Allison Hubel, PhD
Training Program Director and Mentor
Allison Hubel, PhD is a Professor of Mechanical Engineering in the College of Science and Engineering and the Director of the Biopreservation Core Resource at the U of MN. Dr. Hubel has been involved in preservation of cellular therapies and blood products for almost two decades. Hubel has studied preservation of lymphocytes, umbilical cord blood, peripheral blood stem cells from mobilized donors, and mesenchymal stem cells. These studies have involved development of both liquid storage solutions and cryopreservation of the blood cells. A microfluidic device designed to removal cryoprotective agents from frozen and thawed cells has also been developed based on research from the Hubel laboratory.
Hubel has a long history of involvement in education and training. As a Director for Graduate Studies in the Department of Mechanical Engineering, she was responsible for recruiting, admissions and administering a graduate program with ~300 graduate students. In addition, Hubel has a decade long history of professional training in the area of preservation. In 2005, Hubel developed a professional short course on preservation and has offered it ever since.
David McKenna, MD
Training Program Director and Mentor
David McKenna, MD is a Professor of Laboratory Medicine & Pathology, Scientific & Medical Director of Molecular & Cellular Therapeutics (the cGMP facility of the University of MN), Director of the Division of Transfusion Medicine, Laboratory & Medical Director of the Cell Therapy Laboratory, and Program Director of the Fellowship in Transfusion Medicine/Blood Banking. Dr. McKenna has been greatly involved with medical education of undergraduates, medical students, residents in anatomic and clinical pathology, pediatrics, and medicine, and fellows in transfusion medicine and hematology/oncology/transplantation. He has extensive experience in the development of novel cell therapies, playing an integral role in the successful submission of more than two-dozen investigational new drug (IND) application filings with the FDA. He is directly responsible for the Chemistry, Manufacturing, and Controls (CMC) section of the IND application and works closely with FDA prior to initiation and throughout the entirety of clinical trials. He has presented at national and international meetings on the process of product development, including translational development, optimization/ scale-up of methods, and CMC writing.
Dr. McKenna has been involved with the NHLBI-sponsored PACT (Production Assistance for Cellular Therapy) group, and he is an active member of several professional organizations including the AABB, for which he has served on several committees and the board of directors. He is the co- leader of the Cell Therapy Team of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative and a co-chair of the CIBMTR Cell Therapy/Autoimmune Disease Working Committee. In addition to translational research/clinical scale-up of biotherapeutics, his research interests include umbilical cord blood stem cells, and QA/QC in cellular therapy.
Claudio Brunstein, MD, PhD
Claudio Brunstein, MD, PhD: Associate Professor, Department of Medicine, Clinical Director and Medical Director for Unrelated Donor Transplantation, Blood and Marrow Transplantation Program, University of Minnesota Medical Center. Dr. Brunstein has focused much of his career on the development of novel cellular therapy strategies to extend the use and improve the safety and efficacy of alternative donors for hematopoietic cell transplantation, in particular umbilical cord blood (UCB). He has been involved in several NIH funded clinical trials. In work with colleagues at UM he demonstrated the safety and efficacy of the double UCB and non-myeloablative therapy UCB transplant platform. He served as national co-PI as our institution’s experience was taken into a national multicenter study by the Bone Marrow Transplant –Clinical Trials Network, and he is currently the national co-PI on a randomized clinical trial comparing the UM non-myeloblative platform to haplo-identical donors. As part of an NHLBI RC1 grant he served as both the PI and IND sponsor on a clinical trial studying the effect of complement fragment 3a on homing and engraftment of UCB. As part of an NCI funded Program Project Grant, and as PI and IND sponsor, he worked on the first-in-human study demonstrating the feasibility and safety of cGMP manufactured natural T regulatory cells in adults with hematological malignancy. More recently, he has been a co-investigator in a first-in-human study demonstrating the safety and efficacy of StemRegenin-1 to massively expand UCB CD34+ cells reducing the period of neutropenia by 2 weeks.
