Mayo Clinic’s new Clinical Trialist Training Program is teaching these valuable, albeit often overlooked, skills to physicians and researchers. The program, which is offered by Mayo’s Center for Clinical and Translational Science, provides protected time over two years for individualized training with a mentor.

We are true pioneers in this area. Right now, there are no standards for training clinical trialists. We are blazing a new but much-needed path.

— Prasad Iyer, M.D.

Each scholar in the program designs and implements a pilot trial and completes both experiential learning rotations and a curated selection of graduate coursework.

“We are true pioneers in this area,” says Prasad Iyer, M.D., chair of the Division of Gastroenterology and Hepatology and director of the new program. “Right now, there are no standards for training clinical trialists. We are blazing a new but much-needed path.”

The Clinical Trialist Training Program is just one example of the ways in which Mayo Clinic is shaping the future of clinical trials. Current efforts also include a focus on reducing activation time for trials and matching patients to trials for their conditions with automated processes integrated into electronic health records.

Mayo Clinic has one of the most extensive clinical trials programs in the world with more than 2,500 active trials ongoing at any given time.

To learn more, visit Mayo Clinic News Network.

The post Setting New Standards for Clinical Trial Expertise appeared first on Mayo Clinic Magazine.

Dr. Shah has a distinguished 25-year career in National Institutes of Health-funded research on advanced liver disease. He brings expertise in basic science, artificial intelligence and clinical trials to this pivotal role. Mayo Clinic Magazine had the opportunity to discuss what led Dr. Shah to this position and his vision for the future of research at Mayo Clinic.

How do you balance and integrate your research responsibilities with clinical and leadership duties in your current role?

I focus a lot on creating a vision to work toward with my team and then supporting them so that our team members can all work together and support one another. I also want them to feel safe coming to me for help when they need it. I have so much gratitude for all the people who have helped me in my career, and I’m thankful to be able to support so many others through my leadership duties.

I’m thrilled to now be in the position of leading the Research shield at Mayo Clinic. At Mayo, our research and practice are intertwined. My medical practice helping patients each and every day connects directly to our expansive research program aimed at finding solutions that don’t exist today. Ultimately, building trust and creating supportive teams means that we can all work together to focus on our primary value: putting the needs of our patients first.

What brought you to Mayo Clinic?

It was serendipity. While I was doing my fellowship at Yale, my wife took a position in the Twin Cities. During that time, I came to Mayo for a month to do a transplant rotation, and that made all the difference for me. I met a lot of role models here at Mayo — Drs. Nick LaRusso, Greg Gores, Russ Wiesner. They introduced me to Mayo Clinic and demystified it for me.

When I had this chance to visit and to meet the people here, I saw that it was somewhere that would be a great fit for me and my work. Rochester has a wonderful mix of small-town charm and all the cosmopolitan aspects of a large intellectual city. It’s been a great place to raise kids, and Mayo Clinic has been an amazing place to work. It’s a testament to why I’ve been here for 25 years.

Our digital transformation is allowing us to better organize our data and apply algorithms to gain new insights into disease.

What excites you the most about the future of research at Mayo?

At Mayo Clinic, our research is about finding new cures for patients, especially for serious or complex diseases. That’s the principle that drives everything we’re doing. And from that, there are so many ways now that we can find new cures. We have our traditional pathways, led by our immensely talented research investigators — work in the lab discovering new insights into the biology of disease, designing and testing new therapies for treating those diseases, and bringing those new treatments into the clinic for patients.

Now we have many other ways, like Mayo Clinic Platform, where we can start to utilize patient data from around the world to reimagine how we do clinical trials. Artificial intelligence can speed up the pathway to drug discovery. Our digital transformation is allowing us to better organize our data and apply algorithms to gain new insights into disease. These are just some of the pathways that will help us get to more cures. All of these tools are accelerating the pace of research, and in turn the pace of treatments, and all of that will mean our patients get better therapies faster than ever before.

The post Reimagining the Future of Research With Vijay Shah, M.D. appeared first on Mayo Clinic Magazine.

