Vacation Donation: Maryland Educator Receives Kidney Thanks to New Colleague’s Generous Gift

“I felt like the clock was ticking against me.”

Gary Simmons, of Glen Burnie, MD, was doing everything he could to maintain his healthy lifestyle while battling kidney failure caused by diabetes. He ate right, worked out three times a week, rode his bike over 30 miles every weekend, and just started a new job with the special education staff at Lindale Middle School in Linthicum, MD. Despite his best efforts, Simmons could tell that his condition was worsening late last year.

“It was an immediate fear of death that set in with me,” he says. “Not knowing that I had options to sustain my life. I have two young kids, and while my quality of life was deteriorating, their quality of life was deteriorating. I wasn’t able to do a lot of things that I needed to.”

Simmons sought help from transplant specialists at MedStar Georgetown University Hospital, who immediately ordered dialysis treatment and listed him for a kidney transplant.

A Desperate Plea Answered

Danelle Chapman and Gary Simmons
Danelle Chapman and Gary Simmons

Simmons’ physicians explained that the only way to cut down his time on the waiting list was to find someone willing to give him one of his or her kidneys; a living donor.

“They talked about self-advocacy,” Simmons says. “I sent my story out to just about everyone that was in my e-mail contacts.”

That list included friends, family, and many of the people he had only recently contacted initially about his current position at Lindale Middle School. Simmons received a reply from his boss, Danelle Chapman, who hired him only a few months prior.

“She responded the next day saying, ‘Hey, I’m going to look into this to see if I can donate to you.’”

Simmons was shocked.

“I didn’t think it made any sense. She just gave me a job,” he says. “She really didn’t know me besides from school. I said, ‘Nobody’s really that kind.’ But it turns out she is.”

Choosing the Gift of Life

Chapman chairs the school’s special education department and, until Simmons’ e-mail, did not know the severity of her colleague’s illness. She says the decision to become his living donor was not a difficult one.

“First, I realized he was in his forties and raising two kids. I already knew about his work ethic and his community service. He’s just an all-around great guy,” Chapman says. “I felt like he had a lot to give, and it was important to extend the quality of his life so that he could be there for his kids and provide for them.”

She kept her word, undergoing tests and examinations at the MedStar Georgetown Transplant Institute (MGTI) to determine if she could donate to Gary.

“It’s a phenomenal program,” Chapman says. “Everyone was very kind throughout in explaining the procedure. They were extremely supportive.”

Plotting a New Course

Unfortunately, the results of the tests showed that Chapman and Simmons were not a blood match, meaning that her kidney could not be donated directly. Fortunately, there are other options.“Paired kidney exchange (PKE) is just one of the tools we use to complete living donor transplants even if the donor and recipient are not biologically compatible,” says Jennifer Verbesey, MD, director of the Living Donor Transplant Program at MedStar Georgetown University Hospital. “Through the exchange, we can connect our pairs with others in the same position across the country and ultimately find matches. The goal is to build donation chains so that two, three, four or more people can end up getting a new kidney instead of just one person.”

After agreeing to take part in the paired kidney exchange, Chapman could finally deliver the big news.

“I think the look on his face was very surprised,” Chapman recalls through laughter.

“I didn’t know whether to scream, to cry, or to shout. I’ll be honest, I was in such shock that I was motionless,” says Simmons. “It was amazing. God gave me a job and put me in a place where people were really looking after me.”

One Kidney Saving Two Lives

Simmons after his successful surgery
Simmons after his successful surgery

Coordinators at MGTI were able to fit both patients into the paired kidney exchange network. A blood match recipient was found for Chapman’s kidney and, in return, Simmons would receive a compatible kidney back from another donor in the exchange.

“It’s pretty amazing when I think about the impact because it definitely effects so many more people than just Gary,” Chapman says.

“She started off with the intention of helping me but, at the end of the day, she ended up saving two lives,” said Simmons.

