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Friday, January 29, 2021 11:23:37 AM
What you referenced...
Dr. Amit N Patel for the invaluable contributions to UC-MSC manufacturing and infusion protocols over the years; Jadi Cell for providing the initial UC-MSC master cell bank (cells provided at no cost by JadiCell - US Patent # 9,803,176 B2) used in this trial, further expanded at the Diabetes Research Institute (DRI) cGMP Facility to generate the Investigational Product;
The below was further up in report...
2.5 UC-MSC investigational product
UC-MSCs were manufactured as previously described.38 UC-MSCs were culture-expanded from a previously established and characterized master cell bank (MCB) derived from the subepithelial lining of a UC, collected from a healthy term delivery (kindly provided by Jadi Cell and Amit Patel, M.D.).37, 39 The MCB and its source tissue were tested according to the applicable U.S. Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) and Foundation for the Accreditation for Cellular Therapy (FACT) standards for cellular therapies.
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