EACH YEAR, MAYO CLINIC physicians and scientists conduct high-impact, cure-enabling clinical trials that provide patients around the world access to novel diagnostics and therapeutics as part of Mayo’s integrated medical practice. Mayo Clinic welcomed Owen Garrick, M.D., as the dean of clinical trials in October 2023 and tasked him with strengthening Mayo Clinic’s standing as a national leader of innovative, demand-generating clinical trials for patients everywhere. Dr. Garrick spoke with Mayo Clinic Magazine as he embarked on his new role.

Why did you choose to join Mayo Clinic?

The easy answer is — it’s Mayo Clinic. It’s like playing for the New York Yankees in baseball. What I’ve seen thus far at Mayo is that all the people here are first-rate, fantastic individuals. The teams of people at Mayo are really smart and very dedicated. During my interview process, a physician told me that a lot of clinicians and researchers aren’t in the news, because at Mayo Clinic, we feel the patients are the heroes. There was a sincerity around that, and that honesty and openness really drew me toward this opportunity.

Our patients always deserve better and deserve more, so we work harder in research to find those answers.”

What is your definition of clinical trials?

Clinical trials are all about creating and finding new ways of curing disease, preventing disease, supporting patients — and that could be new molecules, new drugs and compounds, new devices, new surgical techniques, new population health and population science, and more. But more than that, it’s the notion of never being satisfied with what we have now. Our patients always deserve better and deserve more, so we work harder in research to find those answers.

How do you plan to transform clinical trials?

There’s already an established level of excellence here in terms of research and clinical trials, and there’s a willingness for continuous improvement. When you’re recognized as No. 1, it’s because you’re providing the best healthcare, the best education and the best research experiences. We don’t just want to reduce the burden of patients participating in clinical trials, we want them to be excited. And when they’re excited and engaged about their healthcare, they can help us think through what the next research questions are that we need to evaluate and find answers for.

What trends can we expect in clinical trials?

The first is broadly personalized medicine, or making sure that new drugs and approaches work in all populations and knowing what does not work for a segment of the population. That leads into making sure that all populations are represented in research. There are a couple of approaches. One, include more ethnic, racial and geographic diversity in trials, but also, decentralize trials, which is really about having broader populations participate. We actually bring research to the patients versus having them come to where the researchers are. I think it’s fantastic because it decreases the burden to participate in research and expands the pool. And with a representative sample of the population, you can begin to see what truly works to open up personalized healthcare for more individuals.

The post Transforming Clinical Trials With Owen Garrick, M.D. appeared first on Mayo Clinic Magazine.

In July 2020, Mayo Clinic announced a $100 million commitment to eliminate racism and advance equity and inclusivity over the next decade.  

This Black History Month, Mayo Clinic Magazine is highlighting the work of physicians who are working to improve diversity and health equity at Mayo Clinic and beyond.   

This article originally appeared on the Mayo Clinic News Network website. Learn more at newsnetwork.mayoclinic.org.  

Lionel Kankeu Fonkoua, M.D., is an oncologist with Mayo Clinic Comprehensive Cancer Center who specializes in the treatment of gastrointestinal cancers. He's also a Robert Winn Career Development Award recipient dedicated to helping minority and at-risk patients through research and clinical trials.   

Dr. Kankeu Fonkoua is leading a clinical trial through the Robert A. Winn Diversity in Clinical Trials Award Program.   

"It's a program that's designed to make sure those clinical trials are community designed, conducted and informed to make sure that whatever research we do, we have the intent from the get-go of thinking about the communities that are at risk, vulnerable and most likely to benefit," Dr. Kankeu Fonkoua says. 

His study focuses on the immigrant African and Asian communities of Minnesota with a high prevalence of hepatitis-induced hepatocellular carcinoma­ — a type of liver cancer.  

"This is an at-risk population that we are intentionally targeting, because they are not represented in a lot of our immunotherapy trials," he says.  

And that can be a problem for the patients who need treatment the most.  