Both successful surgeries took place during the same week in late July. Gary had his new kidney transplanted by Dr. Verbesey just two days before his birthday on July 25th. It’s a gift he will never forget.

“Danelle gave me a job, she gave me a birthday gift, and she gave me a kidney!” he says.

Overwhelming Support

In an additional show of support and kindness, another teacher from Lindale Middle School, Terra Greene, is serving as Simmons’ caretaker throughout his recovery from transplant surgery. Gary plans on returning to work in October or November. Chapman says she’ll be ready for the start of the new school year in late-August, and she is excited to eventually tell students all about her summer vacation.

MedStar Georgetown Transplant Institute performs more living donor kidney transplants than any other healthcare institution in the Washington D.C. metropolitan area. It is also recognized as a national leader in kidney exchange and the management of recipients and donors who are incompatible. Only a handful of transplant centers in the United States offer this option to their patients. For more information, visit: MedStarGeorgetown.org/LivingDonor

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Outpatient Lab has Moved

The Outpatient Lab has moved! The Outpatient Lab is under a complete renovation and has been temporarily relocated to the 1st Floor of the Main building. The Lab is now located in the Laboratory Medicine hallway, adjacent to the orange elevators. Patient must register in the registration area by the Chapel on 1 Main, close to the entrance of the Main building.

Think a hysterectomy is the only solution for fibroids? Think again. Treatment can involve a simple prick to the wrist

WASHINGTON D.C. – When Nicole Austin-Hillery looks at her wrist, she sees a small, pinhole-sized scar. It’s the only visible sign of her recent treatment for uterine fibroids.

Nicole Austin-Hillery
Nicole Austin-Hillery

“It is hardly noticeable at all,” she says. “It looks like I have a little tiny mole there. There’s absolutely nothing. I don’t even think about that.”

July is recognized as Fibroid Awareness Month. Nationwide, one in three women suffer from fibroids, including 80% of African American women and 70% of Caucasian women by the time they reach the age of 50. Oftentimes, the tumors can cause very heavy menstrual bleeding, pelvic pain, increased abdominal girth and urinary symptoms.

Earlier this year, Austin-Hillery, a D.C.-based civil and human rights attorney underwent uterine fibroid embolization (UFE) at MedStar Georgetown University Hospital. UFE is an established, minimally invasive procedure that treats fibroids without the need for major surgery. Several years ago, Austin-Hillery did have surgery to remove her fibroids, but the benign pelvic tumors came back.

“They eventually grew to even bigger sizes and in multiplicity beyond what they had been originally,” she says. “I could really feel the impact of those fibroids and how they were interfering with my daily activities, particularly when it came to exercise.”

She was looking for way to address her discomfort without undergoing another operation like a myectomy or hysterectomy. After researching UFE on her own, Austin-Hillery was referred to Interventional Radiologist Theresa Caridi, MD, who specializes in the procedure.

Dr. Theresa Caridi
Dr. Theresa Caridi

“One in five women are under the impression that a hysterectomy, or surgical removal of the uterus, is the only way to treat uterine fibroids. It’s not true,” said Dr. Caridi. “Treatments like uterine fibroid embolization can be just as effective and carry fewer risks of major complications than surgery.”

During UFE, the fibroid is starved of blood supply as portions of connecting uterine arteries are blocked by a microscopic substance known as embolic or bead.

“We deliver the substance through a small catheter that’s inserted into either the patient’s wrist or upper leg. It only takes one to two hours,” Caridi says. “The fibroids aren’t removed but, following the procedure, they shrink into scars over several months.”

Austin-Hillery went forward with UFE and had the procedure in February 2019. The procedure only required a local anesthetic, she remembers being somewhat aware throughout. Afterwards, she did feel some side effects like nausea and abdominal discomfort, especially during the first day or so following the procedure, but they improved relatively quickly. A far cry from the recovery following a myectomy or hysterectomy.