Linda J Burns, MD
Linda J Burns, MD: Vice President and Medical Director of Health Services Research, National Marrow Donor Program/Be The Match and Member, Center for International Blood and Marrow Transplant Research (CIBMTR) Executive Committee. From 1992 to 2014, Dr. Burns was a member of the Adult Blood and Marrow Transplant Program at the University of Minnesota where she was Professor of Medicine. Dr. Burns also served as the inpatient BMT Medical Director and Director of the Institute Site Specific Teams for the Masonic Cancer Center, as well as the fellowhsip program director for her division. She is the only three - time awardee of the Division of Hematology, Oncology and Transplantation academic mentor award, the 2012 recepient of the Eric G. Neilson, MD Distinguished Professor Award from the Association of Specialty Professors, received the 2013 Distinguished Service Award from the University of Missouri-Columbia, served as a Director of the American Society for Blood and Marrow Transplantation from 2010-2013, and served as the President of the American Society of Hematology in 2014, Dr. Burns joined the National Marrow Donor Program/Be The Match, where she is the Medical Director of Health Services Research.
Claudia Cohn, MD, PhD
Claudia Cohn, MD, PhD: Associate Professor, Department of Laboratory Medicine and Pathology, Laboratory and Medical Director, Blood Bank Laboratory, University of Minnesota. Dr. Cohn leads a complex and active blood bank, and teaches medical students, residents, and fellows, as well as medical teams throughout the hospital system. The focus of her teaching and clinical research is blood utilization and patient blood management. Given her expertise in infectious disease, she also is quite heavily involved in this field as it relates to Transfusion Medicine. Dr. Cohn is an active member of the Transfusion Transmitted Disease Committee of the AABB.
Julie Curtsinger, PhD
Julie Curtsinger, PhD: Senior Research Associate and Coordinator of Translational Therapy Laboratory (TTL). Dr. Curtsinger’s clinical interests include immune monitoring services for clinical trials at the University of Minnesota. Research interests include basic immunology research. Dr. Curtsinger works with project managers and other clinical trials staff to determine how the correlative research goals of clinical trials can be met using TTL services.
Keli Hippen, PhD
Keli Hippen, PhD: Assistant Professor in the Division of Pediatric Bone Marrow Transplantation at the University of Minnesota. Dr. Hippen’s research involves conducting basic and translational research on human regulatory T cells. Dr. Hippen has developed two separate protocols for expanding human nTreg, as well as a xenogeneic GVHD model to determine potency. His work resulted in three ‘first-in-human’ phase I trials for the suppression of GVHD following allogeneic stem cell transplant. Dr. Hippen has also developed and translated a protocol for the induction of suppressive function in CD4+25- T cells (i.e. non-Treg). In addition to developing these protocols, Dr. Hippen’s lab is involved in evaluating the clinical products and refining the manufacturing process. He also works with the University of Minnesota Translational Therapy Lab to develop, evaluate and analyze the immune monitoring that is conducted on patients receiving Treg therapy.
Andrew Johnson, MD
Andrew Johnson, MD: Assistant Professor of Laboratory Medicine and Pathology and Medical Director of the Apheresis Blood Donor Center at the University of Minnesota. Dr. Johnson’s research centers on apheresis. Developing projects include management of anticoagulation during therapeutic plasma exchange in patients with special coagulation needs and use of apheresis in solid organ and hematopoietic stem cell transplant patients. Dr. Johnson participates in the education of medical students, residents, fellows, and visiting scholars in several specialties.
Diane Kadidlo, BS
Diane Kadidlo, BS: Facility Director, Molecular and Cellular Therapeutics at the University of Minnesota. Ms Kadidlo plays a key role in coordinating the transfer of cell and tissue models from the laboratory bench to clinical trials while ensuring compliance with the Food and Drug Administration’s (FDAs) Good Manufacturing Practices/Good Tissue Practices. In addition to her directorship role she serves as the Supervisor for University of Minnesota Medical Center, Fairview, Clinical Cell Therapy Laboratory, overseeing the production of cell and tissue products in support of the University of Minnesota’s Blood and Marrow Transplant Program.