"It's very important to make sure that the at-risk population — the vulnerable population that's going to most likely benefit the most from the therapy — is represented,” says Dr. Kankeu Fonkoua. “It's hard to tell a patient this is a clinical trial, that had 1,000 patients, and only 1% to 2% were actually like you.” 

Representation and building trust matter when working with patients.  

"It helps me in that initial contact, that initial trust. Someone might be more receptive if they know it's coming from someone of the same race, from the same ethnicity or, more importantly, from the same background and life experience."  

Through the study, Dr. Kankeu Fonkoua hopes to help patients who are not eligible for surgery by combining radiation therapy with a type of immune cell that’s modified in a laboratory and given after radiation therapy.  

"These are therapies that five to 10 years ago or more, we didn't have the ability to do. And I think that's kind of where we are moving forward," Dr. Kankeu Fonkoua says.  

What may be surprising is that Dr. Kankeu Fonkoua says he did not intend to be a doctor, but his grandmother's battle with gastric cancer changed his career trajectory.  

"There were not a lot of options, not a lot of meaningful treatment options, and there was not a lot of research going on," says Dr. Kankeu Fonkoua. "My parents definitely raised me with that scientific method — both scientists — but I think the drive to go into this humane profession, the spirit behind it, is my grandmother."  

He says his grandmother's spirit inspires him still to this day.  

"To be honest, in every patient, I see her and the opportunity to hopefully provide better care and hopefully better outcomes than what she had."  

Dr. Floyd Willis on the importance of inclusive nervous system disorders research

Mayo Clinic neuro-oncologist is shaping the next generation of physicians 

The post Mayo Clinic Oncologist Dedicated to At-Risk Patients, Increasing Diversity in Clinical Trials  appeared first on Mayo Clinic Magazine.

Dr. Willman discusses her thoughts on proton beam therapy, patient navigators, genomics in cancer care and more on the Mayo Clinic Q&A podcast from October 2021. The excerpt highlights below were edited for clarity.

There's a lot of work happening at Mayo Clinic related to cancer care. Can you tell us about your efforts to engage our communities?

There’s a growing awareness in our culture and our society that we have to find ways to disseminate outstanding cancer care to everyone. Mayo Clinic is deeply engaged and is looking at the characteristics of communities in the Upper Midwest, the Southwest and the Southeast. I think the greatest opportunity for me is that our communities and populations are very diverse.

That gives Mayo Clinic a footprint to begin to understand how to implement and disseminate cancer care to very diverse communities in the South; to predominantly Black, Hispanic and indigenous communities in the Southwest; and to more recent immigrant communities.

We have the ability to determine how to best disseminate care and how to conduct research that really affects the people in these communities. That will be a huge part of our strategic effort in the next five years.

What are some research endeavors and cancer clinical trials that people can enroll in?

Cancer clinical trials are essential to advancing our knowledge in cancer care. Over 90% of children 15 and under who have cancer are treated in a cancer clinical trial. That means they're treated under a very detailed protocol to capture all their data and information. We're testing new drugs.

We have improved outcomes in children with cancer so rapidly over the last 20 years because we treat everybody in the context of a clinical trial, or a very regimented protocol and study.

The tragedy today is less than 5% of adults with cancer in America are treated in clinical trials. And then when you start looking at African Americans, American Blacks, Hispanics, American Indians, Asians — their rate of participation in cancer clinical trials is even lower. An NCI comprehensive cancer center like Mayo is expected to have a massive cancer clinical trials program.

Mayo Clinic every year does a very large number of cancer clinical trials, but we're actually going to increase that number even greater and coordinate the clinical trials we have going on between medicine, surgery, radiation oncology, medical oncology, pediatrics — and accelerate clinical trials.

Virtually every cancer patient I meet is really altruistic. They want to participate in a trial if you present one to them because they're advancing the science perhaps not only for their well-being but for future patients.

There's a real altruism in cancer medicine. We just need to bring these trials to patients and have them available to participate.