“MedStar Georgetown was great. They checked on me. I called them when I had questions. Around day three, I started to feel better,” Austin-Hillery says.

Best of all, she feels like uterine fibroid embolization worked. According to Dr. Caridi, the fibroids will continue shrinking for up to a year after the procedure, but Austin-Hillery says the difference is already noticeable.

“I’m continuing to see changes in my abdominal area. My menstrual cycles are much better,” she says. “My comfort level when I exercise is just off the charts. Overall it was a win-win for me.”

For more information, visit: MedStarGeorgetown.org/Fibroids.

To schedule an appointment with a MedStar Georgetown interventional radiologist, please call 202-444-5478 or complete an online appointment request form

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Indoor Tanning May Be an Addiction Abetted by Both Genetic and Psychiatric Factors

WASHINGTON — A combination of elevated symptoms of depression along with modifications in a gene responsible for dopamine activity, important to the brain’s pleasure and reward system, appear to influence an addiction to indoor tanning in young, white non-Hispanic women.

That finding comes from a new study, reported by researchers at Georgetown Lombardi Comprehensive Cancer Center and published online June 11 in Annals of Behavioral Medicine.

Excess exposure to ultraviolet radiation can lead to melanoma and non-melanoma skin cancer. Most UV exposure is from the sun, but exposure from indoor tanning is common in certain people and accounts for 10 percent of skin cancer cases in the U.S. There will be an estimated 96,480 new cases of melanoma in the United States and 7,230 deaths from the disease in 2019.

This study compiled survey responses from 292 non-Hispanic white women in the Washington, D.C. area, 18 to 30 years of age, who used indoor tanning beds, sunlamps, or sun booths. The survey asked questions about values and behaviors that might predispose a person to a tanning addiction, as well as a series of questions to determine if they had symptoms of depression.

The researchers also collected saliva samples to obtain DNA to look for 34 single nucleotide polymorphisms (SNPs) in five different genes. SNPs are changes in one of the base molecules on a strand of DNA. The specific SNPs that researchers looked at were in genes known to be related to pathways that reward addictive behavior.

“By demonstrating that genes in behavioral reward pathways are associated with tanning addiction, we are providing stronger evidence that tanning addiction is a cancer risk behavior in need of intervention,” says lead author Darren Mays, PhD, MPH, an associate professor of oncology and member of the Cancer Prevention and Control Program at Georgetown Lombardi. “This finding adds to a growing body of evidence from animal studies and neuroimaging studies that have been done in humans.”

The researchers adjusted their analyses based on indoor tanning frequency, value of appearance, and depressive symptoms. They found a more than two-fold increased odds of indoor tanning addiction in modifications to the rs4436578 SNP and a slightly less than two-fold increased odds of addiction in modifications to the rs4648318 SNP. When looking at whether the SNPs interacted with depressive symptoms to increase the risk of indoor tanning-addiction, they found a more than 10-fold increase if there were modifications to the rs4436578 SNP and a more than 13-fold increase in the rs4648318 SNP. This knowledge should be helpful if screening for risk of addiction is shown to be beneficial in reducing the chance that people will engage in a cancer-causing activity.

Mays work in tanning addiction continues with a study, just getting underway, that will explore the effectiveness of text messaging as an intervention to help young women quit if they are addicted to indoor tanning. The research is funded by the Prevent Cancer Foundation.

“This grant will enable us to test behavioral interventions in young women who are addicted to indoor tanning,” Mays says. “We have used text messaging to intervene in other behaviors and have found that the personalized conversation we can deliver through this medium can help people take steps to quit.”

In addition to Mays, authors include Jaeil Ahn, PhD, and Bingsong Zhang, MS, from the Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center and Michael B. Atkins, MD, David Goerlitz, MS, and Kenneth P. Tercyak, PhD, from Georgetown Lombardi.

