Author contributions
K.M.: site Principal Investigator (PI)—literature search conceptualization, study design, investigation, writing original draft and data interpretation. M.G.: Director of Clinical Research: conceptualization, study design, writing original draft and data interpretation. S.B.: study PI and sponsor to FDA—conceptualization, funding acquisition, study design, resources, data interpretation, review and editing. A.A.: project administration, review and editing, study design and data collection. W.C.B.: study design, data collection and data interpretation. L.B.: Director of Clinical Research Sanford—study design, review and editing. B.B.: site PI—review and editing, study design, data collection and investigation. P.C.: data generation, data interpretation, review and editing, and formal analysis. C.B.C.: study design, data collection and data interpretation. K.A.E.: study design, data analysis, data interpretation, writing original draft, review and editing, and methodology. G.G.: data interpretation, review and editing, and formal analysis. J.H.: site PI—review and editing, study design, data collection and investigation. K.J.: Sanford—study design, project administration and writing (figures and tables). L.K.: study design, data interpretation and conceptualization. C.K.: site PI at Sioux Falls—review and editing, study design, data collection and investigation. J.K.: study design, review and editing, data interpretation, and oversight of laboratory manufacturing human cord tissue MSCs for the clinical trial. R.A.M.: data collection as co-PI. B.N.: site PI at Fargo—review and editing, study design, data collection and investigation. K.R.: study design, review and editing, data interpretation and conceptualization. V.V.: site PI at Sioux Falls—data collection and investigation. C.Y.: study design, data interpretation and conceptualization. H.D.: conceptualization, funding acquisition, study design, resources, data interpretation, and review and editing.