Virtually every cancer patient I meet is really altruistic. They want to participate in a trial if you present one to them because they're advancing the science perhaps not only for their well-being but for future patients.

- CHeryl L. Willman, M.D., Director, Mayo Clinic Cancer Center

How does philanthropy impact the work of Mayo Clinic Cancer Center?

Philanthropy is absolutely critical to our work. We could not do any of the innovative things in genomic sequencing, in the development of new radiation therapies, in our community outreach engagement, in recruiting the very best faculty, in supporting our education and training programs without our benefactors.

The post Mayo’s Cancer Director: ‘There’s a Real Altruism in Cancer Medicine’ appeared first on Mayo Clinic Magazine.

It was bug season in North Dakota, so Dawn didn’t think much of it. “When I told my hairdresser that, she said, ‘I really think you need to get it checked out.’ She saved my life,” Dawn recalls.

Dawn met with a local dermatologist to have the spot examined. A few hours after her biopsy, Dawn’s dermatologist told her she had melanoma, a form of skin cancer.

Dawn’s dermatologist wanted her to see a local oncologist as soon as possible, but there were no appointments available.

“With that kind of news, I got worried,” Dawn says.

Dawn visited her local physician for another trusted opinion. His comment was even more unsettling: “This looks pretty serious.”

He then picked up the phone and called Mayo Clinic to make a referral.

After receiving news of availability and discussing with her husband, John, and their son, Tom, Dawn made an appointment at Mayo Clinic in Rochester. Dawn and John made the trip to Mayo Clinic and met with Eric J. Moore, M.D., the next day. Dr. Moore scheduled surgery for Dawn two days later.

“We're fortunate to have the No. 1 medical system in the world a six-hour drive away,” Tom says. “We never really questioned that we were going to go to Mayo.”

In October 2011, after several appointments and the initial surgery to remove the spot, doctors confirmed that Dawn’s melanoma was late stage.

“The physicians at Mayo Clinic were all so kind and caring,” Dawn says. “They really wanted to give me hope that this diagnosis was not fatal.”

A month after surgery, Dawn developed an infection in the incision on the top of her head. Dawn happened to be in Minneapolis with family, and they decided to head to Mayo Clinic in Rochester's emergency department about 75 miles away. When they arrived, she was amazed to see a doctor waiting for her who had read her chart and was up to speed on what was going on.

“That is remarkable patient care,” Dawn says.

Finding Hope in a Clinical Trial

In early 2013, doctors performed a precautionary lung X-ray and found that melanoma had spread to her lungs. Dawn's oncologist, Robert R. McWilliams, M.D., suggested she enroll in a clinical trial with an immunotherapy drug, conducted by Svetomir N. Markovic, M.D., Ph.D., a medical oncologist and hematologist who specializes in the care of patients with advanced melanoma.

“Dr. Markovic said a clinical trial was her only option, and that the survival rate at the time was 2%,” Tom says. “I still remember sitting in our home office, my dad and I Googling this stuff, looking for papers on outcomes and survival rates. That's what we found — 2%.”

Dawn decided to take part in the study.
“It was always equally as important to her that she was participating in a clinical trial, not knowing if it would help her, but knowing that the results would eventually help others,” John says.

Best Bet: Surgery

By the end of 2013, Dr. McWilliams and thoracic surgeon Stephen D. Cassivi, M.D., M.S., decided that surgery on both lungs was now Dawn’s best bet.

“I got back to the hospital, and in my room on the whiteboard there was a sign that said, ‘Welcome back, Dawn!’ I just felt like everybody took such good care of me," Dawn says. "They didn't know it, but they were challenging me too. I had to get my lungs working again." In July 2015, another spot was found on her right lung. Dawn then had three stereotactic radiation treatments, a noninvasive radiosurgery technique. After her treatments, Dawn came back to Mayo Clinic every six months for routine testing.

The Patients Are Waiting

At Mayo Clinic Comprehensive Cancer Center, a culture of innovation and collaboration is driving research breakthroughs that are changing approaches to cancer prevention, screening and treatment and improving the lives of cancer survivors. Generous benefactor support propels our research forward, helping us make these important discoveries, faster.