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100th Patient Treated with Proton Therapy at MedStar Georgetown University Hospital

WASHINGTON, D.C. – Physicians and hospital staff are celebrating the first 100 patients treated at the MedStar Georgetown University Hospital Proton Therapy Center, the first and only center of its kind in the Washington D.C. metropolitan area. Proton therapy is the latest cancer-fighting technology designed to shrink some previously untreatable tumors.

MedStar Georgetown providers with Proton therapy some patientsThe proton therapy system used by radiation oncologists at MedStar Georgetown is the most advanced cancer treatment technology currently available. Using pencil beam scanning (PBS) and HYPERSCAN™ technology, physicians can precisely target tumors anywhere in the body with minimal exposure to healthy tissues. This is especially beneficial for younger patients, who have a higher likelihood of living many years after their cancer has been cured.

“With conventional radiation, when we aim at a target, there’s full dose radiation in front of the target and full dose radiation beyond the target. With the protons, they can stop in the center of the tumor,” says Brian Collins, MD, clinical director of the Proton Therapy Center.

“There are certain types of cancer where you have to deliver a very high dose of radiation right next to a critical structure like the spinal cord or brainstem,” says Radiation Oncologist Sonali Rudra, MD, “So, for some patients, proton therapy might be their only radiation treatment option.”

MedStar Georgtown's 100th Proton Therapy PatientThe center’s 100th patient, Kathleen Norris of Lexington Park, Maryland, began receiving proton therapy treatments in April for her inoperable lung cancer. Proton therapy helps Norris’ care team avoid targeting critical nearby organs, like the heart, that may be damaged by conventional x-ray radiation. Norris says she’s thankful for the opportunity to fight her cancer battle with cutting-edge tools never-before available in her area.

“This proton is so advanced.  It was able to hit my cancer without damaging my other tissues and it could avoid my heart.  I’m so glad.  The tumor has already shrunk by forty percent,” Norris said. “I’ve done really well. I’ve been very lucky.”

In March 2018, Martha Ramos, a mother of two from Germantown, Maryland, became the first patient treated by doctors at the MedStar Georgetown University Hospital Proton Therapy Center. Before treatment, Ramos underwent multiple operations to remove a non-cancerous recurring brain tumor. Some cells deep in the brain could not be removed in surgery. Proton therapy eradicated those remaining cells and preserved her quality of life.

“I want to have more time to be a mom to my children. I want to be very healthy so I can be there for them and help them in life,” Ramos said after treatment. “I am very, very grateful that my medical team at MedStar Georgetown told me about proton therapy. I now look forward to a long and happy life.”

Since proton therapy was approved by the Food and Drug Administration in 1988, over 75,000 patients have been treated at only about 30 centers across the United States. Now, patients have access to this state-of-the-art technology in Washington D.C.

National Cancer Institute Renews Prestigious Designation of Georgetown Lombardi Comprehensive Cancer Center

(Washington, D.C) - MedStar Georgetown University Hospital is proud to announce that the National Cancer Institute (NCI) has once again designated its research partner, Georgetown Lombardi Comprehensive Cancer Center, with its coveted distinction, "comprehensive cancer center."

First awarded to Georgetown Lombardi in 1974, MedStar Georgetown University Hospital serves as one of the cancer center’s primary hospital affiliates in Washington D.C.  Additionally, for the first time, MedStar Washington Hospital Center was also named as a Georgetown Lombardi primary hospital affiliate. 

"As the only NCI-designated comprehensive cancer center in the District of Columbia, we’re able to offer a comprehensive suite of services to our patients, providing them with research-inspired cancer care that they simply can't get anywhere else," says Dr. Louis M. Weiner, director of Georgetown Lombardi and the MedStar Georgetown Cancer Institute.

The MedStar Georgetown Cancer Institute combines medical expertise, the latest therapies, and research across the region. "What makes us special is the concept of cura personalis, or the care of the whole person. We don't treat diseases – we use evidence-based medicine to treat people in the context of their own lives, families, and communities. Having cancer is very frightening. Being a cancer patient can be a lonely journey.  At our hospital, you're going to be treated like a person, not like a disease," says Dr. Weiner. 