Walter Low, PhD
Walter Low, PhD: Professor and Vice Chair for Research, Department of Neurosurgery and Physiology, University of Minnesota. The focus of Dr. Low’s research has been on the development of progenitor/stem cell therapies for neurological disorders. His work was the first to demonstrate that transplanted fetal cholinergic neurons from the medial septal nucleus could innervate the denervated hippocampal formation and restore learning and memory function in rats. Dr. Low’s work was also the first to demonstrate that transplanted fetal Purkinje cells could restore locomotor function in a transgenic mouse model of spinocerebellar ataxia; and that transplanted human umbilical cord blood stem cells can ameliorate neurological deficits and reduce infarct volume in rodents with ischemic stroke. The studies require the isolation and culture of stem/progenitor cells, and cord blood derived stem cells. His expertise in cell culture and experience in training graduate students and postdoctoral fellows will be utilized in this R25 grant application for the use of blood- and marrow-derived stem cells. Dr. Low has trained over 24 graduate students and 38 postdoctoral fellows/visiting faculty.
David Mair, MD
David Mair, MD: Assistant Professor of Laboratory Medicine & Pathology, University of Minnesota School of Medicine, and Senior Medical Director with American Red Cross (ARC) Blood Services. Dr. Mair and the ARC have collaborated with the UM for years on the transfusion medicine training of fellows, residents, medical technology students. Dr. Mair was responsible for the medical student blood banking course for several years. He is the Director of the ARC’s National Neutrophil antibody testing laboratory where he has extensive research expertise in testing for pathogenic alloantibodies implicated in transfusion-related acute lung injury (TRALI). Dr. Mair also has experience in infectious disease testing for transfusion-transmitted pathogens such as babesia.
Jeffrey Miller, MD
Jeffrey Miller, MD: Professor of Medicine, Director, Cancer Experimental Therapeutics Initiative, Deputy Director, Masonic Cancer Center, University of Minnesota. Dr. Miller has been interested in NK cell development, NK cell biology and the acquisition of NK cell receptors throughout his entire academic career. Currently, the lab is focused on mechanisms, which determine NK cell killer immunoglobulin receptor (KIR) acquisition and function (NK cell education). He has developed state-of-the-art functional readouts to study NK cells from the laboratory and in the clinic based on high resolution testing. He was the first to report that haploidentical allogeneic human NK cells can persist and expand after adoptive transfer. Based on these studies a significant part of his effort is trying to understand how to exploit NK cells for therapeutic purposes against infection, cancer and how to improve outcomes from allogeneic hematopoietic cell transplantation. Achieving this goal has led to a focused effort to understand the transcriptional regulation of KIR, the role of miRNA in developing NK cells, novel receptors on NK cells and the hierarchy of these receptors in NK cell education. Most recently, he has been exploring mechanisms of how CMV reactivation after hematopoietic cell transplantation educates NK cells and promotes their survival. CMV reactivation has a powerful and lasting effect on shaping the NK cell repertoire after hematopoietic cell transplantation. CMV reactivation is the only known infection that definitively induces adaptive NK cells (cells that are long lived and respond to subsequent exposures with enhanced response). Dr. Miller’s experience and translational expertise integrates well with the aims outlined in this proposal to explore the mechanism of how adaptive NK cells are induced by CMV to enhance innate immunity against cancer targets. With greater than 20 years of experience in NK cell biology, translation and clinical trials, he is devoted to team science and mentoring. He has developed a superb team of world experts, has supervised greater than 300 NK cell products and sponsored 7 INDs.
John Miller, MD, PhD
John Miller, MD, PhD:
John Miller, MD, PhD:Vice President and Senior Medical Director at the National Marrow Donor Program (NMDP). Dr. Miller is actively involved in quality systems associated with cellular therapies and serves on both the NMDP standards committee and the Foundation for the Accreditation of Cellular Therapy Collection Standards Committee and the NMDP Cord Blood Advisory Group. His work over the last decade has focused on cord blood collection, processing and quality control.