10 Years Later

After numerous PET scans and appointments and with the strong support of family and friends, Dawn officially completed her time with the oncology program at Mayo Clinic in July 2020 — 10 years after the first spotting of melanoma and five years since the last recurrence.

Following completion of her treatments, Dawn and her family decided to support Mayo Clinic through philanthropy. Mayo Clinic recognizes the Botsford Family Foundation as a Major Benefactor for the family’s generosity.

"I can't say enough about the people and the facilities at Mayo Clinic," Dawn says. "The entire team of researchers, providers and staff who saved my life and always gave me hope is something the clinic can be very proud of.”

For John and Tom, Mayo Clinic means even more.

“Not only did Dr. Markovic and the team at Mayo Clinic save my mom, but they allowed her to get to know her grandkids," Tom says. "That’s something you can never put a price on.”

Mayo Clinic is solving the world’s most serious or complex medical challenges — one patient at a time.

Make a gift now to help transform the future of health care today.

Eds Note: The individual featured in images was following social distancing guidelines, and in compliance with Mayo Clinic’s COVID-19 safety guidelines while unmasked.

The post Dawn’s Journey: Overcoming a Near-Zero Survival Rate appeared first on Mayo Clinic Magazine.

When clinical trials can’t move forward because of a lack of participants, important medicine development is delayed. At the same time, if diverse groups can’t participate, health disparities worsen.

But there’s a solution at hand. Digital technologies are improving access to studies while also making them more inclusive for underrepresented groups who often face participation barriers.

A Mayo Clinic Proceedings review published in 2023 examined how new digital technologies like electronic health records, online patient portals and remote patient monitoring are improving clinical trial participation.

Electronic health records help to rapidly identify people who are eligible for a trial. They also track how participants are doing, reducing the number of follow-up appointments needed. As more people acquire smartphones and smartwatches, many can participate in clinical trials remotely without having to travel long distances to a research facility.

Researchers recognize some limitations to these technologies and say there is no one-size-fits-all approach. For example, they may exclude older, less tech-savvy participants. That’s why scientists call for hybrid trials, in which digital elements like a mobile app are combined with in-person visits.

Source: Discovery's Edge

The post Digital Technologies Improve Clinical Trial Recruitment appeared first on Mayo Clinic Magazine.

“When he’s busy doing his butterfly thing and you’re observing, you don’t even notice the damage,” she says, reflectively. “You accept it and go on the best you can.” 

The butterfly reminds her of her own journey. A retired clinical social worker, Cynthia loves working in her garden, writing poetry, volunteering at Mayo Clinic as a medical research advocate — where she has been a patient for nearly 30 years — and spending time with family and her three dogs and cat. But when she started experiencing severe shortness of breath in 2014, these passions began slipping away.

Daunting Diagnosis

At first, Cynthia thought her difficulty breathing was a symptom of her asthma. She was unable to lie down without her lungs filling with fluid. She sometimes coughed uncontrollably. She did not have the energy to work in her garden and needed to cut back on the time she spent volunteering. Sensing that there was more to the story, Cynthia’s pulmonologist at Mayo Clinic referred her to cardiologist Barry A. Borlaug, M.D.

The diagnosis was not good — Cynthia had stage 3 heart failure with preserved ejection fraction, a type of heart failure in which pressure builds up in the heart chambers, reducing the heart’s reserve capacity to cope with stresses, such as physical activity. It can be caused by the combination of aging, high blood pressure, and metabolic-inflammatory stress put on the heart and blood vessels due to obesity, Dr. Borlaug says. 

There is no proven treatment for this condition, which affects millions of people in the United States, especially women over 60. Women with this type of heart failure outnumber men 2 to 1, roughly. “It’s a huge public health problem,” Dr. Borlaug says. 

Clinical Trials Journey

When Dr. Borlaug told Cynthia that about half of the people with this disease die within five years, she immediately snapped into problem-solving mode. 