Of the 1,500 cancer programs in the United States, only 50 have this prestigious designation and Georgetown Lombardi is the only such center in the Washington, D.C. area.  

In order to renew its NCI designation, the cancer program in 2018 went through a rigorous, peer-reviewed grant renewal process conducted by cancer center experts from across the country. The renewal occurs every three to five years.

M. Joy Drass, MD, Executive Vice President and Chief Operating Officer of MedStar Health, says, "As the clinical partner for Georgetown Lombardi, our patients receive personalized care from physicians who are also, through innovative clinical trial research, offering breakthrough advancements in diagnostics, new technologies, and novel therapeutics. Our long-standing partnership provides patients with unparalleled access to a multidisciplinary team of experts, clinicians, and researchers who are leading the way in how cancer is detected and treated."

The NCI approved Georgetown Lombardi as a "consortium center" reflecting an integrated cancer research program with John Theurer Cancer Center, part of Hackensack Meridian Health in New Jersey. MedStar Georgetown, Georgetown Lombardi, and John Theurer began their clinical and research relationship in 2013 through which the world-class Bone Marrow and Blood Stem Cell Transplant Program at MedStar Georgetown was established. Because of this program MedStar Georgetown has been able to offer patients with blood cancers the latest in bone marrow transplantation, CAR T cell therapy and other new immunotherapies that require the infusion of cells into people to attack cancer.

Cancer-fighting technologies like proton therapy, which opened at MedStar Georgetown in 2018, and CyberKnife that has been used to treat cancers at the hospital since 2002 are also examples of the cutting-edge care available to treat patients in the region. 

The NCI designation as a comprehensive cancer center indicates that Georgetown Lombardi excels in laboratory science, clinical research and population-based programs, along with robust translational research that bridges these areas. It also demonstrates expansive public education and outreach capabilities, which focus on the community.

The populations in Washington, D.C., and in Bergen County, New Jersey, where the John Theurer Cancer Center is located have some of the highest cancer incidence and death rates in the country. Georgetown Lombardi researchers are working on new ways to address the underlying causes so that strategies to address these health disparities can be implemented and refined.

Edward B. Healton, MD, MPH, Executive Vice President for Health Sciences and Executive Dean of the medical school at Georgetown University Medical Center underscores the critical role of Georgetown Lombardi in the communities it serves.

"An important aspect of the research, outreach and education activities carried out at Georgetown Lombardi focuses on eliminating disparities in minority and medically underserved populations," Healton says. "This is especially important in the communities served by both Georgetown and Hackensack, as our special collaboration has the potential to be deeply impactful."

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Marianne Worley
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Brendan McNamara 
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Philanthropic Leaders Advance the New Medical/Surgical Pavilion with Commitment to Neurosciences

Washington, D.C.– Thanks to an inspiring multimillion-dollar philanthropic investment from the Bernstein Family, which includes Wilma and Stuart Bernstein, Richard Bernstein, Tracy and Adam Bernstein, and Lisa and Josh Bernstein and the Diane and Norman Bernstein Foundation, as well as Nancy and Marc Duber, who is executive vice president and chief operating officer of the Bernstein Companies real estate firm, the Medical/Surgical Pavilion at MedStar Georgetown University Hospital will be home to the Bernstein Family Patient Care Floor for Neuroscience Excellence.

Currently under construction, the facility’s design puts patient care and comfort at the forefront while promoting the very latest best practices in neurological care. Incorporating the most advanced medical technologies, the floor will be home to 52 patient beds in tranquil patient rooms, and both intensive care and intermediate care units.

