Scalable Culture Techniques to Generate Large Numbers of Purified
CLINICAL ARTICLE Scalable culture techniques to generate large numbers of purified human Schwann cells for clinical trials in human spinal cord and peripheral nerve injuries Aisha Khan, MSc, MBA,1,3 Anthony Diaz, MS,1,2 Adriana E. Brooks, MS,1,3 S. Shelby Burks, MD,1,2 Gagani Athauda, MD,7 Patrick Wood, PhD,1,2 Yee-Shuan Lee, PhD,3 Risset Silvera, BS,1,3 Maxwell Donaldson, BA,1,3 Yelena Pressman, MS,1 Kim D. Anderson, PhD,8 Mary Bartlett Bunge, PhD,1,2,4 Damien D. Pearse, PhD,1–3,6 W. Dalton Dietrich, PhD,1,2,4,5 James D. Guest, MD, PhD,1,2 and Allan D. Levi, MD, PhD1,2 1The Miami Project to Cure Paralysis, 2Department of Neurological Surgery, 3Interdisciplinary Stem Cell Institute, and Departments of 4Cell Biology and 5Neurology, University of Miami Miller School of Medicine, Miami; 6Bruce W. Carter Department of Veterans Affairs, Veterans Affairs Medical Center, Miami; 7Department of Cellular Biology and Pharmacology, Herbert Wertheim College of Medicine, Florida International University, Miami, Florida; and 8Department of Physical Medicine and Rehabilitation, MetroHealth Medical Center, Institute for Functional Restoration, Case Western Reserve University School, Cleveland, Ohio OBJECTIVE Schwann cells (SCs) have been shown to play an essential role in axon regeneration in both peripheral nerve injuries (PNIs) and spinal cord injuries (SCIs). The transplantation of SCs as an adjunctive therapy is currently under investigation in human clinical trials due to their regenerative capacity. Therefore, a reliable method for procuring large quantities of SCs from peripheral nerves is necessary. This paper presents a well-developed, validated, and optimized manufacturing protocol for clinical-grade SCs that are compliant with Current Good Manufacturing Practices (CGMPs).
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