Shanna Morgan, MD
Shanna Morgan, MD: is a medical director at the American Red Cross, North-Central Region and an adjunct Assistant Professor in the Division of Transfusion Medicine within the Department of Laboratory Medicine and Pathology at the University of Minnesota. In addition, Dr. Morgan covers the blood bank at the Minneapolis Veterans Affairs Health Care System.
She maintains customer support for the University of Minnesota Medical Center, Fairview (UMMC, F), Minnesota. She also attends at UMMC,F, East and West Bank/Masonic Children’s Hospital Apheresis, Blood Bank, and Special Coagulation. Dr. Morgan has a strong interest in donor health and blood product safety, rare diseases and neurological diseases treated with apheresis, massive transfusion, simulation, and education of trainees. She is involved in teaching HCPs at all sites. She is also active in NHLBI, CAP, ASFA, NMDP, MNABB and AABB.
Paul Orchard, MD
Paul Orchard, MD: Professor, Department of Pediatrics, Division of Blood and Marrow Transplantation. Dr. Orchard is the Director of the Inherited, Metabolic and Storage Disease Transplantation Program at the University of Minnesota. His group is a world-leading center for the treatment of these disorders by hematopoietic stem cell transplantation. Dr. Orchard’s clinical practice is now primarily focused on transplantation with the emphasis on the use of hematopoietic stem cell transplantation for non-malignant, inherited disorders. Dr. Orchard has extensive experience in the design and implementation of clinical trials for inherited leukodystrophies, osteopetrosis and Hurler syndrome (MPS I). This includes experience in the writing of clinical protocols, including IND applications in this population of patients. Dr. Orchard’s basic research is in the area of gene therapy approaches, including the generation and testing of retroviral and lentiviral vectors.
Rita de Cassio Ramos Perlingeiro, PhD
Rita de Cassio Ramos Perlingeiro, PhD: Professor of Medicine, Lillehei Professor in Stem Cell and Regenerative Cardiovascular Medicine, Cardiovascular Division, Lillehei Heart Institute, University of Minnesota. Dr. Perlingeriro's laboratory has a long-term interest in understanding the moluecular mechanisms controlling lineage-specific differentiation of pluripotent stem cells (i.e. embryonic and adult reprogrammed stem cells), and applying this information to efficiently generate tissue-specific stem/progenitor cells endowed with in vivo regenerative potential. Her laboratory's research projects include transcriptional mechanisms and signaling pathways controlling mesodermal cell fate, strategies to enable translational applicaiton of iPS cells to treat muscular dystrophies, genetic correction of disease and patient specific iPS cells, and dissection the mechanisms associate with stem cell self-renewal and long-term engraftment. Dr. Perlingeiro's ultimate goal is to develop safe strategies to enable their future therapeutic applications.
Fran Rabe, MS
Fran Rabe, MS: Fran has over 30 years of experience working in the areas of tissue and cell quality assurance and regulatory compliance. She is currently the Director for Quality Assurance aspect of operations at the University of Minnesota Molecular and Cellular Therapeutics (MCT) Facility, a GMP facility that manufactures standard and IND hematopoietic products, pancreatic cellular products and active pharmaceutical ingredients.
Fran has extensive experience with audits, FDA IND submissions and working directly with FDA as it relates to the regulation of cellular and tissue products.
In addition to holding a Masters Degree in Manufacturing Systems, Ms. Rabe is an American Society for Quality (ASQ) Certified Quality Manager.