“We are so very grateful to the Bernstein family for their generous gift, which will make a real and lasting impact for our patients and caregivers helping us to bring the world class care we deliver to a new world class, state-of-the-art facility,” says Michael C. Sachtleben, president of MedStar Georgetown University Hospital and a senior vice president for MedStar Health.

For former U.S. Ambassador Stuart Bernstein and Mrs. Bernstein, this partnership was motivated by gratitude for their personal experiences with two leading clinicians at MedStar Georgetown University Hospital. “At the Department of Neurology, my family experienced true excellence in care,” says Ambassador Bernstein. “Our philanthropic investment is intended to promote the life-changing work that MedStar Georgetown clinicians perform each day—and in doing so, to support the health and well-being of our community.”

As business and property owners in Georgetown, the Bernstein Family is especially excited to have the Hospital’s new Medical/Surgical Pavilion in their neighborhood. It will represent a new standard in how patients receive their care by offering private patient rooms, state-of-the-art operating rooms, a beautiful new green space to enhance the patient experience and compliment the healing environment, and a brand-new Emergency Department which will double in size and provide a more accessible, efficient and welcoming community resource for Georgetown residents and businesses.

One of the visionary partners, Mr. Duber, member of the board of directors and chair of the Philanthropy Committee at MedStar Health, along with his wife Nancy Duber, hope that this philanthropic investment will inspire others to partner with MedStar Georgetown. “The Medical/ Surgical Pavilion is an opportunity to support MedStar Georgetown at a pivotal moment in its long history,” says Marc Duber. “From growing our local health resources to facilitating broad-reaching research breakthroughs, this expansion is a cause worth cheering.”

To see more, including architectural renderings of the new pavilion, please visit MedStarGeorgetown.org/NewBuilding.

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Marianne Worley
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Brendan McNamara 
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Continence Confidence: Prostatectomy Patients Reporting ‘Startling’ Success After Robotic Retzius-Sparing Surgery

For healthcare industry executive Sean Hawkins, prostate cancer runs in the family. After his own diagnosis last year, the then 49-year-old already knew the potential challenges of treatment -- including losing control of his bladder. However, a breakthrough method of prostate surgery known as Retzius-sparing is now eliminating continence issues for many men treated at MedStar Georgetown University Hospital.

MedStar Georgetown Patient Sean Hawkins“You go through all sorts of mental gymnastics when you’re confronted with cancer,” he says. “My main concern was the ability to get back to normal.”

After consulting with MedStar Georgetown urological surgeon Keith Kowalczyk, MD, Hawkins learned that he was a candidate for radical prostatectomy – or removal of his entire prostate. Despite the possibility of temporary (and sometimes permanent) continence issues, Hawkins was willing to make difficult sacrifices for another chance at a cancer-free life.

“The first thing people do is go to the store and buy the 300-count diapers,” he says. “I had diapers under my desk and meetings were spaced out to allow for bathroom breaks. I built in contingencies to anticipate a lot more frequency. I was also sort of budgeting coffee and fluid intake.”

After a successful surgery, Hawkins returned to work only 2 weeks later. He sat through his first round of meetings without a continence problem.

“I didn’t really have any major issues. I kept waiting and wearing the diapers and pads as a precaution. I worried about getting up or sneezing,” he says. “I was tempted to text Dr. Kowalczyk and ask if there was something going on, because I wasn’t having the control problems I anticipated. It was startling for sure.”

During his prostatectomy, Hawkins was one of the first patients to undergo the new Retzius-sparing approach; a more technically advanced, robotically-assisted technique. Kowalczyk, who specializes in robotic surgery, learned the approach from urological surgeons in Italy. He says Retizus-sparing removes the prostate by way of an alternate route, preserving attachments to the bladder and urethra that may play a key role in continence preservation. He is part of a small group of urological surgeons in the United States now performing the procedure on a regular basis.

“The big advantage is that these patients become continent much earlier, sometimes immediately” says Dr. Kowalczyk. “Patients getting the standard approach do well -- but it tends to be a much slower process, sometimes up to a year, in regaining their continence.  This is likely due to the need to cut through crucial suspension ligaments that seem to be important in maintaining continence.”

