Mesenchymal Stromal Cells

Dr. Peiman Hematti joined the Section of Hematology/Bone Marrow Transplantation at the University of Wisconsin-Madison in July 2004 as an Assistant Professor in the Department of Medicine. Dr. Hematti has completed a combined Internal Medicine/Pediatrics residency at the Cleveland Clinic Foundation and then Hematology fellowship at the National Heart, Lung and Blood Institute at the National Institutes of Health. His clinical interests are in inpatient care of hematopoietic stem cell transplant patients. He is the director of the clinical hematopoietic cell processing laboratory, and in that capacity oversees all the peripheral blood stem cell collections from the patients and processing of their products. Dr. Viswanathan has 10 years of experience leading multi-disciplinary teams of translational researchers, clinicians, nurses, manufacturing technicians, quality assurance manager, IT programmers and project managers who translate cell-based research into clinical trials. She specializes in commercial product development of biologics with specific expertise in stem cell translational research, preclinical pharmacology, GMP-compliant cell manufacturing of cell-based products, and working with regulatory agencies. She is currently Associate Director of the Cell Therapy Program at University Health Network in Toronto where she oversees the scientific, strategic, operational, regulatory, quality, pre-clinical strategy for the development of clinical-grade cells. In addition, Dr. Viswanathan works with the Center for Commercialization of Regenerative Medicine (CCRM), leading a vision for a Canada-wide national clinical program network, CellCan, that will concentrate on harmonizing practices, sharing strategies for clinical manufacturing of stem cells in Canada.

Preface Armand Keating

1. MSCs Translational Process Sowmya Viswanathan, Amin Adibi and Shashank Bhatt

2. Preclinical Animal Testing Requirements and Considerations John M. Centanni

3. Delivery and Tracking Considerations for Cell Based Therapies Eric G. Schmuck and Amish N. Raval

4. Allogeneic Versus Autologous Mesenchymal Stromal Cells and Donor to Donor Variability Muna Qayed, Ian Copland, Jacques Galipeau

5. Mesenchymal Stromal Cell Production in Academic Centers: Challenges and Opportunities David H. McKenna

6. Bioreactor for Scale-Up: Process Control Eytan Abraham, Siddharth Gupta, Sunghoon Jung, Erika McAfee

7. GMP Requirements Adrian P. Gee

8. Mesenchymal Stromal Cells and the Approach to Clinical Trial Design: Lessons Learned From Graft Versus Host Disease Neil Dunavin, A. John Barrett & Minoo Battiwalla

9. Regulatory Pathway for Mesenchymal Stromal Cell-based Therapy in the United States Robert Lindblad, Ashraf El Fiky, Deborah Wood, Gillian Armstrong Miller

10. Global Regulatory Perspective for MSCs Anthony Lodge, Giulia Detela, Jacqueline Barry, Patrick Ginty and Natalie Mount

11. The health economics for regenerative medicine: how payers think and what that means for developers Christopher McCabe and Tania Bubela

12. Mesenchymal stromal cells: Clinical experience, challenges and future directions Peiman Hematti