“My first reaction was, ‘What do we do?’” Cynthia says. “I see myself as a partner in my care, not a recipient. You need to be in charge of your own care in a meaningful way. What can I do in conjunction with my doctors to make sure I live as well and as long as I can?”

Cynthia asked Dr. Borlaug if there were any clinical trials focused on heart failure with preserved ejection fraction. “He brightened up and said, ‘Are you interested?’” Cynthia says. “I said, ‘You bet I am.’ We started our clinical trial journey together.”

Over the next five years, Cynthia enrolled in any cardiovascular clinical trial Dr. Borlaug was working on that showed promise for helping patients with this type of heart failure.  

A Long History

Cynthia trusts the physicians and researchers at Mayo Clinic so much, in part, because of her long history with the institution. Long before she was diagnosed with heart failure, she had first decided to seek care at Mayo in the early 1990s for a skin condition that had been misdiagnosed elsewhere. She was amazed to walk out of her first dermatology visit with an accurate diagnosis and treatment plan. 

Over the last three decades, Cynthia has traveled 600 miles from Kansas to Mayo Clinic in Rochester, Minnesota, for her medical care. Her care team has treated her for a myriad of serious, complex conditions, including breast cancer, kidney cancer and kidney failure. She has also been seen by experts in endocrinology for weight loss; ophthalmology for glaucoma; rheumatology for osteoarthritis, inflammatory arthritis and gout; pulmonology for reactive airway disease and asthma; and pain medicine to manage her chronic pain. 

“When you walk into Mayo, the atmosphere is very positive and uplifting,” she says. “It’s a comforting place to be.” 

A Promising Solution

By the spring of 2019, Cynthia had participated in six cardiovascular clinical trials with Dr. Borlaug. 

He was working on a new study and believed she would be a perfect fit. The small phase 1 trial focused on testing a new, Mayo-invented surgery called a pericardiotomy. Dr. Borlaug’s hypothesis was that surgically opening up the pericardium — the outer layer of the heart — could relieve some of the pressure in the heart, giving it room to fill with blood better prior to pumping. It would be the first attempt in human volunteers to address heart failure with preserved ejection fraction.

For Cynthia, it was an easy decision. Even if she did not benefit in the long run, she would be helping future patients by participating in cardiovascular research. 

“I’ll do anything to keep my heart as healthy as I can and help anyone with this disease,” she says. “It’s really exciting.” 

Cynthia was one of four women who participated in the study, which was first made possible by a gift from a benefactor. Eventually, more funding was secured through grants and the Mayo Clinic Transforming Clinical Practice award. The procedure involved deflating the left lung and drilling a hole near the rib cage so the pericardium could be opened, removing its compressive effects on the heart. Then, the lung was reinflated.

The study’s first phase is complete, Dr. Borlaug says. Now he and the research team are looking at whether it benefited the participants. One indicator they are looking for is improved exercise capacity among the participants. Another is fewer and less severe symptoms.

Dr. Borlaug and his team are working to secure funding for the second phase of the study. Also, they’re pursuing FDA approval for a Mayo Clinic-invented device that will avoid the need to deflate the lung.  

Cup Half Full 

Today, more than one year after her procedure, Cynthia feels like she has her life back. She was able to scale back some of the medications she takes for her heart. 

“I can lie down flat without my lungs filling up with fluid,” she says. “I can bend over and pull weeds without almost losing consciousness. I’m doing better. The reason is the quality of care and intervention at Mayo.”

Dr. Borlaug is able to monitor the pressures in Cynthia’s heart from Minnesota through a device that was implanted in her pulmonary artery before her pericardiotomy procedure, as part of a separate clinical trial. 

“That, more than anything, has given me peace of mind,” Cynthia says. 

To manage and monitor her heart failure and kidney failure, she travels to Mayo Clinic for in-person appointments with her doctors every six weeks. She also receives digital care. 

