2018] doi: 10.7326/M17-1235

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Despite 20 Years of Programs and Policies, Racial Disparities in Kidney Transplants Widen

MedicalResearch.com Interview with:

Tanjala S. Purnell, PhD MPH Assistant Professor of Surgery, Epidemiology, and Health Behavior and Society Core Faculty, Epidemiology Research Group in Organ Transplantation Johns Hopkins University Associate Director for Education and Training, Johns Hopkins Center for Health Equity Member, OPTN/UNOS Minority Affairs Committee

Dr. Purnell

Tanjala S. Purnell, PhD MPH
Assistant Professor of Surgery, Epidemiology, and Health Behavior and Society
Core Faculty, Epidemiology Research Group in Organ Transplantation
Johns Hopkins University
Associate Director for Education and Training, Johns Hopkins Center for Health Equity
Member, OPTN/UNOS Minority Affairs Committee 

MedicalResearch.com: What is the background for this study?

  • Our study was motivated by the fact that we know live donor kidney transplants are associated with longer life expectancy and higher quality of life than deceased donor kidney transplants or long-term dialysis treatment. We also know that Black and Hispanic adults are more likely than White adults to have end-stage kidney disease but are less likely than White patients to receive live donor kidney transplants.
  • Over the last 2 decades, there have been several transplant education programs implemented within transplant centers and dialysis centers, and legislative policies enacted to improve overall access to live donor kidney transplants for patients. We wanted to see whether these programs and policies resulted in narrowed racial and ethnic disparities in access to live donor kidney transplants in the United States. 

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Alcohol-Harm Paradox Linked To Drinking Patterns

MedicalResearch.com Interview with:
“Alcohol” by Jorge Mejía peralta is licensed under CC BY 2.0Dr. Eirik Degerud, PhD

Norwegian Institute of Public Health

MedicalResearch.com: What is the background for this study?

Response: Alcohol-related hospitalisations and deaths are more frequent among individuals with low socioeconomic position, despite that they tend to drink less on average. This is referred to as the alcohol-harm paradox. Alcohol is associated with both higher and lower risk of cardiovascular disease, depending on the drinking pattern. We wanted to assess if the paradox was relevant to these relationship also. Continue reading

Benefits of Transplanting Hepatitis C Infected Livers May Outweigh Risks

MedicalResearch.com Interview with:

Jagpreet Chhatwal, PhD Assistant Professor, Harvard Medical School MGH Institute for Technology Assessment Boston, MA

Dr. Chhatwal

Jagpreet Chhatwal, PhD
Assistant Professor, Harvard Medical School
MGH Institute for Technology Assessment
Boston, MA and

Sumeyye Samur PhD Postdoctoral Fellow MGH-Harvard Medical School

Dr. Samur

Sumeyye Samur PhD
Postdoctoral Fellow
MGH-Harvard Medical School

MedicalResearch.com: What is the background for this study?

Response: The number of patients who are in need of liver transplant continues to rise whereas the availability of organs remains limited, therefore, it becomes is important to utilize all available livers.

Under the current practices, only Hep-C infected patients are eligible to receive infected livers. However, with the advent of high efficacy drugs, number of infected recipients has decreased over the last decade. On the other hand, with the rise of opioid use, number of Hep-C infected organs increased. With this contradiction, it becomes paramount of importance to utilize the infected livers which could help save more lives on the transplant waiting list.

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Stem Cell Transplantation Offers Hope For Severe Scleroderma

MedicalResearch.com Interview with:

“Breastfeeding welcome here” by Newtown grafitti is licensed under CC BY 2.0

Picture of a female patient’s left arm, showing skin lesions caused by Scleroderma
Wikipedia image

Keith M. Sullivan, M.D.
James B. Wyngaarden Professor Of Medicine
Division of Cellular Therapy
Duke University Medical Center
Durham, North Carolina 27710, USA 

MedicalResearch.com: What is the background for this study? What are the main findings?

  • Scleroderma with internal organ involvement is a devastating  autoimmune disorder with considerable morbidity and high mortality which have not changed in 40 years of reporting. Effective new therapies are needed.
  • Despite 2 prior randomized trials showing benefit for reduced-intensity stem cell transplant vs. conventional cyclophosphamide immune suppression, clinical practice in the US did not change due in part due to concern about patient safety and durability of response (attached).
  • The current randomized trial compares 12 monthly infusions of cyclophosphamide with high-dose chemotherapy plus whole-body irradiation designed to wipe-out (myeloablate) the defective, self-reactive immune system and replace with the patients own stem cells which had been treated to remove self-reacting lymphocytes. This was the first study to test if myeloablative autologous could re-establish a normal functioning immune system in patients with scleroderma.

