Research Highlights

Fostering Innovation Through Research

The Department of Surgery had a very productive year in both clinical and basic science research. The Faculty Mentoring Program is operational with established teams or “research pods.”Each division has clear visions for health services research and translational science or innovation arms and inter-institutional resources have been identified in many cases to help support these pods.

Message from  the Vice Chair of Research

Our research mission is to create a bedside to bench and back again culture of discovery and innovation at MUSC.

As I look back over the year, I am humbled at the way everyone in the department has taken this mission on as their own and created a palpable shift in our culture toward academic productivity and innovation while maintaining high clinical productivity and excellent patient care.

The research roadmap that the research council rolled out in 2018 highlighted several areas of growth opportunities in clinical research, human centered design and basic science collaborations.

Here is the impact since the roadmap's inception:

• Dave Taber, Pharm.D. and Heather Evans,M.D., MS have expanded clinical research within the department.
• The Human Centered Design program launched with an immediate impact: responding to the N-95 mask shortage with a 3D mask and cartridge system with printing plans. The mask and cartridge system received national and international attention, won the MUSC Innovator Award, and is currently on display in the South Carolina State Museum.
• Every Department of Surgery Ph.D. researcher is extramurally funded at the national level.
• Jean Marie Ruddy, M.D. has transformed resident research into a high-functioning enterprise creating a meaningful and productive experience for each resident in the program.

I invite you to read through the highlights in this report and know that this is just a few high points in a program that has a deep commitment in translating the latest developments, understanding and technology into improved surgical patient care.

Michael J. Yost, Ph.D., FAIMBE, FNAI

Professor of Surgery and Bioengineering
Vice Chair, Research
Department of Surgery

Improving Surgical Outcomes Through Disparities Research

Investigators within the Department of Surgery are nationally recognized in studying the causes and consequences of healthcare disparities in vulnerable patient populations; most notably African Americans.

Our researchers are conducting pioneering interventional studies with the goal of reducing the impact of race and socioeconomic status on health outcomes.

Within our clinical trials, we have a strong track record of enrolling patients that are underrepresented in research. Often these patient populations are missing in clinical trials and inclusion is of paramount importance to providing best clinical outcomes to all populations.We strive to include a highly diverse patient population in all of our clinical trials in transplantation. Many of our other clinical trials, including oncology, cardiac surgery and acute care surgery clinical trials, have similarly diverse populations.

Vascular Surgery Active in Clinical Trials

Vascular Surgery had an active FY20.

• Assessment of the GORE® EXCLUDER®Conformable AAA Endoprosthesis (CEXC Device) in theTreatment of Abdominal Aortic Aneurysms

Sponsor: Gore

• Aneurysm Treatment Using the Heli-FX™EndoAnchor System Global Registry (ANCHOR)

Sponsor: Medtronic

• A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients with Critical Limb Ischemia

Sponsor: Hemostemix

• A Prospective, observational, global, multicenter,post-market registry of the Valiant Navion™Thoracic Stent Graft System (DISSECT-N)

Sponsor: Medtronic

Innovation and Entrepreneurship

The MUSC Department of Surgery is a leader in innovation and discovery that allows us to transform technology into improved surgical patient care. Our teams of physicians, scientists and engineers have developed new technologies and devices to advance surgical science.

International Partnerships

 

Pandorum Technologies, Pvt. Ltd. and the Transplant Research and ImmunoBiology Institute (TRII) along with the Center for Cellular Therapy (CCT) have partnered to push forward bioengineered tissues and cellular therapies in the treatment of diseases spanning corneal wound healing and COVID-related lung disease. These translational activities have utilized the strengths of MUSC's Department of Surgery bench-to-bedside culture.

The TRII along with the CCT at MUSC have been a ‘one stop shop’ for an aspiring start-up like Pandorum Technologies, operating in the field of tissue engineering and regenerative medicine, in the journey to clinical translation of its novel therapies developed to serve patients with unmet clinical needs.The team and the infrastructure at MUSC have been critical for the formulation optimization, cGMP grade material production, clinician study design, execution,and guidance through clinical regulatory approval maintaining global standards with ‘patients first’ in mind- driven by precise decision making and fast execution atan affordable cost.

We are looking forward to an exciting journey ahead.

Tuhin Bhowmick, Ph.D.
Co-founder, CEO
Pandorum Technologies Pvt. Ltd.

Research Funding

FY20 was an outstanding year for research with our portfolio reaching nearly $6 million in extramural funding, a 49% increase from the previous year.

Research Pods Create Energy and Synergy

SORIN

The Surgical Outcomes Research and Innovation Nucleus (SORIN) was formalized in 2019 and serves to foster the development, testing and implementation of innovative therapeutic and health services interventions aimed at improving outcomes in patients undergoing surgery at MUSC.

• SORIN has a diverse and active portfolio of clinical research endeavors, including nearly 50ongoing clinical trials across all surgical disciplines housed within the Department of Surgery. We actively follow nearly 600 patients enrolled in our trials. We are currently testing new drug therapies,devices and cellular-based interventions designed to improve and extend the lives of South Carolinians seeking surgical care within our institution.
• Embedded within SORIN and an arm of the Transplant Research and ImmunoBiology Institute(TRII) is the Transplant Clinical Research Core (TCRC). The main function of the TCRC is to facilitate the benchtop-to-bedside concept within organ transplantation by streamlining the process of innovative therapies moving from the laboratory to clinical trials and use within usual care.
• The TCRC currently oversees 15 clinical trials, of which nine are actively enrolling and six are in the follow-up phase. Within these 15 trials, we actively follow 262 transplant recipients.
• These clinical trials are testing novel therapies and innovations designed to improve outcomes in transplantation.

