Center for Cellular Therapy

Our mission is to provide a leading-edge cellular therapy program to support the growth of innovative cellular therapy products at MUSC.

Our vision is to be a top-tiered center for cellular therapy with well-funded and top-ranking translational research programs bridging the gap between basic science and its clinical practice.

Our experienced team is available to provide services to investigators to:

• produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current cGMP standards as required by federal regulations
• serve as a regulatory resource to MUSC in the preparation of cell and gene-therapy based INDs
• facilitate clinical development of novel cellular therapies

We provide access to highly trained and dedicated staff with expertise in all aspects of cellular therapy and cGMP phase I/II clinical trials. In addition to technical experience, we have extensive QA/QC knowledge to secure FDA compliance during the development of each cellular product. For more information, contact Tara Duke, MLS (ASCP)cm,  QA Director, at duket@musc.edu or 843-792-6468.

Meet Our Directors

 

Prabhakar Baliga, M.D.

Chair and Medical Director

 

Hongjun Wang, Ph.D.

Co-Scientific Director Islet Processing and Stem Cell Therapy Programs: The Wang Laboratory focuses on pancreatic islet cell biology and transplantation immunology in the treatment of type 1 and type 2 diabetes and chronic pancreatitis. Learn more about important research being done in Dr. Wang's lab.

 

Shikhar Mehrotra , Ph.D.

Co-Scientific Director Oncology and Immunotherapy Programs: Research interests include T cell biology, Activation Induced Cell Death of a T cell (AICD), T cell development in immunity and tolerance, identification of high-affinity TCR for prostate cancer, the role of cytokines in T cell persistence. Learn more about important research being done in Dr. Mehrotra's lab.

Meet the Research Staff

 

Tara Duke, MLS (ASCP)^CM

Tara Duke is a Research Instructor in the Department of Surgery at the Medical University of South Carolina.  She is the Director of Regulatory Affairs and Quality Assurance, experienced in providing oversight in the areas of quality control, quality assurance, and quality improvement as it applies to the Center for Cellular Therapy (CCT). Tara’s responsibilities include ensuring all procedures/polices are in compliance with the regulatory requirements of all applicable agencies and followed by staff.  One of the agencies includes FACT accreditation indicating the CCT lab has met the most rigorous standards in the aspect of cellular therapy processing. Continuous monitoring of all regulatory/accreditation updates to ensure full compliance with changes, addition, deletions, and version updates.  Tara will ensure the quality of all products and services provided by the CCT. Education: Biology, University of South Carolina, Medical Technology, Medical University of South Carolina

 

Brianna Stanton

Brianna Stanton is a Research Specialist at the Medical University of South Carolina in Charleston, SC. She graduated from Charleston Southern University where she received her Bachelor of Science Degree in Biology. After college she gained experience in the Biology field through teaching, working in animal medicine, and working in diagnostics using molecular biology and electron microscopy. She currently works in the Center for Cellular Therapy processing stem cells, islet cells, and T cells to be infused in patients for various clinical trials. 

 

Wenyu Gou, Ph.D.

Wenyu Gou, Ph.D. is the Assistant Program Manager for Islet Processing. Project: Islet transplantation and islet cell biology. Islet transplantation is an ideal treatment to cure diabetes and total pancreatectomy with auto-islet transplantation patients. Most islet cells die immediately post transplantation due to hypoxia and innate inflammatory responses. By preventing the islet cell death after transplantation, the patient will have more chance to get insulin-free. Even though taking exogenous insulin can help to control the blood glucose level, the metabolic disorder still can’t improve. My current research is studying the mechanism of clinical therapies and islet cell biology.

 

Inhong Kang, Ph.D.

Inhong Kang, Ph.D., is a Staff Scientist at the Medical University of South Carolina (MUSC) in Charleston, SC. She obtained her B.S. degree in Biology, her Master’s degree in Genetic engineering, and her Ph.D. in Molecular Medicine. She has worked as a Post-Doc at MUSC for 8 years, and her academic and research experience provides her with an excellent background in multiple biological disciplines including molecular biology, immunology, and genetics. In the Center for Cellular Therapy she currently performs Peripheral Blood Mononuclear Cell isolation, CAR-T cell processing, islet cell isolation, Mesenchymal Stem Cell culturing, EILSA, and Flow cytometry.

 

Connor Klee

Connor Klee is a Research Specialist at the Medical University of South Carolina in Charleston, SC. He obtained a Bachelor of Science in Biological Sciences at the University of South Carolina in Columbia, SC, where he gained laboratory experience in cell and molecular biology, bacteriology, physiology, ecology, and comparative vertebrate anatomy. In the Center for Cellular Therapy, he performs Autologous Islet Transplantation, Autologous Hematopoietic Progenitor Cell Apheresis, Peripheral Blood Mononuclear Cell Isolation, antibody staining, flow cytometry, and Mesenchymal Stem Cell culturing.

The CCT offers a variety of immunomonitoring services. Customizable services range from processing and storage of patient samples for clinical trials to processing and analyzing human samples for research purposes. Resources include:

• Reporting to regulatory agencies, sponsors, and IRB's of record.
• Preparation of standard-of-care cell products for cell therapy.
• Cell products for experimental IND-based cell therapy.
• Full-spectrum service from minimally manipulated to extensively cultured cells.
• Quality management, including quality assurance, quality control, and quality oversight committee.
• Responsive team that develops competency in all cell manipulations, including purification, culture and cytokine expansion, antigen exposure, cell differentiation protocols, and gene transfer.
• Comprehensive support--starting with IND preparation and regulatory guidance to development of Standard Operating Procedures and product delivery reimbursed by users.

The Foundation for the Accreditation of Cellular Therapy (FACT) recognizes MUSC as a Cellular Center that exceeds standards in patient care and laboratory practices. 

The Center for Cellular Therapy is located on the 2nd floor of the Clinical Sciences Building.  The 1000 square foot state-of-the-art facility consists of three ISO14644-1 compliant cGMP clean room suites that are fully functional and independent allowing maximal usage.