Due to the COVID-19 pandemic, she has not been able to volunteer at Mayo in person for the last few months, but that has not slowed her work as a patient research advocate. So far this year, she has co-written six articles with researchers to share her experiences with cancer, heart failure and participating in clinical trials. It is her goal in life to “bring the patient voice to the research table,” to help the researchers who develop new treatments for patients like her.

Beyond being a volunteer and a patient advocate, Cynthia has also generously given to Mayo Clinic in gratitude for the care she’s received. Mayo Clinic honors Cynthia by recognizing her as a Major Benefactor. 

Like the butterfly with the broken wing, Cynthia is able to do all of the hobbies she loves again, despite the medical challenges she has faced.  

“I take great pleasure in being alive and seeing that my cup is half full.”

The post New Surgery Offers Hope for Heart Failure Patient appeared first on Mayo Clinic Magazine.

Mohamad Bydon, M.D., a Mayo Clinic neurologic surgeon and the lead author, cautions that each patient is different, so it's too early to consider stem cell therapies as a treatment or cure for paralysis from spinal cord injury. Dr. Bydon adds that much like early trials in general, the stem cell trials are going to show variable response rates – with some moderate responders, some superresponders and some non-responders.

"While in this case, the first subject was a superresponder, others did not respond in the same manner. We do not yet understand all of the necessary biology needed to achieve neurological recovery in paralyzed individuals," says Dr. Bydon. "One of our objectives in this study and future studies is to better delineate who will be a responder and why patients respond differently."

Those First Steps

For the past 10 years, Chris Barr had gone to San Francisco’s Ocean Beach near the Golden Gate Bridge every week to ride the waves and swim. The ocean was Chris’ place of peace as a former lifeguard and competitive swimmer.

Chris doesn’t remember what happened that day in February 2017, but people nearby recall him falling off his surfboard headfirst into a sandbar.

Chris’ neck was broken in eight places. Unconscious, he floated facedown in the cold Pacific as his lungs filled with water. Luckily, a close friend, Chet White, happened to be resting from the waves on the shore and sprang into action when he saw a surfer in distress — though he didn’t recognize the man as Chris at first.

“I ran out, maybe a hundred yards, and grabbed this lifeless body by the shoulder,” Chet says. “Then 20 feet from the edge of the water another surfer came up and helped pull Chris the rest of the way.”

A passing beachcomber, who happened to be a nurse, met them at the shore and began CPR. Chris was not responding. His face was blue and almost unrecognizable to Chet, who’d known Chris for 30 years. They had traveled the world on surfing adventures together, and Chris was the best man at his wedding. When paramedics arrived and transported Chris to a nearby hospital, Chet wasn’t sure if he’d see his friend again.

Pull the Plug

When Chris’ wife, Debbie, arrived at the hospital, she didn’t yet understand the severity of the accident. It would be several days before doctors met her outside of his room to explain her husband’s nerves were not responding. Chris was paralyzed below his neck and faced the possibility of being on a ventilator for the rest of his life. She knew her husband as an active, dynamic man — this was not how they imagined their future together.

“No sooner did I finish talking with those doctors than I walked into the ICU and Chris, who was intubated, mouthed to me ‘pull the plug,’” Debbie says. “I burst into tears and asked him for more time. It seemed like there was no hope.”

Over the next several days friends arrived from around the country to lend their support. Debbie asked each of them to talk to the team of doctors about any options Chris might be able to pursue, to ask questions she may have overlooked.

“Chet was angry,” Debbie says. “He didn’t want to give up. He knew there were new advances in technology and science happening all the time, and from the moment he talked to Chris about stem cells, it was game on.”

Plateauing Progress

Before stem cells and other regenerative technologies could be explored, however, Chris had to finish his recovery in the hospital. After a month, he no longer needed a respirator. Despite other advances, he remained paralyzed, only able to move his toe. His muscles were atrophying, and he had lost 40 pounds.

Over the months while continuing his recovery at home, Chris began to see improvement. With intensive rehab he regained some movement and strength in his limbs, but Chris still struggled to understand exactly what he would be capable of in his new life.