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Letermovir (Prevymis) Prevents CMV Infection in Stem Cell Transplant

MedicalResearch.com Interview with:

Francisco M. Marty, M.D Associate Professor, Harvard Medical School Dana–Farber Cancer Institute and Brigham and Women’s Hospital

Dr. Marty

Francisco M. Marty, M.D
Associate Professor, Harvard Medical School
Dana–Farber Cancer Institute and
Brigham and Women’s Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Cytomegalovirus (CMV) is the most common infection in patients who undergo allogeneic hematopoietic-cell transplantation (bone marrow transplantation with cells from donors different than the patient). Up until now, we had no antiviral agent that could be used for prophylaxis (prevention) of CMV post-transplant because of the side effects of drugs available to date (ganciclovir, valganciclovir, foscarnet, cidofovir).

This trial confirmed that letermovir was highly effective in preventing CMV infection when used in the first 100 days after allogeneic HCT, was associated with minimal side effects of concern and was also associated with lower all-cause mortality by Week 24 post-HCT.

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Capsule Fecal Transplant As Effective as By Colonoscopy for C. Diff Infections

MedicalResearch.com Interview with:

Clostridium difficile CDC image

Clostridium difficile
CDC image

Dina Kao, MD, FRCPC
Division of Gastroenterology, Department of Medicine
University of Alberta
Edmonton, Alberta, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We wanted to see what would be the best way to deliver fecal microbiota transplantation (FMT.)

There were many controlled studies of FMT delivered by various methods, showing different success rates. Not only were the route of delivery different, but the amount of donor stools also varied greatly from study to study. It appeared that most of the studies delivered by the upper routes gave a smaller amount of donor stool compared to the studies delivering FMT by colonoscopy.

Our hypothesis was that given the same amount of donor stool, the effectiveness would be similar by capsules and by colonsocopy.

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Non-Medical Factors Affect Racial Disparities in Kidney Transplant Wait Lists

MedicalResearch.com Interview with:
Yue-Harn Ng,
MD
University of New Mexico

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: ​African Americans (AA) have a higher incidence of end-stage renal disease but lower rates of kidney transplantation (KT) compared to whites (WH).  Disparities persist after adjusting for medical factors.  We assessed the relationship of non-medical (eg. cultural, psychosocial, knowledge) factors with kidney transplantation wait-listing (WL) within the context of racial differences.

​In this longitudinal cohort study, we found that African American patients were less likely to be wait-listed compared to White patients.  This difference was influenced by factors including age, comorbidities, socio-economic status, being on dialysis, having a living donor, transplant knowledge and social support.

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Transplant Network Undercaptures Post-Transplant Skin Cancers

MedicalResearch.com Interview with:

Thuzar M.Shin MD, PhD Assistant Professor of Dermatology Hospital of the University of Pennsylvania

Dr. Shin

Thuzar M.Shin MD, PhD
Assistant Professor of Dermatology
Hospital of the University of Pennsylvania

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Organ Procurement Transplant Network (OPTN) collects data on cancers that develop after organ transplantation. Previous studies have shown incomplete reporting to the OPTN for many cancers (including melanoma). Skin cancer is the most common malignancy in solid organ transplant recipients and the most common post-transplant skin cancer, cutaneous squamous cell carcinoma (cSCC), is not captured in standard cancer registries. We hypothesized that cSCC and melanoma are underreported to the OPTN. When compared to detailed medical record review obtained from the Transplant Skin Cancer Network database (JAMA Dermatol. 2017 Mar 1;153(3):296-303), we found that the sensitivity of reporting to the OPTN was only 41% for cSCC and 22% for melanoma. The specificity (99% for cSCC and 100% for melanoma) and negative predictive values (93% for cSCC and 99% for melanoma) were high. As a result, the OPTN database is unable to robustly and reliably distinguish between organ transplant recipients with and without these two skin malignancies.

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CMV Infections Increase Complications and Costs After Stem Cell Transplantation

MedicalResearch.com Interview with:

Dr. Jonathan Schelfhout, PhD Director, Outcomes Research Merck & Co. Inc. North Wales, PA

Dr. Schelfhout

Dr. Jonathan Schelfhout, PhD
Director, Outcomes Research
Merck & Co. Inc.
North Wales, PA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The cost of hematopoietic stem cell transplantation has received increased attention after it was identified as a top 10 contributor to increasing healthcare costs in an AHRQ 2016 report. Many recent studies have explored the cost of HSCT but additional research is needed on the costly complications that can follow the transplant procedure. This research is particularly relevant for inpatient decision makers, as most transplant centers receive one bundled payment for the transplant and the treatment of any complications over the first 100 days.

