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Workshop on Improved Characterization of Mesenchymal Stem Cells for Clinical Trials

Held: Wednesday, May 8th at SMC Campus Center, UMB  

In conjunction with the Center for Excellence in Regulatory Science and Innovation (M-CERSI), the Food and Drug Administration (FDA), the Department of Orthopedics, the University of Maryland Center for Stem Cell Biology & Regenerative Medicine hosted a half day workshop on Mesenchymal Stem Cell (MSC) Characterization. FDA lists over 200 active clinical trials involving MSCs.

The event was attended by faculty and trainees from UMB, FDA, Johns Hopkins, as well as many others. Guest speakers included Drs. Arnold Caplan (Case Western Reserve University), Robert Deans (Athersys, Inc.), Jacques Galipeau (Emory University), Stanton Gerson (Case Western Reserve University), Dara Kraitchman (Johns Hopkins University), Donald Phinney (Scripps Research Institute) and Amitabh Varsheny (UM-College Park).

The Center for Stem Cell Biology & Regenerative Medicine was involved in every aspect of the event, and Dr. Curt Civin was the first speaker of the day. His enthusiastic start of the event carried throughout the entire program. The Department of Orthopedics also hosted a speaker’s dinner which allowed the speakers to coordinate their presentations that channeled into an excellent learning experience for all.

Plans have already begun for another joint event in 2014. Please check our website in early Spring 2014 for details.

Notes From Presentations

Welcome and Some Lessons from Hematopoietic Stem Cells
Curt Civin, MD
Director, Center for Stem Cell Biology & Regenerative Medicine
Associate Dean for Research
Professor of Pediatrics and Physiology
University of Maryland School of Medicine

Importance of Regulatory Science: Driving Biomedical Innovation by Advancing Regulatory Science at FDA
Frank Weichold,PhD
Director of Regulatory Science and Innovation
Food and Drug Administration

Towards Improved Characterization of MSCs
Steven R. Bauer, PhD
Chief, Cell and Tissue Therapy Branch
Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies
FDA/Center for Biologics Evaluation and Research

The Science of MSCs and Regenerative Medicine: Cell-Based Therapy = The New Medicine
Arnold I. Caplan, PhD
Director, Skeletal Research Center
Professor of Biology
Professor of General Medical Sciences (Oncology)
Case Western Reserve University

Imaging and Applications of MSCs in Pre-Clinical Animal Models
Dara L. Kraitchman, VMD, PhD, FACC
Associate Professor, Department of Radiology
Section Head, Cardiovascular Intervention
Johns Hopkins University

ISCT Perspective on Characterization of MSCs for Clinical Trials
Donald G. Phinney, PhD
Professor, Department of Molecular Therapeutics
The Scripps Research Institute

Characterization of MSCs for Clinical Applications
Jacques Galipeau, MD, FRCP(C)
Co-Director, Winship Cancer Institute Tumor Immunology-Immunotherapy
Director, Emory Personalized Immunotherapy Center [EPIC]
Professor of Hematology and Medical Oncology
Professor of Pediatrics & Medicine
Emory University

Mesenchymal Stem Cells: Clinical Application and Outlook (The CWRU Experience)
Stanton Gerson, MD
Asa and Patricia Shiverick -- Jane Shiverick (Tripp) Professor of Hematological Oncology
Director, Case Comprehensive Cancer Center
Director, National Center for Regenerative Medicine
Case Western Reserve University

Industry Perspective: Experience with MSC Characterization
Robert Deans, PhD
Executive Vice President, Regenerative Medicine
Athersys, Inc.

Systems Biology/Bioinformatics and Characterization of Stem Cell-Based Cell Therapy Products
Amitabh Varsheny, PhD
Director, University of Maryland Institute for Advanced Computer Studies
Professor of Computer Science
University of Maryland, College Park

Carl G. Simon, Jr., PhD
Biologist, Biosystems & Biomaterials Division
Biomaterials Group
Material Measurement Laboratory
National Institute of Standards and Technology