“I could move a few things,” Chris says. “Nothing was really functional, but I was encouraged by the progress. Six months after the accident, however, all progress stopped.”

Mohamad Bydon, M.D., a neurosurgeon at Mayo Clinic, learned about Chris’ case after Chris was first hurt. Dr. Bydon is a leading researcher in the use of regenerative medicine to restore function to people who have experienced traumatic injuries of the spine. When Chris’ progress plateaued, Dr. Bydon was ready to help.

“We want to intervene when the physical function has plateaued, so that we do not allow the intervention to take credit for early improvements that occur as part of the natural history with many spinal cord injuries,” Dr. Bydon says. “The hope is that we will have novel treatments for spinal cord injuries in the coming years that will be different from what we have today.”

At nine months after his injury, Chris became patient No. 1 of 10 enrolled in an FDA-approved phase 1 clinical trial at Mayo Clinic using a tissue-derived stem cell therapy to treat humans with traumatic spinal cord injury.

The goal of the phase 1 clinical trial is to research feasibility, safety and dosing of the stem cell therapy. It was made possible through a multidisciplinary team, including the departments of Neurologic Surgery, Neurology, and Physical Medicine and Rehabilitation, as well as the Center for Regenerative Medicine; the Department of Laboratory Medicine and Pathology’s Immune, Progenitor and Cell Therapeutics Lab; and the Neuro-Informatics Laboratory. Support from Mayo Clinic benefactors, combined with additional internal and external grants, ensured the clinical trial would take place.

The study team included Dr. Bydon; Wenchun Qu, M.D., Ph.D., a physical medicine and rehabilitation physician; and Allan Dietz, Ph.D., a transfusion medicine scientist who leads the team that developed and manufactures the cells, among many others.

"Mayo Clinic has been taking the lead in translating decades of research and treating neurological conditions,” says Dr. Qu.

Between 250,000 and 500,000 people worldwide suffer a spinal cord injury each year, often with life-changing loss of sensory and motor function, according to the World Health Organization. Up to 90% of these cases are from traumatic causes. Currently, there is no way to reverse the devastating effects of paralysis from spinal cord injuries.

A Memorable Walk

In January 2018, 11 months after his injury, Chris was surrounded by a group of close friends who came to surprise him for his birthday. They gathered at Mayo Clinic in Rochester, Minnesota, to recognize two milestones — a birthday many thought Chris wouldn’t reach, and the injection of 100 million stem cells in his lower back.

“There was improvement in literally two weeks,” says Chris. “We did leg tests, walk tests, finger motor tests. Most of them improved by 25% to 50% — some were over 100%. It was pretty wild.”

Over the next 18 months, Chris was observed as he continued to undergo physical and occupational therapy back at home in California. Researchers dubbed him a super-responder. He showed improved grip and pinch strength, manual dexterity, sensory scores, and progress toward independent walking.

Months later Chris would return to Mayo Clinic for the team to evaluate progress again. He took his first steps alone as he went to shake Dr. Bydon’s hand. They decided it was time to celebrate.

“Dr. Bydon’s team is the A-team, the dream team,” Chris says. “They’re the best from every school and every country in their discipline. I got to actually walk around the table and shake their hands. They were blown away. It was pretty emotional for them and us.”

Says Dr. Bydon: “The recovery that Chris had was beyond our expectations. Being able to see that is very gratifying.”

More First Steps

Further study is needed to scientifically verify the effectiveness of stem cell therapy for paralysis from spinal cord injury. It is uncertain when or if this procedure will have FDA approval for routine clinical care.

“I don’t know if these are baby steps or Neil Armstrong steps — but they are absolutely steps in the right direction,” Chris told ABC’s Good Morning America in a segment about his story.

And they’re steps Chris never thought he’d get to take on his own again.  

“The stem cell trial is such a huge part of my story,” Chris says. “The hopelessness of paralysis is unlike anything you can imagine. This … is hope.”

Our team of 766 physician researchers, 254 career scientists and 4,027 research personnel work diligently to make discoveries that provide patients with hope.

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