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Microtransplantation Can Be Safe and Effective For Older AML Patients

MedicalResearch.com Interview with:
Huisheng Ai, MD, Director

Department of Hematology and Transplantation,
Affiliated Hospital of the Academy  of Military Medical Sciences,
Beijing, China 

MedicalResearch.com: Which of these results did you find most interesting or surprising?

Response: First, we must stress that microtransplant dramatically improved the outcome of older patients with AML.

As we know, older AML patients often possess unfavorable prognostic factors, organ dysfunction, and slow post-chemotherapy hematopoietic recovery. Therefore, the general treatment outcome is unsatisfactory even though the incidence is increasing by age with low complete remission (CR) rates (34% to 65%) and poor short-term survival (Two years overall survival was about 11% to 25%).

This study involved cases from multiple centers of China, USA and Spain, and found that microtransplant could not only significantly improve complete remission rate in older AML patients among all age groups from 60 to 85, but also improve 1-year and 2-year overall survival and disease free survival especially in patients aged 60 to 75. Second, microtransplant completely overcomes the restriction of HLA typing. The donor could be the patient’s haploidentical family member, or unrelated and fully mismatched one. The incidence of graft-versus-host disease (GVHD) was only 1.1%, even if no any GVHD prevention was given. Other treatment related complications and mortality were also decreased.

These results are much better than those of traditional chemotherapy, myeloablative and non-myeloablative transplant, which provides a more safe and effective treatment choice. We are looking forward to seeing the revision of NCCN guideline for older AML to make microtransplant benefit more older patients.

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Deceased Donor Kidneys Offered Median of 7 Times Before Acceptance For Transplant

MedicalResearch.com Interview with:

Dr. Anne Huml MD Center for Reducing Health Disparities Case Western Reserve University MetroHealth Medical Center Cleveland, Ohio

Dr. Huml

Dr. Anne Huml MD
Center for Reducing Health Disparities
Case Western Reserve University
MetroHealth Medical Center
Cleveland, Ohio 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Overall, about 600,000 Americans have end stage renal disease and require chronic dialysis treatment or a kidney transplant to survive. Compared to chronic dialysis, kidney transplantation results in better survival and quality of life and lower health care costs. Approximately 100,000 patients are listed for a kidney transplant. However, only 17,000 transplants occur per year with two-thirds of these coming from deceased donor organs. Annually, over 8,000 patients either die waiting for a kidney transplant or are removed from the waiting list for being too ill. Waiting times vary based on geography, but it is not unusual for patients to wait upwards of 5 years for a kidney transplant. There are sizeable race, gender, and socioeconomic disparities in access to kidney transplantation.

In this study, we evaluated the outcomes of deceased donor kidney offers and their association with donor and waitlisted patient characteristics. Differences in kidney offer outcomes to patients at the top of the waiting list may contribute to disparities in transplantation.

When a deceased donor organ becomes available, a match run list is created that ranks potential recipients in priority order based upon several characteristics, including waiting time and immunologic criteria. At the discretion of the transplant center, organ offers to patients on their waiting list can be accepted for transplant, or refused for a particular patient. The offers continue down the match run list in sequential order. For each potential recipient in whom the organ is not transplanted, a refusal code is generated and catalogued with the United Network of Organ Sharing, or UNOS. UNOS identifies 37 unique refusal codes and categorizes them into donor-related, transplant center bypassed for pre-specified criteria, recipient-related, histocompatibility-related, program-related, or other reasons for refusal.

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IgG Endopeptidase Has Potential To Reduce Kidney Transplant Rejection

MedicalResearch.com Interview with:

Stanley C. Jordan, M.D Director, Division of Nephrology Medical Director, Kidney Transplant Program Medical Director, Human Leukocyte Antigen and Transplant Immunology Laboratory Cedars-Sinai, Los Angeles, CA

Dr. Jordan

Stanley C. Jordan, M.D
DirectorDivision of Nephrology
Medical DirectorKidney Transplant Program
Medical Director, Human Leukocyte Antigen and Transplant Immunology Laboratory
Cedars-Sinai, Los Angeles, CA 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background for this study is as follows: Patients who are highly HLA sensitized have antibodies to transplant targets create an immunologic barrier to transplant. Currently, there are no approved therapies for elimination of these antibodies. Desensitization is available but is not always successful and most desensitized patients are still transplanted with a positive crossmatch. Thus, many patients are not able to receive life-saving kidney transplants unless newer therapies to remove antibodies are found.