Kowalczyk says traditionally, prostatectomy patients can wait from 6 months up to a year to regain continence, if it comes back at all. In patients who have undergone the Retzius-sparing surgery at MedStar Georgetown, 96% of patients regained adequate urinary continence after only 6 weeks, with only 23% wearing one “safety” pad just for reassurance even if not needed.

Hawkins with his Family“I can really confidently tell my patients now that this should not be a problem,” Kowalczyk says. “They’ve just been doing astonishingly well.”

For some patients, like Hawkins, incontinence is never a problem at all. Aside from a healing incision scar, he reports no other side effects or complaints from the surgery. Considering all possible outcomes, Hawkins says his journey from the prostate cancer diagnosis to recovery has been a smooth one.

“I’m very fortunate and thankful. From the minute I walked into the hospital to the minute I was wheeled out, I couldn’t have asked for faster, better treatment. To be able to say that out loud in an affirmative manner is very important to me.”

Watch the video below as Dr. Kowalczyk answers commonly asked question about prostate cancer and the use of robotic surgery to treat prostate cancer. 

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Marianne Worley
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Pager: 202-405-2824
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Brendan McNamara 
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[email protected]

Personalized Medicine Clinical Trial Underway for Type of Incontinence Common in Women

WASHINGTON D.C. – A novel clinical trial aims to study a treatment for a common problem among older women––accidental urine leakage––by using a patient’s own muscle cells. The study, now underway in the Washington area, is for women with stress urinary incontinence that has not been addressed by conservative treatment such as behavior modifications and pelvic-floor muscle exercises.

Stress urinary incontinence, or SUI, often occurs when the tissues that support the bladder and/or the muscles that regulate the release of urine weaken, and can have a negative impact on a woman’s quality of life. The condition is especially common after childbirth. For patients with SUI, leakage can be triggered by physical activity or stressors such as coughing, sneezing, laughing, or heavy lifting.

In the new study, conducted by Georgetown University at MedStar Georgetown University Hospital, researchers will examine the safety and effectiveness of an investigational product (autologous muscle derived cells for urinary sphincter repair or AMDC-USR) derived from a woman’s own muscle cells that are collected, processed, and then injected into the tissues of the urinary passage.

“Being able to use a woman’s own cells as a treatment for stress urinary incontinence holds promise, and we’ll know more about whether this treatment is safe and effective for these women after this clinical trial is completed,” says the study’s principal investigator, Elizabeth Timbrook Brown, MD, MPH, assistant professor of urology at Georgetown University School of Medicine and a specialist in the medical and surgical management of urinary incontinence at MedStar Georgetown University Hospital.

The clinical study lasts two and a half years and participation includes approximately 8 to 11 office visits and 3 to 5 scheduled phone calls. The study will consist of a screening period, which may last up to 8 weeks to determine eligibility.

If eligible, Brown will perform a biopsy to collect muscle tissue from the thigh. Local anesthesia will be used for the office procedure.

“The muscle tissue is then grown in a laboratory until there are enough cells to be injected into the urinary passage as a second office procedure,” Brown explains. “It is believed the cells will become part of the tissue where they have been injected. In theory, we think this may help women have more control over urine storage and urination and may decrease urinary leakage.” Current conservative treatment options are available for women with SUI and include external collection devices (diapers and pads) and pelvic floor exercises. Some examples of surgical treatments include injection of bulking agents into or around the urethra, a synthetic mesh midurethral sling, or creation of a sling using a woman’s own tissues, as well as other surgical procedures.