“We are assessing new antiviral therapies, new methods and therapies to diagnose, prevent and treat rejection and innovative methods to care for our patients using mobile health, remote monitoring and telehealth services,” said Dave Taber, Pharm.D.,who leads the surgical outcomes nucleus.

“This is particularly salient given the current COVID 19pandemic; allowing our patients to receive optimal care while safely residing in their homes and local communities. Our ultimate goal is to be at the forefront of the science of transplantation and improve the lives of transplant recipients.”

TRII

The Transplant Research and ImmunoBiology Institute(TRII) was formalized in 2019 and encompasses both clinical research in the Transplant Clinical Research Core(TCRC) and basic/translational research in both the LeePatterson Allen Transplant ImmunoBiology Laboratory(TIBL) and the ImmunoEngineering Core.

Additionally, the TRII is a comprehensive federally and privately funded institute that also engages the Center for Cellular Therapy and the Foundation for Research and Development for all aspects of transition of therapeutics to patient care.

The Patterson Barclay Memorial Foundation was instrumental in the development of the TIBL and formalization of the entire institute. Dr. Satish Nadig serves as the institute scientific director and Drs. David Taber, Carl Atkinson, and Michael Yost serve as directors to the TCRC, TIBL and the ImmunoEngineering Cores respectively. The TRII has partnered with various industries (both domestic and international) to move transplant-related therapeutics closer to the bedside.Recently, these industry ties have led to the TRII focusing on COVID-related therapeutics as well.

In 2019, the Patterson Allen Family members gifted $1.5M through the Patterson Barclay Memorial Foundation to the Transplant Research and ImmunoBiology Institute Fundwith the desire for community partners and patients to match their gift to reach the needed $3M goal. 

Lipo-ImmunoTech Receives STTR Grant

 

Lipo-ImmunoTech, LLC, a startup based in Charleston, South Carolina,recently received a Phase I Small Business Technology Transfer (STTR) grant of justover $224,000 to continue to develop its novel adoptive cell therapy technology for cancer. The startup is a joint venture involving Shikhar Mehrotra, Ph.D., an immunologist, and Besim Ogretmen,Ph.D., a sphingolipid expert.Lipo-ImmunoTech also executed an option agreement with the MUSC Foundation for Research Development, which gives it the rights to evaluate the technology further with an eye toward eventually licensing it for commercialization./

Wang Laboratory Active in Clinical Trials

 

The Wang Lab, led by Hongjun Wang, Ph.D. has had an active FY20.

• Type 1 diabetes (T1D) NIH R01 clinical trial: With the joint efforts from the Wang Laboratory, the clinical team led by Dr. Charlie Strange, the Center for Cellular Therapy, the OB/GYN Department, andthe strong support from the Department of Surgery, the multidisciplinary team has met their Year 1 patient enrollment goal in this trial.
• Chronic pancreatitis trial: They have enrolled 46 of the 48 chronic pancreatitis patients for their AAT trial and are now transitioning to the data analysis phase.
• Novel cell and gene therapy for the treatment of diabetes and chronic pancreatitis: Their first paper on this topic was accepted for publication in the journalStem Cell Translational Medicine (IF: 6.4).

Center for Cellular Therapy Expands Scope

The Center for Cellular Therapy (CCT) is an FDA registered cGMP level facility that meets the most rigorous standards in the aspect of processing of cells. FY20 saw a significant increase in the scope of work the CCT performs:

• In addition to sustaining the Islet Cell Transplant program, the CCT now supports the MUSC Blood and Marrow Transplant Program.
• A new clinical research infrastructure has now been established with clinical trial coordinators, IRBand analytic support.
• As part of MUSC's response to COVID, the CCT rapidly developed an in-house seroassayand facilitated the establishment of the COVID-19 antibody testing, with the capacity to perform thousands of tests a day.
• Additionally, this year the CCT has established strong extramural funding from the NIH and VA.

South Carolina Surgical Quality Collaborative

The South Carolina Surgical Quality Collaborative (SCSQC) is comprised of a group of hospital systems dedicated to improving the quality and value of general surgical care in South Carolina. SCSQC is led by a leadership team representing the South Carolina Hospital Association, Health Sciences South Carolina, MUSC, and Blue Cross Blue Shield of SC.Mark Lockett, M.D., vice chair of Veterans Affairs and chief of Surgery at the Ralph H. Johnson VA Hospital, serves as the Surgeon Lead for the Collaborative.

The initial study, published in the June 2018 American Surgeon, was a retrospective observational analysis that showed outcome rates for select general surgery procedures across a group of hospitals involved in the SCSQC. The study found SCSQC member facilities improved outcomes in 15 of 16 quality measures over the two-year period of the initiative.

“SCSQC provides a mechanism by which we can obtain better outcomes by providing actionable and believable data and facilitating collaboration between surgical leaders across the state,” said Dr. Lockett.