Ganesh Raveendran, MD, MS
Ganesh Raveendran, MD, MS: Associate Professor of Medicine, Interventional Cardiology,
Medical Director, Cardiac Catheterization Laboratory. Dr. Raveendran’s focus is on myocardial salvage and repair for post-acute myocardial infarction and chronic heart failure. He is an active member of the Cardiovascular Cell Therapy Research Network (CCTRN), an NHLBI-sponsored grant, which studies cell therapy for heart disease. In his role at the UM, he has successfully initiated and completed recruitment of a single-center cell therapy trial using bone marrow mononuclear cells in LVAD patients (ASSURANCE), which will evaluate the mechanistic changes and fate of cell delivery on hearts. Dr. Raveendran has been involved in several multicenter clinical trials as both a site PI and member of data safety monitoring boards. His involvement in clinical trials complements his clinical expertise as an interventional cardiologist.
Robert Schumacher, PhD
Robert Schumacher, PhD
Robert Schumacher, PhD, is the Scientific Director for the Center for Translational Medicine at the University of Minnesota. Dr. Schumacher has broad translational development experience in academia and in the pharmaceutical industry and has led programs in various stages of development, from early preclinical to late clinical. As scientific director for the Center for Translational Medicine (CTM) he has worked successfully with scientists, clinicians and inventors to advance the University’s most promising research-based cell therapies, pharmaceuticals, biologics and devices into clinical and commercial development. This includes designing effective and efficient preclinical development and testing programs, conducting critical preclinical pharmacology, pharmacokinetic, safety and toxicology studies, developing investigational new drug (IND) applications, and securing approval from FDA and other regulatory agencies to conduct first-in-human clinical trials. Over the past several years he and his team have performed preclinical proof-of-concept, feasibility and IND-enabling (GLP) safety studies to facilitate the translation of dozens of University-discovered technologies in diverse therapeutic areas. Five CTM-supported technologies have progressed into clinical development and/or been commercialized and an additional six are in the IND-enabling stage of development. Current projects include potential therapies for trauma-induced acute blood loss, acute respiratory distress syndrome, muscular dystrophy, and various cancers.
John E. Wagner, Jr., MD
John E. Wagner, Jr., MD: Professor of Pediatrics, Division Director, Blood and Marrrow Transplantation Program, University of Minnesota. Dr. Wagner is a leading clinical and translational investigator in the field of marrow transplantation, focused specifically in the area of stem cell- and immune-based therapies. He is PI of a NCI-funded Program Project Grant on the biology and transplantation of the hematopoietic stem cell and was PI of the NHLBI-sponsored Production Assistance for Cellular Therapies (PACT) Program from its inception in 2003 until 2015, continuing to oversee investigations in the Translational Laboratory of the Center for Molecular and Cellular Therapeutics. While most well-known for his work in UCB transplantation generally and hematopoietic stem cell expansion, isolation and expansion of regulatory T cells and generation of thymic progenitors from umbilical cord blood, he is also known for the development of novel treatment strategies for Fanconi anemia and Epidermolysis Bullosa, transforming their survival expectations and quality of life.
Nicole Zantek, MD
Nicole Zantek, MD, PhD: Associate Professor, Department of Laboratory Medicine and Pathology, Medical Director, Special Coagulation Laboratory, University of Minnesota. Dr. Zantek’s expertise is in hemostasis testing and blood utilization. As a faculty member in the Division of Transfusion Medicine at the University of Minnesota, Dr. Zantek is directly involved in direct patient care and laboratory administration. Dr. Zantek’s main research interest is hemostasis testing. Specifically, her work is focused on testing in acquired states such as ventricular assist devices, apheresis, and medications to better understand the impact of these forces on hemostasis. Dr. Zantek’s work includes the Minnesota Heart Health Program-Partners in Prevention effort to promote aspirin use, a platelet function study for patients with peripheral vascular disease receiving antiplatelet therapy, monitoring anticoagulation in patients with antiphospholipid syndrome, and in vitro testing of a possible reversal agent for the anticoagulant dabigatran, and several studies exploring quality issues in testing Finally, Dr. Zantek is actively involved in teaching and was awarded the 2014 Clinical Pathology Resident Teacher Award by the Anatomic Pathology/Clinical Pathology residents at the University of Minnesota.