Women ages 50 to 75 with SUI are invited to volunteer in this phase 3, randomized, double blinded, placebo-controlled study. Participants will be “randomized” into one of two study groups––half will receive AMDC-USR (injections with cells) and the other half will receive a placebo (injections that look and feel exactly the same but will have no cells). Randomization, is done by computer. Neither the volunteers nor the researchers will know what group you are in (double blinded). If the participant receives the placebo injection, the participant will still have the option of receiving a second injection with their own cells (the AMDC-USR product) after 12 months.

Based on information from similar clinical studies using AMDC therapy, urinary tract infections are very common. Other less common risks will be explained to each participant. Up to 320 subjects at 25 study centers across three countries will take part in this study; approximately 15 subjects per year will participate at Georgetown. There are no study-related charges for the participants.

Cook MyoSite, Incorporated is the sponsor of this study. MedStar Georgetown University Hospital is being paid by Cook MyoSite, Incorporated, to conduct this study. Brown reports having no personal financial interests related to the study.

To learn more about this clinical trial, please click here. Women who are interested in volunteering for the clinical trial should call Kelsey Morgan, BSN, RN at 202-444-7513 or email her at [email protected].

 

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Marianne Worley
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Brendan McNamara 
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Georgetown-Led Study Leads to First FDA-Approved Drug in Decades to Improve Survival in Small Cell Lung Cancer

The U.S. Food and Drug Administration’s approval today of atezolizumab (Tecentriq®, Genentech) in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer (SCLC) marks the end of numerous failed attempts to improve survival for people with the deadly disease.

“This is monumental for lung cancer patients,” says Stephen Liu, MD, an oncologist at MedStar Georgetown University Hospital who specializes in treating lung cancer and co-led the clinical trial leading to today’s approval through the Georgetown Lombardi Comprehensive Cancer Center. “Atezolizumab allowed us to achieve what for we thought for decades was beyond reach: an improvement in survival for these patients.”

Small cell lung cancer makes up about 10 to 15 percent of all lung cancers in the United States.  Almost all people who develop small cell lung cancer have a history of smoking, and, according to the American Cancer Society only about six percent of people with the disease survive five years or more.

“Since the 1980s, our standard treatment for small cell lung cancer has been platinum-based chemotherapy. This regimen reliably provides an initial response that is often dramatic, but almost always short-lived,” says Liu.

The regimen of carboplatin, etoposide and atezolizumab was first explored in an investigator-initiated trial at Georgetown Lombardi in 2016. It soon gave way to the global phase III IMpower 133 trial. Liu and Leora Horn, MD, of Vanderbilt University Medical Center, served as co-principal investigators of the study.

Results were first presented by Liu at the World Conference on Lung Cancer in September 2018 and simultaneously published in The New England Journal of Medicine.

The international, randomized, double-blind, placebo-controlled trial, compared standard chemotherapy alone or given concurrently with atezolizumab, an anti-PD-L1 antibody. The addition of atezolizumab extended overall survival for a median of 10.3 months to 12.3 months without notably increasing side effects. As of now, there has only been about one year of follow-up so the full potential of atezolizumab is not yet known, Liu says.

“In the context of over 40 failed phase III clinical trials, the improvement in survival seen with atezolizumab represents an important achievement,” Liu says.  

 “As SCLC is an unforgiving disease,” says Liu, “our first attempt at treatment is often our only chance to impact the natural history of this highly lethal cancer.”

The National Comprehensive Cancer Network (NCCN) has added atezolizumab to its treatment guidelines as the preferred treatment for extensive stage SCLC.

 “With the addition of atezolizumab to chemotherapy, we have finally moved the needle in SCLC,” says Liu. “It is now our charge to build upon these results and ensure that the next major advance is not another 20 years away.”

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Disclosure: Liu reports having received advisory board/consulting fees Apollomics, AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, Lilly, Merck, Pfizer, Regeneron, Taiho, Takeda.


Click the video below to watch Dr. Stephen Liu talk about cancer of the lung, head & neck and explain why getting involved in clinical trials for these conditions can be of great benefit for some patients, regardless of the stage of their disease.

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