The findings of our study published in the New England Journal of Medicine revealed that the use of the enzyme from streptococcal pyogenes called IdeS® (IgG endopeptidase) is very effective in eliminating donor specific antibodies and allowing transplantation to occur. Antibodies were eliminated from one week up to two months after one treatment with Ides® allowing a safe environment for the transplant to occur. Rejections episodes did occur in some of the patients but were generally mild and easily treatable. Only one patient of 25 lost his allograft during the study. Thus, the study shows promising results for a new approach for elimination of pathogenic antibodies that did not exist before.

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Factors Affecting Interest in Transplant Among ESRD Patients Receiving Dialysis

MedicalResearch.com Interview with:

Deborah Evans, MA, MSW, LCSW Manager, Social Work Services DaVita Kidney Care

Deborah Evans

Deborah Evans, MA, MSW, LCSW
Manager, Social Work Services
DaVita Kidney Care

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: For patients with end-stage renal disease (ESRD) receiving dialysis, receipt of a transplant offers the best possible long-term treatment option. However, the process of becoming qualified to receive a transplant involves many steps, beginning with the patient’s statement of interest.

In this study, we sought to characterize transplant interest among patients in a large dialysis organization in the U.S. and to explore reasons identified by the patients for lack of interest in transplant when applicable.

As of November 2016, of the 182,906 patients with available transplant status information in the LDO database, 58,057 (31.7%) expressed that they were not interested in transplant. Among patients not interested in transplant, the most frequently identified reasons for lack of interest were:

  • Advanced age (25.7%)
  • Perceived poor health (12.0%)
  • Comfortable with current modality (12.0%)
  • Uninterested in further surgeries (11.9%)
  • 13.2% of patients not interested in transplant indicated that “other” factors were responsible for their lack of interest. At the time of the study, we didn’t have any further insight into what might account for these “other” factors.

Compared to patients with transplant status listed as active, those not interested in transplant were:

  • Older (21.4% < 60 years vs 64.6%)
  • More likely to be female (47.7% vs 36.6%)
  • More likely to be white (43.9% vs 30.4%) and less likely to be Hispanic (14.7% vs 22.2%)
  • More likely to be receiving in-center hemodialysis (92.0% vs 73.7%)
  • More likely to have Medicare/Medicaid as primary insurance (91.3% vs. 77.3%)

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Food Costs Can Lead To Less Protein and Phosphorous in Indigent Kidney Transplant Patients

MedicalResearch.com Interview with:

Ms. Shifra Mincer Medical Student in the class of 2019 SUNY Downstate Medical School

Shifra Mincer

Ms. Shifra Mincer
Medical Student in the class of 2019
SUNY Downstate Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hypophosphatemia is commonly encountered in the post-transplant setting. Early post-transplant hypophosphatemia has been ascribed to excess FGF23 and hyperphosphaturia.

Many patients remain hypohosphatemic months or even years after their transplant and the mechanism was assumed to be the same, however, our group recently reported that patients with late post-transplant hypophosphatemia had very little phosphorous in their urine (Wu S, Brar A, Markell, MS. Am J Kidney Dis. 2016,67(5): A18). We hypothesized that they were not eating enough phosphorous to compensate for the acute phosphorous losses they experienced immediately post-transplant.

In this study, using both 3-day diet journals and 24-hour diet recall questionnaires, we found that mean intake of phosphorous and protein was barely at the Recommended Daily Allowance, and that despite 70% of the patients using EBT, 30% of those patients still reported concerns regarding food security. Patients who reported that the cost of food influenced their dietary choices ate 43% less protein (average 48,5 gms vs. 85.8 gms) and 29% less phosphorous (average 887 mg vs 1257 mg). When ability to rise from a chair over a 30 second period was evaluated, only patients who expressed food cost concerns were unable to complete the test.

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Fecal Transplantation Reduced Hospitalizations and Improved Cognitive Function in Cirrhosis Trial

MedicalResearch.com Interview with:

Jasmohan S. Bajaj, M.D. Virginia Commonwealth University Associate Professor Department of Internal Medicine Division of Gastroenterology

Dr. Bajaj

Jasmohan S. Bajaj, M.D.
Virginia Commonwealth University
Associate Professor
Department of Internal Medicine
Division of Gastroenterology

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hepatic encephalopathy is a devastating complication of cirrhosis, which often recurs despite standard of care therapy with lactulose and rifaximin. This has a basis in an altered gut milieu therefore we need to change that in a more meaningful way to help patients. This was an FDA-monitored Phase I safety study of Fecal microbiome transfer (FMT) using a rationally-derived donor compared to standard of care.

We found that FMT was safe and was associated with lower all-cause and hepatic encephalopathy-related hospitalizations over 5 months compared to standard of care.

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